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National Children’s Hospital INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE
CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
Page 24 of 108
INITIAL REVIEW PROCEDURES
2.1. Management of Protocol Submissions
2.2. Use of Study Assessment Forms
2.3. Expedited Review
2.4. Full Board Review Of Submitted Protocols
2.5. Preparation of Meeting Agenda
2.6. Preparation of Meeting Minutes
2.7. Review of a Medical Device Study
2.8. Review of Protocols that Involve Genetic Materials
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National Children’s Hospital INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE
CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
Page 25 of 108
2.1 Management of Protocol Submission
1. Scope
This SOP describes how the NCH IRB/IEC Secretariat manages initial protocol submissions to
NCH IRB/IEC. It covers the actions to be done from the time of submission to the filing of the
original protocol package in the Active Study File cabinet and the preparation of copies of
the package for distribution to the reviewers.
The NCH IRB/IEC accepts all protocols for review to be done by NCH staff and outside
investigators/researchers within and outside NCH.
Specifically researches referred from the PNHRS, DOH with the provision that non-NCH
institutions who submit proposals for NCH review need to have a MOA with NCH. The MOA
should stipulate that the institution agrees to abide by the rules and regulations that the
NCH IRB/IEC follows (which in turn follow PHREB and FERCAP rules); they will provide the
necessary environment to ensure the safe and ethical conduct of the research, including
oversight and stewardship functions as necessary; they will agree to monitoring procedures
that the Committee may deem necessary.
2. Flow chart
Activity Responsibility
1. Receives the initial protocol package for review and
checks the completeness of the “Research Project
Proposal Format”
Secretariat
2. Assigns a permanent code to the package
Secretariat
3. Makes a duplicate of the application form and gives the
duplicate to the person submitting the package.
Attaches original to the protocol package.
Secretariat
4. Have the Principal Investigator sign documents in the
submitted package using the “ Document Receipt Form”
Secretariat
5. Makes a copy of the duly filled up, signed and dated
acceptance form and attaches this copy to the protocol
package
Secretariat
6. Gives the original “Document Receipt Form” to the
principal investigator
Secretariat
7. Log the received protocol in the “Log of Submitted
Protocols”
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National Children’s Hospital INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE
CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
Page 26 of 108
8. Makes copies of the protocol package and prepares
them for distribution to the reviewers
Secretariat
9. Files the original package in a properly coded Protocol
File folder and places it in the Active Study File cabinet
Secretariat
3. Detailed Instructions
Note: All protocols need technical approval prior to ethical review. For National Children’s
Hospital-funded protocols, the Technical Review Committee should have addressed
the technical issues apparent to the study protocol. For non- National Children’s
Hospital funded protocols, a document stating that the research protocol has
undergone and passed technical review should be attached to the study protocol
submitted for ethical review.
Upon submission of the initial protocol for NCH IRB/IEC review, let the principal
investigator or his/her representative fill out a Registration and Application Form
(NCH IRB/IEC-2012-05-2A-RAF and NCH IRB/IEC-2012-05-2B-RAF).
3.1. Make a copy of the filled-in application form and give original to the principal
investigator or his/her representative. Attach the copy to the package.
3.2. Assign a code to the package. The code will be communicated to the principal
investigator in subsequent communications regarding the protocol.
3.3. Fills out and makes a duplicate copy of the Registration & Application Form (NCH
IRB/IEC-2012-05-2A-RAF or NCH IRB/IEC-2012-05-2B-RAF) in the presence of the
principal investigator or his/her representative and checks the documents being
submitted and marks the submitted documents on the checklist that is found on the
form. The duplicate copy of the NCH IRB/IEC-2012-05-2A-RAF or NCH IRB.IEC-2012-05-
2B-RAF) will be attached to the protocol package, while the original is given to the
principal investigator or his/her representative.
3.4. A protocol package has to include the following:
3.4.1. For Full Board Review
1) Accomplished registration and application form
2) Full protocol
3) Research project proposal format
4) Executive summary
5) Declaration of no conflict of interest
6) Data collection form/s /Questionnaires etc.
7) Informed Consent form (English and local dialect)
8) Assent form (as necessary)
9) Budget
10) CV of proponent and co-investigators and their GCP Certificate (as
necessary but mandatory for sponsor-initiated studies)
11) GANTT Chart (as necessary)
12) Ads for recruitment, if applicable
13) Technical approval document
14) Ethics Review Board Fee
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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15) Institutional Fee payable upon approval of research
3.4.2. For Social and Behavioral Research
1) Letter of intent by the reserachers addressed to the Medical Center
Chef (MCC) through NCH IRB/IEC Chairman
2) Research title page, Table of contents
3) Research paper – Chapter I to III
4) Validated Survey Questionnaire
5) Result/Certification of Validation of survey questionnaire from a
statistician
6) Ethics Review Board Fee
7) Institutional Fee payable upon approval of research
Note: That both the Secretariat and the principal investigator or his/ her
representative should sign after the description or name of each document in the
protocol package.
3.5. Make a duplicate of the filled out form and ensure that the date is stated and is
signed. Attach the duplicate acceptance form to the received package.
3.6. Give the original copy of the acceptance form to the principal investigator or
his/her representative.
3.7. Log the protocol in the logbook for submitted protocols.
3.8. Manage the protocol package:
3.8.1. For protocols requiring a full board review,
3.8.1.1. Makes copies of the protocol package for file, for each reviewer, and
for each NCH IRB/IEC member. Puts the original copies in a file folder.
3.8.1.2. Puts the code of the protocol in front of the file folder.
3.8.1.3. Files the folder in the Ongoing Review Files cabinet
3.8.2. For protocols that can be subjected to expedited review,
3.8.2.1. Make 4 copies of the protocol package for file and for each
reviewer. Put the original copies in a file folder.
3.8.2.2. Puts the code of the protocol in front of the file folder.
3.8.2.3. File the folder in the On-going Review Files cabinet.
3.9. Prepare the copies of protocol for distribution to the reviewers. Include blank copies
of the Study Protocol Assessment Form (NCH IRB/IEC-2012-05-2C-SPAF) and the
Informed Consent Assessment Form (NCH IRB/IEC-20120-05-2D-ICAF) in the package.
3.10. Enter in the Log of Received Protocols the names of the reviewers to whom the
packages are to be delivered, the date of actual delivery, the name of the person
who delivers them, and the names of the recipients of the packages.
NOTE:
1. All protocols shall need technical approval prior to ethical review.
2. Reviewers are selected on the basis of their expertise. Research proposals
are given to both institutional and lay/non-institutional members for review.
The institutional members analyze the ethical procedures of the proposal
while the lay/ non-institutional members assess the informed consent form.
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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4. Relevant Forms
NCH IRB/IEC-2012-05-2A-RAF Registration and Application Form
NCH IRB/IEC-2012-05-2B-RAFSBBR Registration and Application
Form for Social and Behavioral Basic
Research
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
Page 29 of 108
NCH IRB/IEC-2012-05-2A-RAF
REGISTRATION AND APPLICATION FORM For Initial Review and Resubmission
SECTION I: APPLICATION INFORMATION
1. Study Protocol Code: 1.1 NCH IRB/IEC CODE:
2. Type of Submission 2.1 Initial Review
2.2 Resubmission (responses to initial review recommendations or
submission of studies with investigator-initiated changes prior to
ethics approval). NOTE: version and date of version must be
inserted as a document footer for all resubmissions
3. Date of Submission: <dd/mm/yyyy>
4. Study Category 4.1 Research involving human participants
4.2 Research involving non-human living vertebrates
4.3 Others (indicate):
5. Type of study: 5.1 Pre-clinical Research
5.2 Non-clinical trial, specifically (choose one):
5.2.1 Diagnostics
5.2.2 In vitro study
5.2.3 Genetic or genomic research
5.2.4 Stem Cell Research
5.2.5 Herbal Research
5.2.6 Complementary and Alternative Medicine Research
5.2.7 Research on Assisted Reproductive Technology
5.2.8 Research on Indigenous Materials
5.2.9 Review of medical records
5.2.10 Epidemiological study
5.2.11 Socio-behavioral Research
5.2.13 Health informatics
5.2.14 Operations/process research
5.3 Clinical Trial Type 1 (drug or pharmaceutical trials,
diagnostic trials, trials on devices, and other therapy trials)
intended for marketing registration
5.4 Clinical Trial Type 2 (drug or pharmaceutical trials,
diagnostic trials, trials on devices, and other therapy trials) NOT
intended for marketing registration
5.5 Post Marketing Surveillance
5.6 Others, please indicate:_________________________________
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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6. Category of Investigator 6.1 NCH Faculty/REPS
6.2 NCH Undergraduate Student
6.3 NCH Graduate Student (MS, PhD, Medical Student)
6.4 NCH/Study Group Researcher, Faculty, UR, URA
6.5 NCH Fellows, Residents, Nursing staff, Researcher
6.6 Non-NCH (NOTE: This category requires completion of
PART III: AUTHORIZATION AND ACKNOWLEDGEMENT OF REVIEW
below)
6.7 Others, please specify: __________________________________
7. Purpose of study 7.1 Academic requirement (Thesis, Dissertation, Training
Requirement)
7.2 Independent research work
7.3 Multi-institutional or multi-country collaboration
7.4 Others (indicate):
8. Study Title
9. Study Protocol Synopsis Please write a synopsis (maximum 500 words) of the study in the space
provided below based on the specified components, and indicate
page where such components may be found in the full study protocol
or in annexes/appendices. If items are not applicable, indicate by
N/A. Attach the full study protocol to this application.
