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Institutional Human Ethics Committee

Introduction

The Institutional Human Ethics Committee (IHEC) of Mahatma Gandhi Medical College & Research Institute (MGMCRI), Pondicherry was established in the year 2009, aimed at promoting ethical clinical research that protects the rights and safety of study participants. The undergraduates, post graduates 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 Expedited Review Committee.

Function

How to submit a proposal for ethical clearance

  1. 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.
  2. 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.
  3. Application must be addressed to the Member Secretary / Chairperson of IHEC, MGMCRI.
  4. 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)
  5. Application received only 4 weeks before the schedules meeting will be eligible to be taken up for the next upcoming meeting.
  6. It is the PI`s responsibility to submit the corrections advised within the stipulated time (preferable within 5 working days).
  7. Incomplete Forms/ Protocols are liable to undue delays
  8. The Complete Protocol Package as per the IHEC SOP is necessary to initiate the Review process
  9. 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.
  10. Six monthly or annually progress report and study closure report are mandatory.
  11. 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.
  12. Decision on ethical waiver, exemption review, expedited review or full board review rest solely with the IHEC.

Relevant Resources

1. Preparation of Standard Operating Procedures for Institutional Human Ethics Committee, MGMCRI.
2. Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC,MGMCRI
3. Handling Conflict of Interest among Ethics Committee Members
4. Selection and Responsibilities of Independent Consultants
5. Procedures for allowing Guest/ Observer to visit Institutional Human Ethics Committee or attend IHEC meeting
6. Management of Submission of Research Study Protocol and Study Related Documents
7. Categorization of New Research Study Protocols for Initial Review
   7A. Initial Full Board Review of New Research Study Protocols
   7B. Expedited Review of Research Study Protocols
   7C. Exemption from Ethics Review of Research Study Protocols
8. Agenda Preparation, Meeting Procedures and Recording of Minutes
9. Review of Resubmitted and Amended Protocols and Protocol-related Documents
10. Continuing Review of Study Protocols
11. Review of Protocol Deviations / Violations
12. Review of Serious Adverse Event (SAE)
13. Review of Study Completion Reports
14. Management of Premature Termination / Suspension / Discontinuation of the Study
15. Waiver of Written/ Verbal Informed Consent
16. Site Monitoring and Post Monitoring Activities
17. Dealing with Participant’s Requests and/or Complaints to Institutional Human Ethics Committee
18. Maintenance of Active Study Files, Administrative Records of the Ethics Committee, Archival of Closed Files and Retrieval of Documents
19. Reviewing Proposals Involving Vulnerable Populations
20. Preparation for Audit / Inspection
21. Training and Assessment of Institutional Human Ethics Committee (IHEC) Members

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