standard operating procedures · 16 sop-16 : waiver of written or verbal informed consent 181 of...

FMMCIEC SOP

FMMCIEC SOP . Version 11. Revision No. 10.

Date of Revision : 25.11.2017. Issue Date : 24.12.2017. Validity Date : 23.12.2018.

Next Revision Due Date : 24.11.2018

of 216

Standard Operating Procedures

Father Muller Medical College Institutional Ethics Committee (FMMCIEC),

Father Muller Charitable Institutions,

Father Muller Road, Kankanady,

MANGALORE-575002.

Copy No :

Issued to :

FMMCIEC SOP




of 216

FMMCIEC : SOP

I. Prepared by : SOP teams of IEC

II. Reviewed by :

Dr.Shivashankara A.R., Member Secretary, FMMCIEC

Dr. Varadaraj Shenoy, Clinician and Senior Member, FMMCIEC

III. Approved and Issued by :

Dr. Ashok Shenoy K.,

Chairperson, FMMCIEC

FMMCIEC SOP




of 216

Distribution List

Following are the Authorized Holders of Controlled Printed Version No. 11 of FMMCIEC SOP.

Copy No. Name of Member Role/Designation in Ethics Committee

1 Dr. Ashok Shenoy K. Chairperson

2 Dr. Shivashankara A.R. Member Secretary

3 Mr. Eric Sequeira Legal Expert; Vice Chairperson

4 Dr. Varadaraj Shenoy K. Member-Clinician

5 Dr. Safeekh AT Member-Clinician

6 Dr. Sudhir Prabhu Joint Secretary, Clinician

7 Dr. Anup Kumar Shetty Member-Basic Medical Scientist

8 Mrs. Veena Manoj Member-Lay Person

9 Mrs. Anuradha Shetty Member-Social Scientist

10 Fr.Dr. Leo D‟Souza Member-Theologian/Ethicist

Soft copy of the FMMCIEC SOP (PDF ) is made available in website of Father Muller

Charitable Institutions.

FMMCIEC SOP copy (PDF) is issued to Principal investigators of Clinical Trials.

Member Secretary of FMMCIEC is the custodian of the soft copy (MS word) and office copy

of the FMMCIEC SOP.

FMMCIEC SOP




of 216

Amendment Record

Sl. No. Date Details of Amendment Done Page No. Reason for

Amendment

1 01.09.2016. Revision of the document :

1.Title page, Distribution list,

Amendment record, table of

contents –revised

2 .Brief description of SOP –

added

3. Objectives of IEC-added

4.Composition of IEC, roles and

responsibilities of IEC members,

policy for changing the members

and tenure of membership are

revised

5.Review procedure-criteria for

expedited review and full review

are mentioned in detail

6.Annexures added –format for

submitting research proposals;

patient information sheet and

informed consent form in

Kannada, Progress report

format, Format for submission

of revised/additional documents,

member ship consent letter .

Many pages

revised

Reconstituted IEC

taking up revision

of SOP as per

ICMR guidelines

FMMCIEC SOP




of 216

2 25.11.2017 All SOPs are revised and details

added .Uniform pattern is

followed for all SOPs. New

SOPs are added. SOP document

is separated from policy

document.

IEC is reconstituted with effect

from 1st December 2017.

Many pages.

Thorough

revision of

SOP

Annual review of

SOPs; and

Updating of SOPs

as per NABH

standards for

Accreditation of

Ethics

Committees,

ICMR guidelines

of 2017; and

CDSCO

guidelines

FMMCIEC SOP




of 216

Table of Contents

Sl.No. Content Details Page No.

A Title Page 1 of 216

B SOP preparation and Issue Details 2 of 216

C Distribution List 3 of 216

D Amendment Record 4 of 216

E Table of Contents 6 of 216

F List of Abbreviations 8 of 216

G List of Annexures 9 of 216

H Individual SOPs Page 13

onwards

I. SOPs

1 SOP-1 : Preparation of FMMCIEC SOP 13 of 216

2 SOP-2 : Constitution of FMMCIEC 17 of 216

3 SOP-3 : Handling conflict of interest among Ethics Committee members 40 of 216

4 SOP-4 : Selection of Independent Consultants/Subject Experts 44 of 216

5 SOP-5 : Allowing Guests or Observers to FMMCIEC Meetings 49 of 216

6 SOP-6 : Guidelines for Submission of Protocols to FMMCIEC 51 of 216

7 SOP-7 : Review Procedures : Categorization Review for Review, Initial Review 84 of 216

8 SOP-8 : Agenda Preparation, Meeting Procedures and Minutes 96 of 216

9 SOP-9 : Continuing Review 111 of 216

FMMCIEC SOP




of 216

10 SOP-10 : Review of resubmitted and amended protocols and protocol-related

documents

119 of 216

11 SOP-11 : On-Site Monitoring of Protocols 126 of 216

12 SOP-12 : Review of Protocol Violations/Deviations 150 of 216

13 SOP-13 : Review of Final Reports and Study Completion Reports 157 of 216

14 SOP-14 : Training and Assessment of IEC Members 160 of 216

15 SOP-15 : Review Serious Adverse Events (SAE) Reports 164 of 217

16 SOP-16 : Waiver of written or verbal informed consent 181 of 216

17 SOP-17 : Management of premature termination , suspension, discontinuation of

the study

183 of 216

18 SOP-18 : Reviewing proposals involving vulnerable populations 186 of 216

19 SOP-19 : Dealing with participants‟ requests and complaints coming to IEC 197 of 216

20 SOP-20 : Self Assessment /Internal Audit of FMMCIEC 200 of 216

21 SOP-21 : Maintenance of active study files, administrative records of IEC,

archival of closed files and retrieval of documents

204 of 216

22 SOP-22 : Preparation for Audit/Inspection 213 of 216

J References 216 of 216

FMMCIEC SOP




of 216

List of Abbreviations

AE : Adverse Event

CDSCO : Central Drugs Standard Control Organization

COI : Conflict of Interest

CTRI : Clinical Trial Registry of India

DCGI : Drug Controller General of India

DSMB : Data and Safety Monitoring Board

FMCI : Father Muller Charitable Institutions

FMMCIEC : Father Muller Medical College Institutional Ethics Committee

GCP : Good Clinical Practice

ICD : Informed Consent Documents

ICMR : Indian Council of Medical Research

IP Investigational Product

LAR : Legally Acceptable Representative

NABH : National Accreditation Board for Hospitals and Health Care Providers

PI : Principal Investigator

SAE : Serious Adverse Event

SUSARS Serious Unexpected Serious Adverse Reactions

SOP : Standard Operating Procedures

TOR : Terms of Reference

FMMCIEC SOP




of 216

List of Annexures

Annexure

No.

Name Page No.

1 Allotment of team members for preparation of SOP 16

2.1. IEC member Appoint Proposal Letter 27

2.2. Acceptance Letter from Member 28

2.3 . Final Appointment Letter : Member 29

2.4. Final Appointment Letter : Chairperson 31

2.5. Final Appointment Letter : Vice Chairperson 33

2.6. Final Appointment Letter : Member Secretary 34

2.7. Consent Letter : Member 37

2.8. Confidentiality Agreement to be Signed by Members 38

2.9. Confidentiality Agreement to be Signed by the Secretariat 39

3. Conflict of Interest Declaration Form 43

4.1. Appointment Letter : Subject Expert/Independent Consultant 46

4.2. Consent Letter : Subject Expert/Independent Consultant 47

4.3. Confidentiality Agreement to be Signed by Subject Expert/

Independent Consultant

48

5.1. Confidentiality Agreement to be Signed by Guest/Observer 50

6.1. Guidelines for Conducting Clinical Research in FMMC 57

6.2. Guidelines for Submission of Documents for Review to FMMCIEC 58

6.3. Protocol Submission Form for Clinical Trials 60

6.4. Checklist for Submission of Documents of Clinical Trials 70

6.5. Protocol Submission Form for Academic Studies 72

6.6. Budget Form for Academic Studies 76

6.7. Format of Informed Consent Documents 78

6.8. Father Muller Medical College Institutional Ethics Committee Fee

structure

83

7.1. Review Form of FMMCIEC 88

7.2. Checklist for Risk-Benefit Assessment 90

FMMCIEC SOP




of 216

7.3. Definition and Categorization of Risk 92

7.4. Checklist for Review of Informed Consent Documents 93

7.5. Checklist for Review of Clinical Trial Contract 95

8.1. Agenda of Meetings 103

8.2. Leave Letter Format 104

8.3. Minutes of Meetings 105

8.4. Decision Letter (Clinical Trials) 107

8.5. Decision Letter (Academic Studies) 109

9.1. Continuing Review Application Form (Clinical Trials) 113

9.2. Continuing Review Application Form (Academic Studies) 115

9.3. Continuing Review : Review Form 116

9.4. Decision Letter (Continuing Review) 117

10.1. Resubmission Form For Investigators 122

10.2. Resubmission Checklist 123

10.3. Resubmission Form Review Form 123

10.4. Protocol Amendment Request Form 124

10.5. Protocol Amendment Review Form 124

10.6. Decision on Protocol Amendments 125

11.1. On –Site Monitoring Checklist 130

12.1. Protocol Deviation/Violation Reporting Form 155

12.2. Protocol Deviation/ Violation Record Form 156

13 Study Completion Report Form 159

14.1. Assessment Form For IEC Members 162

14.2. Training Records of the Member 163

14.3. Self-assessment Form for IEC Chairperson 163

15.1. SAE data elements 170

15.2. SAE reporting form 172

15.3. SAE analysis form 176

15.4. SAE subcommittee appointment letter 179

15.5. SAE subcommittee consent form 180

FMMCIEC SOP




of 216

16 Application Form for Requesting Waiver of Consent 182

17 Study Premature Termination Report 185

18.1. Checklist for Research Involving Children 188

18.2. Checklist for Research Involving Pregnant Women and Fetuses 190

18.3. Checklist for Research Involving Cognitively Impaired Individuals 193

18.4. Checklist for Research Involving Students, Employees or Residents 195

18.5. Checklist for Genetic Research 196

19 Request/Complaint Form for Participants 199

20.1. Document Request Form 203

20.2. Log for Disposal of Study Documents 203

21.1 Format of Internal Audit Schedule 205

21.2. Checklist for Internal Audit of IEC 206

22 Audit and Inspection Preparation Checklist 214

FMMCIEC SOP




of 216

I. STANDARD OPERATING PROCEDURES

(SOPs)

1 to 22

FMMCIEC SOP




of 216

1. SOP-1 : PREPARATION OF STANDARD OPERATING PROCEDURES OF

FMMCIEC

1.1. Purpose: To define the process for writing, reviewing, distributing and amending SOPs of

FMIEC. These SOPs ensure that the activities of FMIEC are conducted in accordance with

Indian regulations and relevant, national and international ethical guidelines. Uniformity of

the processes of FMMCIEC is ensured by SOPs.

1.2. Scope : Writing, verifying, reviewing, revising/amending and issuing the SOPs of FMIEC

1.3. Responsibilities: The SOPs are reviewed and revised once a year. In the interregnum,

amendments if required are done and notified. The Chairperson of FMMCIEC appoints the

teams for preparation/ revision of SOPs. The prepared SOPs are reviewed by all members

of FMMCIEC in a meeting. The Chairperson verifies and approves the SOPs. The

Chairperson authorizes the Member Secretary to issue the SOPs as per the distribution list.

The secretariat staff of FMMCIEC assist in clerical work and distribution.

1.4. Procedure :

1.4.1. The Chairperson of FMMCIEC appoints teams for preparation/revision of SOPs.

Number of teams will depend on the amount of work involved.

1.4.2. Each team will have a leader and two or three members. The team leader should be

the one who has thorough understanding of the ethical review process, evident by

his/her experience and the training he/she has undergone. The leader will discuss

with the team members and design the SOPs.

1.4.3. Each SOP will have following headings :

1) Purpose

2) Scope

3) Responsibilities

4) Procedure in detail

5) Flow Chart (as applicable)

6) Annexures

1.4.4. The draft of the SOP will be presented in the meeting of full committee.

Suggestions or corrections from the members will be incorporated.

FMMCIEC SOP




of 216

1.4.5. The SOPs are reviewed by the Chairperson, the Member Secretary and a senior

member of FMMCIEC. The Chairperson will be the final approving authority for

SOPs

1.4.6. The Member secretary, FMMCIEC is authorized by chairman, and will be

responsible for printing the SOP

1.4.7. The members are trained on the SOPs, and then they are issued a hard copy of the

SOP

1.4.8. The new SOP is effective from the date of issue

1.4.9. Soft copy (PDF) will be made available in the website of Father Muller Charitable

Institutions (www.fathermuller.edu) for reference of all stake holders.

1.4.10. Soft copy (PDF) will be issued to principal investigators and sponsors of regulatory

trials, NABH coordinator of FMMCH, CDSCO, NABH assessors, any other

stakeholders after permission from the Chairperson , FMMCIEC

1.4.11. One each of soft copy in MS-Word, soft copy in PDF , hard copy of the current

version, will be maintained in the secretariat of FMIEC.

1.4.12. The SOP will be reviewed once a year. The procedure for preparation will be

followed for revision of SOP as well.

1.4.13. When the revised SOP is made, it becomes the current version, and the previous

version will be considered “obsolete”. The Member secretary will take back the

“obsolete” version and then issue “current” version to the members. The members

will not keep the “obsolete” versions with them.

1.4.14. Secretariat will mark the “obsolete versions” and will keep only one copy of the

“obsolete” version for reference. Other copies will be disposed of by shredding.

1.4.15. If any changes are required in the SOP in between (other than regular revision) due

to any suggestions from members of FMIEC, implementation of revised guidelines,

etc., amendments will be made. The chairperson will assess the need for

amendment and authorize the Member Secretary to do the needed amendments.

Only the soft copy in PDF will be issued to all members within seven days of

amendment approval.

http://www.fathermuller.edu/

FMMCIEC SOP




of 216

1.5. Flow Chart : SOP Preparation

Appointment of SOP Teams by Chairperson of FMMCIE

Teams prepare drafts of SOPs

Discussion of the SOP Drafts in the Meeting of Full Committee

Incorporating Suggestions of Members

Review of SOPs by Chairperson, Member Secretary and a Senior Member of FMMCIEC

Approval by Chairperson

Training the Members of IEC on SOPs

Issue of SOPs; Effective date of IEC.

FMMCIEC SOP




of 216

1.6. Annexure for SOP-1 :

Annexure-1: Allotment of team members for preparation of SOP (Version 11)

Team

No.

Team members SOPs to be prepared

I Dr.Varadaraj Shenoy

–Team leader;

Dr. Anup Kumar Shetty –Member;

Mr. Sudeep MJ Pais - Member

1) Guidelines for submission of protocols ;

2) Categorization of review of protocols –Full, expedited and

exempted from review;

3) Continuing review of study protocols

4) Study completion reports

5) On site monitoring of approved studies

II Dr . Shivashankara A.R.

-Team leader;

Fr. Dr. Leo D‟Souza –Member.

Dr. PJ Kurian -Member

1) Procedure for Preparation of SOP;

2) Constitution of Ethics Committee;

3) Handling conflict of interest among Ethics Committee

members;

4) Selection and responsibilities of Independent consultants;

5) Procedure for allowing guest or observer;

6) Agenda preparation, meeting procedures and recording of

minutes;

7) Review of resubmitted and amended protocols and protocol-

related documents

8) Preparing for Ethics Committee audit inspection.

III Dr. Sudhir Prabhu –Team leader;

Mrs. Veena Manoj – Member;

Mrs. Irene Alvares -Member

1) Review of protocol deviations/violations;

2) Review of serious adverse events (SAE) reports;

3) Maintenance of active study files, administrative records of

IEC, archival of closed files and retrieval of documents;

4) Training and assessment of IEC members.

IV Dr. Safeekh AT- Team leader;

Mr. Eric Sequeira – Member;

Mrs. Anuradha Shetty –Member

1) Management of premature termination , suspension,

discontinuation of the study;

2) Waiver of written or verbal informed consent;

3) Dealing with participants‟ requests and complaints coming to

IEC;

4) Reviewing proposals involving vulnerable populations.

FMMCIEC SOP




of 216

2. SOP-2 : Constitution of IEC : Selection, Roles and Responsibilities of Members

of FMMCIEC

2.1. Purpose: The purpose of this SOP is to define and describe the terms of reference, which

provide the framework for constitution, selection, roles and responsibilities of members of

FMMCIEC, and the procedure for maintaining confidentiality of all activities and

documents.

2.2. Scope : This SOP is applicable to appointment of members of FMMCIEC; defining their

roles and responsibilities

2.3. Responsibility: The appointment of the members of FMMCIEC will be done by the Head

of the Institution. Every member is expected to follow this SOP

2.4. Procedure :

2.4.1. The FMMCIEC is primarily for Father Muller Medical College Hospital. So,

the appointing authority for the FMMCIEC is Dean of Father Muller Medical

College.

2.4.2. The Dean of Father Muller Medical College appoints the Chairperson, Member

Secretary and other members of the committee, in consultation with Director of

Father Muller Charitable Institutions.

2.4.3. The Dean sends an official request letter to the members who will confirm their

acceptance to the Dean by providing all required information such as curriculum

vitae, and certificates of training on research ethics and good clinical practice.

The consent letter includes consent from the member, declaration of

maintaining confidentiality of research project- related

data/documents/discussions, and willingness to get updated on research ethics,

good clinical practice and regulations on human research. On receiving this

consent, the Dean will issue the final appointment order.

2.4.4. Composition of FMIEC :

2.4.4.1.The FMMCIEC is multi-disciplinary and multi-sectorial in composition.

It is independent and shall have 7 to 15 members. The Chairperson shall

be from outside the institution. The member Secretary will belong to the

institution. There will be adequate representation of age and gender, and

FMMCIEC SOP




of 216

mix of scientific and non-scientific members. The basic composition of

FMMCIEC is as per the guidelines of CDSCO.

2.4.4.2. The Composition shall be as follows : (as per CDSCO guidelines)

1) Chairperson (Non-affiliated to the institution)

2) Member Secretary (From the institution)

3) Joint Secretary (From the institution, Optional)

4) Two Clinicians (From the institution)

5) One Legal expert (Non-affiliated to the institution)

6) Basic medical scientist (Person with basic MBBS degree and post-graduation in

Biochemistry/Pathology/Microbiology / Pharmacology)- (From the institution)

7) One Philosopher/Theologian/Ethicist (Non-affiliated to the institution)

8) One Social Scientist/Representative from non-governmental organization/social

worker(Non-affiliated to the institution)

9) One Lay person from the community (Non-affiliated to the institution)

2.4.4.3. The Chairperson and Member Secretary will not have the dual roles in the ethics

committee. They can‟t fulfil the role of a member (clinician/basic medical scientist/social

scientist/legal expert, etc..) as it interferes with their own responsibilities.

2.4.4.4. All members including Chairperson, Member Secretary and joint Secretary will review

the research proposals. The Member Secretary does not have voting rights. Chairperson will

exercise voting if it is required to make a decision on ethical approval to a research proposal.

One of the members is designated as Vice Chairperson.

2.4.5. Criteria for Selection of FMMCIEC members:

2.4.5.1. Chairperson:

1) Should be from outside the institution

2) Should have a minimum of three years experience as a member of an IEC

3) Should have undergone training in “Good Clinical Practice” and “guidelines for

conducting biomedical research on human beings”

4) Should not have any known record of professional misconduct

2.4.5.2. Vice Chairperson:

1) Should be from outside the institution; he/she is selected from the members of IEC

2) Should have a minimum of three years experience as a member of an institutional ethics

FMMCIEC SOP




of 216

Committee


2.4.5.3. Member Secretary:

1) A senior faculty from the institution with a postgraduate degree, and with a minimum

experience of five years in the institution.

2) Should have undergone training in “Good Clinical Practice” and “guidelines for

conducting biomedical research on human beings”

3) Should have a minimum of three years experience as a member of an institutional ethics

Committee

4) Should have worked as a convener/member of any committees/core teams of the

Institution

5) Should have good communication skills


2.4.5.4. Joint Secretary:

1) A faculty from the institution with a postgraduate degree

2) Should have attended any training/workshop on research methodology/good clinical

Practice/ethical guidelines for clinical research

3) Should have good communication skills


2.4.5.5. Members:

1) Members will be selected in their personal capacities based on their qualification,

experience in domain field, interest, ethical and/or scientific knowledge and expertise, as well

as on their commitment and willingness to volunteer the necessary time and effort for the IEC.

2) They should not have any known record of professional misconduct.

3) The basic medical scientists and clinicians should have post graduate qualifications.

4) The Lay Person should not have any graduate or post graduate qualification in any science

discipline. He/she is a literate person from the public or community. He/she is aware of the

local language, cultural and moral values of the community

5) The legal expert should have a basic degree in law from a recognized university with a

minimum experience of three years in the legal field .

FMMCIEC SOP




of 216

6) The social scientist is someone expert in the study of human society and its personal

relationship like anthropologist, scientist and penologist. He/She also may be a representative

of a non-governmental organization.

7) Theologian is a person involved in preaching of various religious activities while an ethicist

has a background in law or philosophy. One of them is included as a member in FMMCIEC.

8) A newly appointed member who has not undergone any training in ethics/good clinical

practice /ethical guidelines of biomedical research on human beings does not have the voting

rights. He/she has to undergo training within six months of the appointment. The member gets

the voting rights once he/she undergoes training.

2.4.6. Requirements from Members when they give consent to be the members of

FMMCIEC:

The secretariat should collect a copy of recent curriculum vitae from all the members. The

copies of degree certificates and medical council registration certificates should be collected

from medical members of committee. In addition, certificates of training if any, in research

methodology/ethics in clinical research/good clinical practice/Guidelines for biomedical

research on human beings should be collected and filed in the IEC office.

2.4.7. Consent Letter and Confidentiality agreement from Members:

1) When the members agree to be part of FMMCIEC, they need to sign a consent letter in

which they declare their commitment for all activities of the committee, and maintaining

confidentiality of activities and documents of FMMCIEC

2) The staff of secretariat of FMMCIEC has to sign an agreement of maintaining

confidentiality

3) Chairperson of FMMCIEC will sign on all the confidentiality forms of members and

secretariat staff

2.4.8. Tenure of Membership:

The tenure of membership will be for a continuous period of 2 years from the date of

appointment.

2.4.9. Appointment of New Members:

New members will be appointed under following circumstances:

1) When a regular member completes his/her tenure

2) If a regular member resigns before the completion of the term

FMMCIEC SOP




of 216

3) If a regular member ceases to be a member due to any reason such as death or

disqualification

4) To fulfil the membership requirements as per SOP/guidelines/regulations

The new member will be identified by the Chairperson based on the membership

requirements after discussion by the IEC. The name of new member to be appointed may

be suggested by members of IEC. Chairperson sends the proposal to head of the institution.

The final decision on appointment is taken by head of the institution.

2.4.10. Continuation of Membership after the Tenure:

The tenure of the members in the FMMCIEC is two. After the completion of two years,

at least 1/3rd

of the members will be replaced by new members. The replacement of a member will be

done with new member of the same category (clinician/lay person/social scientist/philosopher, etc…).

The decision on continuation of a member will be taken by the Dean of Father Muller Medical

College. The Dean may take suggestions from the Chairperson and the Member Secretary. However,

the final decision is taken by the Dean. A member can have maximum two continuous terms in

FMMCIEC. He/she may become a member again in FMMCIEC after a gap of at least two years. The

Dean will communicate to those who are replaced, acknowledging their service and contribution to the

ethics committee. For the Chairperson and the Member Secretary replacements, same procedure will

be followed. The Chairperson and Member secretary could get a second term after completion of the

tenure. The Chairperson and Member Secretary can have maximum two consecutive terms.

The Dean will send an appointment proposal letter to the members who will replace existing

members and also to the existing members who are going to continue. After obtaining consent, final

appointment letter will be issued.

2.4.11. Conditions to be fulfilled by a member after appointment:

1) Members must submit a recent, signed CV

2) Members must submit training certificates in ethics and GCP

(if available during induction)

3) Members should be ready to undergo training in ethical guidelines and GCP and submit

the training certificates to the Member Secretary, FMMCIEC

4) Members must be willing to publicize his/her full name and affiliation

FMMCIEC SOP




of 216

5) Should sign the confidentiality agreement, and maintain confidentiality regarding

documents, discussions, and related matters of FMMCIEC.

2.4.12. Termination of Membership: This refers to termination from membership even

before the member completes his/her tenure. Reasons for termination may be

resignation of the member from the FMMCIEC, resignation of the member

from the institution, death of the member or disqualification of the member.

2.4.12.1. Voluntary termination: It is due to resignation of the member. The resignation

has to be submitted in writing to Chairperson, FMMCIEC. One month prior notice

is necessary for the resignation. It will be effective from the date of acceptance by

the Chairperson.

For affiliated members: If a member resigns from the institution (Institutions of FMCI), even if

he/she does not submit resignation to FMMCIEC, the membership to FMMCIEC stands

automatically cancelled. This termination is effective once the member is relieved from the

institution.

2.4.12.2. Disqualification :

A member is disqualified from membership under following circumstances :

A) Misconduct :

a) If the Chairperson or the Member Secretary receives a communication in writing from

public /investigators/ another member of IEC regarding misconduct of the member

b) If the Chairperson observes/gets information on any type of professional /ethical

misconduct (not maintaining confidentiality /not declaring of conflict of interest/any

type of bias towards research studies/investigators , reviewed by FMMCIEC)

c) Action to be taken: The Chairperson satisfies himself/herself that prima facie a case

exists before initiating any action. If in the opinion of the Chairperson, the matter of

significance and integrity of the IEC could be questioned, he/she will first keep the

member under suspension till the final decision is taken. During the period of

suspension, the member will not have any voting rights, privileges and will not perform

any duties of a member of FMMCIEC.

FMMCIEC SOP




of 216

The Chairperson will call for a meeting of FMMCIEC, following the usual rules of

quorum. The suspended member will be given sufficient opportunity to defend

himself/herself in the meeting. The decision will be taken by consensus.

B) Disqualification due to continuous absence: a member will be disqualified if he/she

does not attend more than three consecutive meetings of IEC. If the member has given

a prior intimation to Chairperson/member Secretary about the absence, the member will

be given an opportunity to continue with the membership. This member will be issued a

warning from Chairperson. However, the membership will cease if this habit repeats

once again.

In case of absence without intimation for more than three consecutive meetings of

FMMCIEC, the member is liable for disqualification. The member will be issued a one

month notice by the Chairperson seeking explanation for the absence. If the member

gives satisfactory explanation for the continued absence and assures attendance for

future meetings, the Chairperson may decide on continuation of the membership. In the

absence of any reply from the member, the Chairperson will discuss the matter of

disqualification of membership in the meeting of FMMCIEC. Final decision on

disqualification is taken by the Chairperson.

In all the above cases of disqualification, the Chairperson communicates to the Dean,

Father Muller Medical College in writing. The decision of disqualification is

communicated to the member by the Dean.

2.4.13. Roles and Responsibilities of Chairperson of FMMCIEC:

i) To conduct meetings and to be accountable for efficient functioning of the

committee

ii) To ensure active participation of all members in all discussions and

deliberations

iii) Seek conflict of interest from members and ensure quorum and fair decision

making

iv) Handling of complaints against investigators, IEC members, conflict of interest

issues and requests for use of IEC data

v) To ratify the minutes of previous meetings

vi) To review serious adverse events with causality assessment

FMMCIEC SOP




of 216

vii) Is the final authority of FMMCIEC to take any decision on disqualification of

members and recommend to the head of the institution for termination of the

member.

viii) Is the approval authority for SOPs of FMMCIEC

ix) responsible for making any communications on behalf of the FMMCIEC to

Head of the institution, CDSCO/DCGI and any other regulatory bodies

2.4.14. Roles and Responsibilities of Member Secretary of FMMCIEC:

i) To organize an effective and efficient procedure for receiving, preparing,

circulating and maintaining each proposal for review

i) To schedule IEC meetings, prepare the agenda and minutes

ii) To organize IEC documentation, communication and archival

iii) To arrange for training of IEC secretariat and members

iv) To ensure that SOPs are updated as and when required

v) To ensure adherence of IEC functioning as per SOPs

vi) To prepare for and respond to audits and inspections

vii) To Ensure completeness of documentation at the time of receipt of protocols ,

and timely inclusion in the agenda for IEC review

viii) To assess the need for exemption from review, expedited review or full review

Joint Secretary: Will function as Secretary in his/her absence; helps the Secretary in

recording minutes of meetings, sorting out the research proposals for review,

documentation, and in preparation for audits and inspections.

2.4.15. Roles and Responsibilities of Members of FMMCIEC (In General for all Members):

1) All members are expected to review the research proposals and attend the ethics

committee meetings, and participate in the discussions and deliberations

2) To review the revised submissions, additional submissions, progress reports and final

reports

3) To review the reports of serious adverse events, and recommend appropriate actions

4) To carry out monitoring visits at study sites as and when needed

5) To maintain confidentiality of the documents and deliberations of ethics committee

meetings

6) To declare conflict of interest if any, to the Chairperson

FMMCIEC SOP




of 216

7) To participate in continuing education activities in research ethics and get updated on

relevant guidelines and regulations.

2.4.16. Roles and Responsibilities of Basic Medical Scientist:

Scientific and ethical review with special emphasis on the intervention, benefit-risk

analysis, research design, methodology statistics, continuing review process, serious

adverse events, progress report and final report.

2.4.17. Roles and Responsibilities of Clinician:

1) Scientific review of protocols including review of the intervention, benefit-risk

analysis, research design, methodology, sample size, site of study and statistics

2) Ongoing review of the protocol, serious adverse events, progress report and final

report.

3) Review medical care, appropriateness of the facility and principal investigator,

provision for medical care, management and compensation.