1. Technical Synopsis
a. Objectives/Expected output
b. Literature review rationalizing the design
c. Research design
d. Sampling design, sample size
e. Inclusion criteria, exclusion criteria, withdrawal criteria
f. Data collection plan
g. Specimen collection and processing plan (including plans for
specimen storage and duration of storage)
h. Data analysis plan (including statistical basis for design, as
applicable)
i. Rationalization for choice of study site (including capacity of site
to address known risks of study protocol, such as availability of
equipment and facilities, as applicable) (Cross reference
information with statements provided in the informed consent)
2. Ethical Considerations Section
a. Protection of privacy and confidentiality of research information
including data protection plan
b. Vulnerability of research participants
c. Risks of the study (including social risks)
d. Benefits of the study
e. Patient-related compensations/reimbursements/entitlements
f. Informed consent process and recruitment procedures
g. Terms of reference of collaborative study (as applicable, such as
intellectual property agreements and similar concerns)
h. Terms of available study-related insurance
10. Study Duration (in months)
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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11. Use of special
populations or
vulnerable groups
11.1 Children (under 18)
11.2 Indigenous People
11.3 Elderly
11.4 People on welfare/social assistance
11.5 Poor and unemployed
11.6 Patients in emergency care
11.7 Homeless persons
11.8 Refugees or displaced persons
11.9 Patients with incurable diseases
11.10 Others (indicate):
11.11 Not applicable
12. Endorsing/College/ Unit/
Institution
12.1 College of Allied Medical Professions
12.2 College of Arts and Sciences
12.3 College of Dentistry
12.4 College of Medicine
12.5 College of Nursing
12.6 College of Pharmacy
12.7 College of Public Health
12.8 National Teacher Training Center for the Health
Professions
12.9 School of Health Sciences
12.10 NCH (Put institute or office): <name of institute or office>
12.11 NCH (Put department and section): <name of
department & section>
12.12 NCH (local): <name of institution>
12.13 NCH (foreign institution): <name of institution>
13. Study site 13.1 NCH unit
13.2 Non-NCH with local IRB/ERB/ERC
13.3 Non-NCH without local IRB/ERB/ERC
14. Funding agency: 14.1 (NAME):
TYPE OF FUNDING AGENCY
14.1 NCH unit
14.2 Investigator
14.3 PHL Government agency/office/entity
14.4 Multilateral Agency (UN agencies and other
intergovernmental agencies)
14.5 Private company or Non-governmental organization
(NGO)
14.6 Others (indicate):
15. Study Budget NOTE: This refers to line item amounts. However, if a separate budget
sheet is available, just indicate total amount and attach budget sheet
16. Previous ethics approval
or clearance issued by
other sites
16.1 Name of Institutional Review Board or Ethics Review
Committee:
16.2 Date of ethics approval:
16.3 Date of expiration of ethics approval:
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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16.4 Not applicable
17. Principal Investigator <Title, First Name, Last Name>
18. Birthday <dd/mm/yyyy>
19. PI Address <Institutional Address>
20. PI Telephone:
21. PI Facsimile:
22. PI Mobile:
23. PI Email:
24. Other Ongoing studies 24.1 Title:
24.1.1 NCH IRB/IEC Code (if
applicable):
24.3 Title:
24.3.1 NCH IRB/IEC Code
(if applicable):
24.2 Title:
24.2.1 NCH IRB/IEC Code (if
applicable):
24.4 Title:
24.4.1NCH IRB/IEC Code
(if applicable):
25. Declaration of Conflict of
Interest of PI
25.1 I have no conflict of interest in any form (financial, proprietary,
professional) with sponsor, the study, Co-Investigators, or the site
25.2 I have personal/family financial interest in the results of the
study
NATURE: 25.3 I Have proprietary interest in the research (patent, trademark,
copyright, licensing)
NATURE: 26. Other investigators with
corresponding task
description (add
additional rows as
applicable)
Co-Investigator:
Task description:
Co-Investigator:
Task description:
Co-Investigator:
Task description:
27. Submitted by: <Title, First Name, Last Name>
Study
designation
28. PI signature NCH IRB - f
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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SECTION II: SCIENTIFIC/TECHNICAL REVIEW APPROVAL ENDORSEMENT This section should be signed by the Chair/Head of the Scientific/Technical Review committee/office that
reviewed the scientific soundness of the study and issued the appropriate approval. Alternatively, results of
Scientific/Technical Review disposition may be appended to this application, instead of completing this section,
provided that the information required below had been appropriately addressed. STUDY PROTOCOL TITLE: <with Version Number and Date>
Principal Investigator: <Title, First Name, Last Name>
I confirm that the(NAME OF SCIENTIFIC/TECHNICAL REVIEW COMMITTEE/OFFICE) has reviewed and approved the
following study protocol-related information: Objectives/Expected output supported by literature review; overall
research design; sampling design, sample size, Inclusion/exclusion/ withdrawal criteria; data collection plan and
specimen collection, processing, and storage as applicable; data analysis plan including statistical
design/framework, as applicable.
Issuing committee/office: Head of committee/office: <Title, First Name, Last Name>
Signature: Date of Signature: <dd/mm/yyyy>
SECTION III: INSTITUTIONAL ENDORSEMENT This section should be signed by the head of unit (administrative authority legally empowered to sign on behalf the
unit such as Dean, Director, and the like) of the Principal Investigator. This section is required only for initial
submission, provided there are no changes in study protocol information below. STUDY PROTOCOL TITLE: Principal Investigator: <Title, First Name, Last Name>
I confirm that I have read this Application and that the research will be implemented under the oversight of this
Department/Institution in accordance with the conditions of approval by the National Children’s Hospital
Institutional Review Board/Independent Ethics Committee. I also confirm that the Principal Investigator has a
regular appointment in this institution.
Issuing unit/college:
Head of unit: <Title, First Name, Last Name>
Signature: Date of Signature: <dd/mm/yyyy>
SECTION IV: AUTHORIZATION AND ACKNOWLEDGEMENT OF REVIEW This section should be completed by the signatory official who can sign on behalf of the institution that has
oversight on the research site, IF the research site is OUTSIDE the scope of authority of NCH and the PI is non NCH
personnel. If not applicable, put N/A in all fields. This section is required only for initial submission, provided there
are no changes in study protocol information below. STUDY PROTOCOL TITLE: Principal Investigator: <Title, First Name, Last Name>
This is to certify that the <NAME OF RESEARCH SITE>:
1) Has no local Institutional Review Board/ Ethics Review Committee; and
2) Authorizes and acknowledges the National Children’s Hospital Institutional Review Board/Independent Ethics
Committee (NCH IRB/IEC), located at the 264 E. Rodriguez Sr. Blvd., Quezon City, to perform the ethical review
of the abovementioned study protocol in accordance with international ethical standards and national
regulatory requirements, and oversee the conduct of the research study which includes progress monitoring,
adverse event monitoring, and site visits.
