Initial Review
Initial Review
Logo of the
Institute
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(Name of the Institution) EC Ref. No. (For office use):
General Instructions : a) Tick one or more options as applicable. Mark NA if not applicable
b) Attach additional sheets if required
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Co-investigator/student/fellow
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Refer to National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017 on Page 36 Table 4.2. for types of review
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Include telephone/mobile, fax numbers and email id Version 2.0 01
2. FUNDING DETAILS AND BUDGET
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4. METHODOLOGY
Justification for the sample size chosen (100 words); In case of qualitative study, mention the criteria used for
saturation ...................………………………………………………………………………………………………………………………………….........................
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Summarize in the simplest possible way such that a person with no prior knowledge of the subject can easily understand it.
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Version 2.0 02
(b) Is there an external laboratory/outsourcing involved for investigations?4 Yes o No o NA o
Date of review: dd mm yy
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If participant samples are sent outside for investigations, provide details of the same and attach relevant documentation such as an MTA / MoU
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(c) Is there any reimbursement to the participants? Yes o No o
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(e) Are there any participant recruitment fees/ incentives for the study provided to the PI / Institution?
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(a) i. Are there any anticipated physical/social/psychological discomforts/ risk to participants? Yes o No o
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(b) What are the potential benefits from the study? Yes No If yes, Direct Indirect
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Are reporting procedures and management strategies described in the study? Yes o No o
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7. INFORMED CONSENT
(a) Are you seeking waiver of consent? If yes, please specify reasons and skip to item no. 8 Yes o No o
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For categories of risk refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017, Page 6 Table 2.1
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The term adverse events in this regard encompass both serious and non-serious adverse events. Version 2.0 04
(b) Version number and date of Participant Information Sheet (PIS):…………………………………......................………………………
(f) Provide details of consent requirements for previously stored samples if used in the study7
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(g) Elements contained in the Participant Information Sheet(PIS) and Informed Consent Form (ICF)
Simple language o Data/ Sample sharing o Compensation for study related injury o
Risks and discomforts o Need to recontact o Statement that consent is voluntary o
Alternatives to participation o Confidentiality o Commercialization/ Benefit sharing o
Right to withdraw o Storage of samples o Statement that study involves research o
Benefits o Return of research results o Use of photographs/ Identifying data o
Purpose and procedure o Payment for participation o Contact information of PI and Member o
Others(Specify) o Secretary of EC
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8. PAYMENT/COMPENSATION
(a) Who will bear the costs related to participation and procedures8 ?
PI o Institution o Sponsor o Other agencies o (specify)
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(b) Is there a provision for free treatment of research related injuries? Yes o No o N/A o
If yes, then who will provide the treatment? …………………………………………………………………………………………..........................
(c) Is there a provision for compensation of research related SAE? If yes, specify. Yes o No o N/A o
Sponsor o Institutional/Corpus fund o Project grant o Insurance o
(d) Is there any provision for medical treatment or management till the relatedness is determined for injury to the
participants during the study period? If yes, specify. Yes o No o N/A o
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(e) Is there a provision for ancillary care for unrelated illness during the study period? If yes, please specify.
Yes o No o N/A o
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Information on re-consent requirements can be found at National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
2017, Page 54 in Section 5.8.
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Enclose undertaking from PI confirming the same Version 2.0 05
9. STORAGE AND CONFIDENTIALITY
If identifiers must be retained, what additional precautions will be taken to ensure that access is limited /data is
safeguarded? (e.g. data stored in a cabinet, password protected computer etc.) …………………………………………………….
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(b) Who will be maintaining the data pertaining to the study? …………..……….......................……………………………………………….
(c) Where will the data be analyzed9 and by whom? ……………………….……………………..............................……………………………..
(d) For how long will the data be stored? ………………………………………...………………………........................…………………………………
(e) Do you propose to use stored samples/data in future studies? Yes o No o Maybe o
If yes, explain how you might use stored material/data in the future?...................................................................................
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(a) Will the results of the study be reported and disseminated? If yes, specify. Yes o No o NA o
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(b) Will you inform participants about the results of the study? Yes o No o NA o
(c) Are there any arrangements for continued provision of the intervention for participants, if effective, once the
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(d) Is there any plan for post research benefit sharing with participants? If yes, specify Yes o No o NA o
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(e) Is there any commercial value or a plan to patent/IPR issues? If yes, please provide details Yes o No o NA o
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(f) Do you have any additional information to add in support of the application, which is not included elsewhere in
the form? If yes, provide details. Yes o No o
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For example, a data entry room, a protected computer etc. Version 2.0 06
SECTION E: DECLARATION AND CHECKLIST 10
o I/We confirm that all investigators have approved the submitted version of proposal/related documents.
o I/We confirm that this study will be conducted in accordance with the latest ICMR National Ethical Guidelines
for Biomedical and Health Research Involving Human Participants and other applicable regulations and guide-
lines.
o I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics Act 1940 and its
Rules 1945 as amended from time to time, GCP guidelines and other applicable regulations and guidelines.
o I/We will comply with all policies and guidelines of the institute and affiliated/collaborating institutions where
this study will be conducted.
o I/We will ensure that personnel performing this study are qualified, appropriately trained and will adhere to
the provisions of the EC approved protocol.
o I/We declare that the expenditure in case of injury related to the study will be taken care of.
o I/We confirm that an undertaking of what will be done with the leftover samples is provided, if applicable.
o I/We confirm that we shall submit any protocol amendments, adverse events report, significant deviations
from protocols, progress reports and a final report and also participate in any audit of the study if needed.
o I/We confirm that we will maintain accurate and complete records of all aspects of the study.
o I/We will protect the privacy of participants and assure confidentiality of data and biological samples.
I/We hereby declare that I/any of the investigators, researchers and/or close relative(s), have no conflict of
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interest (Financial/Non-Financial) with the sponsor(s) and outcome of study.
I/We have the following conflict of interest (PI/Co-I):
o
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o I/We declare/confirm that all necessary government approvals will be obtained as per requirements wherev-
er applicable.
Name of PI: ………………....................................................................................................................................……………......................
dd mm yy
Signature: ........................……………………………….............................................................................................
dd mm yy
Signature: ........................……………………………….............................................................................................
Signature: ........................………………………………............................................................................................. dd mm yy
dd mm yy
Signature: ........................……………………………….............................................................................................
These formats are adaptable and can be modified by the Ethics Committee members depending on their needs and requirements
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