parul university institutional ethics committee for … · the parul university institutional...

PU-IECHR SOP Version IInd April 2015 of 18

PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH (PU-IECHR) STANDARD OPERATING PROCEDURE (SOP)

Version Number: IInd Version, April 2015 Prepared by: Member Secretary Reviewed and Approved by: All Committee Members Validity: Till Next Revision Total Number of pages: 18


OBJECTIVE

To ensure that the content of Institutional clinical trial documentation is relevant and accurate, the submissions by respective personnel are prepared and progressed in consistent manner and are subject to standard ethical review and approval procedure, laid down by competent authority from time to time.

1. POLICY

The Parul Arogya Seva Mandal Institutional Ethics Committee for Human Research (PASM-IECHR) has been established in Aug-2012 in the city of Vadodara, Gujarat, India to function in accordance with

ICH, GCP and WHO guidelines

Ethical Guidelines for Biomedical Research on Human Subjects by Indian Council of Medical Research New Delhi and

Schedule “Y” of drugs and Cosmetics Rules, 1945 with latest amendments published by Ministry of Health and Family Welfare, (Department of Health) New Delhi.

The Parul University Institutional Ethics Committee on Human Research (PU-IECHR) essentially targets patient care and ethical aspects of research and education. It safeguards the rights, safety and wellbeing of all trial subjects. Special attention will be paid to trials that may include vulnerable subjects. The Committee will ensure that clinical trials are conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP.

2. APPLICLABILITY

The Standard Operating Procedures listed in this Manual are applicable for,

3.1 All members of the PASM-IECHR

3.2 All investigators and Sponsors/CRO’S of PU and Outside PU submitting an application to this committee

4. PROCESS OUTLINE

4.1 APPLICATION PROCEDURE


Inquiries to find out the schedule for the next meeting of the PU-IECHR should be made with the office of the Member Secretary. The PU-IECHR must receive submission at least two weeks prior to next meeting. Prescribed numbers of copies of each of the below mentioned documents are to be submitted along with an application/submission letter from the Principal Investigator.

Application form should be procured and submitted in last updated format available on website of university, with enclosures includes,

Trial Protocol, Protocol Amendments if any to previously submitted protocol, Investigator Brochure, Patient Information Sheet and Informed Consent Form in English, Hindi and Gujarati along with back translations and / or Translation Certificate, Available safety reports, Investigator undertaking, CV of Principal Investigator, Insurance certificate (Where applicable), Copy of approval of institution where trial is to be carried out (Where applicable), Any other study specific documents, DCGI application and or approval (Where applicable).

When all the above requirements are met;

PU-IECHR accepts the proposal.

Includes it on Agenda for next PU-IECHR Meeting.

4.2 PRE MEETING PROCEDURE

MEMBER SECRETARY will,

Confirms date, time and agenda with all members & confirms the venue of the meeting.

Circulates the Agenda, Previous Meeting Minutes and a copy of all proposals and all study documents to each member for review.

Informs each Principal Investigator or Sub-investigator to attend the meeting at the appointed time for his/her proposal presentation.

Ensures that the meeting will be fully constituted and quorum is met as per specifications

4.3 MEETING PROCEDURE

A quorum of at least 5 members as per Schedule Y must be present.


Members may designate a Chairperson, who may act in his/her absence.

Previous Minutes and matters arising thereby will be discussed.

Each submission is discussed in detail and a list of queries is compiled.

Queries related to the protocol/study being discussed by the committee will be answered by Investigator/ sponsor representative.

If any of the members are participating in a trial that is under review by the Committee, he/she may not participate in the discussion on that submission and must absent him/herself from the vote.

A consensus is generated basis of voting procedure shown in annexure on whether to approve the protocol.

4.4 POST MEETING PROCEDURE

Recorded Minutes are kept on file.

All sponsor/investigator of protocols submitted for reviews are informed of the committee’s decision and any recommendations in writing.

Investigators/Sponsors who submitted Amendments or Adverse events for review will be notified of the committee’s decision in writing.

All correspondence to the Investigators/Sponsors must be signed by either the chairperson and member secretary.

All Ethically Approved Trials must include; PU-IECHR Application/Proposal Form with enclosures, and Copy of PU-IECHR approval.

5.0 COMMITTEE PROCEDURES

5.1 COMPOSITION OF COMMITTEE.

5.1 .1

The PU-IECHR shall be composed of Chairperson; a Member Secretary, and 5-6 members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community interests.


The members will be selected to have an equitable representation of all specialties, which includes scientists, clinicians, and members of the community, a lawyer / expert in ethics, a social worker and layperson.

