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 2019-2022

 

S.NO

NAME

DESIGNATION

POST IN ETHICS COMMITTEE

External / Internal

1

Dr. P. JambulingamFormer Director, ICMR- Vector Control Research Centre,Department of Health Research, MH & FW)

Chairperson

External

2

Dr. G. SivagnanamProfessor & Head of Department of Pharmacology, IGIDS

Deputy Chairperson

External

3

Dr. Latha ChaturvedulaProfessor Obs. & Gynaecology, JIPMER

Clinician

External

4

Dr. Reena GulatiAdditional Professor of Paediatrics, JIPMER

Clinician

External

5

Dr. Medha RAdditional Professor,Department of Biochemistry, JIPMER

Basic Medical Scientist

External

6

Dr. K. ChandrasegaranRetd. Associate Professor Dr.Ambedkar Govt. Law College

Legal Expert

External

7

Dr. A. Hannah Rachel VasanthiProfessor, Department of Biotechnology, Pondicherry University

Scientist

External

8

Dr.S.Arul Jothi SelviAssistant Prof. in Zoology, Periyar Government Art College

Lay person

External

9

Mr. R AngamouttouProfessor of Social Sciences, KGNC

Social Scientist

External

10

Dr. N. AnanthakrishnanProfessor of Surgery, MGMCRI

Clinician

Internal

11

Dr. C. AdithanDean (Research) and Professor of Pharmacology, MGMCRI

Basic Medical Scientist

Internal

12

Dr. Lokesh SProfessor & Head of Medicine, MGMCRI

Clinician

Internal

13

Dr. Siva Ranganathan GreenAssociate Professor of Medicine, MGMCRI

Member Secretary

Internal

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. Siva Ranganathan Green,
Professor of General Medicine, 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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