Institutional Human Ethics Committee

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, 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 subcommittee.

Function

The researcher in MGMCRI who wishes to undertake clinical research on human participants follow a systematic protocol so that the rights, safety and well-being of the study participants are protected. After approval from the Institutional Research Committee, the researcher who undertakes study on human participants submits the proposal to the Institutional Human Ethics Committee. The IHEC conducts regular meetings for reviewing the research proposals and give suggestions to the investigators to make their research ethical, thereby approving the research proposal or disapproving it if it does not comply ethically. All researchers who undertake research projects in humans should get approval from IHEC before commencement of the study.

Members

IMPORTANT GUIDELINES REGARDING FUNCTIONING OF IHEC

  • Institutional Human Ethics Committee (IHEC) will be held quarterly.
  • After the notice of the ethical committee to submit the research proposals for ethical clearance, the researcher needs to submit both hard and softy copies of the proposal and other necessary documents to the member secretary, IHEC on any working day till the last day mentioned in the circular.
  • All proposals should be written in English language and consent forms should be in both English and Tamil.
  • Atleast three week prior notice regarding ethical meeting will be provided to the researchers.
  • Serious adverse events should be intimated to IHEC within twenty four hours of occurrence of the event.
  • The ethical approval is valid only for the period mentioned in the certificate of approval.
  • Any change in study procedure, site and investigator should be intimated to the IHEC.
  • Annual report of the project to be submitted to IHEC for approval.
  • Members of IHEC have right to review the trial/study with prior intimation.

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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