There will be adequate representation of age, gender, community, etc. in the Committee to safeguard the interests and welfare of all sections of the community society.

Members should be aware of local, social and cultural norms, as this is the most important social control mechanism. The committee will comprise of a diverse working group without any gender bias.

A member should sign a consent form and provide a bio-data for record

The composition may be as follows: -

1. Chairperson

2. Basic Medical Scientists.

3. Clinicians from Different Specialty.

4. Legal Experts.

5. One Social Scientist / Representative of Non-Governmental Voluntary Agency / Philosopher/Ethicist.

6. One Lay Person from the community.

7. Member Secretary.

8. One Pharmacy Expert

PU-IECHR must include at least one member whose primary area of interest / specialization is non- scientific. Current composition of committee is mentioned in Annexure-I (Pg no 18).

5. 1 .2

The following qualities are sought in the PU-IECHR members:

Interest and Motivation


Commitment and Availability

Experience or Education

Respect for divergent opinions

Interest in committee work

Integrity and Diplomacy.

5.1.3 QUORUM REQUIREMENTS

For review of each protocol of PU-IECHR there shall be at least 5 members with the following representations:

1. Basic Medical Scientist

2. Clinician

3. Legal Expert

4. Social Scientist / representative of non-governmental voluntary agency / philosopher / ethicist.

5. Lay person from the community.

No quorum should consist entirely of members of one gender. A quorum should include at least one member whose primary area of expertise is in a non-scientific area. Only those PU-IECHR members who are independent of the clinical trial and the sponsor of the trial should vote/provide opinion in matters related to the study.

5.1.4 TERMS OF APPOINTMENT

Duration

The members of the PU-IECHR will be appointed for duration of 2 years. There will be no bar on the members serving for more than one term.

Renewal

The membership may be renewed after the stated terra of 2 years.

Replacement procedures


The members may be replaced at the discretion of the committee members when a majority vote is obtained.

Removal procedure

A member may be relieved of his/her membership in case of a conduct unbecoming for a member of the Ethics Committee or inability to participate in the meetings on any grounds.

Voting status

All nominated members including member secretary have the power to vote.

5.1.5 CONDITIONS OF APPOINTMENT

Name, age, gender, profession, and affiliation will be documented whenever the committee is constituted or there is a change in the membership.

Conflict of interest to be disclosed, if any, exists.

Members must apprise themselves of the relevant documents, Schedule ‘Y’, GCP — ICH guidelines and the ICMR code.

An investigator can be a member of the PU-IECHR, however the investigator-as-member cannot participate in the review and approval process for any project in which he or she has a present or potential conflict of interest.

5.1.6 OFFICERS

The PU-IECHR will have the following Office bearers who have the expertise and professional qualification to review what comes in.

Chairperson

The Chairperson should be a highly respected individual preferably from a reputed institution, fully capable of managing the PU-IECHR and the matters brought before it with fairness and impartiality.

The task of making the PU-IECHR a respected part of the community will fall primarily on the shoulders of this individual. The PU-IECHR must be perceived to be fair and impartial, immune from pressures brought before it either from professional and non-professional sources.

Member Secretary


The Member Secretary will be member committed to the task of coordinating and managing the activities of the committee. He / She will be responsible for scheduling the meetings, describing the agenda and ensuring the function of the committee as per the norms and policies described in this manual.

5. 1 .7 INDEPENDENT CONSULTANTS

The PU-IECHR may call a subject expert to offer expertise as and when required. The PU-IECHR will establish a standing list of independent consultants to provide special expertise to the EC on proposed research protocols. These consultants may be experts in specific diseases or methodologies, or they may be representatives of communities, patients, or special interest groups. Independent consultant cannot vote.

5.1 .8 EDUCATION FOR PASM-IECHR MEMBERS

PU-IECHR members have a need for initial and continued education regarding the ethics and science of biomedical research. The PU-IECHR members will be encouraged to keep abreast of all national and international developments in ethics through orientation courses on related topics by its own members or regular training organized by constituted bodies.

PU-IECHR members will receive introductory training material in the work of a PU-IECHR as well as ongoing opportunities for enhancing their capacity for ethical review.

5.2 FUNCTIONS OF THE COMMITTEE

To consider the justification for conducting the proposed trial and the circumstances under which proposed trial is to be conducted and, where the committee considers that the proposed trial is justified and it is satisfied with those circumstances, it shall give its approval to the conducting of the proposal trial, in compliance with the ICH GCP guidelines.

The committee shall not consider the proposed clinical trial justified unless it is satisfied that the risks to be incurred by participants would be commensurate with the objectives of the trial.