4) Thorough review of protocol, investigator‟s brochure and other protocol related

documents

2.4.18. Roles and Responsibilities of Lay Person:

1) Ethical review of the proposal, informed consent documents along with translations

2) Evaluate benefits and risks from the participant‟s perspective, and opine whether

benefits justify the risks

3) Serve as a patient /participant/community representative and bring in ethical and

societal concerns

2.4.19. Roles and Responsibilities of Legal Expert:

1) Ethical review of the proposals, informed consent documents along with translations,

MOU, clinical trial agreement, regulatory approval, insurance document, compensation

proposals, other site approvals, investigator‟s undertaking, and protocol-specific other

permissions. ; 2) Interpret and inform members about new regulations if any

2.4.20. Roles and Responsibilities of Social Scientist:

1) Ethical review of the proposals, informed consent documents along with translations

2) Assess impact on community involvement, socio-cultural context

3) Serve as representative of community/society and bring in ethical and societal

concerns

FMMCIEC SOP




of 216

2.4.21. Roles and Responsibilities of Philosopher/Theologian:

1) Ethical review of the proposals, informed consent documents along with translations ;

2) Assess impact on religious or philosophical context; 3) Bring in ethical concerns

2.4.22. Secretariat of FMMCIEC:

Secretariat is composed of the clerical staff and attenders.

Secretariat will assist the Member Secretary and joint Secretary in all their functions. The clerical staff

are involved in receiving the proposals, preparing the communication letters, approval letters, and any

other typing work assigned by Member Secretary and Chairperson .They are also involved in typing

agenda for the meeting, typing the proceedings of meetings , and preparation for the meetings. The

secretariat staff need to sign a confidentiality agreement. Attenders are involved in distribution of

research proposals to members for review and physical arrangements for the meetings.

2.4.23. Payment of Remuneration to FMMCIEC Members: The FMIEC members are paid

honorarium for attending meeting of IEC and onsite monitoring visit. The remuneration is decided by

the head of the institution while appointing the members. In addition, the institution may sponsor the

members to attend trainings on ethical guidelines and GCP.

2.5. Flow Chart: Constitution of FMMCIEC

Sending Appointment Proposal Letters : By Dean, FMMC

Receiving Acceptance from Members

Sending Final Appointment Letters : By Dean, FMMC

Consent Letter signed by the Members

Confidentiality Agreement Signed by the Members

Members Trained on SOP

Completion of Two Years Tenure; One third of the Members Retire and

FMMCIEC Reconstitution Done

FMMCIEC SOP




of 216

2.6. Annexure for SOP-1

Annexure -2.1. Appointment Proposal Letter

To:

Dr./Mr/Ms. ------------------------

Address: ------------------------------

Sub: Reconstitution of FMMCIEC

Dear Sir /Madam,

The FMMCIEC has completed tenure of two years. I acknowledge your services and contribution as a

member of FMMCIEC for the last two years. As a part of the reconstitution of FMMCIEC, I request

you to the member/Member Secretary/Chairperson of FMMCIEC for the next two years, effective

from ---------------------------.

A detailed appointment letter will be issued once I receive acceptance letter from you. I request you to

submit your recently updated, signed CV along with certificates of training on GCP, Bioethics and

guidelines on biomedical and health science research.

With Regards,

Dean, FMMC

Copy to: The Director, FMCI; The Administrator, FMMCH; The Administrator, FMMC.

FMMCIEC SOP




of 216

Annexure 2.2. FATHER MULLER MEDICAL COLLEGE INSTITUTIONAL ETHICS

COMMITTEE (FMMCIEC)

ACCEPTANCE OF APPOINTMENT AS A MEMBER OF FMIEC

To : The Dean,

FMMC, Mangalore.

Dear Sir,

Sub : Acceptance of Appointment as a Member of FMMCIEC

Ref : Your Proposal Letter No. ---------------------------------------------, Dated. ------------------------------

I am thankful to you for appointing me as a member of FMMCIEC with effect from 1st December

2017. I herewith accept my appointment.

I am ready to undergo regular training on good clinical practice, ethical guidelines on biomedical and

health science research and bioethics as required . I shall regularly participate in the IEC meeting to

review and give my unbiased opinion regarding the ethical issues. I shall not keep any literature or

study related documents with me after the discussion and final review. I shall maintain the entire

research project related information confidential. I shall sign the confidentiality agreement, and shall

declare conflict of interest if any as and when applicable

I am submitting my recently updated, signed CV and certificates of training as requested by you.

Thanking You,

Yours Sincerely,

Signature :

Name :

Designation and Department/Affiliations:

Date : Place :

FMMCIEC SOP




of 216

Annexure 2.3.

Father Muller Medical College Institutional Ethics Committee(FMMCIEC)

Appointment Letter : Member

To :

------------------------------

Sub : Appointment as member of Father Muller Institutional Ethics Committee.

Category : Basic Medical Scientist/Clinician/Theologian/Social Scientist/Lay Person/ Legal Expert

Dear Sir/ Madam, I am pleased to select you as a member of Father Muller Institutional Ethics

Committee with effect from -----------------. As a member of the committee, you will have tenure of

two years.

You will be receiving an honorarium of Rs. -----------------------------per sitting for the services

rendered by you.

I request you to kindly extend your co operation to the Chairperson and Member Secretary of

FMMCIEC, in effective and efficient functioning of FMMCIEC.

Please find the enclosed terms and conditions of your appointment, roles and responsibilities.

You will be issued a copy of the policies and standard operating procedures of FMMCIEC once you

sign the consent letter and confidentiality agreement .

You will have the voting rights in the IEC only after you receive the initial training on policies and

standard operating procedures.

Congratulations and all the best.

With Regards,

Dean, FMMC.

FMMCIEC SOP




of 216

Terms and Conditions of appointment, and Roles and Responsibilities of Member, FMMCIEC

1) You shall maintain high ethical standards and should not be unduly influenced while

performing assigned roles in the FMMCIEC

2) You should be willing to place your full name, profession and affiliation to the ethics

committee in the public domain

3) Be willing to sign a confidentiality agreement , and to maintain confidentiality of the

documents and deliberations of ethics committee meetings

4) To read, understand, accept and follow the conflict of interest policy of ethics committee, and

declare conflict of interest if any during your appointment, and initial review and final review

of research proposals .

5) As a member of FMMCIEC you need to do initial review, final review of research proposals

and evaluate progress reports and final reports . You need to participate in onsite monitoring

visits and review of serious adverse events as and when required. You are required to attend

regular as well as emergency meetings of FMMCIEC. You are expected to participate actively

in all discussions and deliberations of FMMCIEC.

6) You shall not keep any literature or study related documents with you after the discussion and

final review

7) Willing to undergo training or update programmes on relevant guidelines and regulations,

research ethics ,and good clinical practice during the tenure as ethics committee member

8) As per the policy of the committee, any member not attending three consecutive meetings will

be replaced by another person of the same category in IEC. Any member showing any kind of

professional misconduct will be terminated from membership.

9) One month notice on either side will be necessary prior to resignation/termination of

appointment.

The Details of the roles and responsibilities of a member of FMMCIEC are mentioned in the

policies and standard operating procedures of FMMCIEC.

FMMCIEC SOP




of 216

Annexure 2.4.


Appointment Letter : Chairperson

To :

----------------------------------

Sub : Appointment as Chairperson of FMMCIEC

Dear Sir/Madam,

I am pleased to appoint you as the Chairperson of FMMCIEC with effect from ------------------. You

will have a tenure of two years from the date of appointment.

As head of the institution, I assure you that FMMCIEC will be provided with all required

infrastructure and facilities required for its effective functioning. The ethics committee will be

independent in its functioning and decision making, without any undue influence from anybody

including the authorities of the institution.


rendered by you.


I request your services in the effective and efficient functioning of FMMCIEC.


With Regards,

Dean,

FMMC.

FMMCIEC SOP




of 216

Terms and Conditions of appointment, and Roles and Responsibilities of Chairperson,

FMMCIEC

1) As Chairperson of FMMCIEC, you are required to finalise the revision of SOP of FMMCIEC

in co ordination with the Member Secretary, and you will be final approval authority for SOPs.

2) You shall maintain high ethical standards and should not be unduly influenced during while









6) As Chairperson of FMMCIEC, you shall conduct the meetings of FMMCIEC and ensure active

participation of all members in the discussions and deliberations.

7) You shall seek conflict of interest from members and ensure quorum and fair decision making

8) You are the authorized and responsible for handling of complaints against investigators, IEC

members, conflict of interest issues and requests for use of IEC data

9) You are the authority and responsible for ratifying the minutes of meetings, to review serious

adverse events with causality assessment.

10) You are the authority of FMMCIEC to discuss with members and recommend to the Dean,

FMMC, the disqualification of members (if required) before the completion of their term .

11) You need to do initial review, final review of research proposals and evaluate progress reports

and final reports . You need to lead the IEC team for onsite monitoring visits


final review


research ethics ,and good clinical practice during your tenure in the FMMCIEC.




FMMCIEC SOP




of 216


appointment.

16) You will be responsible for making any communications on behalf of the FMMCIEC to Head

of the institution, CDSCO/DCGI and any other regulatory bodies

The Details of the roles and responsibilities of Chairperson and members of FMMCIEC are

mentioned in the policies and standard operating procedures of FMMCIEC.

--------------------------------------------------------------------------------------------------------------------

Annexure 2.5.


Appointment Letter : Vice Chairperson

To :

----------------------------------

Sub : Appointment as Vice Chairperson of FMMCIEC

Dear Sir/Madam,

I am pleased to appoint you as the Vice Chairperson of FMMCIEC with effect from ------------------.

You will have a tenure of two years from the date of appointment.

As Vice Chairperson, you will be handling the roles and responsibilities of the Chairperson in his/her

absence.

You are requested to refer to the policies and standard operating procedures of FMMCIEC .



With Regards,

Dean, FMMC.

FMMCIEC SOP




of 216

Annexure 2.6.


Appointment Letter : Member Secretary

To :

----------------------------------

Sub : Appointment as Member Secretary of FMMCIEC

Dear Sir/Madam,

I am pleased to appoint you as the Member Secretary of FMMCIEC with effect from ------------------.

You will have a tenure of two years from the date of appointment.

As head of the institution, I assure you that FMMCIEC will be provided with all required

infrastructure and facilities required for its effective functioning. The ethics committee will be

independent in its functioning and decision making, without any undue influence from anybody

including the authorities of the institution.


rendered by you.




With Regards,

Dean,

FMMC.

FMMCIEC SOP




of 216

Terms and Conditions of appointment, and Roles and Responsibilities of Member Secretary,

FMMCIEC

1) As Member Secretary of FMMCIEC, you are required to do the needful for the revision of

SOP of FMMCIEC in co ordination with the Chairperson.

2) You shall maintain high ethical standards and should not be unduly influenced while









6) As Member Secretary, you are required to organize an effective and efficient procedure for

receiving, preparing, circulating and maintaining each proposal for review

7) To schedule IEC meetings, prepare the agenda and minutes

8) To organize IEC documentation, communication and archival

9) To arrange for training of IEC secretariat and members

10) To ensure that SOPs are updated as and when required

11) To ensure adherence of IEC functioning as per SOPs

12) To prepare for and respond to audits and inspections

13) To Ensure completeness of documentation at the time of receipt of protocols , and timely

inclusion in the agenda for IEC review

14) To assess the need for exemption from review, expedited review or full review

15) You will be responsible for making communications on behalf of FMMCIEC, to investigators,

members of FMMCIEC and sponsors .

16) You need to do initial review, final review of research proposals and evaluate progress reports

and final reports . You need to lead the IEC team for onsite monitoring visits


final review

FMMCIEC SOP




of 216


research ethics ,and good clinical practice during your tenure in the FMMCIEC.





appointment.

The Details of the roles and responsibilities of Member Secretary of FMMCIEC are

mentioned in the policies and standard operating procedures of FMMCIEC.

--------------------------------------------------------------------------------------------------------------

FMMCIEC SOP




of 216

Annexure 2.7. Father Muller Medical College Institutional Ethics Committee(FMMCIEC)

Consent Letter from Appointed Members

To :

Dean,

Father Muller Medical College, Mangalore.

Sub : Consent to be the Chairperson/Vice Chairperson/Member Secretary/Member of Father

Muller Medical College Institutional Ethics Committee.

Ref : Your letter No.--------------------------------------; Dated ----------------------------------------

Dear Sir/Madam,

In response to your letter, I give my consent to be the Chairperson/Vice Chairperson/Member

Secretary/Member of Father Muller Medical College Institutional Ethics Committee. I shall execute

my roles and responsibilities as per the policies and standard operating procedures of FMMCIEC, and

as mentioned in my appointment order. I shall maintain high ethical standards, and will not be unduly

influenced in discharging my assigned work.

I will sign the confidentiality agreement during my induction. I am aware of the conflict of interest

policy of FMMCIEC, and I will declare conflict of interest (if any) during my induction as a member,

review of research proposals and decision making in FMMCIEC.

Thanking You,

Yours Sincerely,

Signature :

Name :

Designation and Department/Affiliations:

Date : Place :

--------------------------------------------------------------------------------------------------------------------

FMMCIEC SOP




of 216

Annexure-2.8. : Confidentiality Agreement to be Signed By Member of FMMCIEC

In recognition of the fact, that I, _________________________________________________

(Member’s name, his/her position on FMMCIEC and affiliation) herein referred to as the

“undersigned”, have been appointed as a member of the FMMCIEC and have been asked to assess

research studies involving research participants in order to ensure that they are conducted in a humane

and ethical manner, adhering to the highest standards of care as per the national, and local regulations

and institutional policies and guidelines and international and national guidelines.

The appointment of the undersigned as a member of the IEC is based on individual merits and not as

an advocate or representative neither of a home province, territory or community nor as a delegate of

any organization.

The IEC must meet the highest ethical standards in order to merit the trust and confidence of the

communities in the protection of the rights and well-being of research participants and the

undersigned, as a member of the IEC, is expected to meet the same high standards of ethical behavior

to carry out its mandate.

This agreement encompasses any information deemed Confidential provided to the Undersigned in

conjunction with the duties as a member of the FMMCIEC. All Confidential information (and any

copies and notes thereof) shall remain the sole property of the FMMCIEC. The undersigned agrees to

hold all confidential information in trust or confidence and agrees that it shall be used only for

contemplated purposes and shall not be used for any other purpose or disclosed to any third party.

Written confidential information provided for review shall not be copied or retained.

I, ________________________________________________ (name of the IEC member) have read

and accept the aforementioned conditions as explained in this Agreement.

Signature Date

Chairperson‟s Signature and Date

[The original (signed and dated Agreement) will be kept on file in the custody of the FMMCIEC. A

copy will be given to the Undersigned.]

I acknowledge that I have received a copy of this Agreement signed by the FMMCIEC Chairperson

and me.

Signature and Date

-----------------------------------------------------------------------------------------------------------------------

FMMCIEC SOP




of 216

Annexure-2.9. : Confidentiality Agreement to be Signed By Secretariat Staff of FMMCIEC

I, _________________________________________________

(Staff’s name and designation) herein referred to as the “undersigned”, have been appointed as a staff

of the IEC office. This agreement encompasses any information deemed confidential provided to the

Undersigned in conjunction with the duties as a staff of the IEC. All confidential information (and any

copies and notes thereof) shall remain the sole property of the IEC.

The undersigned hereby agrees not to disclose or utilize, directly or indirectly all confidential

information known to him or her during his tenure of service.

I, ________________________________________________ (name of the IEC office staff) have read

and I accept the conditions as explained in this Agreement.

__________________________ __________________

Signature and Date

__________________________ __________________

Chairperson‟s Signature Date

[The original (signed and dated Agreement) will be kept on file in the custody of the IEC. A copy will

be given to the Undersigned.]

I confirm that I have received a copy of the confidentiality agreement signed by the Chairperson of

FMMCIEC.

__________________________ __________________

Name of the Member, Signature and Date

FMMCIEC SOP




of 216

3. SOP-3: Handling Conflict of Interest Among

Ethics Committee Members

3.1. Purpose: The purpose of this SOP is to describe the process to identify and manage conflict of

interest among Institutional Ethics Committee (IEC) members.

3.2. Scope: This SOP covers the policy related to identification, declaration and management of

conflict of interest and is applicable to all IEC members.

3.3. Responsibility: All FMMCIEC members are responsible for self-identifying and disclosing the

conflict of interest. The Chairperson of FMMCIEC is finally responsible for ensuring that all members

of FMMCIEC self-declare conflict of interest during review of research proposals

3.4. Procedure:

3.4.1. Information to members on conflict of interest:

1) During the appointment of members, one of the conditions is “To read, understand, accept and

follow the conflict of interest policy of ethics committee, and declare conflict of interest if any

at appropriate time”.

2) The member will be signing the consent letter after going through the terms and conditions in

the appointment letter.

3) The conflict of interest policy of the FMMCIEC will be explained to the members on

induction. It will be a part of the trainings imparted to the members

3.4.2. Types of Conflict of Interest (COI):

3.4.2.1. Personal COI: If the investigator of a research proposal has close and immediate

family relationship with the member of FMMCIEC (spouse, son/daughter, parents, sibling,

dependent) ; If the FMIEC member is a collaborator, Principal investigator, co investigator,

financer, research staff, consultant for a research proposal which has come for review in FMIEC;

If a research proposal is submitted by a departmental colleague with whom the member has

conflict of interest (dispute, bias, any benefits, etc.. ,) –if applicable and if the member feels there

is a conflict of interest.

FMMCIEC SOP




of 216

3.4.2.2. Professional COI:

If the IEC member or his/her immediate family member serves as trustee, director, manager, or

scientific advisor of the funding agency sponsoring the research.

3.4.2.3. Financial COI:

If the IEC member or the spouse or dependent of a member receives monetary benefits including,

but not limited to, salary or payments for other services (e.g., consulting fees or honoraria), equity

interests (e.g., stock, stock options, or any other ownership interests) and intellectual property

rights (e.g., patents, copyrights, product or service being evaluated).

3.4.3. Procedure for Declaring COI:

3.4.3.1. The IEC member should identify the COI whenever a research proposal is assigned to

him/her for the review. The COI should be declared in the format provided in SOP of FMMCIEC,

and submitted to the member secretary.

3.4.3.2. The IEC members should not participate in discussing, or decision making on research

proposals‟ applications reviewed at any level (exempt, expedited, or full-board) when they have

conflicts of interest except to provide information requested by the IEC.

3.4.3.3. If an IEC member has a COI for review outside a meeting (e.g., the expedited procedure/

amendments), he or she should notify the IEC Secretariat and return the documents.

3.4.3.4. If an IEC member has a COI for a study for which he or she has been assigned as a

primary reviewer, he or she will inform the IEC secretariat so that the review is reassigned to other

members.

3.4.3.5. If an IEC member has a COI for review of research study at a meeting, he or she will

inform the Chairperson and leave the meeting room while discussion of the study takes place.

He/she may stay in the meeting room only to answer questions about the research. This is

applicable also for IEC meetings at which discussion on serious adverse events,

deviations/violations, amendments/ continuing review reports related to studies are discussed

FMMCIEC SOP




of 216

3.4.3.6. The IEC member who declares COI and leaves the meeting does not count towards the

quorum for the vote. The member‟s absence under these circumstances is called a recusal, not an

abstention or an absence.

3.4.3.7. If an IEC member finds that he/she has a COI during the conduct of a research project

approved by IEC, he/she shall report the conflict to the IEC at the next IEC meeting.

3.4.3.8. At the beginning of each meeting, the FMMCIEC Chairperson asks the members to

disclose any COI concerning any of the items on the agenda. During the meeting, IEC member

having conflict discloses the existence of the conflict just before the review of the relevant item

begins.

3.4.3.9. If the Chairperson has a conflict of interest for a particular project, this should be so

declared and handled like any other member‟s conflict is handled. An acting Chairperson should

be appointed for discussion on such a project.

3.4.3.10. When determination regarding existence of COI is uncertain, more information is

gathered from relevant sources and determination is done by the IEC member with the help of the

IEC Chairperson / Member Secretary or by IEC Chairperson / Member Secretary (as applicable)

3.4.3.11. The IEC Chairperson has the final authority to determine whether a COI has been

managed or eliminated appropriately for research participant protection. The IEC shall not

approve a research study proposal where a COI is not managed or eliminated

3.4.3.12. The declaration and management of COI should be recorded in the proceedings of the

FMIEC meetings.

3.5. Annexure :

FMMCIEC SOP




of 216

Annexure-3 : Conflict of Interest Declaration Form

To : Chairperson , FMMCIEC.

Dear Sir,

I am aware of the COI policy of FMMCIEC.

I herewith declare my conflict of interest with regard to the following research proposal

submitted to FMMCIEC for review.

Protocol No.

Study Title :

Name of Principal Investigator :

Type of COI (Personal/ Professional/Financial) and the Reason :

Hence, I stay away from reviewing this research proposal, any deliberations/discussions on

this study, and refrain from any decision making.

Name and Signature of Member

Date :

Name and Signature of Chairperson :

Date :

FMMCIEC SOP




of 216

4. SOP-4 : Constitution of Subject Expert Panel :

Selection, Roles and Responsibilities

4.1. Purpose: The purpose of this SOP is to define and describe the terms of reference, which

provide the framework for constitution, selection, roles and responsibilities of independent

consultants , and the procedure for maintaining confidentiality of all activities and

documents.

4.2. Scope : This SOP is applicable to appointment of independent consultants of FMMCIEC;

defining their roles and responsibilities

4.3. Responsibility: The appointment of the members of subject expert panel (panel of

independent consultants) for FMMCIEC will be done by the Head of the Institution. The

independent consultants need to maintain confidentiality of the reviews, meetings and

documents.

4.4. Procedure :

4.4.1. Appointment:

4.4.1.1. The Chairperson and the Member Secretary place a proposal to the Dean, FMMC for

appointing independent consultants. Independent consultants are experts from various subjects for

which experts are not available among regular members of FMMCIEC. The consultants could be

affiliated or non-affiliated to FMMC. The Dean of FMMC appoints independent consultants.

4.4.1.3. The Dean communicates to the consultants a proposal of appointment. The consultant will

confirm their acceptance to the Dean by providing all required information such as curriculum vitae,

and certificates of training on research ethics and good clinical practice. The consent letter includes

consent from the member, declaration of maintaining confidentiality of research project- related

data/documents/discussions, and willingness to get updated on research ethics, good clinical practice

and regulations on human research. On receiving this consent, Dean will issue the final appointment

order. The list of independent consultants is maintained in the office of FMMCIEC.

4.4.1. Tenure: The tenure of appointment of an independent consultant is 2 years. The panel will be

reviewed and revised every two years.

4.4.2. Consulting an Independent Consultant for Review :

FMMCIEC SOP




of 216

The Member Secretary in consultation with the Chairperson decides on sending a research proposal

for review depending on the requirement. The requirements are as follows:

1) If the research is from a specialty for which experts are not available in the FMMCIEC, and there is

need for expert opinion. The subject experts could be affiliated or non-affiliated. Preferably, subject

non-affiliated experts are invited to review to avoid any bias or conflict of interest. The suggestion for

requirement of expert may also come from the Chairperson or any member of FMMCIEC who feels

the necessity during review process.

2) The Member Secretary requests the independent consultant to review the research proposal

(expedited/full review as required). The review form and proposal copy along with all enclosed

documents (budget form, questionnaire, proforma, informed consent documents, etc..). For the

expedited review, the consultant is requested to do the review and submit the filled review form to the

ethics committee secretariat within one week. This review will be placed before the full committee

meeting for ratification.

3) For full review, the consultant is requested to attend the meeting of FMMCIEC. He/she should be

present only during the presentation of that particular proposal which was reviewed by him/her. The

opinion of the consultant is taken. However, the consultant does not have voting rights

4.4.3. Requirements from Independent Consultants: The secretariat should collect a copy of recent,

signed curriculum vitae from the independent consultants. In addition, certificates of training if any,

in research methodology/ethics in clinical research/good clinical practice/Guidelines for biomedical

research on human beings should be collected and filed in the IEC office. The consultants should also

sign a confidentiality agreement

4.4.4. Conditions to be fulfilled by a consultant after appointment:

1) Must submit a recent, signed CV

2) Must submit training certificates in ethics and GCP (if available during induction)

3) Members must be willing to publicize his/her full name and affiliation

4) Should sign the confidentiality agreement, and maintain confidentiality regarding

documents, discussions, and related matters of FMIEC.

5) Should declare “conflict of interest” whenever it exists

FMMCIEC SOP




of 216

4.4.5. Termination of Membership: The consultant is a member only for the review of specific

research proposals. Any independent consultant found of professional conduct will be terminated

from the membership.

4.5. Annexures :

Annexure-4.1. : Appointment Letter of Independent Consultant

To : Dr. --------------

Dear Sir/Madam,

Sub: Proposal of Appointment as “Subject Expert” for Institutional Ethics Committee

I am pleased to appoint you as a member in “The Panel of Subject Experts” of Father Muller Medical

College Institutional Ethics Committee. Following are the terms and conditions of appointment.

1) You will not be a regular member of Ethics Committee

2) As a subject expert, you are required to review of research proposals pertaining to your

subject/specialty area, whenever you are requested by the Member Secretary of Ethics

Committee. Whenever requested, you are required to complete the review in the stipulated time

of one week. Review form which is provided along with the proposal needs to be filled.

3) For the research proposals categorized under “Full Review”, you have to attend the meeting of

Ethics Committee along with the filled review forms. You have to be present in the meeting

only for the presentation of that proposal reviewed by you. You can clarify any queries with

the researcher/investigator during the meeting, and will share your opinion with the regular

members of ethics committee.

4) For the research proposals categorized under “expedited review”, you will not be attending the

meeting. Only the filled review form has to be sent to Member Secretary of Ethics Committee.

5) You will not have any voting rights in the Ethics Committee meeting

6) You need to sign a letter of conflict of interest, and declare to maintain confidentiality of the

discussions and reviews

7) You will be paid a remuneration of Rupees ---------- /proposal for the review work done

With Regards, Dean, Father Muller Medical College, Mangalore.

FMMCIEC SOP




of 216

Anenxure-4.2 : Father Muller Medical College Institutional Ethics Committee –

Consent Letter from Appointed Member of “Subject Expert Panel”

To :

The Dean,

Father Muller Medical College, Mangalore.

Sub : Consent to be the member of Subject expert panel of Father Muller Medical College

Institutional Ethics Committee.

Ref : Appointment letter No.--------------------------------------; Dated ----------------------------

Dear Sir,

In response the appointment letter, I give my consent to be the member of Father Muller Institutional

Ethics Committee “subject expert panel”. As a subject expert, I shall do review of research proposals

pertaining to my subject/specialty area, whenever I am requested by the Member Secretary of Ethics

Committee. I shall participate in the ethics committee meetings whenever asked to do so. I shall

maintain the entire research project related information confidential. I am ready to declare conflict of

interest whenever I have the conflict of interest with regard to any research proposal. The research

proposal-related materials given to me for review will be returned to ethics committee once I complete

the review process.

Thanking You,

Yours Sincerely,

Signature :

Name :

Designation and Department/Affiliations :

Date : Place :

FMMCIEC SOP




of 216

Annexure-4.3 : Confidentiality Agreement to be Signed By Independent consultant of

FMMCIEC

In recognition of the fact, that I, _________________________________________________

(Consultant‟s name, his/her position on IEC and affiliation) herein referred to as the “undersigned”,

have been appointed as a member of the subject expert panel of FMMCIEC and have been asked to

assess research studies involving research participants in order to ensure that they are conducted in a

humane and ethical manner, adhering to the highest standards of care as per the national, and local

regulations and institutional policies and guidelines and international and national guidelines.

The appointment of the undersigned as a consultant of the FMMCIEC is based on individual merits

and not as an advocate or representative of a home province, territory or community nor as a delegate

of any organization.

The IEC must meet the highest ethical standards in order to merit the trust and confidence of the

communities in the protection of the rights and well-being of research participants and the

undersigned, as a member of the IEC, is expected to meet the same high standards of ethical behavior

to carry out its mandate.

This agreement encompasses any information deemed Confidential provided to the Undersigned in

conjunction with the duties as a member of the subject expert panel of FMMCIEC. All Confidential

information (and any copies and notes thereof) shall remain the sole property of the FMMCIEC. The

undersigned agrees to hold all confidential information in trust or confidence and agrees that it shall be

used only for contemplated purposes and shall not be used for any other purpose or disclosed to any

third party. Written confidential information provided for review shall not be copied or retained.

I, ________________________________________________ (name of the consultant) have read and

accept the aforementioned conditions as explained in this Agreement.

Signature Date

Chairperson‟s Signature Date

[The original (signed and dated Agreement) will be kept on file in the custody of the FMMMCIEC. A

copy will be given to the Undersigned.]

I acknowledge that I have received a copy of this Agreement signed by the FMMCIEC Chairperson

and me.

Signature Date

FMMCIEC SOP




of 216

5. SOP-5 : Allowing Guests or Observers to

FMMCIEC Office/ Meetings

5.1. Purpose: To describe procedures to be followed by Institutional Ethics Committee (IEC) and the

Guest/ Observer whenever he/she visits the IEC Office or attends an IEC full board meeting. The SOP

is needed to ensure adequate protection of confidentiality of information related to research studies

5.2. Scope: This SOP covers the procedure related to visits of guests or observers to FMMCIEC

office and meetings of FMMCIEC

5.3. Responsibility: Member secretary in consultation with chairman is responsible to decide whether

to allow a guest or observer to visit FMMCIEC office or attend meetings of FMMCIEC. The guests or

observers are responsible for maintaining confidentiality of activities, discussions and documents of

FMMCIEC

5.4. Procedure:

5.4.1. Request from Guest or Observer: The individuals who wish to know about the activities of

FMMCIEC need to submit a written request (e mail or hard copy) addressed to Member Secretary of

FMMCIEC. The reasons for the visit to FMMCIEC office or meetings of FMMCIEC should be clearly

stated in the request letter. The request letter should be submitted at least one week in advance to the

visit.

5.4 .2. Decision on Allowing the Guest or Observer: The member secretary consults the chairman

and takes the decision to allow or not to allow the guest or observer. The guest or observer should not

have any conflict of interest with any investigator presenting the proposal on that day. If the member

secretary is not satisfied with the reasons for visit, he/she may deny permission to the guest or

observer. The decision is communicated to the person (guest/observer) in writing (e mail or hard copy

of the letter). The date and time of visit to FMIEC office and meetings is informed to the guest or

observer.

