Institutional Human Ethics Committee
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.
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.
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.
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
1. Cover letter-template
2. Curriculum Vital for the Investigators
3a. Checklist for protocol submission-Student
3b. Checklist for protocol submission-Faculty
3c. Checklist for protocol submission-Clinical Trial
4. Declaration or Integrity statement
5. Review Exemption Form
6. Expedited Review ( to be submitted along with cover letter)
7. Requisition for waiver of consent
8. Protocol related documents Amendment Request and Assessment Form
9. Continuing Review Application Form
10. Data Elements for reporting serious adverse events occurring in a clinical trial
11. Study Completion Report
12. Request or Complaint form
13. Document Request Form
14. Checklist-Requirements for research involving children
15. Checklist-Requirements for research involving pregnant women & fetuses
16. Checklist-Research involving students, employees or residents
17. Checklist-Research involving cognitively impaired adults
18. Checklist-Considerations for genetic research
- CDSCO- New Drugs and Clinical Trials Rules 2019
- ICH Good Clinical Practice Guidelines E6 (R2). The International Council for Harmonisation (ICH)
- WEB-CIOMS-Ethical Guidelines
- WHO Guidelines on ethical issues in public health surveillance
- WHO Standards and operational guidance for ethics review of health-related research