5.3 COMMITTEE RESPONSIBILITIES

1. To safeguard the rights, safety and wellbeing of all trials subjects.

2. To provide the guidelines for submission of documents to the PU-IECHR for review


3. To review proposed trial with regards to the following: -

The objectives of the proposed trial and its planning and organizational structure.

The qualifications and competence of each person who would conduct the trial and whether appropriate the resources available to them.

The criteria to be used for the recruitment and the selection of participants /patients. The extent and nature of the medical examination that persons selected as participants/ patients are to undergo before participating in the trial.

The extent to which the health of the participants is proposed to be monitored during and after the trial.

Details of any inducements or rewards, monetary or otherwise to be made for becoming or being participants.

Any payments whether monetary or otherwise to be made to a person, for conducting the clinical trial or any part of the trial.

The criteria to be used to ensure that the identity of each participants/ patient remains confidential. Any payments whether monetary or otherwise to be made to any person for facilities used for the purposes of the trials.

5.4 FEES OF THE COMMITTEE

Fees will be charged by the PU-IECHR for Protocol review, which will be received together with the documents as mentioned in section 4. 1. Fees will also be charged for review or amendments to the Protocol. This fee is to cover administrative expenses. An EC fee is to be paid by draft in favor of “PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH”. Such fees will be used by the office to have regular EC meetings, to maintain an office, secretarial staff, computer and internet connection, printer, fax and phone line, travel allowance and also obtain storage for archiving the office documents. The PU-IECHR reserves rights to modify the fee structure or waiver in any way under special circumstances, as understood by the university management. The fees will be charged as follows;

Proposal Type

Nature of Applicant

1st Application For Every Revision

Academic Student 1000 500 Faculty Member

1000 1000


PhD Scholar 2000 1000

Govt. Sponsored

Student/ Faculty (Small work-Budget less than 1 lakh)

5000 1500

Student/ Faculty (Big work-

Budget more than 1 lakh)

10000 1500

PhD Scholar 10000 3000 Industry

Sponsored Student/ Faculty 15000 1500

PhD Scholar 20000 3000

5.5 COMMITTEE REVIEW PROCEDURE

All members to be notified at least one week before the meetings.

Agenda, Previous Minutes and documents for review for the new study to be circulated and should reach to all the committee members at least one week prior to the proposed EC meeting.

When protocols involve more than minimal risk to human subjects, meaning a greater risk than found in ordinary daily life, they must be reviewed by the Ethics Committee. A review of the Ethics Committee is defined as a regular meeting of quorum (5 or more) of the committee members.

The Committee will meet on as and when required. Project applications must be submitted at least two weeks prior to each meeting.

Each committee member will be circulated with the study documents made available by the sponsor / investigator.

The Sponsor representative Investigator delegate will be invited to attend the meeting to present and answer any questions on the protocol. The protocol is then discussed by the committee until a consensus is reached and then a vote on whether to approve the protocol is taken. Following the Ethics committee meeting the sponsor / investigator will be informed of the protocol status.

Approval: If full ethical approval is granted, the company / investigator may begin the research proposed in the protocol when it has been outlined in a letter.


Conditional Approval: Conditional approval of a protocol may be granted, requiring modifications in the protocol and/or patient information sheet and / or patient consent form before initiation or responses to specific inquires by the Ethics Committee. In this case, the sponsor/ investigator should submit a cover letter along with a modified submission form, protocol, consent form or supplemental information as requested with the changes highlighted. No research may be started until all conditions have been met and full approval has been obtained. Where conditional approval is granted, the Chairperson and Member Secretary may review the modified submissions and grant approval subject to the affirmation of the committee in its following meeting.

Deferral: A deferral protocol must be revised and resubmitted to the Ethics Committee

Rejection: Protocols may be rejected by the Ethics Committee. This may occur if a protocol has been deferred several times and the Ethics Committee feels that the proposed research is not justified and /or poses severe or unnecessary risk to the subjects.

Amendments: Amendments to approved trials may be submitted and reviewed by the Chairperson and approval issued as appropriate subject to affirmation by the committee at its following meeting.

Expedited Review: Proposals, which are recommended for minor revisions, will be reviewed by a sub committee appointed by the PU-IECHR for clearance and approved by the Chairperson. The approvals will be reported in the next PU-IECHR meeting by Member Secretary. The revised form of proposals requiring major changes will be reviewed at the next ethics committee meeting.

Validity: The EC approval will be valid for I year from the date of its grant. If the clinical study is not initiated within this time period the PU-IECHR expects to be informed about the reason for the delay and a fresh review will have to be obtained to initiate the trial beyond this period.