5.4.3. Responsibilities of the Guest or Observer: The guest or observer should sign the

confidentiality agreement during his/her visit to FMIEC office, before getting any details of the

functioning of the committee. If the guest/observer wants to attend only the meeting of FMIEC, he/she

should sign the confidentiality agreement before entering the meeting hall. Only after obtaining

FMMCIEC SOP




of 216

confidentiality agreement signed by the guest or observer, he/she will be allowed to attend the

meeting. He/she can visit the FMIEC/attend the meeting of FMIEC only on the date and time

mentioned in the permission letter from FMIEC. The guest or observer should not ask any questions to

the investigators in the meeting of FMIEC. Also, doubts or clarifications should not be asked to the

members of FMIEC in front of the investigators.

The observer or guest will not be provided with any SOPs or documents of FMIEC in hard or soft

copy. Only verbal explanations will be given. He/she is allowed to see the documents after signing the

confidentiality agreement.

5.4.4. Information Given to Guest or Observer During Visit to FMIEC: During his/her visit to

FMIEC office, the guest will get the necessary and allowable information from the member Secretary.

For any doubts or clarifications Member Secretary gives explanations.

5.4.5. Information Given to Guest or Observer During FMIEC Meeting: During the FMIEC

meetings, the guest or observer will be silently observing the proceedings. For any clarifications or

doubts, the member secretary will give explanations after the meeting.

5.5. Annexures :

Annexure 5.1: Confidentiality Agreement Form For Guest / Observer Attendees to IEC/ IEC Meetings

I, ________________________________ (name), understand that I am being allowed to visit IEC office

facility / attend the IEC meeting on ___________ at _______am as a Guest. The venue of the IEC meeting will

be _____________________. I may become aware of some confidential information during my visit to IEC /

during the course of the IEC meeting. Upon signing this form, I ensure to take reasonable measures to keep the

information as confidential.

Signature of Guest/Observer Date :

Signature of Chairperson Date :

I, _________________________________________________ (name) acknowledge that I have received a copy

of this Agreement signed by the IEC –Chairperson and me. __________________________

__________________ Signature of the Guest ; Date

FMMCIEC SOP




of 216

6. SOP-6 : Submission of Documents to FMMCIEC

and Management of Submitted Documents

6.1. Purpose: This SOP describes the guidelines for submission of protocols to FMMCIEC and how

the secretariat manages the submitted protocols

6.2. Scope: The Scope this SOP includes:

1. Submission of Research Project and related documents for Initial Review of the Protocol

2. Resubmission of Protocols or Research Projects with corrections

3. Submissions of written communications related to the protocol

4. Continuing Review of Approved Protocols :

a. Protocol completion/Termination

b. Protocol deviations/violation

c. SAE initial/ follow up/ final reports

d. Submission of Protocol deviations, Protocol violations

6.3. Responsibility: It is the responsibility of the Principal Investigators to submit the protocols as per

the guidelines of FMMCIEC. It is the responsibility of IEC Secretariat to receive and record the

received protocols. and any other documents for review. The Member Secretary is responsible for

scrutinizing the received documents.

6.4. Procedure :

6.4.1. Documents to be Submitted by the Principal Investigator :

6.4.1.1. Time Line : The Principal Investigator should submit the research proposals to the Secretariat

of FMMCIEC as per the following time line :

1) New Proposals for Initial Review/ Re-submission of Protocols with Corrections/ Amended

Protocols and related documents: should be submitted at least 10 days prior to the scheduled

meeting of FMMCIEC (second Saturday of every month).

FMMCIEC SOP




of 216

2) Submission of SAE (On-Site): As per the timelines stated in the SOP for initial and detailed

reporting of SAE.

3) All other documents for consideration at the full board meeting (except those related to

participant safety, which may be submitted any time (must be submitted at least 72 hours in

advance)

6.4.1.2. The following documents shall be submitted to the secretary of the ethics committee.

A) Essential Documents :

1) Covering letter to the Member Secretary

2) Project submission application form for initial review (see annexure)

3) The correct version of the research proposal: 2 sets of hard copies and one soft copy.

4) Relevant administrative approvals (if applicable)

5) Patient information leaflet in English and Kannada ( see annexure )

6) Informed consent form (see annexure) or waiver of consent form

7) Proforma for clinical data collection

8) Budget Proposal

9) Letter from the Department Head Concerned, here non routine or special tests are being done

(applicable to academic studies)

B). the following additional documents are required for regulatory trials

1. Amendments to protocol (if any)

2. Informed Consent Document in Regional languages (if applicable)

3. Back translations of ICDs (if applicable)

4. Translation and Back translation certificates (if applicable)

5. Amendments to the ICD (if any)

6. Case Record Form

7. Recruitment procedures: advertisement, notices, letters to doctors (if applicable)

8. Patient instruction card, identity card, diary etc. (if applicable)

9. Investigator Brochure (if applicable)

10. Regulatory permissions (DCGI approval, FDA marketing/manufacturing license for herbal

drugs, Health Ministry Screening Committee (HMSC) approval, Bhabha Atomic Research Centre

(BARC) approval) (as applicable)

FMMCIEC SOP




of 216

11. Investigator‟s Undertaking to DCGI

12. Administrative sanction from the head of the Institution or Memorandum of Understanding in

case of studies involving collaboration with other institutions. (if applicable)

13. A copy of Administration sanction from the head of the Institution or Memorandum of

Understanding for sending the samples to laboratories outside the Institution. (if applicable)

14. Brief Curriculum Vitae of all the study team members

15. GCP training certificate (within 5 years) of principal investigator, coinvestigator/s and study

coordinator/s. (if applicable)

16. Research Methodology training certificate (within 5 years) of principal investigator, co-

investigator/s and study coordinator/s (if applicable)

17. List of ongoing research studies undertaken by principal investigator

18. Investigator‟s Brochure (as applicable for Drug/Device trials)

19. Agreement to comply with national and international ethical guidelines and GCP protocols

20. Details of Funding agency / Sponsor and fund allocation

21. Clinical Trial Agreement between the sponsors, investigators and the head of the institution(s)

22. Insurance policy (it is preferable to have the policy and not only the insurance certificate) for

study participants indicating conditions of coverage, date of commencement and date of expiry of

coverage of risk

23. Indemnity policy clearly indicating the conditions of coverage, date of commencement and

date of expiry of coverage of risk

24. Memorandum Of Understanding (MOU)for collaborative studies (if applicable)

25. Ethics Committee clearance of other centers (if applicable)

26. Institutional Stem cell Research Committee approval (if applicable)

27. Documentation of clinical trial registration- temporary or permanent CTRI registration no (if

available)

28. Processing fee payment receipt (See Guidelines for investigators)

29. Any additional document(s), as required by IEC

30. The checklist of documents submitted with the protocol

6.4.2. Management of Protocols:

6.4.2.1. Initial Verification and Assigning Protocol Number:

FMMCIEC SOP




of 216

1. The proposals are verified for the completeness If there are any deficiencies the proposals will

be returned to the investigator for resubmission

2. Once a protocol is deemed to be complete in all respects the FMMCIEC secretariat will issue a

protocol number. The No. will be in this format : FMMCIEC/CATEGORY/PROTOCOL

NO./YEAR.

3. The following categories of protocols will be recognised- regulatory trials( RT)/academic

projects( AP).

4. The regulatory trials will include externally or internally funded projects. Intervention studies

funded by the institution will be classified under regulatory trials. All PG theses, staff projects

and other academic projects will be included under AP.

5. The FMMCIEC secretary will screen the proposals and depending on the risk involved

categorizes them into types namely, exemption from review, expedited review and full

committee review

6. The investigator is informed by email and SMS about the presentation date and time

7. Final decision about the categorisation of the proposals vests with the Member Secretary and

his decision will be final and binding on the investigator

8. The criteria for the categorisation of proposals has been given in the annexure

9. The clerk will stamp the receiving date on the first page/last page of the covering letter and

initial it

6.4.2.2. Transmission and Storage of Documents:

1. The clerk will make a photocopy of the completed document receipt form and return the

original copy to the applicants for their records.

2. The hard copies of proposals categorized for full committee review will be sent to all members

of FMIEC at least 1 week prior to the meeting. The soft copies of all protocols ( full and

expedited review ) will be sent by email/CD/pen drive to those members who have opted for

the electronic version

3. The proposals categorised as exempt review will be cleared by the Member Secretary at the

earliest and the decision will be communicated to the investigators

4. All the protocols will be stored in submission file which again will be categorised as regulatory

trials/academic projects/other projects

FMMCIEC SOP




of 216

6.4.3. Resubmission of Protocols with corrections and Amendments of protocol/ related

documents:

1. For resubmitted protocol, the PI will submit one soft copy and one hard copy of the amended

Protocol and related documents

2. The Secretariat will verify the completeness of the documents and confirm that the copy contains

the modifications highlighted with respect to the earlier protocol submitted mentioning the

justification for the amendment.

3. The protocol related documents which do not require to be changed and are already submitted for

the IEC office during initial review are not required to be submitted again.

4. The Member Secretary (MS) will decide

a. if it is a resubmitted protocol it will follow all steps of : categorization as full review/expedited

review and initial review. All the steps followed for a new submission will be followed for the

resubmitted protocol.

b. if it is a resubmitted protocol based on query response, the Member Secretary will handle it as

decided in the meeting (e.g. Carry out review by one or more member(s) selected by the Chairperson.

The selected members are normally those who reviewed and recommended the previous version of

that protocol or keep on full board agenda)

6.5. Flow Chart:

FMMCIEC SOP




of 216

Submission of Documents by PI

Initial scrutiny by Secretariat of FMMCIEC

Allotting Protocol No.

Categorization for Review: Member Secretary

Decision on Proposals for Exempted from Review: Member Secretary

Sending the proposals for expedited/full review

Full board meeting and Decision making

Communication of Decision to PI

6.6. Annexures :

FMMCIEC SOP




of 216

Annexure-6.1 : Guidelines for Conducting Clinical Research in FMMC :

1. All clinical studies should be reviewed and approved by the IEC BEFORE initiation of the

study

2. No retrospective approvals will be granted

3. Studies may be considered for full board or expedited review or may be granted exemption

from review depending on the risk involved.

4. It is mandatory to register regulatory clinical trials in the Clinical Trials Registry of India

(ctri.nic.in).

5. The investigator team should be trained in GCP or ethics in clinical research (and certificates

– valid for 5 years as per FMMCIEC policy).

6. If a clinical study is planned on an “alternative system of medicine” (Ayurveda,

Homeopathy, Siddha, Unani etc.), a Co-Investigator/ Collaborator from that system should be

included in the study team. The co-investigator appointed should be appropriately qualified

and registered with the relevant Council and he/she should not have a conflict of interest with

the study, investigator or sponsor. This is in accordance with the ICMR 2017 guidelines.

7. The research study protocol should be scientific and complete with respect to the following

sections:

A. Introduction with relevant literature,

B. Objectives,

C. Justification for a clinical study (demonstrate clinical equipoise) and its implications for

future,

D. Detailed methodology describing

i. settings of the study,

ii. duration of entire study and duration for participation for each individual,

iii. eligibility criteria (inclusion and exclusion criteria),

iv. sample size (number of participants that may need screening, number that is required to

be completed for analysis)

v. Sampling method

vi. Ethical aspect : A statement saying that the study will be conducted in adherence to

relevant national/international laws; Placebo justification if applicable; Risk benefit

assessment; Compensation for participation if applicable; Compensation for research related

FMMCIEC SOP




of 216

injury; Informed consent process, including Audiovisual recording of consent (AV consent)

if applicable; Ancillary care; Choice of participants; Method of recruitment (if advertisement

etc.); If vulnerable population what protections are in place; Policy regarding autonomy

(voluntariness, right to withdraw); Confidentiality - Statement of Participant confidentiality;

including ownership of data and coding procedures; Policy regarding dissemination of data,

presentation of data, publication.

vii. Description of variables, inpatient/outpatient, number of outpatient visits

viii. Statistics: Sample size determination, Power estimates / level of significance, Tests for

comparison/ any other descriptive statistical analysis.

8. While submitting your research proposal to the IEC, ensure that you have included an

informed consent document that is prepared as per guidelines in Schedule Y (2005), ICMR

2017 guidelines and ICH – GCP (1996).

9. Informed consent documents should be made in English and Kannada and other relevant

regional languages

10. All the consent documents must have Version No, Date, Page no in the footer

11. Separate informed consent documents should be prepared for studies involving minors

(children) and genetic studies.

Annexure-6.2. : Guidelines for Submission of Documents for Review to FMMCIEC :

1. The FMMCIEC will consider only those research protocols which are approved by

Scientific Committee of FMMC, for review by FMMCIEC.

2. The committee meets second Saturday of every month at 3 PM in the senate hall of

FMMC. Depending on the load of research proposals, the frequency of meeting may be

increased.

3. As FMMCIEC has MOU with other sister institutions of FMCI, the proposals from these

institutions will be accepted for review. These proposals need to be forwarded by the

heads of institutions. (Proposals from sister institutions need not go through the scientific

committee of FMMC).

FMMCIEC SOP




of 216

4. The research proposal should be accompanied by other documents (budget form, patient

information sheet, informed consent form, undertaking, questionnaire, proforma of data

collection) as applicable to the study.

5. For case reports, a copy of the informed consent form signed by the patient should be

submitted to FMMCIIEC, along with a copy of the abstract and findings in the case study.

6. The research proposals will be categorized for review as : exempt review, expedited

review and full committee review.

7. For the proposals categorized for full review, the principal investigator will be asked to

present the proposal in the ethics committee meeting.

8. Principal investigator should be available for presentation of the proposal in the meeting

in case of full committee review. Co investigators may accompany the principal

investigator. Under no circumstances principal investigator will be exempted from

presentation except in extraordinary circumstances. Under such circumstances the

principal investigator should inform the Member Secretary in writing. The Chairperson of

FMMCIEC will decide on this matter.

9. Research proposals are sent to members of FMMCIEC for review atleast a week before

the meeting. Investigators should keep this in mind while submitting proposals to

FMMCIEC.

10. Decision of the committee will be communicated to principal investigator within two

working days after the meeting.

11. Research proposals “approved “/ “approved with suggestions” are permitted to start the

work. Research proposals for “resubmission” need to revise the proposals and resubmit

the proposals. For “Rejected” proposals, whole process of submission should be repeated

considering the reasons for rejection

12. If the ethics committee asks the investigators to do CTRI registration, it should be done

and CTRI reg.no. should be communicated to the committee .

13. Ethical clearance is initially issued for one year; after one year the investigator has to

request for continuation of ethical approval.

14. Ethics committee has every right to monitor the research study at any point of study

duration. The principal investigator should submit a report on progress of the study.

FMMCIEC SOP




of 216

Progress report should be submitted every six months (for clinical trials) or one year (for

other studies). After completion of the project, final report should be submitted.

15. Any serious adverse events should be notified to the FMMCIEC within 24 hours. All

protocol deviations, violations and amendments should be informed promptly.

Annexure – 6.3. Protocol Submission Form for Regulatory Trials

I. Proposal Title :

Name, Designation &

Qualifications

Address Tel & Fax

Nos. Email ID

Signature

Principle Investigator

Co-Investigator

Please attach detailed curriculum Vitae of all Investigators (with subject specific publications limited

to previous 5 years)

II. Sponsor information:

1. Indian a) Government Central State Institutional

b) Private

2. International Government Private UN agencies

3. Industry National Multinational

FMMCIEC SOP




of 216

Contact Address of Sponsor:

Total Budget (mention here and enclose the budget form)

III. Type of Study : Epidemiological Basic Sciences Animal studies

Clinical: Single center Multicentric Behavioral

IV. Status of Review :

New Revised

V. Clinical Trials:

Drug/Vaccines/Device/Herbal Remedies:

(i) Does the study involve use of :

Drug Devices Vaccines

Indian Systems of Medicine/

Alternate System of Medicine Any other NA

(ii) Is it approved and marketed

FMMCIEC SOP




of 216

In India UK & Europe USA

Other countries, specify

(iii) Does it involve a change in use, dosage,

route of administration ?

If yes, whether DCGI‟s/Any other Regulatory authority‟s

Permission is obtained ?

If yes, Date of Permission:

Yes

Yes

No

No

(iv) Is it an Investigational New Drug ?

If yes, IND No:

Yes

No

a) Investigator‟s Brochure submitted

Yes

No

b) In vitro studies data

Yes

No

c) Preclinical Studies done

Yes

No

FMMCIEC SOP




of 216

Clinical Study is : Phase I Phase II Phase III Phase IV

d) Are you aware if this study/similar study

is being done elsewhere ?

If Yes, attach details

Yes

No

VI. Brief description of the proposal – Introduction, review of literature, aims(s) & objectives,

justification for study, methodology describing the potential risks & benefits, outcome measures,

statistical analysis and whether it is of national significance with rationale

VII. Subject selection:

(i) Number of Subjects :

(ii) Duration of study:

(iii) Will subjects from both sexes be recruited

Yes

No

(iv) Inclusion / exclusion criteria given

Yes

No

(v) Type of subjects Volunteers Patients

FMMCIEC SOP




of 216

(vi) Vulnerable subjects Yes No

(Tick the appropriate boxes)

Pregnant women children elderly

Fetus illiterate handicapped

Terminally ill seriously ill mentally challenged

Economically & socially

backward any other

(vii) Special group subjects Yes No

(Tick the appropriate boxes)

Captives Institutionalized employees

Students Nurses/dependent armed forces

Any other staff

2. Privacy and confidentiality

(i) Study involves - Direct Identifiers

Indirect Identifiers/coded

Completely anonymised/delinked

Yes No

FMMCIEC SOP




of 216

(ii) Confidential handling of data by staff

3. Use of biological/hazardous materials

(i) Use of fetal tissue or abortus

Yes

No

(ii) Use of organs or body fluids Yes No

(iii) Use of recombinant /gene therapy

If yes, has department of Biotechnology (DBT) approval for

DNA products been obtained ?

Yes

No

(iv) Use of pre-existing/stored/left over samples Yes No

(v) Collection for banking/future research Yes No

(vi) Use of ionizing radiation/radioisotopes

If yes, has Bhaba Atomic Research Centre (BARC)

approval for Radioactive Isotopes been obtained ?

Yes

No

(vii) Use of Infectious/biohazardous specimens Yes No

(viii) Proper disposal of material Yes No

(ix) Will any sample collected from the patients be sent abroad ?

If yes, justify with details of collaborators

Yes

No

a) Is the proposal being submitted for clearance from

Health Ministry‟s Screening Committee (HMSC) /ICMR

for International Collaboration ?

Yes

No

FMMCIEC SOP




of 216

b) Sample will be sent abroad because ( Tick appropriate box)

Facility not available in India

Facility in India inaccessible

Facility available but not being accessed

If so, reasons ……………………

8. Consent : Written Oral Audio-visual

i. Consent form : (tick the included elements)

Understandable language Alternatives to participation

Statement that study involves research Confidentiality of records

Sponsor of study Contact information

Purpose and Procedures Statement that consent is voluntary

Risks & Discomforts Right to withdraw

Benefits Consent for future use of biological material

Compensation for participation Benefits if any on future commercialization

FMMCIEC SOP




of 216

Compensation for study related injury eg: genetic basis for drug development

If written consent is not obtained, give reasons:

(ii) Who will obtain consent ? PI/Co-PI Nurse / Counsellor

Research staff Any other

9.Will any advertising be done for recruitment of Subjects ?

( posters, flyers, brochure,websites – if so kindly attach a copy

Yes

No

10. Risks & Beneifts :

(i) Is the risk reasonable compared to the anticipated

benefits subjects/community/country ?

Yes

No

(ii) Is there physical/social/psychological risk/discomfort

If Yes, Minimal or no risk

More than minimum risk

High risk

Yes

No

(iii) Is there a benefit a) to the subject ?

Direct Indirect

FMMCIEC SOP




of 216

b) Benefit to society

11. Data Monitoring

(i) Is there a data & safety monitoring committee/Board (DSMB) ?

Yes

No

(ii) Is there a plan for reporting of adverse events ?

If Yes, reporting is done to :

Sponsor Ethics Committee DSMB

Yes

No

(iii). Is there a plan for interim analysis of data ? Yes No

(vi) Are there plans for storage and maintenance of all trial database ?

If Yes, for how long ?

Yes

No

12. Is there compensation for participation ?

If yes Monetary In kind

Specify amount and type:

Yes

No

13. Is there compensation for injury?

If Yes, by Sponsor by Investigator

By insurance by any other company

Yes

No

14. Do you have conflict of interest ? Yes No

FMMCIEC SOP




of 216

(financial/non-financial)

If Yes, specify:

15. . Number of protocols handled by the PI at present including current Status of

ongoing studies approved by IEC and carried out by the Principal Investigator.

(Information to be given: whether study is initiated, no. of approved research

participants, no. of research participants enrolled, no. of active research

participants, no. of research participants who have completed the study and total

duration of the study. Describe briefly in a separate sheet, if required)

16 . GCP training certificates of principal investigator and coordinators (Enclose

the copies of certificates)

Yes

No

16. Is the trial registered with Clinical Trial Registry? (mandatory only

for drug trials) Clinical Trial Registry of India(CTRI)/ any other

WHO platform registry

______________________________________________________

Registration number: ____________________________________

If not registered, state the reason____________________________

Yes No

Statement of Compliance:

We hereby declare that the information given above is true and that we will comply with the

guidelines mentioned in the Schedule Y [Drugs and Cosmetic Act 1940; amendment 20th January

2005, 30th January 2013, 8th February 2013 and any other recent notification/s from CDSCO (updated

as applicable)], Ethical Guidelines for Biomedical Research on Human Participants by Indian Council

of Medical Research (2006), Indian GCP Guidelines (2001) and the International Conference on

Harmonisation - Good Clinical Practices (ICH-GCP) Guidelines (1996) while conducting the research

study.

Signature of Principal Investigator with date: ____________________ Signature/s of Co-investigators

with date: 1.________________ 2.__________________3.______________ 4.______________ __

Signature of coordinator: 1.________________________2._____________________

FMMCIEC SOP




of 216

Forwarded by Heads of Department(s) Signature/s with date of Heads of Department(s):

______________, ______________ , ______________, _______________ ______________,

______________ , ______________, _______________ Stamp/Seal of the Department(s)

Annexure -6.4. : Checklist for Submission of Documents:

Sl.No. Document Yes No

1 Protocol Submission Form Duly Filled

2 Covering Letter

3 Protocol - hard copies as required

4 Protocol – soft copy by e mail or CD

5 CV of all investigators

6 Fee for Review

7 Informed Consent Documents in English

8 Informed Consent Documents in Kannada

9 Informed Consent Documents in Other Regional Languages as

Applicable

10 Translation and back translation certificates

11 Case Record Forms/Proforma

12 Research participants recruitment procedures: advertisement, notices

(If applicable)

13 Patient instruction card, identity card, diary etc.

14 Research Participants Questionnaire/s (If applicable)

15 Research participants confidentiality statement

16 Investigator Brochure

17 Insurance certificate and policy

18 Investigator‟s undertaking to DCG(I)

19 DCG(I) approval [if DCGI approval is awaited, the same is

mentioned in the covering letter to the IEC]

20 Clinical Trial Agreement for drug trial / Memorandum Of

Understanding / Copy of clinical trial protocol Material Transfer

FMMCIEC SOP




of 216

Agreement (MTA), as applicable, for collaborator & Govt

sponsored trials (draft if final not ready)

21 FDA marketing/manufacturing license for herbal formulations/

nutraceutics

Bhabha Atomic Research Centre (BARC) approval in case study

involves use of radioisotopes/ ionizing radiations

22 Administrative sanction from the Head of the Institution in case of

collaborative studies with other institutions / foreign agencies (one

copy) Or Memorandum of Understanding (as applicable)

23 Administrative sanction from the Head of the Institution for the

samples to be sent to outside institution (one copy) Or Material

Transfer Agreement (as applicable)

24 Budget Sheet for the Proposed Study (Format for budget sheet stated

below)

25 Signed and dated brief current curriculum vitae of the study team

members (principal investigator, co-investigator, study coordinator )

(one copy only)

26 Ethics Committee clearance of other centres (Total No _____)

27 Current Status of Ongoing Studies approved by IEC and IEC

conducted by principal investigator (information may be submitted

separately )

28 Documentation of clinical trial registration (in Clinical Trial

Registry of India) / any other WHO platform registry (whenever

applicable)

29 GCP training certificates of principal investigator, co investigator/s,

study coordinator/s for interventional clinical trial sponsored by

pharmaceuticals companies of training taken in last 5 years (one

copy only)

30 Any other Documents submitted

FMMCIEC SOP




of 216

Annexure – 6 .5.

SCIENTIFIC COMMITTEE, FAHER MULLER MEDICAL COLLEGE, MANGALURU

AND FATHER MULLER MEDICAL COLLLEGE INSTITUTIONAL ETHICS

COMMITTEE(FMMCIEC).

E MAIL : [email protected]

APPLICATION FORM FOR SUBMISSION OF RESEARCH PROTOCOL

For Office Use Only :

I. SCIENTIFIC COMMITTEE, FMMC :

1) Application Received on :

2) Corrections if Any, informed on :

3) Approved on :

4) Signature of Convener, Scientific Committtee.

II. FMMCIEC :

1) Received on :

2) Protocol No. :

3) Categorized for : Full Review/Expedited Review/Exempted from Review

4) Signature of Member Secretary , FMMCIEC with Date :

mailto:[email protected]

FMMCIEC SOP




of 216

I INVESTIGATOR INFORMATION

1. NAME OF THE INVESTIGATOR

(in block letters)

2. ADDRESS( residential )

3. DEPARTMENT

4. MOBILE NUMBER

5. EMAIL ID ( preferably institution ID

for staff )

6. COURSE AND SUBJECT( only for

PG student projects)

7. REGISTER NO (only for UG students)

II PROTOCOL INFORMATION

1. TITLE OF THE RESEARCH

PROJECT

2. NAME OF THE GUIDE

1. (only for UG and PG students)

3. NAME OF THE COGUIDE/

CO INVESTIGATOR

FMMCIEC SOP




of 216

4. NATURE OF SUBMISSION

A. UNDERGRADUATE ICMR /OTHERS

B. POSTGRADUATE / PhD THESIS / PAPER /POSTER/ CASE

REPORTS/OTHERS

C. STAFF

1

SPONSORED TRIAL/ ORIGINAL

STUDY/ POSTER / CASE REPORTS

III PROTOCOL CHECKLIST (Tick the relevant boxes)

A. TITLE

B. INTRODUCTION AND NEED FOR

STUDY

C. REVIEW OF LITERATURE

D. AIMS AND OBJECTIVES

E. MATERIALS AND METHODS –

study

design, sample size, methodology

F. STATISTICAL ANALYSIS

G. IMPLICATIONS OF THE STUDY

H. REFERENCES IN VANCOUVER

STYLE

I. PROFORMA

J. INFORMED CONSENT FORM

(in English and Kannada )

FMMCIEC SOP




of 216

K. PATIENT INFORMATION SHEET

( in English and Kannada )

L. BUDGET FOR THE PROJECT

(fill up the budget estimation form)

IV OTHER INFORMATION

1. DATE OF PRESENTATION IN THE

DEPARTMENT( applicable only to

UG and PG student projects)

2. DATE OF SUBMISSION TO THE

RESEARCH COMMITTEE

3. PERMISSION LETTER FROM THE

HOD OF DEPT( where non

routine/special

investigations/procedures are being

done for the study)

4. PERMISSION LETTER FROM THE

DEAN( only in relevant cases )

5. E MAIL SUBMISSION DONE ON

SIGNATURE OF THE INVESTIGATOR SIGNATURE OF GUIDE WITH SEAL

SIGNATURE OF THE HOD WITH SEAL

FMMCIEC SOP




of 216

Annexure 6.6. ESTIMATED BUDGET FOR THE PROJECT( APPLICABLE ONLY FOR UG,

PG AND STAFF INITIATED PROJECTS)

NOTE:

1. This application should contain the total cost of routine and special tests done for the project

2. This form should be submitted along with the application form for research protocol to the

scientific committee and email to [email protected] .

3. Also submit hard copy along with each copy of the research proposal submitted to scientific

committee.

AMOUNT IN RUPEES YEAR 1 YEAR 2 YEAR 3 TOTAL

PARTICULARS

STATIONERY,

PHOTOCOPYING,

BINDING

CONSUMABLES

EQUIPMENTS

INVESTIGATIONS

ROUTINE

TESTS DONE FOR

PROJECT (SPECIAL

TESTS-IN HOUSE)

TESTS SENT OUTSIDE

(SPECIAL TESTS

OUTSOURCED)

ANY OTHER MEDICAL

DEVICES/MEDICATIONS

ADDITIONALLY USED


FMMCIEC SOP




of 216

GRAND TOTAL

SL NO NAME OF THE

INVESTIGATION

NO OF

TESTS

TOTAL

AMOUNT

Source of Funding for the Research:

Declare Self-funding: Rs.--------------------------

I declare that the study subjects will not be made to pay for the special

investigations/devices/medications. The cost will be born by me or procured from research grants of --

-------------------------------------------------------.

Name and Signature of Principal Investigator.

Name and Signature of Co investigators :

Name of signature of Guide (for PhD/ PG/UG research)

Date :

FMMCIEC SOP




of 216

Annexure- 6.7. : FATHER MULLER MEDICAL COLLEGE INSTITUTIONAL ETHICS

COMMITTEE:

Format for Patient Information Sheet and Informed Consent Form

Title of the Study :

Names of Researchers/Investigators

Name of Organization :

Name of Sponsor (Grant agency):

Name of Project and Version

This Informed Consent Form has two parts:

Information Sheet (to share information about the study with you)

Certificate of Consent (for signatures if you agree to participate)

You will be given a copy of the full Informed Consent Form

Introduction

Briefly state who you are and explain that you are inviting them to participate in research which you

are doing. Inform them that may talk to anyone they feel comfortable talking with about the research

and that they can take time to reflect on whether they want to participate or not. Assure them that if

they do not understand some of the words or concepts, that you will take time to explain them as you

go along and that they may ask questions now or later

Purpose

Explain in lay terms why the research is being done and what is expected from the results. Explain

why you need to conduct the research with children.

