mgmcri-Committees-Institute Human Ethics Committee (IHEC)

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Institutional Human Ethics Committee (IHEC)

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Guidelines

Composition of Ethics Committee

SOP for IHEC

IHEC Forms

SBV Protocol Proforma Template

DCGI and DHR Registration

Introduction

The Institutional Human Ethics Committee (IHEC) of Mahatma Gandhi Medical College & Research Institute, Puducherry (MGMCRI) was established in the year 2009, aimed at promoting ethical clinical research that protects the rights and safety of study participants. The undergraduates, postgraduates and Ph.D. Scholars, faculties and anyone who undertake clinical research in the institute follow the ethical guidelines necessitated by IHEC, MGMCRI.

The Institutional Human Ethics Committee (IHEC), reviews all research proposals on human participants as per ICMR guidelines 2017. Proposals that have less than minimal risk or no risk is reviewed by the subcommittee. Our IHEC is recognized by Forum for Ethics Review Committees of the Asia and Western Pacific Region (FERCAP), under the SIDCER initiative of the WHO. It is also registered with Department of Health Research (DHR) and Drug Controller General of India (DCGI).

Function

How to submit a proposal for ethical clearance

Prior Approval Certificate: IHEC will consider only those proposals that are approved by Institutional Research Committee (IRC), Postgraduate training and Research Committee (PGRC), Ph.D. doctoral Committee, Clinical Trial Research Committee (CTRC) and other appropriate committee.
All application must be as per the SBV, MGMCRI template format and must be signed by all involved investigators, and other relevant authorities of the Department/ University as applicable.
Application must be addressed to the Member Secretary / Chairperson of IHEC, MGMCRI.
All applications must be submitted in duplicate (print -hard copies) and one soft copy (only in PDF) on a pen drive at the Office of IHEC. (Email submission will not be accepted)
Application received only 4 weeks before the schedules meeting will be eligible to be taken up for the next upcoming meeting.
It is the PI`s responsibility to submit the corrections advised within the stipulated time (preferable within 5 working days).
Incomplete Forms/ Protocols are liable to undue delays
The Complete Protocol Package as per the IHEC SOP is necessary to initiate the Review process
If required the PI may be invited by the Secretary, IHEC to clarify ethical doubts, either orally, or in writing or in form of presentation. In such event, the PI personally or with his Team has to make himself/ team available for the clarification. In the unusual event that the PI is unable to be present he/she representative along with a letter highlighting reasons for absence.
Six monthly or annually progress report and study closure report are mandatory.
Changes in the title, objectives, methodology and /or analysis requires reporting to the IHEC, which will be decided on whether fresh application for ethical clearance is required.
Decision on ethical waiver, exemption review, expedited review or full board review rest solely with the IHEC.

CDSCO- New Drugs and Clinical Trials Rules 2019.

CIOMS-International Ethical Guidelines for Health-related Research Involving Humans.

ICH Good Clinical Practice Guidelines E6 (R2). The International Council for Harmonisation (ICH).

ICMR 2017-National Ethical Guidelines For Biomedical And Health Research Involving Human Participants.

National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic – April 2020.

WHO Guidelines on ethical issues in public health sureilance – 2017.

WHO Standards and operational guidance for ethics review of health-related research – 2011.

WMA Declaration Of Helsinki – Ethical Principles For Medical Research Involving Human Subjects – 2013.

SOP table of contents
1. Preparation of SOP
2. IHEC constitution
3. Handling conflict of interest
4. Responsibilities of ICs
5. Guest visit
6. Management of research protocols
7. Categorization of study
7A. Full board review
7B. Expedited review
7C. Exemption from Ethics Review of Research Study Protocols
8. Preparation of agenda, meeting and minutes
9. Resubmitted and amended protocols
10. Continuing review of study protocols
11. Protocol violations
12. Review of SAE
13. Study completion reports
14. Managing Premature termination of study
15. Waiver of consent
16. Site monitoring
17. Dealing with Participant’s Requests and Complaints
18. Maintenance of records
19. Review of proposals involving vulnerable population
20. Preparation for audit
21. Training of IHEC members