Name of Research Site Address of Research Site Signatory Official <Title, First Name, Last Name>
Position of Official Signature Date of Signature:<dd/mm/yyyy>
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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NCH IRB/IEC-2012-05-2B-RAFSBBR
SOCIAL AND BEHAVIORAL BASIC RESEARCHES
REGISTRATION AND APPLICATION FORM For Initial Review
SECTION I: APPLICATION INFORMATION
1. NCH IRB/IEC Code
2. RESEARCH TITLE
3. Researcher/s 3.1. _____________________________
3.2. _____________________________
3.3. _____________________________
3.4 _____________________________
3.5. _____________________________
3.6. _____________________________
4. Degree & School
5. Description of
respondents including
their characteristics and
age range
6. Number of Projected
Respondents in our
institution
7. Study Duration/
Respondents
participation
8. Description of Data
Gathering Procedure:
9. Please describe safety
measures taken to
protect respondent’s
privacy during
identification of
respondents and
collection of data
10. Please indicate the type
of Informed
Consent/Assent to be
used in the research NOTE: (Informed
Consent/Assent must utilize
language understandable
to the respondents)
11. Submitted by 12. Phone Number &
E-mail Address
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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2.2 Use of Study Assessment Forms
1. Scope
There are two (2) NCH IRB/IEC Assessment Forms for protocol review (see Annex for
samples):
1.1. Study Protocol Assessment Form (NCH IRB/IEC-2012-05-2C-SPAF)
1.2. Informed Consent Assessment Form (NCH IRB/IEC-2012-05-2D-ICAF)
These SOP apply to the use of the Study Assessment Forms in the review and assessment of
protocols submitted to NCH IRB/IEC for initial review and approval by the NCH IRB/IEC. The
NCH IRB/IEC uses two study assessment forms. The two assessment forms, namely the (1)
Study Protocol Evaluation Form and the (2) NCH IRB/IEC Checklist for Informed Consent, are
in the form of checklists and these are accomplished by individual reviewers. Any
comments, evaluation, recommendations and the initial decision of each reviewer
regarding a protocol are all noted in these two forms.
The Study Assessment Forms are designed to standardize the review process and to
facilitate reporting of recommendation and comments given to each individual protocol.
It is the responsibility of the NCH IRB/IEC reviewers to individually fill-in the assessment forms
(the checklists) after reviewing each study protocol. The Secretariat is responsible for
recording and filing the NCH IRB/IEC’s action, relevant points and deliberation about a
particular protocol, including the reason for said action. The consensus regarding the
decisions on each reviewed protocol will be reflected in the Minutes of the meeting.
2. Flow Chart
Activity
Responsibility
1. Look for Study Protocol Assessment Forms (NCH IRB/IEC-2012-05-2C-
SPAF) (checklists) that should come together with the protocol
Reviewer
2. Fill up the Study Protocol Assessment Forms (NCH IRB/IEC-2012-05-
2C-SPAF)as you review the study protocol
Reviewer
3. Submit accomplished Study Protocol Assessment Forms (NCH
IRB/IEC-2012-05-2C-SPAF) for next NCH IRB/IEC meeting
Secretariat
4. The compiled checklists and forms are reproduced for inclusion in
the agenda of the meeting; the decision of the NCH IRB/IEC is
included in the Minutes
Secretariat
5. Inform the principal investigator of NCH IRB/IEC decision through a
letter from the Chair
Chair/Secretariat
6. File copies of duly accomplished forms in the Study File folder of the
particular protocol
Secretariat
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CHAPTER 2. Initial Review Procedures
NCH IRB/IEC SOP/GUIDELINES
Effective Date: 05/04/2012
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3. Detailed Instructions
3.1. The NCH IRB/IEC reviewer checks if the two Study Assessment Forms (Study Protocol
Assessment Form (NCH IRB/IEC-2012-05-2C-SPAF)and Informed Consent Assessment
Form (NCH IRB/IEC-2012-05-2D-ICAF) are attached with each protocol received for
review.
3.2. The NCH IRB/IEC reviewer individually fills out both forms for each protocol.
3.3. The Study Protocol Assessment Form has 25 items, while the Informed Consent
Assessment Form has 33 items. Examples of these forms are found in the Annexes. The
important items in the checklists are:
3.3.1. Need for human study participants for study/rationale and significance of
the study
3.3.2. Objectives of the study
3.3.3. Review of literature
3.3.4. Sample size
3.3.5. Methodology and data management
3.3.6. Inclusion/exclusion criteria
3.3.7. Control arms (placebo, if any)
3.3.8. Withdrawal or discontinuation criteria
3.4. The reviewer signs and submits the checklists together with the reviewed protocol
back to the Secretariat. He/she makes sure that the Secretariat signs for receipt of
both forms and reviewed protocol.
3.5. The Secretariat compiles the checklists and submits these to the Chair.
3.6. The Chair reviews the compiled checklists.
3.7. If the protocol is not approved, the Chair through the Secretariat communicates the
reason/s to the principal investigator for revision.
The Chair also informs the principal investigator that the comments/suggestions
stated in the letter are the results of initial review and after he/she has made the
necessary revisions the protocol will still undergo another review to be conducted by
other NCH IRB/IEC members in an en banc meeting prior to its approval.
3.8. If the protocol is approved by the reviewers, the Chair includes the protocol in the
agenda of the next NCH IRB/IEC meeting.
3.9. The Secretariat includes the compiled checklist in the agenda of the next meeting.
3.10. The protocol and consent is discussed in the NCH IRB/IEC meeting for final decision.
3.11. The checklists are returned to the corresponding protocol’s file folder.
3.11.1. The NCH IRB/IEC decision is communicated to the principal investigator
through a letter, which is signed by the Chair. A copy of the signed letter is
retained in the study file folder of that protocol. On the latter copy, the date
on which the notification has been delivered is noted before being filed.
NOTE: The principal investigator should be informed regarding the review
process his/her protocol will undergo. The protocol will first undergo a
review by the two members of the NCH IRB/IEC. The necessary
revisions to the protocol will then be communicated to the principal
investigator. If the two reviewers have approved the protocol, the
protocol will then be included by the Chair in the agenda for the next
meeting for an en banc review. The protocol will only be given full
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approval once it has been approved by all members of the NCH
IRB/IEC in an en banc meeting.
4. Relevant Forms
4.1. NCH IRB/IEC-2012-05-2C-SPAF Study Protocol Assessment Form
4.2. NCH IRB/IEC-2012-05-2D-ICAF Informed Consent Assessment Form
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NCH IRB/IEC-2012-05-2C-SPAF
STUDY PROTOCOL ASSESSMENT FORM STUDY PROTOCOL INFORMATION
NCH IRB/IEC Code:
Study Protocol Title:
Principal Investigator:
Study Protocol Submission Date:
INSTRUCTIONS To the Principal Investigator: Please indicate in the space provided below whether or not the
specified assessment point is addressed by your study protocol. To
facilitate the evaluation of the assessment point, indicate the page
and paragraph where this information can be found.
To the Primary Reviewer: Please evaluate how the assessment points outlined below have been
appropriately addressed by the study protocol, as applicable, by
confirming the submitted information and putting your comments in the
space provided under “REVIEWER COMMENTS.” Finalize your review by
indicating your conclusions under “RECOMMENDED ACTION” and
signing in the space provided for the primary reviewer.