Type of Research Intervention

Briefly state the intervention. This will be expanded upon in the procedures section

Selection of Participants

FMMCIEC SOP




of 216

State clearly why you have chosen them to participate in this study. Patients may wonder why they

have been chosen for a study and may be fearful, confused or concerned

Voluntary Participation

Indicate clearly that they can choose to participate or not and reassure they will still receive all the

services they usually do if they choose not to participate.. This can be repeated and expanded upon

later in the form as well. It is important to state clearly at the beginning of the form that participation is

voluntary so that the other information can be heard in this context. Participants may also be more

alert at the beginning.

Procedure

Explain what each of the steps or procedures involve. Indicate when the research will take place and

where. If there are surveys, indicate where and how the surveys will be collected and distributed.

Duration

Include a statement about the time commitments of the study for them. Include both the duration of

the study and follow-up, if relevant

Risks and Discomforts

Explain any risks or discomforts including any limits to confidentiality.

Benefits

Describe any benefits to them, to the community, or any benefits which are expected in the future as a

result of the research.

Reimbursements

State clearly what you will provide the participants with as a result of their participation. You will not

be entitled to any compensation beyond reimbursements for expenses incurred as a result of

participation in research. The expenses may include, for example, travel expenses and reimbursement

for time lost..

Confidentiality:

FMMCIEC SOP




of 216

Explain how the research team will maintain the confidentiality of data, especially with respect to the

information about the participant. Outline any limits there are to confidentiality. Note that with focus

groups confidentiality cannot be guaranteed because what is said within the group becomes common

knowledge. Participants can be asked not to share outside of the group but this does not guarantee

confidentiality

Sharing of Research Findings

Include a statement indicating that the research findings will be shared in a timely fashion but that

confidential information will remain confidential. If you have a plan and timeline for the sharing of

information, include the details. Also inform the parent that the research findings will be shared more

broadly, for examples, through publications and conferences.

Right to refuse or withdraw

Explain again the voluntary nature of consent.

Whom to Contact

Provide the name and contact information of someone who is involved, informed and accessible (a

local person who can actually be contacted. State also that the proposal has been approved and how.

Provide the contact number and address of the researchers

Mention that –This research project is reviewed and approved by Ethics Committee of Father Muller

Medical College, Kankanady, Mangalore. This is a committee whose task it is to make sure that

research participants are protected from harm.

The contact details of ethics committee are as follows:

Dr. Shivashankara A.R.,

Member Secretary,

Father Muller Medical College Institutional Ethics Committee,

Kankanady, MANGALORE-02.

Phone : 08242238399; 9880146133. Mail : [email protected]; [email protected].



FMMCIEC SOP




of 216

Dr.Ashok Shenoy K.,

Chairperson of Father Muller Medical College Institutional Ethics Committee,

Professor of Pharmacology,

Kasturba Medical College, Mangalore -01.

Phone : 9880530703. Mail : [email protected]

INFORMED CONSENT

I have read and understood the information/ it has been read to me and explained in an

understandable language about the research project : ------------(title). I have had the opportunity to ask

questions about it and any questions that I have asked have been answered to my satisfaction. I

consent voluntarily to participate as a participant in this research.

Name of Participant__________________

Signature of Participant ___________________

Date ___________________________

Day/month/year

If illiterate

A literate witness must sign (if possible, this person should be selected by the participant and should

have no connection to the research team). Participants who are illiterate should include their thumb-

print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the

individual has had the opportunity to ask questions. I confirm that the individual has given consent

freely.

Name of witness_____________________ AND Thumb print of participant

Signature of witness ______________________

Date ________________________


FMMCIEC SOP




of 216

Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my

ability made sure that the participant understands the procedures to be done:

I confirm that the participant was given an opportunity to ask questions about the study, and all

the questions asked by the participant have been answered correctly and to the best of my ability. I

confirm that the individual has not been coerced into giving consent, and the consent has been given

freely and voluntarily.

A copy of this ICF has been provided to the participant.

Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________

Date ___________________________

Day/month/year

Note : 1. In case of children being the subjects of study ,the parents/guardian has to sign the informed

consent form. This has to be mentioned clearly in the consent form as Name and signature of the

parent/guardian. A statement in the end by the researcher should mention that the protocol was read

out/explained to the parent/guardian of the child .

2. Consent form should be appropriately worded for adults and children (less than 18 years). e.g. If

the participant is less than 18 years of age, instead of „my participation‟, „my child‟s/ward‟s

participation‟ needs to be replaced. In the information sheet, instead of you or your , mention :Your

child” or “your child‟s”

3.The above format should be followed strictly but the wordings may be changed to reflect your

research proposal

FMMCIEC SOP




of 216

Annexure- 6.8. : Father Muller Medical College Institutional Ethics Committee Fee structure :

FMMCIEC charges for the clinical trials as per following details.

The FMIEC fee has been revised with effect from 01st July 2015, the details of the fee structure is as

follows.

1. Initial Review of study documents: (Protocol, ICF and other study documents)

A. International Studies: . 20,000.00

B. Indian Studies : . 10,000.00

2. Expedited Reviews:

( Protocol, ICF and other study documents)

A. International Studies: . 30,000.00

B. Indian Studies: . 15,000.00

3. Continued Reviews: (Review of any other study related documents submitted after initial review,

eg: ICFs, Subject diaries, Dosing cards, Investigators brochure etc.

A)Protocol Amendments and other changes to the Study related documents :

. 3000.00

B) Review of Advertisements (Submitted subsequently initial review) :

. 2000.00

4. Expedited Continued Reviews: (Review of any other study related documents submitted after

initial review, eg: ICFs, Subject diaries, Dosing cards, Investigators brochure etc. . 4000.00

5. Serious Adverse Events Reports : Not charged

All the payments for Ethics committee reviews shall be payable in favour of Father Muller Research

Centre Payable at Mangalore

FMMCIEC SOP




of 216

7. SOP-7 : Review Procedures

7.1. Purpose : The purpose of this SOP is to describe the procedure to categorize new

research study protocols submitted by investigators for initial review into full board /

expedited review or exemption from review process

7.2. Scope : This SOP covers the process of categorization of new research study protocols

submitted to Institutional Ethics Committee (IEC) for initial review.

7.3. Responsibility: The Member Secretary is responsible for categorizing the protocols

for review as full review, expedited review and exempted from review. The

suggestions/guidance of the Chairperson is taken whenever necessary. It is the

responsibility of the members of FMMCIEC to do the review as per the guidelines.

7.4. Procedure :

7.4.1. Exemption from Review : Proposals that are exempted from review include those with

less than minimal risk where there are no linked identifiers. This could be seen in following situations

–i) Research conducted on data that is in the public domain for systematic reviews or meta analysis

ii) Observation of public behavior when information is recorded without linked identifiers and

disclosure would not cause harm the interests of the observed person

iii) Quality control and quality assurance audits in the institution

iv) Comparison among institutional techniques, curricula, classroom management methods

v) Consumer acceptance studies related to taste and food quality

vi) Case reports: FMIEC issues ethical clearance to case reports for presentation /publication on

receiving and verifying informed consent from the patient, abstract of the case report and findings.

Wherever possible patient identity must be masked in the photographs used in case reports.The

Member Secretary may ask for a copy of the informed consent form signed by the patient whenever

the identity of the patient (face) is not masked.

Member secretary will go through (screening for documents to be submitted to IEC) the proposals

which are exempted from review, AND get the decision ratified in the full committee meeting

Exceptions : when research on educational tests, survey or interview procedures, or observation of

public behavior can identify the human participant directly or through identifiers, and the disclosure of

information outside research could subject the participant to the risk of civil or criminal or financial

liability or psychosocial harm; when interviews involve direct approach or access to private papers

FMMCIEC SOP




of 216

7.4.2. Expedited Review: The proposals that pose “no more than minimal risk” are considered for

expedited review. Expedited review will be conducted by chairperson, member secretary and 1-2

designated members. The approval granted through expedited review will be ratified at the next full

committee meeting.

In following situations, expedited review will be done:

i) Minor deviations from originally approved protocols (originally approved through full

review by the IEC),

ii) Revised proposal previously approved through full review or continuing review of

approved proposals where there is no additional risk or activity is limited to data analysis

iii) Research involving non-identifiable specimen and human tissue from sources like blood

banks, tissue banks, left over clinical samples

iv) Research involving clinical documentation materials which are non-identifiable (data,

documents, records)

v) Modifications or amendment to approved protocol including administrative changes or

correction of typographical errors and change in investigator(s)

vi) Revised proposal previously approved through expedited review, full review or

continuing review of approved proposals

vii) Minor deviations from originally approved research causing no risk or minimal risk

viii) Progress/annual reports where there is no additional risk e.g. activity limited to data

analysis.

ix) When in emergency situations like serious outbreaks or disasters a full review is not

possible, prior written permission may be taken before use of test intervention. Such

research can only be approved for pilot study or preliminary work to study the safety and

efficacy of the intervention. Same participants should not be included in the clinical trial

that may be initiated based on the findings of the pilot study

7.4.3. Full Review : All research proposals presenting more than minimal risk that are not covered

under exempt or expedited review should be subjected to full committee review

i) All studies involving interventions (clinical trials) involving trials on new drugs or combinations

of drugs

ii) Studies involving vulnerable population even if the risk is minimal

iii) Collection of blood samples by finger prick, heel prick, ear prick or venipuncture

FMMCIEC SOP




of 216

iv) Collection of peritoneal fluid, pleural fluid, ascitic fluid and cerebrospinal fluid

v) Collection of biological specimen by research purposes by non invasive means – skin

appendages, dental procedures ,excreta and external secretions, stimulated or unstimulated saliva

collection, placenta removed at delivery ,amniotic fluid obtained at the time of rupture of the

membrane prior to or during labor, buccal scrapings, skin swab or mouth washings, sputum

vi) Use of medical devices for study population such as implants and physical sensors

vii) Use of electrocardiography, electroencephalography, echocardiography, thermography,

ultrasound and other imaging techniques, Doppler blood flow

viii) Moderate exercise, muscular strength testing, body composition

assessment, and flexibility testing where appropriate given the age,

body weight, and health of the individual

Viii) Research involving clinical materials (data, documents, records or

specimens) that will be collected solely for non-research (clinical) purposes

IX) Collection of data from voice, video, digital or image recordings made for research purposes

X) Research on individual or group characteristics or behavior not limited to research on perception,

cognition, motivation, identity, language, communication, cultural beliefs or practices, and social

behavior or research employing survey, interview, oral history, focus group, program evaluation,

human factors evaluation, or quality assurance methodologies

7.4.4. Aspects Considered During Review of Research Proposal:

1) Scientific design and conduct of the study : Use of valid scientific methods

2) Social Values : The research must have anticipated social value, and outcome should be

relevant to the health problems of the society

3) Benefit-Risk Assessment: The benefits must justify the risk inherent in the research. Risks may

be physical, psychological, economic, or social; Withdrawal criteria, and rescue medication or

procedures

4) Selection of the Study Population and Recruitment of Research Participants : To ensure

voluntary recruitment, and fair selection of participants as per inclusion and exclusion criteria;

participant is given option to opt out without the routine care being affected; No individuals or

group of persons must bear the burdens of participation in research without any benefits except

FMMCIEC SOP




of 216

in studies where healthy volunteers are involved; Vulnerable group is not recruited unless

proper justification is provided

5) Payment of participation and Compensation Procedures, without inducement but, reimbursing

for incurred cost and convenience

6) Protection of research participant‟s privacy and confidentiality

7) Community considerations : due respect given to community and interests are protected ; no

stigma or discrimination ensues from the proposed research ; plans for communication of

results back to the community at the end of study; plan for dissemination of benefits of

research to the community

8) Qualifications of investigators and assess adequacy of study sites

9) Disclosure of potential conflicts of interest

10) Review of informed consent process

The review of proposals by members is documented in review forms , and in the minutes of meetings

of the FMMCIEC.

7.4. Annexures :

FMMCIEC SOP




of 216

Annexure -7.1. : Review form of FMMCIEC

Serial No of IEC Management Office (Protocol Number)

Proposal Title:

Principal Investigator:

Supporting/Funding Agency:

Project Status: New Revised

Review: Expedited Full Review

Date of Review:

1. Research Design

i. Scientifically sound enough to expose subjects to risk Yes No

ii. Relevant to contribute to further knowledge Yes No

iii Of national importance Yes No

2. Risks

a. Is there physical/social/psychological risk/discomfort? Yes No

b. Is the overall risk/benefit ratio Acceptable Unacceptable

3. Benefits

Direct: Reasonable Undue None

Indirect: Improvement in Any other

science/knowledge

4. Subject selection:

i Inclusion / exclusion criteria addressed? Yes No

ii Vulnerable subjects (woman, child, mentally challenged,

seriously or terminally ill, foetus, economically or socially

backward and healthy volunteers) adequately protected ? Yes No

iii. Special group subjects (captives, students, nurses &

Dependant staff) adequately protected? Yes No

FMMCIEC SOP




of 216

5. Privacy & Confidentiality maintained? Yes No

6. Patient Information Sheet: Adequate Inadequate

7. Consent form components addressed adequately? Yes No

8. Compensation, (if applicable) addressed adequately? Yes No

9. Is there a Conflict of Interest? Yes No

If yes, Acceptable Unacceptable

10. Budget: Appropriate Inappropriate

11. Decision of review

Recommended Recommended with suggestions

Revision Rejected

Any other remarks/suggestions:

Reviewer‟s name and Signature

FMMCIEC SOP




of 216

Annexure -7.2. : REVIEW OF CLINICAL TRIALS; RISK-BENEFIT CHART

HIGH RISK/LOW BENEFIT (CLASS-A)

Risks:

- Completely new drug/formulation

- Highly Toxic substances

- Safety/Effectiveness not established

through earlier studies

- High incidence of SAEs/side effects in

prelim studies

- Inadequate or no risk AE handling

mechanisms

- High data disclosure and data leakage

possibilities

- Affects large no. Of participants

- Violation legal/statutory regulations

- Inadequate project documentation

- Inadequate PI/Staff expertise

- New/untried procedures

Benefits:

- Cost of treatment/drug borne by

participant

- Replaces current drugs with no extra

benefits either treatment wise or cost

wise

- Short term relief as opposed to long term

action

- No post trial alternatives

HIGH RISK/HIGH BENEFIT (CLASS-B)

Risks:

- Completely new drug/formulation

- Highly Toxic substances

- Safety/Effectiveness not established through

earlier studies

- High incidence of SAEs/side effects in prelim

studies

- Inadequate or no risk AE handling mechanisms

- High data disclosure and data leakage

possibilities

- Affects large no. Of participants

- Violation legal/statutory regulations

- Inadequate project documentation

- Inadequate PI/Staff expertise

- New/untried procedures

Benefits :

- Completely new cure

- Preventive for life ie. Vaccinations

- Significant improvement over existing

cures/treatments

- Minimal side effects vis a vis existing treatments

- Elimination of disease rather than temporarily

curative

- Significant reduction in treatment costs/mode (ex.

Pill vs surgery)

- Extension of benefits / availability of treatment

post trial

- Benefits large no. of participants

FMMCIEC SOP




of 216

LOW RISK/LOW BENEFIT (CLASS-D)

Risks:

- Proven/Acceptable toxicity

- Proven safety and efficacy

- Drug/formulation a variation of approved

drug/class of drugs

- SAEs indicate minor/acceptable reactions

, side effects

- No drug but only data analysis

- Minimal data disclosure/leakage

possibilities

- Minimal risk to legal/statutory

regulations

- Standard operating / surgical procedures

Benefits:

- Cost of treatment/drug borne by

participant

- Replaces current drugs with no extra

benefits either treatment wise or cost

wise

- Short term relief as opposed to long term

action

- No post trial alternatives

LOW RISK/HIGH BENEFIT (CLASS-C)

Risks:

- Proven/Acceptable toxicity

- Proven safety and efficacy

- Drug/formulation a variation of approved

drug/class of drugs

- SAEs indicate minor/acceptable reactions , side

effects

- No drug but only data analysis

- Minimal data disclosure/leakage possibilities

- Minimal risk to legal/statutory regulations

Standard operating / surgical procedures

Benefits :

- Completely new cure

- Preventive for life ie. Vaccinations

- Significant improvement over existing

cures/treatments

- Minimal side effects vis a vis existing treatments

- Elimination of disease rather than temporarily

curative

- Significant reduction in treatment costs/mode (ex.

Pill vs surgery)

- Extension of benefits / availability of treatment

post trial

- Benefits large no. of participants

FMMCIEC SOP




of 216

Annexure-7.3. : Definition of Risk (as per Ethical Guidelines for Biomedical Research

on Human Participants, Indian Council of Medical Research, 2017)

Less Than Minimal Risk Probability of harm or discomfort anticipated in the research is nil or not

expected. For example, research on anonymous or non-identified

data/samples, data available in the public domain, meta-analysis, etc.

Minimal Risk Probability of harm or discomfort anticipated in the research is not greater

than that ordinarily encountered in routine daily life activities of an average

healthy individual or general population or during the performance of

routine tests where occurrence of serious harm or an adverse event (AE) is

unlikely. Examples include research involving routine questioning or

history taking, observing, physical examination, chest X-ray, obtaining body

fluids without invasive intervention, such as hair, saliva or urine samples,

etc

Minor Increase Over

Minimal Risk

Increment in probability of harm or discomfort is only a little more than the

minimal risk threshold. This may present in situations such as routine

research on children and adolescents; research on persons incapable of

giving consent;

delaying or withholding a proven intervention or standard of care in a

control or placebo group during randomized trials; use of minimally

invasive procedures that might cause no more than brief pain or tenderness,

small bruises or scars, or very slight, temporary distress, such as drawing a

small sample of blood for testing; trying a new diagnostic technique in

pregnant and breastfeeding women, etc. Such research should have a social

value. Use of personal identifiable data in research also imposes indirect

risks. Social risks, psychological harm and discomfort may also fall in this

category.

More than Minimal Risk Probability of harm or discomfort anticipated in the research is invasive and

greater than minimal risk. Examples include research involving any

interventional study using a drug, device or invasive procedure such as

lumbar puncture, lung or liver biopsy, endoscopic procedure, intravenous

sedation for diagnostic procedures, etc.

FMMCIEC SOP




of 216

Annexure 7.4. : Checklist for Review of Informed Consent Documents:

To check for Yes/No If No, Remarks

Purpose of the Study

A statement that it is a research

Explanation of what a clinical trial is (applicable only to

regulatory trials)

Expected duration of the participation and

frequency of contact with estimated number of participants to

be enrolled, types of data collection and methods

Methods of the study

Benefits to the participant, community or others that might

reasonably be expected as an outcome of research

Any foreseeable risks, discomfort or inconvenience to the

participant resulting from participation in the study

Statement whether the study drug is an approved product or

not

In trials using Placebo, explanation of Placebo and the

possibility that the participant may not receive any drug if on a

Placebo group

Payment/reimbursement for participation and incidental

expenses depending on the type of study

Free treatment and/or compensation of participants for

research-related injury and/ or harm

Freedom of the individual to participate and/or withdraw from

research at any time without penalty or loss of benefits to

which the participant would otherwise be entitled

Statement on confidentiality of information and data collected ;

and concealing the personal identity of the patient

The identity of the research team and contact persons with

addresses and phone numbers

FMMCIEC SOP




of 216

(for example, PI/Co PI for queries related to the research and

Chairperson/Member Secretary of IEC)

Statement of the patient that he/she has understood the details

of the study, and his/her queries are satisfactorily answered

Informed consent form in the correct format, with the

provision for thumb impression of illiterate and impartial

witness

Provision for signature of parents for the studies involving

children

Child assent form as applicable

Language used is simple to be understood by the layperson

Translated version of the ICD in Regional/local language is

available, and matches with the English version

Translation and back translation certificates are submitted

Additional contents of ICD that need to be checked as applicable:

To check for Yes/No If No, Remarks

Any alternative procedures or

courses of

treatment that might be as

advantageous to the participant

as the ones to which she/he is

going to be subjected

If there is a possibility that the

research could lead to any

stigmatizing condition, for

example. HIV and genetic

disorders, provision for pretest-

and post-test counseling

Insurance coverage if any, for

research-related or other

FMMCIEC SOP




of 216

adverse events

Foreseeable extent of

information on possible current

and future uses of the

biological material and of the

data to be generated from the

research

Annexure 7.5. : Checklist for Assessing Contract and Budget :

Yes No Remarks

The clinical trial contract ensures protection of the

research participant

The clinical trial contract ensures privacy and

confidentiality of study participants and their data

Indemnification :

1) Compensation for Participation is

mentioned and explained appropriately

2) Compensation for any SAE is mentioned

and explained appropriately

3) There is a valid insurance agreement

Arbitration : In case of any legal dispute, the

jurisdiction is explained

DCGI permission is obtained

FMMCIEC SOP




of 216

8. SOP-8 : Preparation of Agenda, Conduct of Meeting and

Minutes of Meetings

8.1. Purpose: The purpose of this SOP is to describe the preparation of agenda, distribution of

agenda, preparation for meeting, conducting the meeting and preparing minutes of meetings of

FMMCIEC

8.2. Scope: This SOP applies to administrative processes concerning the preparation of the

agenda and recording minutes of all IEC meetings.

8.3. Responsibility: The Member secretary is responsible for preparation of the agenda,

recording the minutes of meeting and circulation of the minutes to all members of FMMCIEC.

The Chairman conducts the meetings of FMMCIEC, and approves the minutes of meeting.

8.4. Procedure:

8.4.1. The meeting schedule: The FMMCIEC meeting is held once a month on the second

Saturday. Frequency of the meeting is increased depending on the number of research

proposals for full review. The meeting day may be changed (other than second Saturday) if

there is a holiday for the institution or due to any other reasons because of which the

meeting is not possible on second Saturday.

8.4.2. Preparation of Agenda:

8.4.2.1. The research proposals received by the FMMCIEC are categorized for review as : exempted

from review, expedited review and full review. This is done by the Member Secretary who will do the

initial scrutiny of the research proposals. The review is done only for the proposals categorized for

expedited and full review. The expedited review will be done by the Chairperson, the Member

Secretary and one member of FMMCIEC. The full review will be done by all members of FMMCIEC.

8.4.2.2. The research proposals categorized for full review will be included in the agenda for

presentation during the meeting of FMMCIEC. The expedited reviews and exempted from review are

included for ratification by all members in the meeting.

8.4.2.3. The format of the agenda is enclosed in the annexure of this SOP. The agenda includes:

quorum of previous meeting (list of members present and absent), ratification of the minutes of

FMMCIEC SOP




of 216

previous meeting, presentation of the research proposals (full review) by the principal investigators,

ratification of the expedited reviews, presentation of the proposals categorized under “exempted from

review” by the Member Secretary, and any other issues as recommended by the members and

approved by the Chairperson. Other issues could be report of onsite monitoring, training needs,

accreditation of ethics committee, serious adverse events, review of protocol deviations/amendments,

continuing review of research studies, completion reports of research studies, revision of SOPs,

changes in the committee composition, report of subcommittees appointed by the Chairperson (if

any)and emergency concerns.

8.4.2.4. Only those research proposals and documents (informed consent documents, protocol

deviation/amendment notifications, revised submissions, progress reports, study completion reports)

received ten days before the scheduled meeting will be included in the agenda

8.4.2.5. The venue of meeting is ensured before sending the agenda to all members. The agenda will

mention the date, time and venue of the meeting.

8.4.2.6. A hard copy of the agenda, copies for research proposals for review and review forms are sent

to the members at least one week before the meeting. The secretariat is responsible for sending these

documents to all members without fail. The institution provides the transport facility for the same.

8.4.2.7. Even if there are no research proposals for review, the committee shall hold meeting at least

once a month and discuss issues other than review of proposals.

8.4.2.8. If any member is unable to attend the meeting, he/she should inform the Chairperson (through

the Member Secretary) well in advance. (Preferably one week before the scheduled date of meeting).

The leave should be requested in a written leave letter In emergency situations if the member is not

able to inform in advance, e mail communication could be done. If the Chairperson is unable to attend

the meeting, he/she will inform the Member Secretary, and ask him to conduct the meeting with the

Vice Chairperson as the acting Chairperson for the meeting.

8.4.2.9. All regular members of FMMCIEC, independent consultants and principal investigators of

research proposals categorized for full review are required to attend the meeting. If any member is

unable to attend the meeting they need to inform the Chairperson or Member Secretary by any means

of communication. Independent consultants chosen for full review are intimated to attend the meeting

during the presentation of those research proposals which they have reviewed.

FMMCIEC SOP




of 216

8.4.2.10. The principal investigator should attend the meeting and present the proposal. Co

investigators are allowed to attend the meeting.

8.4.3. Conduct of Meeting:

8.4.3.1. The secretariat will help the Member Secretary in arrangements for the meeting

8.4.3.2. The FMIEC full board meeting will be held as per the schedule provided there is quorum as

per requirement

8.4.3.3. There should be the presence of at least 6 members out of the total 10 members of the

committee to constitute quorum.

8.4.3.4. Besides the Chairperson and the Member Secretary the quorum will consist of

One basic medical scientist

One social worker (or a social scientist, theologian, ethicist, philosopher, member

or representative of a non-governmental voluntary agency or a similar person),

A clinician,

A lay person from the community and

A legal expert

8.4.3.5. The signature of all members who attended the meeting will be taken on the attendance sheet

8.4.3.6. Guests or observers may be allowed in the meeting provided they have taken prior permission,

and signed confidentiality agreement

8.4.3.7. The Chairperson initiates the meeting after ensuring quorum. The Chairperson ensures the

quorum for every clinical trial presentation in the meeting.

8.4.3.8. The Chairperson will ask the members whether anyone has any conflict(s) of interest in the

projects to be discussed and if so, to declare the conflict. The Secretariat will obtain signatures on the

Conflict of Interest Agreement Form from members who declare a conflict prior to the start of the

meeting.

8.4.3.9. If a conflict of interest has been declared by a member, the Chairperson will ask the member

concerned to leave the meeting room when the concerned issue is being discussed.

FMMCIEC SOP




of 216

8.4.3.11. The Member Secretary will ask the members whether any points need to be discussed

regarding minutes of the previous meeting. If no points are raised, the minutes will be considered as

confirmed.

8.4.3.12. The Member Secretary will present the agenda of the day‟s meeting for discussion.

8.4.3.13. The meeting shall generally proceed in the order organized in the agenda. However, the

Chairperson may allow adjustments in the order of issues to be discussed depending on the

situation.

8.4.3.14. The Principal Investigators are asked to present the research proposals as per the order of

proposals mentioned in the agenda. When one investigator is presenting the proposal, investigators of

other research proposals should not be present in the meeting room. However, co investigators of the

same research proposal (or guides in case of postgraduate dissertations) are allowed to be in the

meeting room. In case of informed absence of principal investigator, co investigator may be allowed to

make the presentation. However, if the members feel that co investigator is not familiar with the

protocol details, the principal investigator may be asked to attend the next meeting of IEC for the

presentation.

8.4.3.15. The members of FMMCIEC should not discuss on the decisions about the research proposals

when the investigators are inside the meeting room. The members should discuss only after the

investigator leaves the meeting room.

8.4.3.16. For other matters in the agenda (other than full review), the member secretary will present

the review findings (expedited review), list of proposals under exempted from review, protocol

deviations/amendments, etc..

8.4.3.17. Reports of any subcommittees will be presented in the meeting by the heads of respective

committees, as per the agenda

8.4.3.18. The proceedings of the meeting will be recorded by the Member Secretary . If the Member

Secretary has conflict of interest in any research proposal, the joint secretary will do this job.

8.4.4. Decision Making:

FMMCIEC SOP




of 216

8.4.4.1. The final decision on approval of a research proposal is by consensus... In the review forms,

the members need to tick one of the following:

1) Approved 2) Approved with suggestions

3) Resubmit with revisions 4) Rejected

In the “Suggestions” of section of the form, member can write down his/her suggestions of any and

points to be considered for revision of the research proposal. Reasons for rejecting the proposal also

should be mentioned in this section of review form.

Final decision is taken by consensus. The Chairperson ensures participation of all members in the

deliberations.

The decisions are based on risk assessment, scientific validity, and adherence to ethical principles for

the initial and periodic approvals.

8.4.4.2. The independent consultants called to the meeting will be present only for the presentation of

the concerned research proposal. He/she will give the opinion during the meeting and will leave the

meeting room. They don‟t have any voting rights.

8.4.5. Minutes of the Meeting:

8.4.5.1. The minutes of the meeting are prepared by the member secretary on summarizing the

discussions held in the meeting and decision taken by consensus.

8.4.5.2. Following are the contents of the minutes of meeting:

1) Date, time and venue of the meeting

2) List of members who attended and who were absent for the meeting

3) List of guests /observers who attended the meeting

4) Name of the individual who served as chairman for the meeting

5) Ensuring of quorum by the chairman

6) Ratification of minutes of the previous meeting : to be mentioned

7) Research proposals for full review : summary of discussions and approval status

8) Research proposals for expedited review : summary of discussions and approval

status

FMMCIEC SOP




of 216

9) Research proposals exempted from review : list of the proposals

10) Discussion of protocol deviations/amendments , with actions taken

11) Discussion of onsite monitoring visits if any, with actions taken

12) Discussion of progress reports and final reports if any , with actions taken

8.4.5.3. The minutes are prepared within 3 working days of the meeting day

8.4.5.4. The minutes are sent to all members of the committee by e mail and their inputs are taken. The

Chairperson gives the final approval for the minutes

8.4.5.5. The minutes are presented in the next meeting for ratification

8.4.6. Communication of the Decision to Investigators :

8.4.6.1. The decision of the IEC is communicated to the principal investigators. All communications

are done by the member secretary (or joint secretary in his absence).

8.4.6.2. The communication of the decision will include:

1) Name and address of IEC

2) The date and place of the decision

3) The name and designation of the investigators

4) Protocol no. given by the IEC

5) Title of the research proposal reviewed

6) Version No., date, amendment no. of the protocol (for clinical trials)

7) List of documents reviewed (for clinical trials)-clear description of these documents along

with version No., and date.

8) List of IEC members who attended the meeting-clear description of their role and

affiliation

9) A clear statement of the decision reached

10) Any advice by the IEC to the applicant including the schedule /plan of ongoing review by

the FMMCIEC

11) In case of conditional decision, any requirement by IEC, including suggestions for revision,

and the procedure for having the application re-reviewed

12) In case of rejection ,reasons for rejection will be clearly stated

FMMCIEC SOP




of 216

13) Signature of the member secretary with date.