5.5.1 SOP for Vulnerable Population

Purpose of this Standard Operating Procedure (SOP) is to describe procedures to review

proposals involving vulnerable populations. Vulnerable persons are those who are

relatively (or absolutely) incapable of protecting their own interests. More formally,

they may have insufficient Power, intelligence, education, resources, strength, or other


needed attributes to protect their own interests.

It is the responsibility of the Secretariat of IEC to maintain up-to-date tools for review

of research pertaining to vulnerable groups based on new and evolving applicable

regulations and guidelines.

IEC Chairperson/ Member Secretary is responsible for ensuring that IEC members are

well versed in new and evolving regulations and guidelines pertaining to vulnerable

populations, for selecting primary reviewers with appropriate expertise to conduct the

reviews of such research, and for securing appropriate consulting expertise as needed for

selected reviews.

IEC member is responsible for conducting appropriate review of research planned for

vulnerable populations, including an assessment of potential for coercion, in

consultation with any appropriate experts and resources as described in this SOP.

Appointment of reviewers

The Chairperson will appoint two or more members of the IEC who have a thorough

understanding of the ethical review process and experience in the field of research

to review such type of protocols, if required. The reviewers should be familiar and

trained in the concept of vulnerability and protections for participants with diminished

autonomy.

The protocol should be reviewed keeping in mind the following points when it concerns

research that involves groups that could be potentially vulnerable to coercion

Measure to protect autonomy

Risk/benefit determinations with respect to the vulnerability

Bearing unequal burden in research.

Any member of the IEC or Secretariat who would be dealing with such protocols should

be well versed with the potential harm or risk of such population participating in the

study. The checklist for different vulnerable population is being provided in Sections.

Special justification is required for inviting vulnerable individuals to serve as research

subjects and, if they are selected, the means of protecting their rights and welfare must be


strictly applied.

At present PU-IECHR accepts only applications related to research involving Children & Pregnant women from class of vulnerable population.

Applications related to research in following classes of vulnerable population, is not acceptable for approval of PU-IECHR.

Research Involving Fetuses Research Involving Cognitively Impaired Adults Research Involving Students, Employees or Residents Considerations for Genetic Research

SECTION-I

Checklist –Requirements for Research Involving Children

Investigator Study Title:

RISK DETERMINATION

BENEFIT ASSEMENT IEC ACTION

Minimal (i) With or without direct benefit Approvable

Greater than minimal risk

Potential to child Approvable

Greater than minimal risk

No direct benefit to individual offer general knowledge about the child’s condition or disorder.

Approvable case – by- case (ii)

(i) Minimal risk means that the probability and magnitude of harm or discomfort

anticipated in the research are not greater in and of themselves than those ordinarily

encountered in daily life or during the performance of routine physical or psychological

examinations or tests.

(ii) Risk may not be more than a minor increase over minimal risk, consent of both parents

required under normal circumstances.

(iii) Approval to proceed with this category of research must be made by the

Administrator of the IEC with input from selected experts


If the response to any of the below is No, the research is not approvable by the PU-

IECHR.

Yes

No

NA

Does the research pose greater than minimal risk to children?

If yes: Are convincing scientific and ethical justification given?

If yes: Are adequate safeguard in place to minimize these risks?

Does the study involve normal volunteers?

If yes: Is the inclusion of normal volunteers justified?

Have appropriate studies been conducted on animals and adults justified?

If No: Is the lack of appropriate studies conducted on animals and adults justified?

Will older children be enrolled before younger ones?

Is permission of both parents necessary?

If Yes: Are conditions under which one of the parents may be considered: not reasonably available” described?

If Yes: Are the conditions acceptable?

Will efforts be made 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 subjects’ privacy and the confidentially of information regarding

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 counseling and confidentiality accounted for in the research


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 which has implications for other family member? (for example, genetic risk , HIV infection , Hepatitis C)

If Yes: Are adequate mechanisms in place to deal with other members of the family?

Should parents be required to be present during the conduct ofthe Research? (Are proposed subjects to be very young? Are the procedures involved painful? Must subject stay overnight in

SECTION 2

Checklist – Requirements for Research Involving Pregnant Women prior to delivery

Investigator Study Title:

If the response to any of the below is No, the research is not approvable by the PU-

IECHR.

Yes No NA Where scientifically appropriate, preclinical studies, includingstudies on pregnant animals, and clinical studies, including studieson non- pregnant women, have been conducted and provide data forassessing potential risks to pregnant women and fetuses;

The risk to the fetus is not greater than minimal, or any risk to the fetus which is greater than minimal is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus;

Any risk is the least possible for achieving the objectives of the research;

The woman’s consent or the consent of her legally authorized Representative is obtained in accord with the informed consent provisions, unless altered or waived in accord with ICMR guidelines, 2006.