To be filled out by the
PI
ASSESSMENT
POINTS
Indicate if the
study protocol
contains the
specified
assessment
point
Page and
paragraph
where it is
founded
REVIEWER COMMENTS
1. SCIENTIFIC DESIGN YES N/A
1.1. Objectives Review of viability of
expected output
1.2. Literature review Review of results of
previous animal/human
studies showing known risks
and benefits of
intervention, including
known adverse drug
effects, in case of drug
trials
1.3. Research design Review of appropriateness
of design in view of
objectives
1.4. Sampling design
Review of
appropriateness of
sampling methods and
techniques
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1.5. Sample size Review of computation of
sample size
1.6. Statistical analysis
plan (SAP) Review of the
appropriateness of
statistical methods to be
used and how participant
data will be summarized
1.7. Data analysis plan Review of appropriateness
of statistical and non-
statistical methods of data
analysis
1.8. Inclusion criteria Review of precision of
criteria both for scientific
merit and safety concerns;
and of equitable selection
1.9. Exclusion criteria Review of criteria precision
both for scientific merit and
safety concerns; and of
justified exclusion
1.10. Withdrawal criteria Review of criteria precision
both for scientific merit and
safety concerns
2. CONDUCT OF STUDY
2.1. Specimen handling Review of specimen
storage, access, disposal,
and terms of use
2.2. PI qualifications Review of CV and relevant
certifications to ascertain
capability to manage
study related risks
2.3. Suitability of site Review of adequacy of
qualified staff and
infrastructures, including
applicability of UPMREB
FORM2(E)2012 and UPMREB
FORM2(F)2012
2.4. Duration Review of length/extent of
human participant
involvement in the study
3. ETHICAL
CONSIDERATIONS
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3.1. Conflict of interest Review of management of
conflict arising from
financial, familial, or
proprietary considerations
of the PI, sponsor, or the
study site
3.2. Privacy and
confidentiality Review of measures or
guarantees to protect
privacy and confidentiality
of participant information
as indicated by data
collection methods
including data protection
plans
3.3. Informed consent
process Review of application of
the principle of respect for
persons, who may solicit
consent, how and when it
will be done; who may give
consent especially in case
of special populations like
minors and those who are
not legally competent to
give consent, or indigenous
people which require
additional clearances
3.4. Vulnerability Review of involvement of
vulnerable study
populations and impact on
informed consent (see 3.3).
Vulnerable groups include
children, the elderly, ethnic
and racial minority groups,
the homeless, prisoners,
people with incurable
disease, people who are
politically powerless, or
junior members of a
hierarchical group
3.5. Recruitment Review of manner of
recruitment including
appropriateness of
identified recruiting parties
3.6. Assent Review of feasibility of
obtaining assent vis à vis
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incompetence to consent;
Review of applicability of
the assent age brackets in
children:
0-under 7: No assent
7-under 12: Verbal Assent
12-under15: Simplified
Assent Form
15-under18:Co-sign
informed consent form with
parents
3.7. Risks Review of level of risk and
measures to mitigate these
risks (including physical
,psychological, social,
economic), including plans
for adverse event
management; Review of
justification for allowable
use of placebo as detailed
in the Declaration of
Helsinki (as applicable)
3.8. Benefits Review of potential direct
benefit to participants; the
potential to yield
generalizable knowledge
about the participants’
condition/problem; non-
material compensation to
participant (health
education or other
creative benefits), where
no clear, direct benefit
from the project will be
received by the participant
3.9. Incentives or
compensation Review of amount and
method of compensations,
financial incentives, or
reimbursement of study-
related expenses
3.10. Community
considerations Review of impact of the
research on the
community where the
research occurs and/or to
whom findings can
be linked; including issues
like stigma or draining of
local capacity; sensitivity to
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cultural traditions, and
involvement of the
community in decisions
about the conduct of
study
3.11. Collaborative
study terms of
reference Review of terms of
collaborative study
especially in case of multi-
country/multi-institutional
studies, including
intellectual property rights,
publication rights,
information and
responsibility sharing,
transparency, and
capacity building
RECOMMENDED ACTION
APPROVAL
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVAL
JUSTIFICATION FOR RECOMMENDATION
PRIMARY REVIEWER Name
Date: Signature
PANEL SECRETARY Name
Date: Signature
PANEL CHAIR Name
Date: Signature
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NCH IRB/IEC-2012-05-2B-ICAF
INFORMED CONSENT ASSESSMENT FORM
STUDY PROTOCOL INFORMATION NCH IRB/IEC Code:
Study Protocol Title:
Principal Investigator:
Study Protocol Submission Date:
INSTRUCTIONS: To the Principal Investigator: Please indicate in the space provided below whether or not the
specified element is addressed by the informed consent form (ICF). To
facilitate the evaluation of the assessment point, indicate the page and
paragraph where this information can be found.
To the Primary Reviewer: Please evaluate how the elements outlined below have been
appropriately addressed by the informed consent form (ICF), as
applicable, and by confirming the submitted information and putting
your comments in the space provided under “REVIEWER
COMMENTS.”Finalize your review by indicating your conclusions under
“RECOMMENDED ACTION” and signing in the space provided for the
primary reviewer.
To be filled out by
the PI
ESSENTIAL ELEMENTS (As applicable to the study)
Indicate if the ICF
has the specified
element
Page and
paragraph
where
element is
found
REVIEWER COMMENTS
YES N/A 4. A statement that the study
involves research
5. The statement describes the
purpose of the study
6. Study-related treatments and
probability of random assignment
7. Study procedures including all
invasive procedures
8. Responsibilities of the participant 9. Expected duration of
participation in the study
10. Approximate number of
participants in the study
11. Study aspects that are
experimental
12. Foreseeable risks to
participant/embryo/
fetus/nursing infant; including
pain, discomfort, or
inconvenience associated with
participation including risks to
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spouse or partner;
13. Risks from allowable use of
placebo (as applicable)
14. Reasonably expected benefits; or
absence of direct benefit to
participants, as applicable
15. Expected benefits to the
community or to society, or
contributions to scientific
knowledge
16. Description of post-study access
to the study product or
intervention that have been
proven safe and effective
17. Alternative procedures or
treatment available to
participant
18. Compensation or insurance or
treatment entitlements of the
participant in case of study-
related injury
19. Anticipated payment, if any, to
the participant in the course of
the study; whether money or
other forms of material goods,
and if so, the kind and amount
20. Compensation (or no plans of
compensation) for the
participant or the participant’s
family or dependents in case of
disability or death resulting from
study-related injuries
21. Anticipated expenses, if any, to
the participant in the course of
the study
22. Statement that participation is
voluntary, and that participant
may withdraw anytime without
penalty or loss of benefit to which
the participant is entitled
23. Stating that the study monitor(s),
audit(s), the NCH IRB/IEC Ethics
Review Panel, and regulatory
authorities will be granted direct
access to participant’s medical
records for purposes ONLY of
verification of clinical trial
procedures and data
24. A statement that the records
identifying the participant will be
kept confidential and will not be
made publicly available, to the
extent permitted by law; and that
the identity of the participant will
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remain confidential in the event
the study results are published;
including limitations to the
investigator’s ability to guarantee
confidentiality
25. Description of policy regarding
the use of genetic tests and
familial genetic information, and
the precautions in place to
prevent disclosure of results to an
immediate family relative or to
others without consent of the
participant
26. Possible direct or secondary use
of participant’s medical records
and biological specimens taken
in the course of clinical care or in
the course of this study
27. Plans to destroy collected
biological specimen at the end
of the study; if not, details about
storage (duration, type of storage
facility, location, access
information) and possible future
use; affirming participant’s right
to refuse further use, refuse
storage, or have the materials
destroyed
28. Plans to develop commercial
products from biological
specimens and whether the
participant will receive money or
other benefit from such
development
29. A statement that the participant
or participant’s legally
acceptable representative will
be informed in a timely manner if
information becomes available
that may be relevant to the
willingness of the participant to
continue to participate
30. The statement describes the
access of participant to the result
of the study
31. A statement describing the
extent of the participant’s right to
access his/her records (or lack
thereof is à this pending request
for approval of non or partial
disclosure)
32. Foreseeable circumstances and
reasons under which
participation in the study may be
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terminated
33. Sponsor, institutional affiliation of
the investigators, and nature and
sources of funds
34. A statement whether the
investigator is serving only as an
investigator or as both
investigator and the participant’s
health care provider
35. Person(s) to contact with the
study team for further information
regarding the study and whom to
contact in the event of study-
related injury
36. A statement that the NCH IRB/IEC
Ethics Review Panel (specify) has
approved the study, and may be
reached through the following
contact for information regarding
rights of study participants,
including grievances and
complaints:
Name of NCH IRB/IEC Chair
Address: 264 E. Rodriguez Sr. Blvd.,
Quezon City 1102
Email: nch.irbiec.com.ph
Tel: +63 2 7240656 to 59 loc. 114
RECOMMENDED ACTION APPROVAL
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVAL Reasons for
disapproval:
PRIMARY REVIEWER Name
Date: Signature
PANEL SECRETARY Name
Date: Signature
PANEL CHAIR Name
Date: Signature
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2.3. Expedited Review
1. Scope
These SOP apply to the review and approval of study proposals with minimum risk to study
participants, protocol amendments or informed consent changes of currently approved
studies. The acceptance procedure is the same as for any protocol submitted for the first
time to NCH IRB/IEC for review (i.e. The protocol will have to undergo technical review prior
to ethical review). For proposals that are not NCH-funded, the NCH IRB/IEC will require
evidence of technical review or reserves the right to submit the proposal to the TRC for
review, or will have to address both technical and ethical issues.