8.4.6.3. The investigator is asked to register the study in Clinical Trial Registry of India (CTRI) . Any

researcher who plans to conduct a trial involving human participants, of any intervention such as

drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or

behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the

department of AYUSH are expected to register the trial in the CTRI before enrollment of the first

participant.

8.4.7. Validity of Approval: Though the approval is granted for the entire duration of the study, the

validity of the approval letter is only up to one year. Depending on the risk involved, the progress of

the project will be monitored annually .The approval will be continued if progress is satisfactory. The

decision of IEC may be reversed if IEC receives information that may adversely affect the benefit/risk

assessment.

8.4.8 . Calling an Emergency Meeting of FMMCIEC:

8.4.8.1. The Member Secretary in consultation with the Chairperson may call for an emergency

meeting on following occasions:

1) Urgent issues which if not discussed and decided may have adverse impact on patient safety

2) Serious adverse events

3) Other issues deemed appropriate by the Chairperson or the Member Secretary

8.4.8.2. The Secretariat will endeavor to contact each and every IEC member and inform him/her

about the date, time and venue of the meeting as well as the reason for calling for the meeting.

8.4.8.3. The documents for discussion in emergency will be sent by e mail. The notice of this meeting

may be sent at least one day in advance.

8.4.8.4. The rules of quorum will be applicable. If a quorum is not met, the meeting will be postponed

for 15 minutes. However, if there is no quorum at the end of 15 minutes; the meeting would be held

without a quorum provided at least four members (at least one scientific and one non-scientific

member) are present, given the urgency of the matter under consideration. The IEC members will act

according to the relevant IEC SOPs (Expedited Review, SAE review, Review of Protocol

FMMCIEC SOP




of 216

deviations/violations etc.) for discussion and decision-making on the matter under consideration. The

minutes of the emergency meeting would be prepared, distributed, approved and filed as described in

the steps above for regular full board meeting.

8.4.8.5. Calling additional meetings of FMMCIEC: The Member Secretary in consultation with the

Chairperson can call for additional meetings depending on the requirement. These are the meetings

other than emergency meetings. Additional meetings are called if the number of research proposals for

full review are more than 15, and if the FMMCIEC is not able to include discussion of issues such as

progress reports, onsite monitoring, study completion reports, etc..in the monthly meeting due to

constraint of time . The procedure for agenda, conduct and minutes is the same as that followed for the

usual monthly meetings.

8.5. Annexures :

Annexure-8.1 : Agenda format

Meeting No. :

Date and Time of Meeting:

Venue of Meeting:

I. Ratification of the minutes of previous meeting

II. List of Research proposals for full review :

III. List of proposals for expedited reviews

IV. List of proposals exempted from review

V. Protocol deviations/amendments

VI. Study completion /progress reports

VII. Reports of onsite monitoring

VIII. Reports of subcommittees

IX. Any other issues

-----------------------------------------------------------------------------------

FMMCIEC SOP




of 216

Annexure 8.2. Leave Letter

Date :

From :

---------------------------------

Member, FMMCIEC.

To : The Chairperson, FMMCIEC.

Dear Sir,

Sub : Inability to attend the meeting of FMMCIEC.

I am unable to attend the meeting of FMMCIEC scheduled on -----------------------., due to ---------------

----(reason). I request you to kindly excuse me for the absence.

Yours Sincerely,

Name and Signature of the Member .

FMMCIEC SOP




of 216

Annexure-8.3: Format for Minutes of meeting:

Meeting No:

Date and Time :

Venue :

I. Members present and absent : list with designations

II. Guests or observers present : list with designations

III. Name of the individual who served as Chairperson

IV. Ensuring of quorum by the Chairperson

V. Ratification of the minutes of the previous meeting

VI. Research proposals for full review :

The proceedings are recorded as follows ---

Protocol No. Title of the Study Name of the

Principal

Investigator

Remarks by the members

(opinion/suggestion/other

remarks)

Approval status

VII. Research Proposals for expedited review :


Principal

Investigator

Names of the members

who did the expedited

review, with remarks

Approval status

VIII. Research Proposals exempted from review :


Principal

Investigator

New/Revised

Submission

Approval status

IX. Discussion of Protocol Deviations/amendments and actions taken :


Principal

Protocol

deviation/amendment

Action taken

FMMCIEC SOP




of 216

Investigator

X. Discussion of reports of onsite monitoring


Principal

Investigator

Deficiencies observed

during onsite

monitoring

Action taken , with

remarks of

monitoring team

members and Final

decision

XI. Discussion of reports of subcommittees

Team

members

Purpose of the

subcommittee

Brief

description of

the work done

by the

subcommittee

Remarks of the

Chairman

XII. Discussion of Progress Reports and Study Completion Reports :


Principal

Investigator

Remarks on the report

submitted

Action taken as per

the requirement

FMMCIEC SOP




of 216

Annexure-8.4. : Decision Letter Format (For clinical trials)

FATHER MULLER MEDICAL COLLEGE INSTITUTIONAL ETHICS

COMMITTEE (FMMCIEC) , FATHER MULLER MEDICAL COLLEGE

Father Muller Road, Kankanady, Mangalore-575002

Ref. No. -------------------------------- Date :

Dear Dr./Ms/Mr. ---------------------------------------------------(Principal Investigator-name and address)

Your research proposal was reviewed discussed in the ethics committee meeting held on ------------------

and the decision is as follows:

Protocol title: “---------------------------------------”

Protocol No:


Co Investigators :

Version No., date, amendment no. of the protocol :

List of documents reviewed (for clinical trials)-clear description of these documents along with

version No., and date.

Name & Address of Institution :

New review: Exempt review/ Expedited review/ Full review

Review of Revised Submission:

Date of review:

Date and type of previous review, if revised application:

Decision of the Ethics Committee:

> Approved

> Approved with suggestions

> Revision/ Resubmission

> Rejected

Suggestions /Reasons/Remarks:

Recommended for a period of :

FMMCIEC SOP




of 216

The approval is valid for one year. After one year, you are instructed to submit an application

requesting for continuation of ethical clearance for another one year (if required).

You are instructed to register your trial in clinical registry (CTRI) before starting the study, and

submit the necessary evidence to the IEC

Your research work will be continuously reviewed by ethics committee during the study

period.

The investigator/s is/are instructed to carry out the research study as per the protocol approved

by the ethics committee. Any protocol deviations/violations should be brought to the notice of

ethics committee.

The FMMCIEC will be monitoring the conduct of the protocol by on-site monitoring, review

of study-related documents and review of progress reports.

You are instructed to submit progress report of the research project once in every six months

You should comply with the regulations and guidelines on biomedical research on human

participants, and follow good clinical practice

Ethics committee has the right to withdraw the approval if found necessary due to protocol

violations, non-compliance to regulations and guidelines

For any modifications/changes in protocol, investigators and study site you need to submit the

proposal to ethics committee and get the approval.

You should report any serious adverse events in your site or any other site of this clinical trial

to the ethics committee

You need to submit the final report and summary at the termination of the study.

Following members of the IEC were present and involved in decision making.

Name Affiliations Role in the Committee

Following members were absent :


Name and Signature of Member Secretary

FMMCIEC SOP




of 216

Annexure -8.5. : Decision Letter Format (For studies other than clinical trials)


COMMITTEE (FMMCIEC), FATHER MULLER MEDICAL COLLEGE


Ref. No. -------------------------------- Date :


Your research proposal was discussed in the ethics committee meeting held on ------------------and the

decision is as follows:

Protocol title: “”

Protocol No:


Co Investigators :




Date of review:

Date of previous review, if revised application: Nil


> Approved

> Approved with suggestions

> Revision/ Resubmission

> Rejected


Recommended for a period of : 1 Year

FMMCIEC SOP




of 216

The approval is valid for one year. After one year, you are instructed to submit an application

requesting for continuation of ethical clearance for another one year (if required).


period.

You are instructed to submit progress report of the research project annually






Following members of the IEC were present and were involved in decision making.



FMMCIEC SOP




of 216

9. SOP-9: Continuing Review of Protocols

9.1. Purpose : The purpose of this SOP is to describe how continuing review of previously approved

protocols should be managed by the Institutional Ethics Committee (IEC). The purpose of the

continuing review is to periodically monitor the progress of the study, to ensure continuous protection

of the rights and welfare of research participants.

9.2. Scope : This SOP applies to conducting any continuing review of already approved study

protocols at pre-specified intervals. All the projects approved by the IEC will be reviewed at least once

a year. Depending upon the degree of risk to the participants, the nature of the studies, the

vulnerability of the study participants and duration of the study, the IEC may choose to review or

monitor the protocols more frequently.

9.3. Responsibility : It is the responsibility of the IEC Secretariat to remind the PIs and Member

Secretary regarding continued review of protocols at the correct interval. All the approved protocols

will be reviewed annually. It is the responsibility of the Member Secretary to ensure a decision

regarding whether the project needs to be reviewed more frequently is taken during the IEC meeting in

which the project is finally approved. This must be recorded in the minutes. A fresh decision to

increase review may be taken if required based on the SAE reports, monitoring reports, or safety

concerns. This is responsibility of the SAE subcommittee and Member Secretary. The IEC is

responsible for reviewing the progress made in the protocol (number of patients recruited, dropped

out, reasons for drop-out), the occurrence of unexpected events or problems, and compliance of the

investigator regarding IEC communication

9.4. Procedures:

9.4.1. The continuing review of protocols is done by FMMCIEC once in six months for the clinical

trials, and once in a year for the academic studies.

9.4.2. For Clinical Trials: The Member Secretary with the help of the secretariat decides the dates of

continuing review based on the date of approval for the protocol. If the principal investigators do not

send the progress report of the protocols on their own, a reminder notice is sent by the Member

Secretary 15 days before the due date. The IEC secretariat received the documents for continuing

FMMCIEC SOP




of 216

review. The Member Secretary verifies the documents submitted along with the application for

continuing review.

9.4.3. For Academic Studies: An annual report is sought from heads of departments that the studies

done in the Department are conducted as per IEC guidelines. The heads need to submit the report in

the designated format.

9.4.4. Review of Submitted Documents : The documents submitted for continuing review will be

categorized for reviews as : exempted from review, expedited review and full review . The IEC

Chairperson/ Member Secretary/ Member/s will use the Continuing Review Application Form to guide

the review and deliberation process. The Secretariat will send the Continuing Review Application

Form to the designated IEC members.

9.4.5. Decision Making : The investigators of protocols listed for full review will be asked to make a

presentation in the full board meeting of IEC .Decision on the continuation of ethical approval will be

taken by consensus. Following decisions could be taken :

1. Noted - The IEC approves the continuation of the project without any modifications.

2. Modifications recommended: The study protocols that have been suggested modifications by the

IEC may not proceed until the conditions set by the IEC in the decision have been met. The

amendments and the required documents should be amended and submitted to the IEC within one

month for re-review.

3. The project cannot be continued: The reasons for discontinuation of the project should be mentioned

in the letter notifying the decision to the Principal Investigator.

9.4.8. Action to be Taken for Failure of Submission for Continuing Review :

If the PI fails to submit documents for continuing review within the stipulated date, the Member

Secretary sends a reminder notice asking the PI to submit the documents within 7 days. Further, non-

response or failure to submit documents will be discussed in the full board meeting of the IEC. Action

could be one of the following : one more reminder and asking the PI to give an explanation for the

failure to submit documents / withdrawing the ethical approval granted and asking the PI not to

continue the study/ any other action which is deemed appropriate. The head of the institution will be

informed of the decision of the IEC.

9.5. Annexures :

FMMCIEC SOP




of 216

Annexure-9.1. : Continuing Review Application Form (Clinical Trials) :

Name of Principal Investigator : Department :

IEC Protocol No. Title of the Study :

Date of Approval from IEC :

Summary of Protocol Participants :

No. of participants screened _____

No. of participants approved by IEC

No. of recruited participants _____

No. of ongoing participants _____

No. of completed participants ____

No. of participants who refused to consent : -------

------

If any participants have withdrawn from the study

?

Yes : No :

If yes, give the number.

Attach a separate sheet mentioning the reasons for

withdrawal of each participant

Protocol Amendments :

Have there been any amendments to the protocol

/ICD/ any other documents related to the protocol

?

Yes : No :

If yes, whether the amendments have been

brought to the notice of the IEC and approved ? -

--Yes : No :

If the amendments are not brought to the notice of

IEC and not approved , mention those

amendments. (Attach a separate sheet mentioning

the amendments)

Protocol Versions Currently Used :

What is the version No . of the ICD used at

present ? --------------------------------

What is the Version No. of the Protocol used at

present ? -------------------------------

Has any information appeared in the literature, or

evolved from this or similar research that might

affect the IEC/IEC‟s evaluation of the risk/benefit

analysis of participants involved in this protocol?

Yes: No :

If Yes (attach separate sheet if needed)

Whether reports of SAEs so far have been

reviewed by the IEC- _______________

Whether reports of SAEs at other sites have been

submitted to the IEC-__________

Have any participating investigators been added

or withdrawn since last review? Yes No

FMMCIEC SOP




of 216

If Yes (Identify all changes in the attached

narrative)

Is report of interim data analysis available?

Yes (submit as an attachment)

No

Is report of the data safety and monitoring board

available?

Yes (submit as an attachment)

No

Have any investigators developed equity or

consultative relationship with a source related to

this protocol which might be considered a conflict

of interest?

Yes (Append a statement of disclosure)

No

Signature of the Principal Investigator with Date :

FMMCIEC SOP




of 216

Annexure-9.2. : Continuing Review Form (for academic studies)

Name of the Department : Name of the HOD :

Continuing Review Report submitted for the period of :

Sl.

No.

Name of the

Principal

Investigator

Title

of the

Study

Ethics

Committee

Approval

Date

No. Study

participants

Recruited

Study

Completed/On

going

(mention)

If the project was

sponsored/funded,

mention the

funding agency

and amount

funded

If the project

was self-

funded,

mention the

amount self-

funded

I hereby declare that :

1) All the above studies are conducted as per the protocols approved by the FMMCIEC

2) Any Protocol changes/deviations have been informed to the FMMCIEC

3) The applicable ethical guidelines have been followed.

Note : Please mention if any investigator has violated ethical guidelines, specify.

Signature of Head of the Department , Date.

FMMCIEC SOP




of 216

Annexure-9.3. : Continuing Review Form

Name of Principal Investigator : Department :

IEC Protocol No. Title of the Study :

Date of Approval from IEC :

Review to be done by :

1. Expedited Review

Names of Designated IEC Members:

2. Full Board Review

Decision After Review :

1) Approved and the project can be continued without any modifications

2) Modifications recommended - requiring protocol resubmission (State the modifications

required)

3) Protocol should be discontinued (State the Reasons):

Name and Signature of the Reviewer :

Date

FMMCIEC SOP




of 216

Annexure 9.4. : Decision Letter


COMMITTEE (FMMCIEC) , FATHER MULLER MEDICAL COLLEGE


Ref. No. -------------------------------- Date :


Your research proposal was reviewed discussed in the ethics committee meeting held on ------------------

and the decision is as follows:

Protocol title: “---------------------------------------”

Protocol No:


Co Investigators :




Date of review:

Date and type of previous review, if revised application:


> Approved ; the project can be continued

> Modifications Recommended

> The Study should be discontinued


Recommended for a period of :


period.

FMMCIEC SOP




of 216

You are instructed to submit progress report of the research project once in every six months

You should comply with the regulations and guidelines on biomedical research on human

participants, and follow good clinical practice





You should report any serious adverse events in your site or any other site of this clinical trial

to the ethics committee


Following members of the IEC were present and involved in decision making.


Following members were absent :



FMMCIEC SOP




of 216

10. Sop-10: Review of Resubmitted and Amended Protocols and

Protocol-Related Documents

10.1. Purpose: The purpose of this SOP is to describe the review and decision making for

resubmissions of research proposals, amended protocols, protocol-related documents submitted

to FMMCIEC.

10.2. Scope : This SOP applies to the processes involved in review and decision making for

resubmissions and amendments of protocols submitted to

10.3. Responsibility: The secretariat of FMMCIEC is responsible for receiving the

resubmissions, protocol amendments and other protocol-related documents. The Member

Secretary is responsible for verifying the completeness of the documents submitted, and

deciding the type of review to be done. The Chairperson is responsible for the final decision on

the submitted documents.

10.4. Procedure:

10.4.1. Review of Resubmitted Protocols:

10.4.1.1. The research proposals are resubmitted if the FMMCIEC had suggested the investigator to do

so (As recorded in the minutes of the meetings of FMMCIEC). The investigators submit the revised

protocols to the secretariat of FMMCIEC

10.4.1.2. The member secretary will refer to the minutes of meeting of FMMCIEC and decision

letters, and verify the completeness of the revisions done by the investigator.

10.4.1.3. The member secretary will categorize the resubmission for “exempted from review”,

“expedited review” or “full review”.

10.4.1.4. Exempted from Review: If the nature of revision is minor and involves only the changes

such as change in title, name of principal investigator, inclusion of co investigators, corrections of

spelling and grammar, then the member secretary himself/herself will verify the documents without

sending for review by other members of FMMCIEC. The Member Secretary will confirm justification

for the changes . However, he/she will put it in the agenda of next meeting of FMMCIEC, and get the

decision ratified by full committee, with final approval by the Chairperson.

FMMCIEC SOP




of 216

10.4.1.5. Expedited Review: If the original decision of the FMMCIEC meeting was “Resubmit with

revisions” and involves minor changes in study procedure, and submission of informed consent

documents, budget and proforma of data collection, the resubmission is listed for expedited review.

However, if the study protocol involves more than minimal risk, it is listed for full review. The

expedited review will be done by the Chairperson, the member secretary and one member of

FMMCIEC

10.4.1.6. Full Review: If the resubmissions involve major changes in study objectives, procedures,

and if the protocols involve more than minimal risk, the member secretary lists them for full review.

The full reviews will come up for discussion in the full committee meeting of FMMCIEC.

10.4.2. Decision on Resubmitted Protocols: The decision of FMMCIEC will be communicated by

the same procedure which is followed for “new submission”.

10.4.3. Review of Protocol Amendments:

10.4.3.1. The documents for amendments (hard and soft copy) forwarded by the PI will be received by

the Secretariat and verified. The Secretariat will confirm the request for review of amended

Protocol/Protocol related documents from the Principal Investigator on previously approved

Protocol/Protocol related documents. The secretariat will confirm that the amended version of the

protocol and related documents are attached with the application and that the changes or modifications

in the protocol are underlined or highlighted in the amended version.

10.4.3.2. The Secretariat will inform the Member Secretary of receipt of the protocol amendment

10.4.3.3. The Member Secretary will decide on the type of review required for the protocol

amendments submitted by the investigator.

10.4.3.4.The protocol amendments will be categorized for full review if any of the following criteria

are met :

1) The Protocol amendment changes the risk-benefit assessment such as a change in study design,

additional treatments or the deletion of treatments, changes in inclusion/exclusion criteria, change in

method of dosage formulation, such as, oral changed to intravenous, a significant change in the

number of research participants (if the decrease/increase in the number of research participants alters

the fundamental characteristics of the study, it is significant)

FMMCIEC SOP




of 216

2) For regulatory studies, a protocol amendment with above changes would require DCGI approval

10.4.3.5.The protocol amendments will be categorized for expedited review if they do not fit into the

criteria for full review. The expedited review will be done by the Chairperson, the member

secretary and one member.

10.4.3.6.The review will be done using the protocol amendment review form.

10.4.3.7.Full reviews are discussed in the meeting of FMMCIEC. Expedited reviews are ratified in the

meeting.

10.4.4. Decision on Protocol Amendments :

1) Approved

2) Approved with suggestions

3) Resubmit with revisions

4) Not approve the amendment request, stating the reason – but allow the study to

continue as previously approved.

5) Suspend the study until further information is obtained

The procedure for preparation of minutes of meeting, approval for minutes and communication of

decision are same as that followed for “new submissions”.

10.5. Annexure :

FMMCIEC SOP




of 216

Anenxure-10.1.: Resubmission Form For Investigators (to be used for resubmission of

revised protocols /submission of additional documents

1. FMMCIEC - Protocol No.:

2. Date of Ethical Clearance (if approved already)

3. Title :

4. Name of Principal Investigator :

5. Purpose of this submission :

6. Submission details :

Sl. No. Revision/Corrections

Suggested by IEC

Corrections done :

Yes/ No

What correction is

done ? Mention.

7 .List of documents submitted during resubmission:

1)

2)

3)

Date :

Signature of Principal Investigator :

Department and Designation :

Note : Please submit this form along with a covering letter to member secretary, Father Muller

Institutional Ethics Committee, and one soft+one hard copy of the revised proposal, and other

documents.

---------------------------------------------------------------------------------------------------------------

FMMCIEC SOP




of 216

Annexure-10.2. : Checklist to be used by FMMCIEC Member Secretary for Resubmitted

/Revised Protocols

Sl. No. Corrections/Revisions

suggested by Ethics

Committee

Revision Done : Yes/No Remarks on Adequacy

of Revisions

List of Documents submitted by Investigator and seen by FMMCIEC :

1)

2)


-----------------------------------------------------------------------------------------------------------

Annexure-10.3 : Resubmission Review :

Title : Protocol No. :

Date of previous review by FMMCIEC : Nature of Review : Full /Expedited

Number of Review : 2nd

/ 3rd

/4th

Decision of FMMCIEC in the Previous Review :

Opinion of Reviewer :

Tick the

appropriate :

Recommended for Approval

Approved with suggestions Mention the suggestions :

Resubmission not approved Mention the reasons for not

approving :

Further discussions required in the full

committee meeting before giving decision

(applicable for expedited reviews)

Name and Signature of the Reviewer : Date :

FMMCIEC SOP




of 216

------------------------------------------------------------------------------------------------------------

Annexure-10.4 ; Protocol Amendment Request Form

FMMCIEC Protocol Number :

Title :

Name of Principal Investigator : Date of Approval from FMMCIEC :

Number of Amendments : Nature of Amendments :

Briefly state the amendments done :

Reasons for Amendments :

Impact of your amendment on your present study at this site: (modifications in the ICD, re-consent of

research participants, untoward effects likely to occur because of the amendment or any other ) :

Have the changes modifications in the amended versions been highlighted/ underlined? :

Yes/No

Signature of Principal Investigator : Date :

-------------------------------------------------------------------------------------------

Annexure-10.5 : Protocol Amendment Review Form

FMMCIEC Protocol Number :

Title :

Name of Principal Investigator : Date of Approval from FMMCIEC :

Number of Amendments : Nature of Review : Expedited/ Full

Decision : (Tick the appropriate decision )

Approved

Approved with Suggestions

Not Approved but, could continue with the approved version of the protocol

Not Approved and Study to be Suspended until Further Information is Obtained

------------------------------------------------------------------------------------------------------------------

FMMCIEC SOP




of 216

Annexure-10.6 : Decision on Protocol Amendments

To : XXXXX (PI) : Department :

Ref: - IEC No.

Project title -----------------------

Dear Dr._________

We have received from you the following document(s).

1. 2.

At the Institutional Review Board meeting held on _________ the above mentioned documents

were reviewed. After consideration, the IEC has decided to :

Approve: (a) The above mentioned study-related documents

OR (b) The following documents:

1. 2.

The members who attended this meeting held on __________ at which the above mentioned

document was discussed are listed below.

It is to be noted that neither you nor any of your proposed study team members were present

during the decision-making procedures of the Institutional Review Board. OR After reviewing

the documents, the IEC has decided to approve the aforementioned study-related documents.

Yours truly,

_________________________________________

Signature of FMMCIEC Member Secretary with Date

FMMCIEC SOP




of 216

11. SOP-11 : Procedure for On-Site Monitoring of Protocols

11.1. Purpose : The purpose of this SOP is to describe the process of on-site monitoring of protocols

approved by FMMCIEC.

11.2. Scope : This SOP is applicable to the regulatory trials and intervention studies for which on-site

monitoring is undertaken by FMMCIEC.

11.3. Responsibility : The Chairperson and the Member Secretary of FMMCIEC are responsible for

conducting the on-site monitoring. The members of FMMCIEC are responsible to participate in the

monitoring process as and when they are assigned.

11.4. Procedure :

11.4.1. Time and Site of Visit : The decision letter issued to the PI during approval of the protocol

will have the statement on on-site monitoring of the study.

The routine monitoring of the protocols will be done at least once in a year. Three minimum

visits for monitoring are planned : during initial recruitment of subjects, during the progress of

the study (after the submission of first progress report) and after submission of the final report.

The site of recruitment of subjects and the office of the trial site will be visited.

“For-cause monitoring” will be performed at sites for reasons identified by any member of the IEC,

after approval by the Chairperson. The reasons for identifying a particular site for “for-cause

monitoring” could include any one or more of the following:

a. High number of protocol violations,

b. Large number of studies carried out at the study site or by the investigator,

c. Large number of Serious Adverse Events (SAE) reports

d. Scientific misconduct

e. High recruitment rate,

f. Large number of Protocol deviations,

g. Complaints received from subjects, head of the institution or any other person, ( anonymous

complaints received shall be entertained if they affect subject safety )

h. Frequent failure to submit the required documents

FMMCIEC SOP




of 216

i. Any other cause as decided by IEC.( any scientific misconduct by the ethics committee during

periodic monitoring)

11.4.2. Before the Visit:

Irrespective of the cause for conducting monitoring the following procedure will be followed :

1. The Chairperson will identify and select one or more IEC members (henceforth referred to as

monitors) to conduct monitoring of a site. The team will have the Chairperson, the Member Secretary,

One clinician, basic medical scientist, lay person/philosopher/social scientist and legal expert.

2. An appointment letter will be issued by the Chairperson

3. The Member Secretary will consult the team members and the principal investigator to decide the

date of monitoring visit.

3. The agenda of monitoring will be decided by the Member Secretary and the Chairperson

4. The final date will be communicated to the PI (with a request to be available) and monitors.

6. The monitor will receive from secretariat and review the relevant project documents and make

appropriate notes.

7. The Secretariat will provide Monitors with relevant reference material / documents related to the

project

8. Monitors will carry with them Site Monitoring Visit Report Forms collected from the Secretariat

11.4.3. During the Visit:

The Monitoring team will follow the check list and:

1. Check the log of delegation of responsibilities of study team,

2. Check if the site is using latest IEC approved current versions of the protocol, informed consent

documents, case record forms, diaries, advertisements, etc.

3. Observe the informed consent process, if possible,

FMMCIEC SOP




of 216

4. Review randomly selected participants files to ensure that participants are signing the correct

informed consent,

5. Check investigational product accountability is adequately controlled and documented throughout

the product flow at the study site (arrival, dispensing, use, return from the subject and

return/destruction after the study),

6. Check for storage times, conditions and expiry dates to be acceptable and sufficient supplies

available, wherever applicable,

7. Verify that the investigator follows the approved protocol and all approved amendment(s), if any,

8. Ensure that the investigator and the investigator's trial staff are adequately informed about the trial,

9. verify that the investigator and the investigator's trial staff are performing the specified study

functions, in accordance with the approved protocol and any other written agreement between the

sponsor and the investigator/institution, and have not delegated these functions to unauthorized

individuals,

10. Verify that the investigator is enrolling only eligible subjects,

12. Determine whether all SAEs are appropriately reported within the time as per the applicable

regulatory requirement(s). Case record forms would be checked to review the safety data i.e. Adverse

Events (AEs) and SAEs for the volume or severity of adverse events,

13. Review the project files of the study to ensure that documentation is filed appropriately,

14. Review the source documents for their completeness,

15. Collect views of the study participants, if possible.

The team will fill the site monitoring visit form and record the observations.

11.4.4. After the Visit:

The Member-Secretary will present the monitoring report at the next full board IEC meeting. The IEC

will discuss the findings of the monitoring process and take appropriate specific action by voting or

combination of actions, some of which are listed below:

FMMCIEC SOP




of 216

a. Continuation of the project with or without changes,

b. Restrictions on enrollment,

c. Recommendations for additional training,

d. Recruiting additional members in the study team,

e. Revising/ providing qualifications/ experience criteria for members of the study team, termination

of the study, o Suspension of the study, etc.

f. If the findings have serious implications on patient safety, the decision will be taken at the earliest

(emergency meeting within one working day after the visit).

f. The Secretariat will convey the decision to the Principal Investigator in writing within 7 working

days of the meeting. Opportunities for improvement in any area will be emphasized in the report

7. The Secretariat will place the copy of the report in the protocol file.

11.5. Annexure

FMMCIEC SOP




of 216

Annexure-11.1. Site Monitoring Visit Report /Checklist

I. General Details :

FMMCIEC Protocol No. : Study Title :

Date of Approval of the Protocol by FMMCIEC

:

Name and Address of Principal Investigator :

Date of Visit of FMMCIEC team :

Names of Monitoring Team Members :

Date of initiation of the Study :

Duration of the Study :

Type of Study : Regulatory Trial /Funded

Intervention Study/Any Other

Reason for Monitoring (Tick whichever is

appropriate)

Routine :

For Cause : State Reasons

Protocol Violations/Deviations :

SAE :

Recruitment Rate :

Others :

Stage of Visit :

Commencement of the Trial

Trial Progress

Completion of Trial :

Date of last monitoring , if any : Trial Status :

1. Ongoing

2. Completed

3. Recruitment Completed

4. Follow-up, extension study

5. Suspended

6. Terminated

In case of suspended/terminated, give

reasons.

FMMCIEC SOP




of 216

II. Legal and Administrative Aspects :

Yes No NA Remarks

Clinical Trial NOC from

DCGI ( mention along with

Protocol no., Version., date)

If the Subsequent protocol

amendments have been

approved by DCGI ?

Site Facilities are adequate

Valid trial agreement is

available

Valid insurance agreement

available

III. Conduct of Trial :

Organization and Personnel :

Recruitment Status :

Total number of subjects

To be recruited :

Screened :

Screen Failures :

Enrolled :

Withdrawn :

Reasons for withdrawal :

Discontinued :

Reason for Discontinuing :

Completed :

Active :

Yes No NA Remarks

The investigators are

FMMCIEC SOP




of 216

appropriately qualified and

trained to conduct the

trial.