The woman or her legally authorized representative, as appropriate,is fully informed regarding the reasonably foreseeable impact of the research on the fetus or resultant child;

If the research involves children as defined in 45 CFR 46.402(a) who are pregnant, assent and permission will be obtained in accord with the provisions of subpart D of that part;

No inducements, monetary or otherwise, will be offered to terminate a pregnancy;

Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy;

5.6 DOCUMENTATION AND ARCHIVING

All documentation and communication of the PU-IECHR will be dated, filed, and archived. Documents will be archived for a minimum period of 5 years following the completion of a study. Documents that will be filed and archived include, but are not limited to,

Composition

Written standard operating procedures of the PU-IECHR.

The curriculum vitae of all PU-IECHR members.

A record of all income and expenses of the PU-IECHR, including reimbursements and allowances made to the secretary and PU-IECHR members respectively.

The agenda of the PU-IECHR meetings, the minutes of the PU-IECHR meetings.

One copy of all materials submitted by an applicant.

The correspondence by PU-IECHR members with applicants or concerned parties regarding application, decision, and follow-Up.

All written documentation received during the follow-up.

The notification of the completion, premature suspension, or premature termination of a study.


Reports of SAE received with its analysis and action taken for each study.

The final summary or final report of each study

5.7 REGISTRATION OF IECHR

The PU-IECHR has been registered with a Directorate General of Health Services under Ministry of Health and Family Welfare, Government of India with registration number ECR/702/Inst/GJ/2015.

6. SPONSOR/INVESTIGATOR RESPONSIBILITIES

The Sponsor representative /Investigator delegate for the trial should attend the Ethics Committee review meeting. It is the responsibility of the sponsor/ Investigator to provide the Ethics Committee with the appropriate information on the research protocol including initial information, notification of subsequent modifications, terminations and adverse reactions.

6.1 Notification of Amendments

When any revision to an approved research protocol or written consent form is proposed the amendment must be brought to the attention of the ethics committee for approval. Amendments to approved protocols may not be initiated until Ethics Committee approval has been obtained.

6.2 Notification of Serious Adverse Events.

All serious adverse events (SAEs) of drug must be brought to the attention of the ethics committee, within stipulated time conditions prescribed by schedule Y of D & C Act. These events must be accompanied by an explanatory letter from the sponsor or Principal Investigator involved,

6.3 Updated reports of all clinical study must be forwarded to the committee on annual basis. Terminated or completed trial must be notified to the committee.


ANNEXURE-I

COMPOSITION OF PU-IECHR

SR. NO

PASM-IECHR DESIGNATION NAME PROFESSIONAL DESIGNATION

1

CHAIRMAN CUM BASIC MEDICAL SCIENTIST

DR. TEJAS PATEL MBBS, MD

ASSISTANT PROFESSOR, DEPT. OF PHARMACOLOGY, GMERS MEDICAL COLLEGE, VADODARA

2 MEMBER SECRETARY

DR. VIRAL DESAI M. PHARM, PH.D

ASSISTANT PROFESSOR, PARUL INSTITUTE OF PHARMACY & RESEARCH, PARUL UNIVERSITY

3 CLINICIAN DR. SANDEEP H. SHAH MBBS, MD

ASSISTANT PROFESSOR, DEPT. OF PSYCHIATRY, GMERS MEDICAL COLLEGE, VADODARA

4 CLINICIAN Dr. GEETIKA MADAN PATEL MBBS, MD

MANAGING TRUSTEE, PARUL UNIVERSITY

5 CLINICIAN DR.MAULESH G. SHAH MBBS, MS

HOSPITAL SUPRETENDANT AND ORTHOPEDIC SURGEN, PARUL SEVASHRAM HOSPITAL,

6 LEGAL EXPERT

PROF. FOMI P. DWIVEDI MBA, LLM, LL.B

DIRECTOR, PARUL INSTITUTE OF MANAGEMENT, PARUL UNIVERSITY

7 SOCIAL SCIENTIST

DR. DIPTI JOSHI MA, DCPP

CLINICAL PSYCHIATRIST BRIJ PSYCHITRY CLINIC, VADODARA

8 LAY PERSON MR. BAL KRISHNA HOSTEL RECTOR, PARUL UNIVERSITY

9 PHARMACY EXPERT

MS. ARCHANA NAVALE M. PHARM

ASSITANT PROFESSOR, PARUL INSTITUTE OF PHARMACY PARUL UNIVERSITY