The following are types of protocols that can be subjected to expedited review:
1.1. Protocols of a non-confidential nature (not of a private character, e.g. relate to
sexual preference etc., or not about a sensitive issue that may cause social stigma),
not likely to harm the status or interests of the study participants and not likely to
offend the sensibilities nor cause psychological stress of the people involved.
1.2. Protocols not involving vulnerable subjects (individuals whose willingness to volunteer
in a clinical trial may be unduly influenced by the expectation of benefits associated
with participation or of a retaliatory response in case of refusal to retaliate, patients
with incurable diseases, persons in nursing homes, unemployed or impoverished
persons, patients in emergency situations, ethnic minority groups, homeless persons,
nomads, refugees, minors and those incapable of giving consent).
1.3. Protocols that involve collection of small amounts of blood samples (and not too
frequent) e.g. by finger, heel or ear stick.
1.4. Protocols that involve collection of biological specimens for research purposes by
non-invasive means (e.g. collection of body fluids or excreta non-invasively,
collection of hair or nail clippings in a non-disfiguring or non-threatening manner).
1.5. Collection of data for research purposes through non-invasive procedures (not
involving general anesthesia or sedation) routinely employed in clinical practice and
using medical devices which have been already approved for use. Examples of
such procedures include collection of data through application of EEG or ECG
electrodes, acoustic testing, tests using the Doppler principle, non-invasive blood
pressure and other routine clinical measurements, exercise tolerance etc.
However, procedures involving the use of x-rays or microwaves are not
recommended for expedited review.
1.6. Research involving data, documents or specimens that have been already
collected or will be collected for on-going medical treatment or diagnosis
1.7. Proposed continuing reviews, protocol amendments and end of study reports that
have minor modifications and no significant risk to study participants.
2. Flow Chart
Activity Responsibility
1. Receives the submitted documents
and forwards to the Chair
Secretariat
2. Determines that the protocol is for
expedited review
Chair
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3. Assigns reviewers for the expedited
review
Chair
4. Reviewers will do the expedited
review and submit the decision to the
Secretariat
Members / Chair
5. The decision is communicated to the
NCH IRB/IEC members for comments
Approval
No
Yes
Secretariat
6. The decision is communicated with
the principal investigator and
requests for revision and resubmission
of protocol
Notifies the
principal
investigator
and reports
the
approval to
en banc
NCH
IRB/IEC
Secretariat
7. File documents in study file folder of
protocol
Secretariat
3. Detailed Instructions
3.1. The Secretariat receives the submitted documents.
3.1.1. Receive the application documents submitted by investigators.
3.1.2. Check items received using checklist as guide.
3.1.3. Stamp the receiving date on the letter of application and on all the
documents received.
3.1.4. Sign on the “receiver’s name” and put the date on the receiving document
form.
3.2. Criteria for Expedited Review of Amendments/ Revisions
3.2.1. Administrative revisions, such as correction of types
3.2.2. Addition or deletion of non-procedural items, such as the addition of study
personnel names, laboratories, etc.
3.2.3. The research activity includes only minor changes from previously approved
protocol.
3.3. The Chair nominates two or more NCH IRB/IEC members to review the protocol. The
selected members are normally those who reviewed and recommended the
previous version of that protocol, if it is not submitted for the first time.
3.4. The Secretariat sends the revised protocol to the selected members.
3.5. The NCH IRB/IEC members carry out the expedited review on the complete proposal
(study protocol with all the attached documents as mentioned in the guidelines for
submission of proposals).
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3.6. If consensus cannot be reached, the Chair will refer the proposal back to the NCH
IRB/IEC for full review.
3.7. The Secretariat informs the NCH IRB/IEC members of the proposals approved by
expedited review. If any NCH IRB/IEC member raises concern about any of the
proposals presented to it, then that proposal shall undergo a regular review.
3.8. The Secretariat communicates with the NCH IRB/IEC and the principal investigator.
3.8.1. The reviewers forward their comments to the Secretariat.
3.8.2. Full board notification of items approved through expedited review by the
Chair or the designate is accomplished by providing notification and source
documentation of the items in the meeting agenda/notes.
3.8.3. The Secretariat communicates the decision to the principal investigator.
3.9. The Secretariat files the documents in the study file folder of the protocol.
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2.4 Full Board Review of Submitted Protocols
1. Scope
These SOP describe how the NCH IRB/IEC reviewers evaluate a study protocol submitted to
NCH IRB/IEC for the first time.
The Secretariat is responsible for receiving, verifying and managing the contents of both the
hard copies and the electronic version (if any) of the submitted protocol package. In
addition, the Secretariat should create a specific protocol file, make copies of the file and
then distribute the copies to the NCH IRB/IEC reviewers, together with a cover letter where
the due date for returning the reviewed protocol is indicated (See NCH IRB/IEC SOP 2012).
It is the responsibility of the assigned reviewers to thoroughly review the study protocols
delivered to them, give their decision, observation and comments and put all of this in the
Study Assessment Forms before returning the reviewed protocol and assessment form to the
Secretariat on the due date.
2. Flow Chart
Activity
Responsibility
1. Receives the distributed protocol
package
Reviewers
2. Verifies the contents of the package
Reviewers
3. Reviews the protocol and fills out and
sign individual Study Assessment Forms
Reviewers
4. Discuss/es in an en banc meeting of NCH
IRB/IEC if needed
Members/Chair
5. Communicates NCH IRB/IEC decision to
the principal investigator
Approval
No
6. The decision is communicated with the
principal investigator and requests for
revision and resubmission of protocol
Yes
Notifies the
principal
investigator and
reports the
approval to en
banc NCH IRB/IEC
Secretariat/Chair
Secretariat
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3. Detailed Instructions for Reviewers
3.1. Receive the protocol packages
3.1.1. Check the distributed packages.
3.1.2. Fill in the Document Receipt Form (NCH IRB/IEC-2012-05-2E-DRF) upon
receiving the packages, indicate the date and affix reviewer's signature.
3.1.3. Return the signed acknowledgment form back to the delivery
person/Secretariat.
3.2. Verify the contents of the package
3.2.1. Look for the Study Protocol Assessment Forms (NCH IRB/IEC-2012-05-2C-SPAF).
3.2.2. Note the due date for submitting results (accomplished checklists) and the
protocols back to NCH IRB/IEC Secretariat.
3.3. Review the Protocol
3.3.1. Using the requirements for review, take note if there are missing/lacking items
in the protocol and which you feel should be included in the protocol.
3.3.2. Look for the CV or information about the principal investigator/s, study sites
and other documents which you feel should be included or necessary in
order to review the protocol.
3.3.2.1. Consider whether study and training background of the principal
investigator/s relate to the study.
3.3.2.2. Look for disclosure or declaration of potential conflicts of interest.
3.3.2.3. Non-physician principal investigators should be advised by a
physician when necessary.
3.3.2.4. Determine if the facilities and infrastructure at study sites can
accommodate the study.
3.3.3. Using the checklist for Informed Consent Assessment Form (NCH IRB/IEC-2012-
05-2D-ICAF), review the Informed Consent and note any item on the
checklist that is lacking in the Informed Consent document and which you
feel should be added or elaborated.