Check the Medical

Council Registration

certificate and CV of the

investigators.

Check for GCP training

certificates of

investigators.

Determine whether

authority for conducting

various clinical trial

activities were delegated

properly by Investigator to

competent personnel

(obtain the list of

personnel and duty

delegation log).

Check whether the person

whom the authority is

delegated is adequately

qualified and trained for

the activity/activities

assigned.

Obtain the list of all

clinical trials performed by

Investigator (Preferably for

last three years)

Ensure that the

Investigator is involved in

FMMCIEC SOP




of 216

conduct of not more than

three clinical trials at a

time.

Recruitment of Subjects : Screening and Informed Consent

Yes No NA Remarks

Informed Consent

Documents : Current

version is Approved by the

FMMCIEC ?

Check and review the

informed consent for the

screening of the subjects

Check site screening log &

enrolment log and obtain

authenticated copy.

Check whether the

subjects are meeting the

inclusion/exclusion criteria

as per the approved

protocol w.r.t review of

source documents &/or

CRF.

Clinical Examination by

Investigator ( Check

patient file/Source

documents)

Verify ,Clinical

Laboratory Evaluation (

Check Blood Cell Counts,

Biochemical test, Urine

FMMCIEC SOP




of 216

analysis etc.as required by

protocol)

Verify X-Ray, MRI, ECG,

USG or any other

technique required to

ascertain the

inclusion/exclusion

criteria.

Verify, Whether all

conditions of Clinical trial

NOC are followed or not?

Whether IC has been

obtained from each subject

prior to participation of the

subject in the study.

Whether signature/thumb

impression of the

subjects/legal

representative have been

affixed with date.

Whether in case of

illiterate subjects or

illiterate representative of

a subject, there are

signature and details of an

impartial witness.

Have witness/ signature

being personally dated.( If

applicable).

Have patient/witness

signature been personally

FMMCIEC SOP




of 216

dated?

Has the dated signature of

the designated person for

administering informed

consent (IC) been affixed?

Is the designated person

for administering IC

medically qualified?

If IC has been

administered by a

designated person who is

not medically qualified, is

there evidence that

subject's queries of a

medical nature were

answered by a medically

qualified person or the

investigator?

Is the completed ICF

signed and dated by the

investigator?

Check weather re-

consenting is done for

changes in ICF, if any.

Whether appropriate

vernacular consent has

been taken from all

patients?

Whether audiovisual

recording of informed

consent is done for

FMMCIEC SOP




of 216

vulnerable subjects ?

Is audio-visual recording

conducted in a room

conducive to recording of

disturbance free audio and

video of the consent

process?

Check whether the video

recording is free from

disturbance to ensure that

the image is recognizable

and the audio is clearly

audible.

The consent is taken in

language the

participant/LAR

understands best and is

literate in.

Introduction of each

person (person conducting

the informed consent

discussion participant/

legally acceptable

representative (LAR) /

impartial witness)

involved during informed

consent process and

information about

necessity for audiovisual

recording

Information to the

FMMCIEC SOP




of 216

participant/ LAR and

impartial witness (as

applicable) that the

process of taking the

consent is being recorded

for the purpose of

documentation as required

by the government rules.

Information to the




confidentiality of

information and privacy of

participants is assured.

Information to the




recording may be shown to

government agencies or

members from the IEC.

Explanation or narration

by the person conducting

the informed consent

discussion.

Questions asked by the

potential participant/LAR

are answered

satisfactorily.

Allowing ample time and

FMMCIEC SOP




of 216

opportunity to

read/understand the

information in the

informed consent

document or discuss the

same with family

members.

Reading out by the

participant/LAR (or

having read out by

impartial witness) the

statements mentioned in

Informed Consent and

stating whether participant

agrees or not for each

statement.

Documentation of

signatures of all those

involved in the Informed

Consent Process.

Clarity and completeness

of AV recording

Storage of recording in

password protected laptop/

desktop computer and/ or

hard drive and labelled CD

with access allowed only

to the principal

investigator and

designated members of the

study team.

FMMCIEC SOP




of 216

IV. Source Documentation and Case Record Form :

Yes No NA Remarks

Verify condition,

completeness,

legibility, accessibility

of the investigators

source data file. (

source data includes

study subject‟s files,

recording from

automated

instruments, tracings,

X-ray and other films,

laboratory notes,

photograph negatives,

magnetic media,

hospital records,

clinical and office

charts, subject‟s

diaries, evaluation

checklists and

pharmacy dispensing

records)

Whether subject

received the test drug

with respect to dose

and frequency

according to the

protocol;

Determine whether

FMMCIEC SOP




of 216

safety/ efficacy end

point data( Clinical,

laboratory

examination results)

were collected and

reported in accordance

with the protocol

Does medical record

mentions subject ID/

name /hospital

registration number /

and indication that

subjects are

participating in a

clinical trial

Compare the source

document with CRF

and determine whether

source data have been

correctly transcribed

in CRF;

Verify the drop-outs

and reason for drop-

out of subject is

appropriately recorded

Whether the

withdrawal of subject

from the study is

recorded and

appropriately justified

in accordance with

FMMCIEC SOP




of 216

approved protocol.

Verify whether

Standard Operating

Procedure of handling

of Serious Adverse

Event occurred in

clinical trial is

available.

Verify whether all

SAE‟s have been

reported to the

sponsor, EC and

Licensing authority as

per the timelines in

accordance with

Schedule Y.

No. of deaths reported:

Any other non-death

study related injury :

Compensation paid for

study related injury or

death

Verify Whether SOP

for medical care

during serious adverse

event is available or

not.

Verify whether

adequate medical care

have been given to the

subject especially in

FMMCIEC SOP




of 216

the event of inter

current illness, adverse

events including

abnormal lab

parameters;

Verify whether all

study related activities

are performed at site

approved by O/o

DCGI.

Any Protocol

Deviations/Violations

?

Are the Protocol

Deviations/Violations

Reported to

FMMCIEC ?

V. Sponsor-Related Details :

Yes No NA Remarks

Whether investigator

maintain copies of all

report submitted to

the sponsor;

Whether all CRF

were submitted to

sponsor after

completion of study;

Determine whether all

dropout and reason

thereof were reported

FMMCIEC SOP




of 216

to sponsor;

Determine the method

and frequency of

monitoring the

progress of the study

by the sponsor and

corrective action by

site.

Whether sponsor

appointed a monitor

with appropriate

qualification and

experience to monitor

trial at the site.

Whether a log of

onsite monitoring

visit is maintained at

the site.

Is monitor submits

visit report with

deviations if any to

the sponsor.

Whether sponsor

performed an audit as

a part of QA in order

to independent and

separate from routine

monitoring of quality

control function.

In case the

investigator and

FMMCIEC SOP




of 216

sponsor agrees to

prematurely terminate

or suspend the study

for any reason,

whether it was

promptly informed to

study subjects, Ethics

Committee and

Licensing Authority.

VI. Investigational Product-related Details :

Yes No NA Remarks

Review individual subject

record to verify the correct

dose administration with

respect to dose, frequency,

route of administration

Determine whether

unqualified /unauthorised

persons

administered/dispensed

the test drug

Determine whether

adequate record of

quantity of test drug

received , dispensed is

maintained.( Check the

test drug reconciliation

and verify the leftover

drug or balance on the day

of inspection).

Determine whether

FMMCIEC SOP




of 216

storage

condition/monitoring

method are as per

protocol/recommendation;

Whether trial medication

are maintained in secured

manner with controlled

access

Have un-used trial

medications been returned

to the sponsor or disposed

of according to protocol?

Are the drugs dispensing

records being maintained

properly?

Whether the records for

reconciliation of all IP‟s

are maintained?

Are electronic or hand-

written temperature logs

available for the storage

area of the investigational

products?

Verify that investigation

product is appropriately

labelled. (For clinical trial

use only).

VII. Laboratory :

Yes No NA Remarks

Name and address of the

clinical laboratory used in the

FMMCIEC SOP




of 216

study. (Local and Outside).

Whether financial &

Confidentiality agreement

with Investigator and

concerned laboratory (lies) in

place.

Is investigator/Sponsor

verified the accreditation

status and adequacy of the

facilities to perform the

specified tests as per

protocol.

Verify whether the SOP for

sample preparation, handling

and transportation is

available. Verify the

appropriateness of the SOP

VIII. Quality Assurance :

Yes No NA Remarks

Verify whether SOP for all

procedures conducted at site

are available i.e. have a

copy of Site Specific and

Trial specific SOPs

Verify the essential

components of SOP like

who prepared, checked,

authorized and when,

frequency of SOP revision

Whether SOPs for all

operation like screening and

FMMCIEC SOP




of 216

Informed consent Process,

AV recording of ICP of

vulnerable population in

NCE-CTs, SAEs & its

Management,

Communication with

EC/Sponsor/CDSCO,

GCP/Sch.Y, training to trial

team, training assessment


operation like IP handling

and distribution to study

subjects, blood samples

collection, processing

preservation and

transportation to local

laboratory.


operation of storage

cabinets, refrigerators/deep

freezers used to store

samples and IP are

available.

Verify, whether records for

job

description/responsibilities,

qualification and training for

all personnel involved in the

clinical trial is maintained

and stored.

Verify whether the activities

FMMCIEC SOP




of 216

performed are in compliance

with duty delegated by

Investigator

Verify whether concern staff

is adequately trained and

records maintained there of

In case of vaccines, are a

spillage SOP available and

the study team trained to

handle such an incidence?

IX. Record Keeping and Data Handling :

Yes No NA Remarks

Is adequate space

available for document

retention?

Determine whether

documents are maintained

properly and for the

period as specified

Whether necessary

measures have been taken

to prevent accidental or

premature destruction

Whether the archival

access controlled or

restricted to authorized

personnel.

Whether SOP available to

document all steps in data

management in order to

allow step by step

FMMCIEC SOP




of 216

retrospective assessment

of data quality and study

performance.

Whether corrections in

documents carry the date

and initials of

Investigators and

authorized person.

X. Electronic Data :

Yes No NA Remarks

Is electronic data

processing is done by

authorized person?

Verify whether list of

authorized persons to

make changes is

maintained

Verify if provision for

recording of trail of

changes and deletions

made is available.

Whether the hardware

and software use for data

recording and processing

is validated

Name and Signatures of all Monitoring Team Members, with Date :

Decision of IEC, at Full Board Meeting:

Signature of Chairperson and Member Secretary, with Date:

FMMCIEC SOP




of 216

12. SOP-12 : Review of Protocol Deviations and Violations

12.1. Purpose : The purpose of this SOP is to describe action(s) to be taken by the FMMCIEC

when investigator(s)/trial site(s) fail(s) to:

follow the procedures written in the approved protocol,

comply with national and/or international guidelines, statutory provisions, institutional

guidelines or rules or procedures mandated by the FMMCIEC for the conduct of human

research,

respond to the FMMCIEC requests regarding statutory, ethical, scientific or administrative matters,

Willfully change the study technique/study resources which would compromise patient safety

and/or have monetary burden on the study participant.

12.2. Scope

This SOP applies to all FMMCEC approved research protocols involving human research

participants.

12.3. Responsibilities :

a. Principal investigator :- to submit any deviation/violation in the study protocol in the format,

(annexure ) as mentioned in the SOP. Any other reporting format of deviation/violation

submitted will not be accepted.

b. Member secretary :- to present the report in the agenda of the meeting for decision

c. FMMCEC members :- to review such reports

d. Chairperson : Take a final decision on the protocol with consensus of members

12.4.Procedures :

12.4.1. Glossary :

a) Protocol Deviation and Protocol Violation:

Protocol Deviation- A protocol deviation is any change, divergence, or departure from the study

design or procedures of a research protocol that is under the investigator‟s control and that has not

been approved by the IEC. Upon discovery, the Principal Investigator is responsible for reporting

protocol deviations to the IEC using the standard reporting form.

FMMCIEC SOP




of 216

Protocol Violation- A protocol violation is a deviation from the IEC approved protocol that may

affect the subject's rights, safety, or wellbeing and/or the completeness, accuracy and reliability of

the study data. If the deviation meets any of the following criteria, it is considered a protocol

violation. Example list is not exhaustive.

I. The deviation has harmed or posed a significant or substantive risk of harm to the research

subject. For example

• A research subject received the wrong treatment or incorrect dose.

• A research subject met withdrawal criteria during the study but was not withdrawn.

• A research subject received an excluded concomitant medication.

II. The deviation compromises the scientific integrity of the data collected for the study.

For example

• A research subject was enrolled but does not meet the protocol's eligibility criteria.

• Failure to treat research subjects per protocol procedures that specifically relate to primary

efficacy outcomes. (if it involves patient safety it meets the first category above)

• Changing the protocol without prior IEC approval.

• Inadvertent loss of samples or data.

III. The deviation is a willful or knowing breach of human subject protection regulations,

policies, or procedures on the part of the investigator(s). For example

• Failure to obtain informed consent prior to initiation of study-related procedures

• Falsifying research or medical records.

• Performing tests or procedures beyond the individual's professional scope or privilege

status (credentialing)

IV. The deviation involves a serious or continuing noncompliance with federal, state, local or

institutional human subject protection regulations, policies, or procedures. For example

• Working under an expired professional license or certification

• Failure to follow federal and/or local regulations, and intramural research or CC policies

FMMCIEC SOP




of 216

• Repeated minor deviations.

V. The deviation is inconsistent with the NIH Human Research Protection Program‟s research,

medical, and ethical principles. For example

A breach of confidentiality.

Inadequate or improper informed consent procedure.

Minor Protocol Deviation- A minor protocol deviation is any change, divergence, or departure from

the study design or procedures of a research protocol that has not been approved by the IEC and which

does not have a major impact on the subject's rights, safety or well-being, or the completeness,

accuracy and reliability of the study data.

12.4.2. Detection of Protocol deviation/ violation

Protocol deviation/ violation may be detected in one the following ways (but not limited to those

listed below):

a. Self reporting by Principal investigator.

b. The FMMCIEC members while performing on site monitoring.

c. The Secretariat may detect protocol deviation/ violation from failure to comply with

statutory requirements/ failure to respond to requests from FMMICEC within

reasonable time limit/ failure to respond to communication made by FMMCIEC.

d. The FMMCIEC members may detect protocol deviation/ violation when

scrutinizing annual/ periodic reports/ SAE reports/ any other communication

received from the Investigator/ trial site/ sponsor/ study monitor/ contract research

organization.

e. The FMMCIEC Secretariat and/ or FMMCIEC members may become aware of a

protocol deviation/ violation while reviewing study-related documents including

reports filed in by the PI.

FMMCIEC SOP




of 216

f. Communication/ complaint/ information received from a research participant who has

been enrolled or any individual who has been approached for enrolment.

g. Any report/ communication brought to the notice of Member, Secretary/ Jt. Secretary/

Chairperson of FMMCIEC by an independent person.

h. Communication received from the Head of the Institution informing FMMCIEC

about an alleged protocol violation/ protocol deviation.

12.4.3. Receipt of protocol deviation / violation report by the Secretariat

1. The PI will report the protocol deviation/violation as per Annexure .

2. In case protocol deviation/violation is detected by any other person and reported to the

FMMCEC, the Member Secretary will write to the PI to submit a protocol

deviation/violation as per Annexure

3. The Secretariat will notify the Member Secretary of any protocol deviation/violation report

received from the PI/ from any source within 2 working days of receipt of the notification.

12.4.4. Actions to be taken

1. The action of the IEC will be based on:

o The nature and seriousness of the deviation / violation.

o Frequency of deviation/ violation in the study in the past.

o Frequency of deviation/ violation in previous studies conducted by the same PI/

Co-PI or in the same department.

2. Member Secretary will decide on the impact of the protocol deviation / violation and act

accordingly. Depending upon the seriousness, the FMMCIEC shall do the following:

o Ask PI for written clarification as soon as the deviation is received

o If the impact is serious, this report will be shared with the Chairperson and two

or more FMMCIEC members designated by the Chairperson.

o If the impact of the protocol deviation is serious enough, the Member

Secretary will instruct the Secretariat to call for and schedule a full-board

meeting specifically to discuss the issue within 7 working days of the initial

scrutiny

o The Secretariat will put up the information and communication at the next full

board meeting for discussion.

FMMCIEC SOP




of 216

3. The Member Secretary in consultation with FMMCIEC members will review the

information available and deliberate on it.

4. The Chairperson will take a final decision depending on the seriousness of the violation.

The decision will be taken to ensure that the safety and rights of the research participants

are safeguarded. The decision will be taken by consensus, and the quorum required for the

meeting is same as that required for the initial approval of the protocol.

5. The decision taken by IEC could include one or more of the following:

o Determine that no further action is required, or take other actions as

appropriate.

o Inform the PI that the FMMCIEC has noted the violation / deviation, and

instruct the PI to ensure that deviations/ violations do not occur in future

and to follow FMMCEC recommendations.

o Enlist measures that the PI would undertake to ensure that such

deviations / violations do not occur in future.

o Observe the research or consent process (depending on the nature and

frequency of the deviation).

o Suggest modifications to the protocol.

o Alter the interval for submission of the continuing review/ annual project

status.

o Ask for additional training of the investigator and study team

o Reprimand the PI.

o Seek additional information from the PI.

o Conduct audit of trial by the FMMCEC.

o Suspend the study till additional information is made available and

scrutinized.

o Suspend the study till recommendations made by the FMMCEC are

implemented by the PI and found to be satisfactory by the FMMCEC.

o Suspend the study for a fixed duration of time.

o Suspension or termination of the study.

o Revoke approval of the current study.

FMMCIEC SOP




of 216

o Inform DCGI/ other relevant regulatory authorities.

o Keep other research proposals from the PI/ Co-PI under abeyance. Review

and/ or inspect other studies undertaken by PI/Co-PI.

6. This final decision will be recorded on ANNEXURE by the Member Secretary.

12.4.5. Procedure for notifying the PI and other concerned authorities

The Member Secretary will draft a notification letter.

The signed letter by Member Secretary will be sent to the PI and Department Head(s) (if

required on case to case basis) and Institutional Officials (if required on case to case basis).

The FMMCEC secretariat will send a copy of the notification to the relevant national

authorities (if required on case to case basis) and institutes (if required on case to case basis in case

of multi-centric trials ).

12.4.6. Records and follow up to be kept by FMMCIEC secretariat

The Secretariat will keep a copy of the notification letter in the respective project file.

12.5. Annexure

Annexure 12.1 : PROTOCOL DEVIATION/VIOLATION REPORTING

FORMAT

Project no

Project title

Name of PI

Nature of deviation

Nature of violation

Reasons for deviation/violation

Signature of PI

Signature of member secretary/

chairperson with date

FMMCIEC SOP




of 216

Annexure – 12.2 : Protocol deviation/violation record

FMIEC Protocol no.:

Study Title:


Department:

Deviation from protocol

Violation

Description of deviation (s)/violation(s)

Corrective Actions Taken by the Principal Investigator:

__________________________________________________________

Reported by (Name of Principal Investigator/ Study Team Member):

___________________________________________________________

Signature with date:_________________________

Provisional Decision by the Reviewer (Member Secretary and/or Chairperson

and/or FMMCEC Member/s)

Noted

Request the PI not to perform such deviations/ non compliances/

violations in future

Specific recommendations stated below to be followed

a. Suspend the study till IEC recommendations are implemented

b. Suspend the study till information is available

c. Terminate approval of current study

FMMCIEC SOP




of 216

13. SOP- 13 : Review of Final Reports and Study Completion Reports

13. 1. Purpose- The purpose of this Standard Operating Procedure (SOP) is to provide

instructions on the review of Study Completion Report submitted for studies approved by

the Institutional Ethics Committee (IEC).

13.2.. Scope- This SOP applies to the review of the Study Completion Report which is a

written report of every completed study submitted by the Principal Investigator (PI).

13.3. Responsibility- It is the responsibility of the Secretariat/ IEC Chairperson/ Member

Secretary/ Member/s to review the study report and act on it.

13. 4. Procedure :

13.4.1. Receipt of Study Completion Report The Secretariat will receive 1 copy each (soft and

hard) of Study Completion Report for the regulatory trials; and one soft copy only for the

academic projects.

13.4.2. The study completion report is expected from the investigator within 1 month of

completion of the study at the site.

13.4.3. It is the responsibility of the IEC Secretariat to review the report for completeness

The Secretariat shall verify the submitted Study Completion Report along with Study

Completion Report Form and forward it to the Member Secretary within 7 working

days of receipt. The Member Secretary will review the Study Completion Report,

confirm that it is complete and present it at the next full board meeting.

13.4.4. If there is a need felt (e.g. a deviation/ violation is noted), the Member Secretary will

handle it as per the relevant SOP. The Secretariat shall include the Study Completion Report

Form in the agenda for IEC members for discussion at the full board meeting.

13.4.5. During the Board meeting The Member Secretary will present the report and members

can discuss as needed. Following the discussion, the Chairperson may take one of the

following decision:

a) noted / approved b) request for additional information / clarification The Secretariat will

note the decision in the meeting minutes

FMMCIEC SOP




of 216

b) The Member Secretary will draft a letter to the PI conveying decision on the study

completion report. The study shall be considered as closed if the decision by IEC is “Noted” or

“Approved”.

c) The Secretariat will accept and file the Report and get the Study Completion Report Form

signed by the Chairperson . The final report will be placed in the master file and kept in the

archival area.

d) The Secretariat will archive the entire study for a period of 5 years from the date of

completion of the project if the decision is noted and closed.

13.5. Annexure :

FMMCIEC SOP




of 216

Annexure-13 : STUDY COMPLETION REPORT FORM (Filled by principal

Investigator)

FMMCIEC Protocol No. :

Project Title: ______________________________________________________________

__________________________________________________________________________

Principal Investigator

Department

Total no. of study participants recruited

Total no. of study participants approved by the IEC for recruitment

Duration of the study *

Results (summary) with Conclusion: (use extra blank paper, if more space is required).

__________________________________________________________________________

__________________________________________________________________________

*Note: If the final report is not available from sponsor, it may be submitted later to the IEC

once it is ready.

Number of SAEs at our center:

Whether all SAEs intimated to the IEC Yes No

No. of patients withdrawn :

Reasons for Withdrawal of Patients:_____________________________________________

__________________________________________________________________________

__________________________________________________________________________

Signature of Principal Investigator: Date

Action taken: Noted/ Requires more information/ action as follows:

__________________________________________________________________________

__________________________________________________________________________

IEC Meeting date (If reviewed in the meeting)__________________________________ Final

Decision:_______________________________________________

__________________________________________________________________________

Signature of Member Secretary with date: ___________________________

FMMCIEC SOP




of 216

14. SOP-14 : Procedure for Training and

Assessment of Members

14.1. Purpose : The purpose of this SOP is to describe requirements and methodology for training and

performance assessment of the FMMCIEC) members and the Secretariat.

14.2. Scope : This SOP applies to all the FMMCIEC members and the FMMCIEC secretariat.

14.3. Responsibilities

It is the responsibility of the FMMCIEC Chairperson with the assistance of Member Secretary to

ensure that there is adequate initial and continued training of the FMMCIEC members and the

secretariat. The Chairperson is responsible for assessment of all FMMCIEC members and complete a

self-assessment exercise at prescribed intervals.

14.4. Procedure

14.4.1. Topics for training

1) FMMCIEC members should have knowledge of the following:

Relevant research ethics and regulatory guidelines

Roles and Responsibilities of FMMCIEC members

Review of protocol and related documents, including concepts of Risk Benefit assessment,

Equity in recruitment, Autonomy, Confidentiality and Privacy

Recent Developments in relevant health science specialities

SOPs of the FMMCIEC

2) Secretariat should have knowledge and relevant skills for conducting the following activities:

Knowledge about FMMCIEC SOP‟s and also guidelines for submission

Good communication skills – oral and written

Maintenance of FMMCIEC records – both soft and hard copy

14.4.2. Induction Training of new FMIEC Members

FMMCIEC SOP




of 216

1) Every time a new committee is constituted, the members must undergo initial training

within one month on ethics in clinical research and good clinical research and SOPs. An

individual selected as a new member of the FMMCIEC will be required to attend one

meeting as an „Observer‟ before being inducted as a member of the FMMCIEC. The

Member Secretary will provide an introductory training to the new member. The member

during the observer period will not have voting rights, but will have to sign letter of

confidentiality. Appointment of observer as member would be on discretion of chairperson

in consultation with members, following which the appointment letter would be issued to

the member.

2) The newly inducted member will be encouraged to undergo training on good clinical

practice, bioethics and guidelines on clinical research. The authorities of FMMC may

sponsor the member for such trainings.

3) The new member will receive trainings from any member of FMMCIEC or Chairperson or

Member Secretary on the above topics. An expert from clinical research, bioethics or GCP

will be invited to FMMCIEC to give training

4) The in house training sessions of FMMCIEC will have pre test and post test to assess the

effectiveness of trainings.

5) The Member Secretary and the Chairperson will orient all the members on the SOP of

the FMMCIEC.

14.4.3. Ongoing (On Job and Developmental) Trainings at FMMCIEC:

1) Member Secretary, member, Chairperson will be encouraged to receive continued training

by participating in a workshop, conference and/ or retraining program related to research ethics,

as a delegate, faculty, facilitator, etc. at least once every year. The authorities of FMMC may

sponsor the members for such trainings.

2) The Member Secretary of FMMCIEC in consultation with the Chairperson prepares an

annual training schedule, and will conduct trainings or workshops on good clinical practice,

bioethics, relevant guidelines on clinical research and other relevant topics. The resource

persons for such trainings could be a member of FMMCIEC, or an external GCP trained

personnel or a bioethics expert. The trainings is imparted not only to the FMMCIEC members

but, also to the institutional faculty who are investigators of ongoing research studies or

potential investigators .

FMMCIEC SOP




of 216

14.4.4. Training of the Secretariat : The FMMCIEC Member Secretary along with other members

will train the Secretariat on SOPs. There will be initial training and at least one training session per

year on SOPs. The competency of staff in computers and communication skills will be evaluated and

ensured initially at the time of appointment by the Member Secretary and Chairperson.

14.4.5. Assessment of IEC members

1. The FMMCIEC members‟ performance should be evaluated once a year using an

assessment form by the Chairperson.

2. The Chairperson should do self-assessment once a year

14.4.6. Maintenance of training records of the FMMCIEC Members and the Administrative Staff

The secretariat should maintain copies of the certificates of all training workshops and conferences

in research ethics attended by the individual FMMCEC members. The copies will be filed in the

individual members‟ files. The records regarding training copies of the secretariat will also be

maintained in their respective files.

14.5. Annexures

Annexure 14. 1:

Assessment Form for Ethics Committee Members

1. Current tenure

2. Terms served

3. Training received (Training record to be attached)

4. Type of training received

5. No of meetings attended

6. No of projects reviewed per meeting as primary reviewer

7. Participation in SAE report review process- yes/no

8. Participation in site monitoring visits - yes/no

9. Number and type of continuing training workshops organised for FMIEC members (applicable

to Member Secretary)

10. Number and type of continuing training workshops organised for staff of the FMIEC

secretariat (applicable to Member Secretary)

11. Any other significant contribution to the field of research ethics

FMMCIEC SOP




of 216

12. Remarks by the Chairperson on the self-assessment

Annexure-14.2. Training Records of the Member (Trainings in house+attended outside):

Name of the Member :

Designation in FMMCIEC :

Date In

House/Outside

Name/Names

of Trainer/s

Topic Organizer Place

Annexure 14.3: Self Assessment Form for IEC Chairperson

1. Current tenure-

2. Terms served -

3. Training received -

4. Type of training received -

5. No. of meetings held in current year -

6. No of meetings attended-

7. Whether quorum requirement fulfillment ensured as per schedule Y in FMMCEC meetings

8. Whether considerations related to conflict of interest considered

9. Any significant contribution to the field of research ethics

10. Any other comments ___________________________________________________

FMMCIEC SOP




of 216

15. SOP-15: Review of Serious Adverse Events (SAE) in clinical trials

15.1. Purpose : The purpose of this SOP is to describe procedures for the review of initial and

follow-up reports of serious adverse events (SAE) occurring in a clinical trial reported to the IEC

for any study under the oversight of the FMMCIEC.

15.2. Scope : This SOP applies to the review of SAE reports (Adverse events/ SAE onsite as well

as SAEs of the multicenter studies occurring at other sites/offsite) submitted to the FMMCIEC.

15.3. Responsibility: It is the responsibility of the principal investigator/investigator at site to submit

an SAE report to FMMCIEC as well as to DCGI and sponsor . It is the responsibility of the IEC to

review all SAEs reported to the IEC in a timely manner

15.4. Procedures :

15.4.1. Definitions :

1] Serious Adverse Event:

Any untoward medical occurrence that at any dose results in death, is life-threatening,

requires inpatient hospitalization or prolongation of existing hospitalization, results in

persistent or significant disability/incapacity, or is a congenital anomaly/birth defect

2] Serious Adverse Event (AE) or Serious Adverse Drug Reaction (ADR)

An AE or ADR that is associated with death, hospitalization, prolongation of hospitalization,

persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise

life threatening.

3] Adverse Event

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered

a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory

finding), symptom, or disease temporally associated with the use of a medicinal (investigational)

product, whether or not related to the medicinal (investigational) product.

FMMCIEC SOP




of 216

4] Suspected Unexpected Serious Adverse Reactions (SUSARS) : An unexpected adverse reaction

(UAR) is an adverse reaction that is not consistent with the product information in summary of

product characteristics. . A suspected unexpected serious adverse reaction (SUSAR) is any UAR that

at any dose results in death; is life threatening (i.e. the subject was at risk of death at the time of the

event; it does not refer to an event which hypothetically might have caused death if it were more

severe); requires hospitalization or prolongation of existing hospitalization; results in persistent or

significant disability or incapacity; is a congenital anomaly or birth defect.

15.4.2. SAE subcommittee :

1. The Chairperson of FMMCIEC constitutes a SAE subcommittee.

2. The subcommittee consists of members who collectively have the qualifications and

experience to review and evaluate the scientific, medical and ethical aspects of adverse event

reports involving human participants. The subcommittee is be headed by a senior member of

IEC, and comprises clinician, Basic Medical Scientist, Legal Expert, Subject Expert (if a

member from the subject is not there in the IEC) and one representative of the vulnerable

populations (for those trials involving vulnerable populations). The subject expert and the

representative of the vulnerable population are included depending on the area/subject

speciality . The Chairperson can include more members from the medical background

depending on the felt need.

