MGMCRI, SBV

Mahatma Gandhi Medical College and Research Institute (MGMCRI)

A constituent college of

Sri Balaji Vidyapeeth (SBV), PUDUCHERRY

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Institutional Human Ethics Committee (IHEC)

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

  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.
LIST OF MEMBERS FOR THE INSTITUTIONAL HUMAN ETHICS COMMITTEE 2021-2024

Sl. No

NameDesignationPost in Ethics committee

Affiliation

1Dr. P. JambulingamDirector ICMR – Vector Control Research Center PuducherryChairpersonExternal
2.Dr. Indhira SProfessor & Head – Philosophy Pondicherry universityPhilosopher & ethicistExternal
3.Dr. Shahin SultanaProfessor of social worker Pondicherry universitySocial ScientistExternal
4.Dr. Mohandoss B.Advocate – Labour and services law Consultant PuducherryLegal ExpertExternal
5.Dr. Stephen SelvarajAssociate Dean (Research) Professor of Microbiology – MGMCRIBasic Medical ScientistInternal
6.Dr. Uma NarayanamurthyAssociate Professor – Pharmacology MGMCRIBasic Medical Scientist (Pharmacologist)Internal
7.Dr. Mohamed HanifahProfessor & Head – Medicine & CCU MGMCRIClinicianInternal
8.Dr. Krishnagopal RProfessor & Head – orthopedics MGMCRIClinicianInternal
9.Dr. Karthikeyan KAssociate Professor – Pediatrics MGMCRIClinicianInternal
10.Dr. SaravanakumarAssociate Professor – Gen. Surgery MGMCRIClinicianInternal
11.Dr. Lopamudra B. JohnProfessor – Obstetrics & Gynecology MGMCRIClinicianInternal
12.Mrs. Prabavathi RAssistant professor Sri Sharadha college of education VillupuramLay personExternal
13.Dr. Barathane DAssociate Professor – Pharmacology MGMCRIMember secretary (Pharmacologist)Internal
Click here for the Constitution of the Committee

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

Certificate Course in Bioethics on Human Research

 
GCP workshop

 
SIDCER
Member Secretary:
Dr. Barathane D, Associate Professor – Pharmacology, MGMCRI.
Address:
Office of Institutional Human Ethics Committee,
College block, 1st floor, (Adjacent to Dept of Pathology),
MGMCRI, Pondi-Cuddalore Road,
Pillayarkuppam,
Puducherry 607402,
India.
Email: ihec@mgmcri.ac.in
Telephone No.: 0413-2616700 (Extension No.: 754)
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