3.3.4. Look for Assent Form if the protocol calls for children 12 years to under 15
years old (Simplified Assent Form) as study participants. The procedure for
getting the assent of minor-aged study participants should be clear (the
objective of the study and the procedures to be done should be explained
to the child separately, for example).
3.4. The reviewer is advised to note the following Review Guidelines:
3.4.1. In assessing the degree of risk against the benefit, determine whether the risks
are reasonable in relation to anticipated benefits; and/or if the risks can be
minimized.
3.4.2. Study participants are selected equitably especially if randomization is not to
be used. Study participant's information sheet should be clear and adequate
3.4.3. There is voluntary, non-coercive recruitment of study participants.
3.4.4. The Informed Consent is adequate, easy to understand and properly
documented.
3.4.5. There should be a translation of the Informed Consent document into the
local dialect which should be plain and comprehensible by the general
public.
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3.4.6. The procedure for getting the Informed Consent is clear and unbiased.
3.4.7. The persons who are responsible for getting the Informed Consent are
named and introduced to the study participants.
3.4.8. The research plan makes adequate provision for monitoring the data
collected to ensure the safety of study participants, where appropriate.
3.4.9. There are adequate provisions to protect the privacy of study participants
and to maintain the confidentiality of data, where appropriate.
3.4.10. There is provision for compensation to study participants. This should be
reasonable provision for medical/psychosocial support; treatment for study
related injuries, as well as compensation for participation to cover
reasonable expenses like transport and lost wages because of participation.
3.4.11. There are appropriate safeguards included to protect vulnerable study
participants.
3.4.12. Contact persons with address and phone numbers are included in the
Informed Consent.
3.4.13. There is clear justification for the use of biological materials (note SOP on
review of protocols using genetic and/or biological materials which have
potential for genetic research).
3.4.14. There are appropriate contracts or memoranda of understanding especially
in collaborative studies (see SOP on Review of Collaborative Studies).
3.5. Examine community involvement and impact/benefit of the study to community
and/or the institution. If relevant, the reviewer looks for the following in the protocol:
3.5.1. Community consultation
3.5.2. Involvement of local researchers and institutions in the protocol design,
analysis and publication of the results
3.5.3. Contribution to development of local capacity for research and treatment
3.5.4. Benefit to local communities
3.5.5. Availability of study results
3.6. After reviewing the protocol and the documents, the reviewer makes a decision.
3.6.1. Record the decision by marking in the desired block at the back of the
Informed Consent Assessment Form: Approved, Approved with
recommendation, Resubmitted, or Disapproved.
3.6.2. Include comments, suggestion and reason for disapproval.
3.6.3. Check the completeness and correctness of the assessment forms. Indicate
the date and affix the reviewer's signature in the decision form. Submit the
completed forms to the Secretariat together with the protocols.
3.7. Submit the completed forms to the Secretariat together with the protocols.
3.8. Attend and participate actively in the en banc meeting regarding the reviewed
protocol/s.
3.9. For NCH-funded proposals, a member of the Techincal Review Committee (TRC)
shall sit in the en banc meeting as a consultant to address technical issues.
3.10. The NCH IRB/IEC en banc then makes a decision on the protocol either to approve
or approve with modifications or disapprove.
3.11. If the study is approved, the NCH IRB/IEC determines the frequency of continuing
review from each investigator.
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3.11.1. The Secretariat sends an Action Letter/Approval Letter along with the
approved documents to the principal investigator.
3.11.2. The letter contains identification of the document approved, the date set by
the NCH IRB/IEC for frequency of continuing review, and a review of other
obligations and expectations from the principal investigator throughout the
course of the study.
3.11.3. An approval is placed on every page of each consent form approved by
the NCH IRB/IEC.
3.12. For non-NCH-funded proposals, NCH IRB/IEC may request the Techincal Review
Committee (TRC)to provide additional technical input as deemed necessary.
3.13. If the NCH IRB/IEC votes not to approve the study, the Secretariat immediately
notifies the principal investigator in writing about the decision and the reason for not
approving the study.
3.14. If the principal investigator wishes to appeal regarding the decision, he/she may do
so through written request submitted to the NCH IRB/IEC.
3.15. If the NCH IRB/IEC requires modifications to any of the documents, the Secretariat
either generates the revisions to the documents or sends a written request of the
specific changes to the Principal Investigator asking him/her to make the necessary
changes and re-submit the documents to the NCH IRB/IEC.
3.16. The final recommendations of the NCH IRB/IEC should be written on the approval
letter.
3.17. The Secretariat drafts the approval letter, gives to the Chair to sign, then sends it to
the principal investigator. There should be a file/received copy with specific date. All
information regarding the date of the NCH IRB/IEC decision such as the date when
decision was written and signed by the Chair, and date when it was delivered
to the principal investigator, are entered in the “Log of Submitted Protocols”.
3.18. All documented deliberations regarding a protocol are filed in the study file of that
protocol. Keep a copy of the "Notice of NCH IRB/IEC Decision" in the corresponding
file. Place the original documents of the application review and the assessment
forms in sequence of approval number in the study file folder of the protocol.
4. Relevant Form
NCH IRB/IEC-2012-05-2E-DRF Document Receipt Form
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NCH IRB/IEC-2012-05-2E-DRF
DOCUMENT RECEIPT FORM DATE
RECEIVED NCH IRB/IEC
CODE TITLE PRINCIPAL
INVESTIGATOR RECEIVED BY TYPE OF
SUBMISSION E – Expedited
FR-Full Review
REMARKS
Prepared by:
_________________________________
Secretary, NCH IRB/IEC
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2.5 Preparation of Meeting Agenda
1. Purpose:
This Section is aimed at describing the process of preparation and distribution of the
agenda for NCH IRB/IEC meetings.
2. Scope
2.1. This SOP provides instructions for the preparation, review, approval, and distribution
of meeting agenda prior to the regular NCH IRB/IEC meeting.
2.2. It is the responsibility of the Secretariat to consult with the NCH IRB/IEC Chair
regarding matters to be taken up in a meeting, preparation and approval of the
agenda, and distribution to NCH IRB/IEC members one week before the scheduled
meeting.
3. Workflow
Activity Responsibility
1. Prepare meeting agenda
Secretariat
2. Have agenda approved by the Chair
Secretariat
3. Distribute notice of meeting and agenda to
NCH IRB/IEC members
Secretariat
4. File the notice of meeting and agenda Secretariat
4. Detailed instructions
4.1. Preparation of meeting agenda before each NCH IRB/IEC meeting
4.1.1. The NCH IRB/IEC has a standard agenda format for its monthly meetings (NCH
IRB/IEC-2012-05-2G-MM). However, the Secretariat should still consult the Chair on
the agenda for the particular month before finalizing the agenda.
4.1.2. The regular agenda items are:
4.1.2.1 Review of previous meeting Minutes
4.1.2.2 Approval of Minutes
4.1.2.3 Business arising from the Minutes
4.1.2.4 Reports on protocols/amendments reviewed for the month
4.1.2.4.1 New protocols
4.1.2.4.2 Resubmitted protocols
4.1.2.4.3 Amendments/revisions
4.1.2.4.4 Terminated/completed protocols
4.1.2.4.5 Clarifications on particular protocols to be made by Principal
investigator/s, if any
4.1.2.4.6 Report on SAEs
4.1.2.5 Administrative matters
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4.1.2.6 Others
4.1.2.7 Setting of date of next meeting
4.1.2.8 Adjournment
4.1.3 Recommendations on protocols requiring clarifications in an en banc NCH
IRB/IEC meeting are made by NCH IRB/IEC reviewer/s, who inform/s the
Secretariat accordingly. The Chair instructs the Secretariat to inform the principal
investigator/s, in writing and by phone, at least a week before the meeting. The
reason/s for inviting them is/are stated in the letter. The time slot for their
appearance at the NCH IRB/IEC meeting is also communicated in the letter.
4.1.4 The Secretariat arranges the venue and other logistics for the meeting at least a
week before the scheduled meeting.
4.1.5 The Secretariat makes copies of the final agenda and sends them, together with
the notice of meeting to the NCH IRB/IEC members, at least one week before
the meeting.