15.4.3. Receipt of Report of SAE :

15.4.3.1. The IEC Secretariat will receive the following documents within the specified time frame if

an SAE is experienced by any research participant:

i) Initial SAE report to be submitted by the Principal Investigator (PI) within 24 hours of occurrence.

ii). Due analysis should be submitted by the PI within 14 days from the occurrence of the SAE

iii) Due analysis will also be submitted by the sponsor within 14 days

iv). The follow up reports of all on-site SAE till the event is resolved.

15.4.3.2. The IEC Secretariat will verify that the report is complete in all respects and that it has been

received at the IEC office within the specified timelines. If the report has been received beyond the

specified time, it will be considered as a protocol violation and action should be taken as described in

SOP for protocol deviations. The IEC Secretariat will sign and write the date on which the report is

FMMCIEC SOP




of 216

received. The Secretariat will forward these reports to the IEC Member Secretary within two working

days.

15.4.4. . Review and Decision on SAE Reports and Communication to PI and Regulatory

Authority by IEC :

15.4.4.1. The Member Secretary will review the SAE report and present to the SAE subcommittee

for review and opinion.

15.4.4.2. At the meeting of SAE subcommittee, the SAE reports will be reviewed with a special focus

on relatedness to the clinical trial, medical management and financial compensation to be given to the

research participants. The applicable formulae and guidelines from the regulatory authority will be

used during this discussion. The SAE subcommittee hold the meeting and site visits as required.

15.4.4.3. If deemed necessary, the SAE subcommittee may refer the issue to the IEC full board. The

report of SAE subcommittee will be presented in the IEC full board meeting. An emergency meeting

of IEC may be held for this purpose. The emergency IEC meeting will be scheduled within 7 days for

the same. The minutes of the SAE Subcommittee/ IEC meeting will include the information on SAE

at the site along with the opinion on the above points on the onsite SAE . The minutes will be

circulated to the IEC members via email and approval/ objection will be sought from the members in a

period of 5 working days. After approval from the Chairperson, the Member Secretary communicates

the decision of FMMCIEC to the PI, within 7 working days after the meeting of SAE subcommittee.

15.4.4.4. The PI will be requested to reply to the query letter on the SAE report within 7 working days.

The opinion regarding relatedness, medical management and compensation for research related injury

will be communicated to the Licensing authority (DCGI) within 30 calendar days of the occurrence of

the SAE in case of regulatory clinical trials.

15.4.5. Reports of SAE Occurring at Other Sites : The investigator will need to submit the SAEs

occurring at other sites (CIOMS and SUSARS) in the form of soft copies only (CD) along with the

appropriate covering letter (hard copy) mentioning the total number of reports and its details .

The SAEs occurring at other sites will be reviewed by the Secretary of the IEC / SAE Subcommittee

(as applicable) and informed to other members and discussed in the forthcoming scheduled meeting.

The agenda and minutes of the meeting will include the information on SAEs at other sites

15.4.6. Onsite AE :

FMMCIEC SOP




of 216

15.4.6.1. The IEC Secretariat will receive the following documents pertaining to AE experienced by

the research participants for research proposals approved by the IEC:

1. On site AE reports to be submitted by the PI annually in the continuing review report.

2. In view of the risk assessment of a given research proposal the IEC can request adverse events to be

reported earlier, if deemed necessary at specified timelines in the project approval letter

15.4.6.2. The IEC Secretariat will verify that the report is complete in all respects and signed and dated

by the PI and that it has been received at the IEC office within the specified timelines. If the report has

been received beyond the specified time, it will be considered as deviation.

15.4.6.3. The reports are forwarded to the Member Secretary of IEC may put the AE reports for

discussion at full board if deemed necessary Queries, if any on the report will be communicated to the

PI by the Member Secretary of IEC following full board meeting.

15.4.7. Review during Full Board Meeting of FMMCIEC: A report of the SAEs is presented in the

full board meeting of FMMCIEC during the monthly meeting. In case of the SAE occurring at the site

to be discussed at the full board meeting, the member secretary will also provide the relevant

information including updates on SAE that have occurred earlier at the site. The Chairperson will

invite members to voice their opinions and ensure free and frank discussion. The decision is arrived at

by consensus.

15.4.8. Decision of FMMCIEC on SAE :

The FMMCIEC arrives at one or more of the following decisions on review of SAE report.

4) Following detailed review of the SAE reports and related documents, the IEC/

SAE Subcommittee can suggest one of the following actions:

Note the information about the SAE in records for future reference.

Request further follow up information and/ or additional details.

Ask for periodic follow-up of the research participant till SAE is resolved

Depending on complexities of issue, IEC/ SAE Subcommittee may decide to

seek opinion of outside expert consultant who is requested to respond within 14

working days.

FMMCIEC SOP




of 216

Provide recommendations regarding/ raise queries related to compensation for

study related injury and death

5) Type of Action Taken following Full Board Meeting :

Suggest changes/ amendments in protocol, Patient Information Sheet/ Informed

Consent Document/ Investigators‟ Brochure/ any other study related documents.

Suspend the study till additional information is available.

Suspend the study till review is completed (safety monitoring of ongoing

patients to be continued).

Suspend the study till amendments requested for by the IEC are carried out.

Suspend enrolment of new participants.

Suspend certain activities under the protocol.

Direct the PI to inform participants already enrolled in the study about the AEs

and if required obtain their consent again (re-consent) regarding continuation in

the research trial.

Direct the PI to inform participants already enrolled in the study about the AE

and request them to undertake additional visits, additional procedures,

additional investigations, etc. as prescribed in the amendment.

Terminate the study.

Any other appropriate action

15.4.9. The decision shall be recorded in the minutes of the full board IEC meeting.

15.4.10. If the recommendation from the IEC includes suspension of the study or suspension of

any one or more of the study-related procedures or activities, amendments in the protocol or

other study-related documents (excluding Investigators‟ brochure), re-consenting of research

participants, the decision will be conveyed to the PI through telephone, fax or email within 24

hours. Such a communication will be documented by the IEC Member-Secretary in the study

file. A formal letter to the PI informing about the IEC recommendations in such situations will

be sent within 5 working days of the IEC meeting having taken place.

15.5. Flow Chart :

FMMCIEC SOP




of 216

IEC Secretariat Receives SAE Report

SAE Report Submitted to Member Secretary

Verification of SAE Report for Completeness: Member Secretary

Review by SAE Subcommittee

Presentation of SAE Subcommittee Report in IEC Full Board

Decision Making in IEC: by Consensus

Communication of Decision to PI : Member Secretary

FMMCIEC SOP




of 216

15.6. Annexures :

Annexure-15.1. Data Elements for reporting serious adverse events occurring in a clinical

trial.

1. Patient Details :

Initials & other relevant identifier (hospital/OPD record number etc.) :

Gender : Age and/ or date of birth ;

Weight : Height :

2. Suspected Drug/Drugs :

Generic name of the drug

Indication(s) for which suspect drug was prescribed or tested

Dosage form and strength o Daily dose and regimen (specify units - e.g., mg, ml,

mg/kg) Route of administration

Starting date and time of day

Stopping date and time, or duration of treatment

3. Other Treatment(s) :

4. Details of Suspected Adverse Drug Reaction(s)

Full description of reaction(s) including body site and severity, as well as

the criterion (or criteria) for regarding the report as serious. In addition to

a description of the reported signs and symptoms, whenever possible,

describe a specific diagnosis for the reaction

Start date (and time) of onset of reaction

Stop date (and time) or duration of reaction.

Dechallenge and rechallenge information.

Setting (e.g. hospital, out-patient clinic, home, nursing home).

5. Outcome :

Information on recovery and any sequelae; results of specific tests and / or

treatment that may have been conducted.

For a fatal outcome, cause of death and a comment on its possible

relationship to the suspected reaction; Any post mortem findings.

FMMCIEC SOP




of 216

Other Information: anything relevant to facilitate assessment of the case,

such as medical history including allergy, drug or alcohol abuse; family

history, findings from special investigations etc.

6. Details about Investigator :

Name o Address o Telephone number

Profession (speciality)

Date of reporting the event to Licensing Authority:

Date of reporting the event to Ethics Committee overseeing the site:

Signature of the Investigator

FMMCIEC SOP




of 216

Annexure – 15.2. : Checklist SAE Report Submission (For Onsite SAE)

Sl. No. Details

1. Country Name :

2. SAE report of death or other than

death, Please tick (✓)

Death : Other Than Death :

3. In case of Serious Adverse

Event(SAE), please specify if there

is any injury to the participant

(Please specify Yes/No) in the box

4. Protocol Title

5. Protocol Study No./ ID /Code

6. Copy of Clinical Trial permission

obtained from CDSCO

7. CTRI Registration No.

8. Sponsor(Address with contact no

and Email)

9. CRO (Address with contact no and

Email)

10. Initial / Follow-up (FU) : Mention

11 In case of follow-up: Date & Diary

no of initial or recently submitted

report information


a) Initials & other relevant identifier

(hospital/OPD record number etc.)

b) Gender

c) Age and /or Date of Birth

d) Weight

e) Height

13. Suspected Drugs

FMMCIEC SOP




of 216

a) Generic Name of the Drug

b) Indication(s) for which suspect drug

was prescribed or tested

c) Dosage form and strength

d) Daily dose and regimen (specify

units - e.g., mg, ml, mg/kg)

e) Route of administration

f) Starting date and time of day

g) Stopping date and time, or duration

of treatment

14. Other Treatment(s)

Provide the same information for

concomitant drugs (including non

prescription/OTC Drugs) and

nondrug therapies, as for the

suspected drug(s).

15. Details of the events

a) Full description of event (s)

including body site and severity, as

well as the criterion (or criteria) for

regarding the report as serious. In

addition to a description of the

reported signs and symptoms,

whenever possible, describe a

specific diagnosis for the reaction.

b) Start date (and time) of onset of

reaction.

c) Stop date (and time) or duration of

reaction.

d) Dechallenge and rechallenge

information

FMMCIEC SOP




of 216

e) Setting (e.g., hospital, out-patient

clinic, home, nursing home).

16. Outcome

a) Information on recovery and any

sequelae; results of specific tests

and/or treatment that may have been

conducted.

b) For a fatal outcome, cause of death

and a comment on its possible

relationship to the suspected

reaction; any post-mortem findings.

c) Other information: anything relevant

to facilitate assessment of the case,

such as medical history including

allergy, drug or alcohol abuse;

family history; findings from special

investigations etc.

17. Details about the Investigator

a) CT Site Number, if any

b) Name

c) Address

d) Telephone/Mobile Number & Email

e) Profession (specialty)

f) Date of reporting the event to

Licensing Authority:

g) Date of reporting the event to Ethics

Committee overseeing the site:

h) Signature of the Investigator

18. Details about the Ethics

Committee

a) Name & Address

FMMCIEC SOP




of 216

b) Name of Chairperson & Address

c) Telephone/Mobile Number

d) Email

19. Adverse Event Term/ Details of

SAE

20. Causality Assessment

(Related/Unrelated) by

Investigator.

21. Causality Assessment

(Related/Unrelated) by

Sponsor/CRO.

22. Details of compensation provided

for injury or death. In case no

compensation has been paid,

reason for the same :

23.a) Duly filled SAE Form as per

Appendix XI of Schedule Y

23.b) Laboratory investigations report

/Discharge summary (if available

and applicable)

23.c) Post-mortem report (if applicable)/

Any additional documents)

Note: Information not relevant to a particular SAE should be marked with NA

FMMCIEC SOP




of 216

Annexure -15.3. : Serious Adverse Event (SAE) Analysis Report (For Onsite SAE)

Sl.

No.

Details

1. Country Name :

2. SAE report of death or other than death, Please tick (✓) Death : Other

Than

Death :

3. In case of Serious Adverse Event(SAE), please specify if there is any

injury to the participant (Please specify Yes/No) in the box

4. Protocol Title

5. Protocol Study No./ ID /Code

6. Copy of Clinical Trial permission obtained from CDSCO

7. CTRI Registration No.

8. Sponsor(Address with contact no and Email)

9. CRO (Address with contact no and Email)

10. Initial / Follow-up (FU) : Mention

11 In case of follow-up: Date & Diary no of initial or recently submitted

report information


a) Initials & other relevant identifier (hospital/OPD record number )

b) Gender

c) Age and /or Date of Birth

d) Weight

e) Height

13. Suspected Drugs

a) Generic Name of the Drug

b) Indication(s) for which suspect drug was prescribed or tested

c) Dosage form and strength

d) Daily dose and regimen (specify units - e.g., mg, ml, mg/kg)

e) Route of administration

FMMCIEC SOP




of 216

f) Starting date and time of day

g) Stopping date and time, or duration of treatment

14. Other Treatment(s)

Provide the same information for concomitant drugs (including non

prescription/OTC Drugs) and nondrug therapies, as for the suspected

drug(s).

15. Details of the events

a) Full description of event (s) including body site and severity, as well as

the criterion (or criteria) for regarding the report as serious. In addition

to a description of the reported signs and symptoms, whenever possible,

describe a specific diagnosis for the reaction.

b) Start date (and time) of onset of reaction.

c) Stop date (and time) or duration of reaction.

d) Dechallenge and rechallenge information

e) Setting (e.g., hospital, out-patient clinic, home, nursing home).

16. Outcome

a) Information on recovery and any sequelae; results of specific tests

and/or treatment that may have been conducted.

b) For a fatal outcome, cause of death and a comment on its possible

relationship to the suspected reaction; any post-mortem findings.

c) Other information: anything relevant to facilitate assessment of the case,

such as medical history including allergy, drug or alcohol abuse; family

history; findings from special investigations etc.

17. Details about the Investigator

a) CT Site Number, if any

b) Name

c) Address

d) Telephone/Mobile Number & Email

e) Profession (specialty)

f) Date of reporting the event to Licensing Authority:

g) Date of reporting the event to Ethics Committee overseeing the site:

FMMCIEC SOP




of 216

h) Signature of the Investigator

18. Details about the Ethics Committee

a) Name & Address

b) Name of Chairperson & Address

c) Telephone/Mobile Number

d) Email

19. Adverse Event Term/ Details of SAE

20. Causality Assessment (Related/Unrelated) by Investigator.

21. Causality Assessment (Related/Unrelated) by Sponsor/CRO.

22. Details of compensation provided for injury or death. In case no

compensation has been paid, reason for the same :

23.a) Duly filled SAE Form as per Appendix XI of Schedule Y

23.b) Laboratory investigations report /Discharge summary (if available and

applicable)

23.c) Post-mortem report (if applicable)/ Any additional documents)

Details of payment for medical management of SAE? (please give information who paid how

much was paid, to whom, with evidence of the same)

What is the investigator‟s assessment for the amount of compensation to be paid?

What is the sponsor‟s assessment for the amount of compensation to be paid

Has the participant made a claim? Yes No

If yes, for how much amount _________________ If no, please ensure that the participant /

nominee have been made aware of his/her‟ rights regarding compensation. Please submit

documentation regarding the same

_____________________________________________________________________

______________________________________________________________________

Signature of the Principal Investigator : Date:________________

FMMCIEC SOP




of 216

Annexure 15.4. : CONSTITUTION OF SAE SUBCOMMITTEE of FMMCIEC

Following members of FMMCIEC have been appointed as members of SAE subcommittee.

1.----------------------------------------------------------

2.

3.

4.

5.

Roles and Responsibilities:

1) The SAE subcommittee is responsible for reviewing any serious adverse event (SAE)

reported to FMMCIEC.

2) The SAE subcommittee members will evaluate the scientific, medical and ethical aspects

of adverse event reports involving human participants

3) At the meeting of SAE subcommittee, the SAE reports will be reviewed with a special

focus on relatedness to the clinical trial, medical management and financial compensation

to be given to the research participants. The applicable formulae and guidelines from the

regulatory authority will be used during this discussion.

4) The SAE subcommittee hold the meeting and site visits as required

Please refer to the SOP of FMMCIEC for further details.

Chairperson, FMMCIEC.

FMMCIEC SOP




of 216

Annexure- 15.5. : CONSENT FORM : SAE SUBCOMMITEE

Dear Sir/Madam,

In response to your letter, I give my consent to be the Chairperson//Member Secretary/Member of

SAE subcommittee of Father Muller Medical College Institutional Ethics Committee. I shall execute

my roles and responsibilities as per the policies and standard operating procedures of FMMCIEC, and

as mentioned in my appointment order. I shall maintain high ethical standards, and will not be unduly

influenced in discharging my assigned work.

I will maintain confidentiality of all discussions an documents . I am aware of the conflict of interest

policy of FMMCIEC, and I will declare conflict of interest (if any) during SAE review o and decision

making.

Thanking You,

Yours Sincerely,

Signature :

Name :

Signature of Chairperson, FMMCIEC.; Date.

FMMCIEC SOP




of 216

16. SOP-16: Waiver of Written/Verbal Informed Consent

16.1. Purpose : The purpose of this Standard Operating Procedure (SOP) is to describe the type of

research projects for which the Institutional Ethics Committee (IEC) may grant waiver for requirement

of obtaining written or verbal informed consent.

16.2. Scope : This SOP applies to the all protocols submitted for review by the IEC that ask for

consent waiver.

16.3. Responsibility : It is the responsibility of the IEC to review and approve a request for

verbal/written consent waiver. The Member Secretary will record the decision in the minutes and in

the Application Form. The Chairperson will sign and date letter conveying the decision.

16.4. Procedure :

16.4.1. The principal investigator should request for waiver of consent on those occasions which are

mentioned below in 16.4.2. When a request for waiver of consent is received from the Principal

Investigator (PI) to the IEC in the given format the following steps are taken:

The IEC Secretariat will check if the concerned documents are filled completely and the

required list of documents is enclosed.

The IEC members will review the request taking into consideration the types of studies for

which waiver of consent may be granted.

The IEC will ensure that there are adequate mechanisms described in the protocol for

protection of the identity of the research participants and maintaining confidentiality of the

study data. (This is necessary as the participant cannot be assured directly about confidentiality

of health data through a formal informed consent process, when consent waiver is granted).

16.4.2. The decision on waiver of consent is taken at the full board meeting of IEC.

The FMMCIEC decides granting waiver of consent on following occasions :

1) Research cannot practically be carried out without the waiver and the waiver is

scientifically justified

2) Retrospective studies, where the participants are de-identified or cannot be contacted;

3) Research on anonymized biological samples/data;

FMMCIEC SOP




of 216

4) Research cannot practically be carried out without the waiver and the waiver is

scientifically justified

5) Retrospective studies, where the participants are de-identified or cannot be contacted;

6) Research on anonymized biological samples/data;

16.4.3. In case of telephonic interviews, waiver of written informed consent may be requested but

verbal consent is mandatory.

16.4.4. The following documents need to be submitted for the IEC review for verbal consent :

A script for verbal consent - a verbal consent script provides all of the elements of consent in a

more informal style. In addition, each subject should be provided with an information sheet

that describes the study and gives contact names and numbers.

The interview schedule (questions to be asked) will confirm that the interview is a simple 5

minute call and that no questions are asked that compromise a person‟s confidentiality or

position.

16.4.5. The decision regarding approval / disapproval of waiver is informed to the Principal

Investigator in writing. If the waiver is not granted, the IEC will provide reasons for the same.

16.5. Annexure

Annexure -16 : Application form for Requesting Waiver of Consent


Department :

Title of the project :

Please Tick the Reasons for Requesting Waiver of Consent :

Research involves „not more than minimal risk‟ :

There is no direct contact between the researcher and participant :

Emergency situations as described in ICMR Guidelines :

Any other (please specify)

Statement assuring that the rights of the participants are not violated :

State the measures described in the Protocol for protecting confidentiality of data and privacy of

research participant

Principal Investigator‟s signature with date: ______________________________________

FMMCIEC SOP




of 216

17. SOP-17 : Management of Premature Termination / Suspension /

Discontinuation of the Study

17.1. Purpose : The purpose of this SOP is to describe how the Institutional Ethics Committee (IEC)

manages premature termination/suspension/discontinuation of a research study. Protocols may be

terminated/suspended/discontinued at the recommendation of the IEC, Data Safety Monitoring Board

(DSMB), Principal Investigator (PI), Sponsor, Regulator or other authorized bodies wherein

participant enrolment and follow-up are discontinued before the scheduled end of the study.

17.2. Scope : This SOP applies to any study previously approved by the IEC that has been

recommended for termination/suspension/discontinuation before its scheduled completion

17.3.Responsibility : It is the responsibility of the IEC to manage the termination of any study

(recommended for termination by Data Safety and Monitoring Board, Principal Investigator,

Sponsor or other authorized bodies or by the IEC)that the IEC has previously approved.

17.4.Procedure :

17.4.1. Recommendation for Termination/ Suspension/ Discontinuation :

a) By PI/Sponsor : An investigator/ Sponsor may put on hold a previously approved

research when in the judgment of the investigator/ Sponsor this is appropriate to

protect the rights or welfare of participants or when new safety information has

appeared in the literature, or evolved from this or similar research.

b) By IEC : IEC members/Chairperson can prematurely terminate/ suspend/

discontinue the study in the following situations:

protocol non-compliance/violation following which IEC decides in full board meeting to

terminate/ suspend/ discontinue the study;

SAEs occurring at trial site may require the study to be prematurely terminated for the

safety of the patients;

When research is not conducted in accordance with IEC policies, is not in compliance with the

local regulations or that has been associated with unexpected serious harm to participants;

Zero accrual for 1-2 years or long-term, low accrual. Suspended protocols remain open and

require continuing review;

The IEC may revoke approval and recommend to stop permanently all activities in a previously

approved research protocol.

FMMCIEC SOP




of 216

Terminated protocols are considered closed and no longer require continuing review.

17.4.2. Receipt of Recommendation of Study Termination :

The Secretariat will receive the study protocol termination/suspension/discontinuation

report submitted by the PI and verify the contents of the report for completeness

and/or other documents.

17.4.3. Review by the IEC :

The Secretariat will inform the Chairperson and Member Secretary regarding

the recommendation for premature termination/ suspension/ discontinuation of

study protocol and the termination/ suspension/ discontinuation report within 3

working days of receipt of the report. The Member Secretary/ Chairperson

shall review the report and either call for an emergency meeting or discuss the

report at the regular full board meeting.

The Secretariat will arrange for an Emergency meeting/ keep matter for

discussion at full board meeting

The Member Secretary in the meeting will inform members of the premature

termination/ suspension/ discontinuation of the project and the reasons for the

same.

If the Premature termination/ suspension/discontinuation Report is unclear or

more information is required from the PI, the Chairperson shall instruct the

Secretariat to seek clarifications/ additional information from the Principal

Investigator.

The Chairperson shall sign and date the study termination/ suspension/

discontinuation report in acknowledgement.

If the IEC has revoked approval/suspended the study, regulatory authorities

and Head of the institution must be informed within 14 working days of the

full board meeting

17.4.4. Notifying the PI :

The Secretariat will prepare a notification letter and send to the PI within 14

working days after the meeting acknowledging the approval of termination/

letter seeking clarifications/information regarding the premature termination.

FMMCIEC SOP




of 216

In case a letter is sent seeking clarifications/information regarding the

premature termination/ suspension/ discontinuation, the PI shall send a written

response within 60 days of receiving the letter.If the PI does not comply, the

matter will be put to the full board meeting for discussion.

The investigator may appeal or respond to the convened IEC in writing.

17.4.5. Storing the Protocol Documents :

The Secretariat will keep the original version of the Premature Termination Report in

the Protocol file and send the file to archive. The protocol documents will be stored

for a period of 5 years from the date of project termination.

17.5.Annexure.

Annexure -17 : Premature Termination Report

Protocol No. :

Protocol Title :

Principal Investigator : Department :

IEC Approval Date : Date of the Last Six-monthly Status Reported Submitted to IEC :

Date of Initiation of the Study : Termination/Suspension/Discontinuation Date : -----------------------------

------------

No. of Participants Enrolled : No. of Participants Completed :

No. of Ongoing Participants : No: of Drop outs :

Reason for Each Drop out : ---------------------------------------------------

Any SAEs ?

No. of SAEs :

Are the SAEs Reported to IEC ?

Yes : No ;

Brief summary of results: (use extra blank paper, if more space is required.

Reason/s for termination/suspension/discontinuation:

Signature of the Principal Investigator with Date.

Discussed in the IEC Meeting Held on :

Action Taken :

Approval of the Premature Termination / suspension / discontinuation of the project

Requires more information/ action as follows:__________________________________ __

_ Signature of Chairperson, IEC with date

FMMCIEC SOP




of 216

SOP-18 : Review of Research Proposals Involving

Vulnerable Population

18.1. Purpose : This SOP describes the requirements and process of review of research that involves

vulnerable participants.

18.2. Scope : This SOP covers the policies and procedures applied to all research dealing with

vulnerable participants submitted to the IEC.

18.3. Responsibility: It is the responsibility of the Member Secretary with Secretariat to maintain up-

to-date tools, like checklists, for reviewing research concerning vulnerable groups based on new and

evolving applicable regulations and guidelines. IEC Chairperson / Member Secretary are responsible

for ensuring that IEC members are well-versed in new and evolving regulations and guidelines

pertaining to vulnerable populations, through regular training programmes. The Member Secretary/

Chairperson is responsible for selecting primary reviewers with appropriate expertise to conduct the

reviews of such research and for securing consulting expertise as and when required for selected

reviews. IEC member is responsible for conducting review of research planned for vulnerable

populations, including an assessment of potential for coercion.

18.4. Procedures :

18.4.1. Definition of Vulnerable Population:

Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their

own interests and providing valid informed consent. They are the individuals whose willingness to

volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of

benefits associated with participation, or of a retaliatory response from senior members of a hierarchy

in case of refusal to participate.

a) economically and socially disadvantaged (unemployed individuals, orphans, abandoned

individuals, persons below the poverty line, ethnic minorities, sexual minorities –

lesbian/gay/bisexual and transgender (LGBT), etc.);

b) unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal to

participate which may lead them to give consent

FMMCIEC SOP




of 216

c) children (up to 18 years);

d) women in special situations (pregnant or lactating women, or those who have poor decision-

making powers/poor access to healthcare);

e) tribals and marginalized communities;

f) refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster

situations;

g) afflicted with mental illness and cognitively impaired individuals, differently abled – mentally

and physically disabled;

h) terminally ill or are in search of new interventions having exhausted all therapies;

i) suffering from stigmatizing or rare diseases; or

j) have diminished autonomy due to dependency or being under a hierarchical system

(students, employees, subordinates, defense services personnel, healthcare workers,

institutionalized individuals, under trials and prisoners).

18.4.2. Reviewing protocols with vulnerable participants:

The protocol should be reviewed as described already under the SOP “Review Procedures”.

Additionally, the protocol should be reviewed to assess if the following points are addressed:

-- Can the research be performed in any other non-vulnerable participants?

--- Is there justification to use vulnerable population?

---- Do the benefits justify the risks

---- Are the participants selected equitably

---- Have the measures to protect Autonomy of the vulnerable population been described

Appropriate Review forms are used

Reviewers: In addition to all members of the IEC, the Chairperson and Member Secretary

include one or two experts who have a thorough understanding of the ethical review process

and experience in the field of research to review such type of protocols. A representative of the

vulnerable population also will be included.

18.4.3. Decision: The decision on allowing trials on vulnerable populations will be taken in a

full board meeting of IEC. The decision will be communicated to the PI. Wherever necessary

the IEC approval should state that if in future the vulnerability status of the participants

changes, for e.g. unconscious patient gaining consciousness or a schizophrenic patient regains

insight, the participant will be re-consented

FMMCIEC SOP




of 216

18.5. Annexures.

Annexure-18.1. : Checklist for Research Involving Children (To be filled by PI and

submitted to IEC ; To be cross verified by Reviewer During Review )


Title of the Protocol :

To be done by Principal Investigator To be done by Reviewer

Risk –Benefit Assessment : (Tick the

appropriate answer)

Risk –Benefit Assessment : (Tick the

appropriate answer)

Less Than Minimal Risk ; Direct Benefit Less Than Minimal Risk; Direct Benefit

Less Than Minimal Risk; Indirect Benefit Less Than Minimal Risk; Indirect Benefit

Greater Than Minimal Risk; Potential benefit to

child

Greater Than Minimal Risk ; Potential

benefit to child

Greater Than Minimal Risk; No direct benefit,

offer knowledge about child‟s condition/disorder

Greater Than Minimal Risk ; No direct

benefit, offer knowledge about child‟s

condition/disorder

Yes No NA

Does the research pose greater than minimal risk to children?

If yes: Are convincing scientific and ethical justifications given?

If yes: Are adequate safeguards in place to minimize these risks?

Does the study involve healthy children?

a) If yes: Is the inclusion of healthy children justified?

Are the studies conducted on animals and adults appropriate and

justified?

a) If No: Is the lack of studies conducted on animals and adults

justified?

Will older children be enrolled before younger ones?

Is permission of both parents necessary?

a) If Yes: Are conditions under which one of the parents may be

considered: “not reasonably available” described?

FMMCIEC SOP




of 216

b) If Yes: Are the conditions acceptable?

Will efforts be made to ensure that parents‟ permission to involve

their children in research studies is free from coercion, exploitation,

and/or unrealistic promises?

Are provisions made to obtain the assent of children over 7 and,

where appropriate, honoring their dissent?

Are provisions made to protect participants‟ privacy and the

confidentiality of information regarding procedures?

Are there special problems that call for the presence of a monitor or

IEC member during consent procedures?

Are special needs of adolescents such as counselling and

confidentiality accounted for in the research design?

Are there any special problems such as confidentiality and reporting

that might arise in sensitive research about child abuse or sexual

practices of teenagers?

Does the research involve possibility of findings which may have

implications for other family members?(for eg. genetic risk, HIV

infection, Hepatitis C)

If Yes: Are there adequate mechanisms in place to deal with other

members of the family?

Are parents required to be present during the conduct of the research?