4.1.6 The Secretariat files a copy of the agenda in the NCH IRB/IEC administrative files.
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2.6 Preparation of Meeting Minutes
1. Purpose
This Section is aimed at describing the process of preparation and distribution of the minutes
of NCH IRB/IEC meetings.
2. Scope
This SOP describes how the Minutes of the NCH IRB/IEC meetings are to be prepared, used,
distributed and filed. As a rule, not all matters discussed during the meeting are included in
the Minutes. Only those pertinent and relevant comments, recommendations and decisions
are summarized in chronological order or other appropriate sequence.
3. Flow Chart
Activity Responsibility
1. Organization of notes taken during the meeting and
tape proceedings
Secretariat
2. Preparation and drafting of the Minutes of Meeting
(NCH IRB/IEC-2012-05-2G-MM)according to the
sequence
Secretariat
3. Approval of the draft of the Minutes of Meeting
Chair/designated
member
4. Preparation and signing of approved Minutes of
Meeting
Secretariat and Chair
5. Filing of Minutes Meeting in NCH IRB/IEC members’
folders and NCH IRB/IEC documents file
Secretariat
4. Detailed Instructions
4.1. The Minutes of the meeting shall be prepared within 2 weeks after its conduct.
4.2. Organization of notes
4.2.1. The Secretariat organizes the notes from the proceedings based on the
agenda of the meeting, using the audio tape of the meeting for verification if
needed. For each item, the following shall be noted:
4.2.1.1. Title of item or issue discussed
4.2.1.2. Important comments about the issue (name of member who made
the comment should be cited)
4.2.1.3. Conclusions/recommendations/decisions regarding the issue (if there
is consensus, there is no need to name those who made the decision)
4.3. Draft of the Minutes
4.3.1. The notes, as organized, are entered in the computer. Grammatical errors
are corrected. A draft copy is prepared using the following format:
4.3.1.1. Date and venue of meeting
4.3.1.2. Minutes of the meeting (NCH IRB/IEC-2012-05-2G-MM)
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4.3.2. Forward a copy of the draft of Minutes to the Chair, for corrections and
approval. The Chair ensures the accuracy of the minutes of the previous
meeting.
4.3.3. Once approved, a final copy of the minutes of the meeting (NCH IRB/IEC-
2012-0-2G-MM)is prepared using the following format:
4.3.3.1. Date and venue of meeting
4.3.3.2. NCH IRB/IEC members and guests who attended the meeting
4.3.3.3. NCH IRB/IEC members who were absent
4.3.3.4. Person presiding
4.3.3.5. Time that the meeting was opened
4.3.3.6. Items discussed as per agenda
4.3.3.7. Name and signature of person who prepared the minutes
4.3.3.8. Date and approval of the Chair
4.3.4 Make copies of approved minutes and enclose a copy in the NCH IRB/IEC
members’ meeting folders.
4.3.5 File original copy of Minutes in the NCH IRB/IEC Minutes folder.
4.3.6 Copies of the Minutes are also distributed to NCH IRB/IEC members during
the next meeting. If a member is absent, the approved Minutes are sent to
him/her.
5. Relevant Form(s)
NCH IRB/IEC-2012-05-2F-NOM Notice of Meeting
NCH IRB/IEC-2012-05-2G-MM Minutes of the Meeting
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NCH IRB/IEC-2012-05-2F-NOM
Date of issuance: ______
NOTICE OF MEETING
TO: <NAME OF NCH IRB/IEC PANEL> Members:
Name 1
Name 2
Name 3
Name 4
Name 5
Name 6
Name 7
Name 8
DATE OF MEETING
TIME OF MEETING
VENUE OF MEETING
AGENDA:
1. Call to order
2. Determination of quorum and presence of non-institutional members
3. Conflict of interest disclosure
4. Reading and approval of the Minutes of the last meeting
5. Business arising from the Minutes
6. Protocol review
6.1. FULL REVIEW
6.1.1. Study Protocols for Initial Review
NCH IRB/IEC Code
Study Protocol Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.2. Resubmissions or Study Protocols for Modification
NCH IRB/IEC Code
Study Protocol Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.3. Study Protocols for Clarificatory Interview
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NCH IRB/IEC Code
Study Protocol Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.4. Application for Protocol Withdrawal
NCH IRB/IEC Code
Study Protocol Submission
Date
<dd/mm/yyyy>
Withdrawal Application
Date
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.5. Study Protocol Amendments Applications
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Amendment Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.6. Continuing Review Applications
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Application Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.7. Final Reports
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Report Date <dd/mm/yyyy>
Title
Name of PI
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Sponsor
Type of Review
Primary Reviewers
6.1.8. AE and SUSAR Reports
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Report Date <dd/mm/yyyy> (Organize AEs under one protocol by date)
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.9. Site Visit Reports:
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Site Visit Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.10. Protocol Deviation/Non-Compliance/Violation Reports:
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Report Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.11. Early Study Termination Application
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Application Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.1.12. Conduct of Study Queries, Complaints, or Grievance Reports
NCH IRB/IEC Code
Study Protocol Approval
Date
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Report Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
6.2. REPORT OF PROTOCOL SUBMISSIONS FOR EXPEDITED REVIEW AND FULL BOARD
PROTOCOLS WITH MODIFICATION EXPEDITED AT THE LEVEL OF THE CHAIR
6.2.1. Study Protocols for Initial Review
NCH IRB/IEC Code
Study Protocol Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
6.2.2. Study Protocols for Modification (or Resubmissions)
NCH IRB/IEC Code
Study Protocol Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
6.2.3. Study Protocol Amendments
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Amendment Submission
Date
<dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
6.2.4. Continuing Review Applications
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Application Date <dd/mm/yyyy>
Title
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Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
6.2.5. Final Reports
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Report Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
6.2.6. Protocol Deviation/Non-Compliance/Violation Reports
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Report Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
6.2.7. Early Study Termination Applications
NCH IRB/IEC Code
Study Protocol Approval
Date
<dd/mm/yyyy>
Application Date <dd/mm/yyyy>
Title
Name of PI
Sponsor
Type of Review
Primary Reviewers
ACTION
7. Other Matters
8. Adjournment
<TITLE, FIRST NAME, LAST NAME> and SIGNATURE
Chair, NCH IRB/IEC Review Panel
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NCH IRB/IEC-2012-05-2G-MM
National Children’s Hospital
I N S T I T U T I O N A L R E V I E W B O A R D / I N D E P E N D E N T E T H I C S
C O M M I T T E E 264 E. Rodriguez Sr. Blvd., Quezon City, 1102
Telephone: +63 2 7240656 to 59 local 114; Mobile: +63 ____________; Email: ___________________
Minutes of the NCH IRB/IEC
REGULAR MEETING
<Date>, <Place>, <Time>
1. ATTENDANCE
PRESENT ABSENT <Member>
<Member>
<Member>
<Member>
<Member>
<Member>
<Member>
<Member>
Others:
Panel Staff
<Name>
<Name>
<Name>
2. CALL TO ORDER
3. DETERMINATION OF QUORUM
4. DISCLOSURE OF CONFLICT OF INTEREST
5. READING AND APPROVAL OF THE MINUTES OF THE LAST MEETING
6. BUSINESS ARISING FROM THE MINUTES OF THE LAST MEETING
6.1. Corrections in the Minutes
6.2. Matters requiring NCH Panel action
7. STUDY PROTOCOL REVIEW
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7.1. FULL REVIEW
7.1.1. Study Protocols for Initial Review
NCH IRB/IEC Code
Study Protocol Submission Date
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
Technical Review
Sponsor
Quorum status
Conflict of interest
Assessment of scientific soundness
1. Objectives/Expected output 2. Literature review 3. Research design 4. Sampling design, sample size 5. Inclusion criteria, exclusion criteria, withdrawal criteria 6. Specimen collection and processing 7. Statistical and data analysis plan 8. PI qualifications 9. Suitability and choice of site 10. Translation of research instruments
Assessment of ethical issues 1. Conflict of Interest: 2. Privacy and confidentiality including data protection plan 3. Vulnerability 4. Risks 5. Benefits 6. Informed consent process and recruitment: 7. Informed Consent Form (ICF) (including translation) 8. Documentation of collaborative study TOR
Conclusion and recommendations
Major revision
Action taken Decision (Major Modification, which require full board deliberation)
Reasons
7.1.2. Resubmissions or Study Protocols for Modification:
7.1.3. Study Protocols for Clarificatory Interview:
7.1.4. Withdrawal of Study Protocol Applications:
7.1.5. Study Protocol Amendment Applications:
7.1.6. Continuing Review Applications:
7.1.7. Final Reports -
7.1.8. AE and SUSAR Reports -
7.1.9. Site Visit Reports -
7.1.10. Study Protocol Deviation/Non-Compliance/Violation Reports:
7.1.11. Early Study Termination Applications -
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7.1.12. Queries from Various Stakeholders -
7.2. REPORT OF PROTOCOL SUBMISSIONS FOR EXPEDITED REVIEW AND FULL
BOARD PROTOCOLS WITH MODIFICATION EXPEDITED AT THE LEVEL OF THE
CHAIR -
7.2.1. Study Protocols for Initial Review -
7.2.2. Resubmissions (study protocols for modification)-
7.2.3. Study Protocol Amendments -
7.2.4. Continuing Review Applications -
7.2.5. Final Reports
NCH IRB/IEC Code
Study Protocol Approval Date
Date of Report
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor
Results reported
Action Decision Points (Approval)
7.2.6. Study Protocol Deviation/Non-Compliance/Violation Reports -
7.2.7. Early Study Termination Applications -
8. OTHER MATTERS
9. ADJOURNMENT
Prepared by:
DATE: 11/05/2012 SECRETARIAT STAFF
Checked by: Signature over <Title, First Name, Last Name>
DATE: 11/05/2012 PANEL SECRETARY
Approved by:
DATE: 11/05/2012 PANEL CHAIR
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2.7 Review of Medical Device Study
1. Scope
The purpose of these SOP is to provide instructions for review and approval of medical
device studies submitted to the NCH IRB/IEC. These SOP apply to the submission and the
review processes of protocols involving the study of new medical devices on human
subjects.
During the review of medical device studies, the NCH IRB/IEC may decide differently from
the way it does in the review of general category studies, clinical drug trials, animal studies,
or studies on the environment. The NCH IRB/IEC must determine if the proposed
investigation has Significant Risk (SR) or Non-significant Risk (NSR), and then the NCH IRB/IEC
should decide if the investigation is approved or not. In determining Significant Risk (SR) or
Non-significant Risk (NSR), the NCH IRB/IEC must review all information submitted by the
principal investigator.
The NCH IRB/IEC should consider the nature of the harm that may result from the use of the
device. If a device being investigated might cause significant harm to any one of the study
participants, the study will be considered Significant Risk (SR). In deciding if a device
presents significant or non-significant risks, the NCH IRB/IEC should consider the device’s
total risks, not those compared with the risks of alternative devices or procedures. If the
device is used in conjunction with a procedure involving risk, the NCH IRB/IEC should
consider the risks of the procedure in conjunction with the risks of the device. The NCH
IRB/IEC may also consult with the regulatory agency or an outside consultant to form its
opinion.
The NCH IRB/IEC may agree or disagree with the sponsor’s initial NSR assessment. If the NCH
IRB/IEC agrees with the sponsor’s initial Non-significant Risk assessment and approves the
study, the study may begin without submission of an IDE (Investigational Device Exemption)
application to the regulatory agency. If the NCH IRB/IEC disagrees, the sponsor must notify
the regulatory agency that an SR determination has been made. The study can be
conducted as an SR investigation following regulatory approval of an IDE application.
2. Flow Chart
Activity Responsibility
1. Submits protocol package
Principal Investigator
2. Manages submitted protocol package
Secretariat
3. Conducts individual review
Reviewer
4. Conducts en banc review
Member
5. Notifies the principal investigator on NCH IRB/IEC
decision
Secretariat
6. Store documents Secretariat
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3. Detailed Instructions
3.1 The same procedure is followed when the protocol is submitted for initial review as in
the submission of any protocol for NCH IRB/IEC review see NCH IRB/IEC SOP 2012.
3.2. When reviewing a protocol on a medical device, the reviewer must look for the
following:
3.2.1. Proposed investigational plan
3.2.2. Informed consent form
3.2.3. Description of the device
3.2.4. Description of study participant selection criteria
3.2.5. Monitoring procedures
3.2.6. Reports of prior investigations conducted with the device
3.2.7. Principal investigator’s curriculum vitae
3.2.8. Principal investigator’s professional license (s)
3.2.9. Risk assessment data / information
3.2.10. Statistics used in making the risk determination
3.2.11. Copies of all labelling for investigational use only
3.3. The reviewer also looks for information/communication from the principal
investigator, if any, whether other NCH IRB/IECs have reviewed the proposed study
and what decision was made especially with regards to the device’s risk.
3.4. A medical device study should always be submitted for an en banc review after
individual reviews are conducted. The NCH IRB/IEC en banc decides whether the
device study poses No Significant Risk (NSR) or poses Significant Risk (SR) to study
participants.
3.5. The principal investigator of a medical device study should always be present during
the en banc NCH IRB/IEC review of his proposal.
3.6. The NCH IRB/IEC decides whether or not the study should be approved.
3.7. The Chair calls for a vote on the medical device study. The NCH IRB/IEC votes to
any of the following:
3.7.1. Approve the study to start as presented with no modifications
3.7.2. Approve the study to start with minor modifications to item/s noted at the
convened meeting and to be followed-up by the Secretariat and Chair after
receiving the requested modifications
3.7.3. Require major modifications and/or request further information to be
resubmitted and subjected to review in the next full board meeting
3.7.4. Disapprove the study and state the reason.
3.7.5. Record the vote of risk assessment in the decision form and the meeting
minutes.
3.7.6. Determine the frequency of continuing review for the approved study.
3.7.7. The principal investigator is notified about the decision of the NCH IRB/IEC
thru the “Notice of NCH IRB/IEC Decision Form.”
If the NCH IRB/IEC votes not to approve the study, the Chair or Secretariat
notifies the principal investigator of the decision and the reason for
disapproving the study in written form. If the principal investigator wishes to
appeal for this decision, he/she may do so by writing to NCH IRB/IEC and
stating the reason for the appeal. This process is stated in the action letter
provided to the principal investigator.
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If the NCH IRB/IEC votes to require modifications to any of the documents,
the Secretariat either generates the revisions to the documents, or sends a
written request of the specific changes to the principal investigator, asking
him/her to make the necessary changes and resubmit the documents to the
NCH IRB/IEC.
3.8. The documents are stored in the active study files.
3.8.1. Prepare an appropriate label.
3.8.2. Store the document packages in the shelf for active files.
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2.8. Review of Protocols that Involve Genetic Materials
1. Scope
These SOP describe the special review that is necessary when a protocol involves the use of
genetic materials. The initial procedures of submission and processing of the submitted
documents do not differ from those used when protocol is submitted to NCH IRB/IEC.
However, when it comes to the individual review of such protocol, some documents
specifically referable to genetic studies are required. In addition, an independent
consultant may be requested to review the study.
2. Flow Chart
Activity
Responsibility
1. Submits protocol package
Principal Investigator
2. Manages submitted protocol package
Secretariat
3. Conducts Individual and/or independent
consultant’s review
Reviewer
4. Conducts en banc review with presence of
independent consultant
Member
5. Notifies the principal investigator on NCH IRB/IEC
decision
Secretariat
6. Stores documents Secretariat
3. Detailed Instructions
3.1. The study protocol is processed using the SOP on Management of Submissions.
3.2. If not submitted with the protocol, a separate Informed Consent for the tissues to be
obtained from the study participant, which will be used for genetic studies, should
be submitted for review.
3.3. Copies of documents are given to reviewers for individual review.
3.4. A copy is given to an independent consultant who is identified by the Chair or
recommended by the members.
3.5. After individual review of the protocol, the protocol is discussed in an en banc NCH
IRB/IEC meeting with the independent consultant preferably present.
3.6. The decision of the NCH IRB/IEC is communicated to the principal investigator.
3.7. The files of the protocol are filed in the study file folder of the protocol.
NCH IRB - f
or vie
wing pu
rpose
s only