(Are proposed participants‟ very young? )

Signature of the Principal Investigator with Date

To be filled by Reviewer :

Comments of the Reviewer : Recommendations of the Reviewer :

Name and Signature of the Reviewer with

Date :

FMMCIEC SOP




of 216

Annexure-18.2. : Checklist for Research Involving Pregnant Women and Fetuses (To be

filled by PI and submitted to IEC ; To be cross verified by Reviewer During Review )



When research involves pregnant women or fetuses

Yes No NA

Where scientifically appropriate preclinical

studies, including studies on pregnant

animals, and clinical studies, including studies

on non-pregnant women, have been

conducted and provide data for assessing

potential risks to pregnant women and

fetuses?

Is the risk to the fetus not greater than

minimal, or any risk to the fetus which is

greater than minimal caused solely by

interventions or procedures that hold out the

prospect of direct benefit for the woman or

the fetus?

Any risk that is the least possible for

achieving the objectives of the research.

Is the woman‟s consent or the consent of her

legally authorized representative obtained in

accordance with the informed consent

provisions, unless altered or waived?

Is the woman or her legally authorized

representative, as appropriate, fully informed

regarding the reasonably foreseeable impact

of the research on the fetus or resultant child?

FMMCIEC SOP




of 216

Will any inducements, monetary or otherwise,

be offered to terminate a pregnancy?

Do individuals engaged in the research have a

part in any decisions as to the timing, method,

or procedures used to terminate a pregnancy?

Do individuals engaged in the research have a

part in determining the viability of a fetus?

Note : If the answer to any of the above is “No”, the research should not be approved.

When research involves neonate after delivery

Yes No NA

Are scientifically appropriate, preclinical and clinical studies,

conducted and provide data for assessing potential risks to neonates?

. Is the individual providing consent, fully informed regarding the

reasonably foreseeable impact of the research on neonate?

Will any inducements, monetary or otherwise, be offered to terminate

a pregnancy?

Do individuals engaged in the research have a part in any decisions

as to the timing, method or procedures used to terminate pregnancy?

Do individuals engaged in the research have a part in determining the

viability of a fetus?

A. Fetuses of uncertain Viability

Does the research hold out the prospect of enhancing the probability

of survival of the particular fetus to the point of viability, and is any

risk least possible for achieving the objectives of the research?

OR

The purpose of the research is development of important biomedical

knowledge which cannot be obtained by other means. Will there be a

risk to the fetus from the research?

Is the legally effective informed consent of either parent of the

neonate or, if neither parent is able to consent because of

FMMCIEC SOP




of 216

unavailability, incompetence or temporary incapacity, the legally

effective informed consent of either parent‟s legally authorized

representative obtained?

B. Nonviable fetuses

Will vital functions of the neonate be artificially maintained?

Is there any risk to the neonate resulting from the research?

The purpose of the research is the development of important

biomedical knowledge that cannot be obtained by other means

The legally effective informed consent of both parents of the neonate

will be obtained except that the waiver and alteration provisions do

not apply. However, if either parent is unable to consent because of

unavailability, incompetence, or temporary incapacity, the informed

consent of one parent of a nonviable fetus will suffice to meet the

requirements of this paragraph. (The consent of a legally authorized

representative of either or both of the parents of a nonviable fetus

will not suffice to meet the requirements of this paragraph.)

Note : If the answer to any of the above is “No”, the research should not be approved.

This type of research can be conducted only after The IEC finds that

(a) The research presents a reasonable opportunity to further the understanding, prevention or

alleviation of a serious problem affecting the health or welfare of pregnant women and/or

fetuses.

(b) The research will be conducted in accordance with applicable regulatory and ethical

guidelines.

Signature of Principal Investigator: __________________ Date _______________


Comments of the Reviewer :

Recommendations of the Reviewer :


Date :

FMMCIEC SOP




of 216

Annexure-18.3. : Checklist for Research Involving Cognitively Impaired Individuals (To

be filled by PI and submitted to IEC ; To be cross verified by Reviewer During Review )



A. Research Involving Cognitively Impaired Adults in which there is Anticipated Direct

Benefit to the participant

Yes No

Is the recruitment of participants justified considering the rationale

and objectives of the study?

The risk is justified by the anticipated benefit to the participants.

The relation of anticipated benefit to the risk is at least as favorable to

the participants as that presented by available alternative approaches

Will the participants be withdrawn if they appear to be unduly

distressed?

The proposed plan for the assessment of the capacity to consent is

adequate.

Consent will be taken from participants capable of being consulted.

Does the consent document include provision for a legally authorized

representative in case participants are not capable of being consulted?

Note : If response to any of the above is “No”, the Research should not be approved.

B. Research Involving Cognitively Impaired Adults in which there is No Anticipated

Direct Benefit to the participant

Yes No

Is the recruitment of participants justified considering the rationale

and objectives of the study?

Are the foreseeable risks to the participants low?

FMMCIEC SOP




of 216

Is the negative impact on the participant„s well-being minimized and

low?

Will the participants be particularly closely monitored?

Will the participants be withdrawn if they appear to be unduly

distressed?

The proposed plan for the assessment of the capacity to consent is

adequate.

Consent will be taken from participants capable of being consulted.

Does the consent document include provision for a legally authorized

representative in case participants are not capable of being consulted?







Date :

FMMCIEC SOP




of 216

Annexure-18.4. : Checklist for Research Involving Students, Employees or Residents (To

be filled by PI and submitted to IEC ; To be cross verified by Reviewer During Review )



Yes No

Have the participants been assured that their status (education,

employment and/or promotion) will not be affected by any decision to

participate or not?

Have the risks to participants been minimized?

Have participants been assured that participation is voluntary (no

signs of coercion)?

Have participants been assured that privacy and confidentiality will be

protected?







Date :

FMMCIEC SOP




of 216

Annexure-18.5. : Checklist for Genetic Research (To be filled by PI and submitted to

IEC ; To be cross verified by Reviewer During Review )



Yes No

Will the samples be made anonymous to maintain confidentiality? If

yes, then the following checklist points are not applicable

Will the results be disclosed?

a) If yes, has the investigator established clear guidelines for

disclosure of information, including interim or inconclusive research

result?

b) Will the results be used in management of current condition of

patient?

Has the appropriateness of the various strategies for recruiting

participants and their family members been considered?

Does the proposed study population comprise family members?

Will family members be implicated in the studies without consent?

Will the samples be destroyed in the future?

Will the samples be used for future research ?

Is genetic counseling being offered?






Date :

FMMCIEC SOP




of 216

19. SOP-19 : Dealing with Participants’ Requests and/or Complaints to

Institutional Ethics Committee

19.1. Purpose: The purpose of this SOP is to describe procedures for dealing with requests for

information by research participants regarding their rights as a participant or to resolve their

complaint/s that is/are related to their participation in research approved by the Institutional Ethics

Committee

19.2. Scope: This SOP applies to handling of requests for information/ complaints made by

participants concerning the rights and well-being of the research participants participating in research

studies by the IEC

19.3. Responsibility: It is the responsibility of the IEC Secretariat and Chairperson/ Member Secretary

to initiate the process of giving information asked by research participants or to address any injustice

that has occurred, if any complaints are received.

19.4. Procedures:

19.4.1. A request, complaint or query, from a research participant will be accepted by the Secretariat

and forwarded to the IEC Member Secretary after entering into the request record form

19.4.2. The Member Secretary may receive a request, complaint or query directly from the participant.

He/she will record it in the request record form and notify the Secretariat.

19.4.3. The Member Secretary will additionally ascertain details of the request/ complaint by

examining any relevant documents and by interviewing the participant if necessary. If required, the

Member Secretary will call for additional relevant information and documents from the Principal

Investigator.

19.4.4. The Secretariat will inform the Chairperson about the request, query or complaint received

from the research participant.

19.4.5. In case of a request for additional information or clarification, the Member Secretary in

consultation with the Chairperson will provide the information himself / herself or will designate one

or more IEC member(s) to provide such information.

FMMCIEC SOP




of 216

19.4.6. In case of a complaint received from a research participant:

A) The Member Secretary, in consultation with the Chairperson will initiate a process to address any

injustice that may have occurred. Depending on the seriousness of the matter, the Chairperson will

direct the Member Secretary to:

Appoint a subcommittee of two or more IEC members for enquiry in order to resolve the

matter.

Call an emergency meeting of two or more IEC members for discussion or

Consider the matter for discussion at the next full board meeting

B) The Chairperson/ Member Secretary/ designated IEC members will assess the situation and

mediate a dialogue between the research participant and PI in an attempt to resolve the matter.

C) The IEC will insist on factual details to determine gap, if any, between truth and individual

perception

19.4.7. The final decision will be taken by the Chairperson based on the recommendation of any

one of the above and it will be informed to the research participant and the PI by the Secretariat.

19.4.8. The information including any action taken or follow-up and final decision will be recorded

in the form and the form is signed and dated.

19.4.9. The IEC members will be informed about the action taken and the outcomes in the

forthcoming IEC meeting (in case of requests/ complaints not discussed in full board meeting) and

minuted.

19.4.10. The Secretariat will place all documents in the relevant study file.

19.5. Annexure.

FMMCIEC SOP




of 216

Annexure - 19. : Request/Complaint Form

Date :

Received by :

Request/ Complaint

received through:

a) Telephone No. :

b) Letter , Dated :

c) E mail, dated. :

d) Walk-in , Date and Time :

Participant‟s Name

Contact details

Address & Phone:

FMMCIEC Protocol

No. :

Title of the Project

:

Starting date of

participation :

Information

requested/

complaint/query

Action taken:

Reviewed by

Final Decision

Date of IEC meeting

(if applicable)

Signature of Member Secretary with Date

Signature of Chairperson with Date

FMMCIEC SOP




of 216

20. SOP-20 : Maintenance of Active Study Files, Administrative Records of IEC,

Archival of Closed Files and Retrieval of Documents

20.1. Purpose : The purpose of this SOP is to describe the process of maintenance of active study files

and other related documents approved by the Father Muller Medical College Ethics Committee

(FMMCIEC), FMMCIEC administrative documents, archival of closed files and retrieval of

documents.

20.2. Scope : This SOP applies to maintenance, archival and retrieval of all study files and study related

documents and FMMCIEC administrative documents by the FMMCIEC secretariat.

20.3. Responsibilities

It is the responsibility of Member Secretary with assistance of Joint Secretary and Secretariat

to ensure that all active study files and FMMCIEC records are prepared, maintained during

the study period and kept securely for a period of five years after the closure/ termination of

the project.

20.4. Procedure : FMMCIEC maintains a master document list which has names of all

files/records/documents maintained in FMMCIIEC.

20.4.1. Maintenance of the Active Study Files

A study master file is the file comprising all essential documents and correspondence

related to the study. This should be created for all proposals at the time of initial

submission to the FMMCEC office. These should include copies of

- Protocol submission form

- Clearance from scientific committee of FMMCIEC (including corrections

suggested by the scientific committee and modifications made)

- Copy of study protocol/research project/trial

- Detailed budget form (including break up of funds utilized/incurred)

- Informed consent documents (patient information sheet and consent form) – in

English and also in local language

- Project timeline including start and approximate completion period

- Statement of intent from PI for periodic review of the project by ethics committee

FMMCIEC SOP




of 216

- All other documents mandatory as per the requirements/merit of the project/trial

(eg : insurance certificate, Permission letters from dean/HOD etc)

- All related documents of the approved study will be gathered, classified

appropriately and placed in the study master file. The protocols will be kept with all

their necessary documents by the month of clearance from the committee so as to

facilitate paper and electronic retrieval. All the necessary documents related to the

protocol will be kept in a file which could include copies of

- All original research proposals reviewed & approved,

- Reviewer‟s assessment forms

- Study approval letter

- Reviewed & approved consent documents, amendments & any other correspondence

- Study progress reports and interim reports,

- Serious adverse event report forms submitted by investigators,

- Any other reports

- FMMCEC correspondence

*Strict confidentiality will be maintained for the contents of the files

*All active files will be kept secured in a file cabinet with controlled access.

*A log book for accessing the files by authorized staff & members will be maintained.

20.4.2. Maintenance of Administrative Records

The FMMCIEC records will include the following:

1. FMMCIEC members' records

• Appointment and acceptance letters of each member

• Signed and dated confidentiality agreements

• Updated Curriculum vitae (hard copy or soft copy)

• Training records for each FMMCIEC member (GCP, SOP)

• Documentation of resignations / terminations

2. FMMCEC membership roster - An FMMCEC roster will be maintained which will

contain:

a. Names of FMMCIEC members

FMMCIEC SOP




of 216

b. Age

c. Gender

d. Evidence of qualifications

e. Role in the FMMCIEC

f. Status of affiliation to institution (e.g., unaffiliated or affiliated)

g. Regular/ Alternate member to the FMMCIEC (if applicable)

3. Correspondence related to changes in FMMCIEC membership with

DCGI, or any other concerned authority

4. FMMCIEC attendance roster

5. Leave letter for absence from any of the meeting with reasons

6. Agenda and Minutes of FMMCIEC meetings

7. Standard operating procedures (SOPs)

8. Annual reports

9. Documents related to Workshops & conferences organized/attended by

FMMCIEC (Continuing education for members & staff)

10. SOP training and distribution logs

11. Financial transactions

12. List of studies approved by FMMCIEC with protocol numbers

20.4.3. Maintenance of Closed Study Files

1. Once the study file is closed (following completion/ premature termination), the

related study files will be shifted to the FMMCIEC Archival room.

2. All closed study files will be archived in the FMMCIEC archival room for a period of

five years from the date of closure of the study.

3. A log book for archival of study documents will be maintained.

20.4.4. Accessibility / Retrieval

1. Study files and administrative records will be made available for audit, making

photocopies on request or any other purpose if authorized by Member Secretary/

Chairperson. Representatives of regulatory authorities may have access at all

times.

2. A log book of retrieval of documents will be maintained.

FMMCIEC SOP




of 216

20.4.5. . Disposal of Closed Files and Copies of Protocols and Documents Submitted for FMMCIEC

Review

1. At the end of the archival period, the closed files will be shredded and disposed

off by authorized FMMCIEC personnel.

2. Extra copies of protocols and documents submitted for FMMCIEC review and

any other extra copies will be shredded by authorized FMMCIEC personnel after

the FMMCIEC meeting without any notification to PI.

3. A formal disposal log will be maintained, providing details of documents that will

be disposed.

20.5. Annexures :

Annexure-20.1. Document request form

Project no

Project title

Name of PI

Requested by

Documents requested

Purpose of request

Signature of requesting person

Signature of PI

Signature of member secretary/ chairperson with date

Annexure -20.2. : Log for disposal of study documents

Project Title Name of No. of Date of Date of Date of Disposed by

No. Principal files FMIEC Study Study (Name & Sign) of

Investigator Approval Initiation Closure Authorized Individual

FMMCIEC SOP




of 216

21. SOP-21: Internal Audit of FMMCIEC

21.1. Purpose : The purpose of this SOP is to describe the procedure for self assessment of

the functioning of FMMCIEC, periodically.

21.2. Scope : This SOP is applicable to self-assessment and internal audit of FMMCIEC

21.3. Responsibility: It is the responsibility of the Member Secretary to prepare the periodic

self assessment /internal audit schedule. It is the responsibility of the Chairperson to ensure

proper and unbiased conduct of internal audit. It is the responsibility of all members of

FMMCIEC to participate in the internal audit as auditor/auditee.

21.4. Procedure :

21.4.1. Periodicity of Self-Assessment / Internal Audit : Two internal audits are

conducted in a year (once in six months).

21.4.2. Preparation of the Audit Schedule : The Member Secretary of FMMCIEC

prepares the audit schedule with approval from the Chairperson. The audit will be conducted

over a period of two days, and involves every standard and objective element of NABH

accreditation standards for ethics committee. The audit checklist will be made available to

the members for doing the audit.

21.4.3. Auditors and Auditee : Every member of FMMCIEC will be the auditor. However,

one will not audit his/her own review. The Member Secretary and the Chairperson will be

the auditee.

21.4.4. Audit Procedure: The audit involves verification of documents of FMMCIEC and

interview with members of FMMCIEC, secretariat, Member Secretary, principal

investigators of regulatory trials and participants of regulatory trials.

21.4.5. Report of Internal Audit: The report of internal audit is submitted to the

Chairperson

21.4.6. Corrective Action: The Chairperson and the Member Secretary will take necessary

corrective actions for the non conformities /partial compliances raised in the internal audit.

The members of FMMCIEC will go through the corrective actions taken.

21.5. Annexures.

FMMCIEC SOP




of 216

Annexure-21.1. Format of the Self- Assessment / Internal Audit Schedule :

FMMCIEC/CCM/----/Year. Date: -----------------------

The periodic internal audit of the FMMCIEC will be held as per the schedule. Each team of

Auditors will have 2 members

Dates Area/Standards of Audit Auditors Auditee

Constitution of IEC, Composition;

Subject Experts; Training and

Assessment of IEC Members; SOP

revision.

Team 1

Member-1 :

Member-2 :

Review Procedures : initial,

continued, completion/final reports;

Meetings of IEC; Decision Making.

Team 2

Member-1 :

Member-2 :

Serious Adverse Events (SAE);

Protocol Deviations and Violations;

On site Monitoring

Team 3

Member-1 :

Member-2 :

Administrative Support; Functioning

of Secretariat; Financial

Transactions; Handling Grievances

and Complaints; Record Keeping

and Archival; Communications

Team 4

Member-1 :

Member-2 :

The auditors are requested to conduct the audit as per the checklist, and complete the audit process as

per the schedule.

There will be an opening meeting on : at :

The closing meeting will be held on: at :

The audit report should be submitted to the Chairperson during the closing meeting.

Member Secretary, FMMCIEC Chairperson, FMMCIEC

(Name, Signature and Date)

FMMCIEC SOP




of 216

Annexure-21. 2 : Checklist for Self-Assessment / Internal Audit of IEC

Scoring for each element should be done as : 0/5/10. If not applicable, mention NA.

Implementation could be assessed checking records/interviews

Objective Element of NABH standards Policy and SOP

(Scoring : 0/5/10)

Implementation

(0/5/10)

Remarks

1.1. Authority for Formation of Ethics Committee : There shall be documented

procedures to establish the authority for formation of IEC as per applicable rules

and regulations

1.1.1. Procedures shall be followed to

specify the authority under which the IEC is

established and administratively governed

1.1.2. There shall be a documented policy to

ensure the independence of the IEC in its

functioning and decision making

1.1.3. The IEC shall function as per

appropriate rules and regulations

1.2. SOPs : The IEC has and follows written SOPs for its different functions as per

applicable rules and regulations

1.2.1. Procedures shall be in place and well

defined for the development, review and

revision of SOPs

1.2.2. Mandatory SOPs are available

1.3. Ethics Committee Composition: The IEC meets the requirements for membership as per

applicable rules and regulations. Procedures are documented and followed

1.3.1. Composition of IEC shall be

multidisciplinary and multisectorial and

adequate for its functioning

1.3.2. Subject experts and representatives of

vulnerable subjects shall be invited as

required with prior intimation

FMMCIEC SOP




of 216

1.3.3. Membership, appointment,

reconstitution and resignation shall be

defined as per terms of reference

1.3.4. Roles and responsibilities of members

shall be well defined

1.3.5. IEC embers shall be trained (initial

and ongoing) in applicable rules and

regulations and IEC SOPs

1.3.6.Conlfict of interest and confidentiality

shall be addressed at the time of

composition

1.4. Protection of Subject Rights, Safety and Wellbeing : The IEC follows documented

procedures for subject protection

1.4.1. Rights and responsibilities of subject

shall be documented and specified

1.4.2. Subject‟s Participation and

withdrawal from the trial shall be voluntary

and with prior intimation

1.4.3. Subjects shall be informed and

comprehend of the associated risks and

benefits of the trial

1.4.4. Confidentiality and privacy of

subjects shall be protected

1.4.5. Monitoring of trials shall be done to

ensure equitable selection of subjects, with

special attention to vulnerable and high risk

subjects

1.4.6. Compensation provided to subjects

for participation in the trial shall be

appropriate and as per the rules and

regulation and is reflected in the contract

FMMCIEC SOP




of 216

1.4.7. Serious adverse events shall be

addressed, adequate medical care provided

and an appropriate reporting mechanism is

followed as per applicable rules and

regulations

1.4.8. Compensation for injury to the

subject shall be as per the rules and

regulations and monitored for

noncompliance

1.4.9. Complaints and concerns of subjects

shall be addressed and managed

appropriately if need arises

1.7.Administrative Support : The IEC follows documented procedures /terms of reference

to ensure that administrative support for its activities is adequate

1.5.1. Adequate finance, human resource

allocation and secretariat for administrative

support work and record keeping shall be

ensured, with due care and confidentiality

1.5.2. There shall be financial transparency

of Ethics Committee activities and

functioning

1.5.3. There shall be a procedure for

communication between IEC,

investigator/relevant site staff, institution

and regulatory authority

1.6. Review Process : The IEC follows documented procedures for initial review of the trial

related documents, review of amendments and periodic review

1.6. 1. Review shall be done by the IEC in a

formal meeting within a reasonable time

following appropriate submission of

documents by investigator as per rules and

FMMCIEC SOP




of 216

regulations and IEC requirement

1.6.2. Initial review of proposed clinical

trial shall evaluate the scientific validity of

the protocol, risk to subjects, expected

benefit and ethical standards as per

applicable rules and regulations

1.6.3. Informed consent document, assent

form and translations shall be reviewed for

appropriateness of language, accuracy and

completeness of information

1.6.4. IEC shall review the informed

consent processes to be followed at the site

for a particular trial to ensure that

subject/LAR/impartial witness are provided

appropriate information, adequate time is

given and impartial witness used as

applicable

1.6.5. Recruitment strategies shall be

evaluated

1.6.6. Proposals involving special group and

vulnerable population shall be evaluated as

per rules and regulations

1.6.7. Contract and budget shall be

evaluated, for indemnity, compensation,

roles and responsibilities as per applicable

rules and regulations

1.6.8. Review of amendments to the

originally approved protocol, consent forms

and investigation brochure shall be done in

formal meetings to evaluate the risk to trial

subjects

FMMCIEC SOP




of 216

1.6.9. Periodic review of trial shall be done

for continuation, risk evaluation and adverse

event monitoring

1.7. Decision Making and Post-Meeting activities : The IEC follows documented procedures

for decision making process and post meeting activities

1.7.1. Decision making process shall be as

per applicable rules and regulations,

ensuring quorum and consensus/voting

requirements are fulfilled

1.7.2. The subject shall be recruited into the

trial only after written approval from IEC

and approval by regulatory authority

1.7.3. Conflict of interest shall be declared

prior to the review and voluntary

withdrawal during decision making process

is documented

1.7.4. Decisions shall be based on risk

assessment, scientific validity and

adherence to ethical principles for the initial

and periodic approvals

1.7.5. Deliberations and decisions made

during the meetings shall be documented,

approved , signed and maintained as

minutes of meeting

1.7.6. Protocol deviations and non-

compliances shall be evaluated and

appropriate actions are taken as per rules

and regulations.

1.7.7. Serious adverse events shall be

analyzed and compensation amount

assessed and reported to regulatory

FMMCIEC SOP




of 216

authority as per rules and regulations

1.7.8. All decisions/opinions shall be

notified to the investigator in writing

1.8. Monitoring : The IEC follows documented procedures for monitoring and for-cause

assessment

1.8.1. Subject‟s rights, safety and wellbeing

shall be monitored

1.8.2. Adequacy and continuity of consent

process shall be ensured

1.8.3. For-cause assessments shall be

conducted following non-compliance and

/or complaints for the trials approved by the

IEC

1.8.4. Opportunities for improvement shall

be identified and appropriate actions are

initiated

1.9. Self-Assessment : The IEC has and follows documented procedures for self-assessment

1.9.1. Periodic self-assessments shall be

conducted

1.9.2. Corrective and preventive actions (as

required) shall be implemented accordingly

1.10.Record Keeping and archival : The IEC follows documented procedures for record keeping

and archiving

1.10.1. Security, confidentiality and

integrity of all proposals and associated

documents shall be reviewed from time to

time and administrative communication

shall be maintained as per regulatory

requirement and with confidentiality

1.10.2. Documents and records shall be

archived after completion/termination of

FMMCIEC SOP




of 216

trial as per applicable rules and regulations

1.10.3. Record retrieval policies and

procedures shall be in place to ensure access

to information for inspection and audit and

continual protection of trial subjects post

trial closure with prior permission in writing

FMMCIEC SOP




of 216

22. SOP-22 : Preparing for Inspection /Audit of FMMCIEC

22.1. Purpose : The purpose if This SOP is to describe the processes involved in preparing for

an audit or inspection of FMMCIEC

22.2. Scope : This SOP is applicable to the FMMCIEC members and secretariat , and to all the

processes involved in preparing for an audit or inspection of FMMCIEC

22.3.Responsibility : The Chairman, the member secretary, all members and secretariat of

FMMCIEC

22.4.Procedure :

22.4.1. Receipt of Information on Audit or Inspection :

On receipt of the written/ mailed communication regarding audit/ inspection visit, the

Member Secretary will inform the Chairperson, IEC members and the Head of Institution,

about the date and purpose of the audit/inspection.

22.4.2. Preparation for Audit or Inspection :

On receiving information about the audit /inspection, IEC Member Secretary and/ or IEC

member/s are given the responsibility by the Chairperson to prepare for the visit with

assistance of the Secretariat. The Member Secretary and / or designated IEC member/s will

make arrangements in accordance with the steps mentioned in the checklist.

The studies with incomplete / missing documents will be dealt with separately and actions

taken will be documented. Care should be taken to ensure that all documents are kept in

the right order for easy and quick access.

22.4.3. On the Days of Audit :

1) The Chairperson / Member Secretary / designated IEC Member/s should

welcome and accompany the auditors/inspectors to the reserved meeting

room. Designated team members must be present in the meeting room.

2) The conversation would start with the auditor/inspector stating the purpose

of the visit and the type of information is needed.

3) The IEC Chaiperson / Member Secretary / IEC Members must answer

questions of the auditors/inspectors clearly, politely, truthfully and straight

to the point.

FMMCIEC SOP




of 216

4) The information and files requested by the auditors/inspectors should be

made available by the Secretariat.

5) The Member Secretary/ designated IEC member/ Secretariat will make note

of the comments, recommendation of the auditors/inspectors.

22.4.4. Correction of Deficiencies Observed at an Audit/Inspection :

1) The Member Secretary/ designated IEC member/ Secretariat will review

comments and recommendations of the auditor/inspector.

2) On receipt of the Audit/ Inspection Report the Chairperson should

implement corrective and preventive measures and set the timeline for

implementation of corrections as stated by the auditor/inspector.

3) The action plan should be communicated by the Member Secretary/

designated IEC member to the auditor/inspector after seeking approval of

the Chairman.

4) A review date for an internal follow-up audit will be decided by the

Chairperson (if applicable).

5) The Member Secretary/ designated IEC member should report the outcome

of the internal follow-up audit to the Chairperson.

22.4.5. Recording the Audit/Inspection Visit :

The Member Secretary/ designated IEC member/ Secretariat must keep the record of the

audit/inspection visit reports and action plans in a separate audit/inspection file. The

completed checklist and findings from the internal follow-up audit (if applicable) must also

be maintained in the internal audit file.

22.5. Annexure :

Annexure-22.1 : Audit and Inspection Checklist

1. Date of letter of communication regarding audit/inspection:

2. Date(s) on which the audit/inspection has been agreed upon:

3. To ensure the IEC members and staff have been informed about the date/s and time.

4. To ensure availability of IEC related information – mandate, terms of reference, organisation

chart (in the print form) in the IEC office.

5. To make sure of availability of latest copy /copies of signed SOPs in print form in the office

and/ or in electronic form on the IEC computer/s.

FMMCIEC SOP




of 216

6. To review the SOPs and note details of any omissions or deviations, with reasons.

7. To ascertain availability of all national and international ethics guidelines and regulations in

print form and / or in electronic form in the IEC office.

8. To check the files of ongoing and complete research study files for the presence of all signed

documents as stated below and to note any missing/ incomplete documentation and actions

taken.

1) Records regarding applications of research studies for review including protocols and

related documents

2) Protocol Assessment Records – Comments of IEC members, Meeting Agenda, Minutes

(documented in individual study file or separately in meeting records file)

3) Communication records with investigator (documented in individual study file)

4) Amendment Approvals (documented in individual study file)

5) SAE reports and SAE related communications with investigator and regulators

6) Protocol deviation/violation/exception reports (documented in individual study file)

7) Continuing and final completion/termination reports (documented in individual study file)

9. To ensure availability of documents regarding list of members, tenure, appointment details,

CVs, baseline and periodic training of IEC members.

10. To ensure availability of documents regarding appointment, CVs and training of staff of

secretariat.

11. To ensure measures for maintaining security of electronic database and office records.

12. To make sure that maintenance, retrieval, storage, archival and tracking of the study files

are done as per the respective SOPs.

13. To ascertain proper labelling and indexing of study files and storage cabinets.

14. To decide which members will communicate with auditors/ inspectors, be available for

audit/inspection, prepare action plan and conduct follow-up audit (if applicable)

15. To report about findings and report received regarding audit/inspection to IEC members at

the full board IEC meeting.

15. To make other arrangements (meeting venue for review of documents, catering,

accommodation, travel) for the visit, as applicable.

FMMCIEC SOP




of 216

References :

1. Guide Book To Standards For Accreditation of Ethics Committees, 1st Edition; NABH,

2015

2. THE DRUGS AND COSMETICS ACT AND RULES, Ministry of Health and Family

Welfare : New Delhi, 2016

3. THE DRUGS AND COSMETICS ACT AND RULES

http://www.cdsco.nic.in/writereaddata/D&%20C%20AMMENDMENT%20BILL(1).p

df

4. THE DRUGS AND COSMETICS ACT AND RULES

http://www.cdsco.nic.in/writereaddata/D&C_ACT_AMENDMENT_2008_file.pdf

5. ICMR. National Ethical Guidelines for Biomedical and Health Research Involving

Human Participants. Indian Council of Medical Research: New Delhi; 2017.

6. FERCI. Standard Operating Procedures. Forum for Ethics Review Committees in

India.

http://www.cdsco.nic.in/writereaddata/D&C_ACT_AMENDMENT_2008_file.pdf