Rajiv Gandhi Centre for Biotechnology Institutional Human Ethics Committee (RGCB IHEC) (Reg.No. ECR/484/Inst/KL/2013)

RGCB IHEC is constituted under the authority of Drugs Controller of India, Central Drugs Standard Control Organization, Drugs and cosmetics (Third Amendment) Rule, 2013, Ministry of Health and Family Welfare (Dept. of Health), government of India

The terms of reference of the committee

IHEC will review and approve all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and wellbeing of all actual and potential research participants. The goals of research, however important, should never be permitted to override the health and wellbeing of the research subjects/participants. The IHEC will take care that all the cardinal principles of research ethics viz Autonomy, Beneficence, Non - malfeasance and Justice are taken care of in planning, conduct and reporting of the proposed research. For this purpose, it will look into the aspects of informed consent process, risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensations wherever required. It will review the proposals before start of the study as well as monitor the research throughout the study until and after completion of the study through appropriate well documented procedures, such as annual reports, final reports and site visits etc. The committee will also examine compliance with all regulatory requirements, applicable guidelines and laws. The mandate of the IHECs will be to review all research projects involving human subjects including human biological materials and human biological data to be conducted at the Institute, irrespective of the funding agency.

Commitments
  • The Committee shall review and accord its approval to a clinical trial and also carry ongoing review of the trial at appropriate intervals, as specified in Schedule Y and the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding the rights, safety and well- being of the trial subjects.
  • In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Committee shall analyze and forward its opinion as per procedures specified under APPENDIX XII of Schedule Y.
  • The Committee shall allow inspectors or officials authorized by the Central Drugs Standard Control Organization to enter its premises to inspect any record, data or any document related to clinical trial and provide adequate replies to any query raised by such inspectors or officials, as the case may be, in relation to the conduct of clinical trial.
  • The Committee shall maintain adequate and accurate records after the completion or termination of the study for not less than five years from the date of completion or termination of the trial (Both in hard and soft copies).
Composition of RGCB-IHEC

The RGCB Human Ethics Committee comprises a panel of distinguished luminaries in various professional and social fields. The committee is chaired by Justice K.T. Thomas, former Honorable Judge of the Supreme Court of India. The complete list of members is given below :

Justice K. T Thomas
Chairman
Former Honourable Judge,Supreme Court of India,
Muttambalam,Kottayam 686004
Dr. C. Adithan
Professor of Pharmacology
Jawaharlal Nehru Institute of Post Graduate Medical Education
and Research (JIPMER), Pondicherry
Dr. V. Ramankutty
Professor
Achutha Menon Centre for Health Sciences
Thiruvananthapuram 695011
Professor. P. M. Gopinath
Senior Scientist,
Manipal Life Sciences Centre,
Manipal University,Manipal, 576 104,
Dr. K. E. Elizabeth
Professor of Paediatrics
SAT Hospital, Medical College
Thiruvananthapuram 695011.
Shri. C Balagopal
Managing Director,Turumo PENPOL
I-2, Jawahar Nagar
Thiruvananthapuram 695 003
Dr. S. Rema Devi
[Former Professor of Sociology, Trivandrum Medical College]
Programme Consultant
International Clinical Epidemiology Network, CERTC, Medical College
Thiruvananthapuram 695 011
Ms. Vimla Menon
Secretary, Cheshire Home
Kawdiar Post
Thiruvananthapuram 695 003
Dr. K. Ramadas
Professor & Chief
Head & Neck Oncology
Regional Cancer Centre
Thiruvananthapuram 695 011
Dr. Sanil George
(Member Secretary)
Scientist E1
Chemical Biology Group
Rajiv Gandhi Centre for Biotechnology
Address of the office of the RGCB IHEC
  • Member Secretary
  • RGCB IHEC
  • Chemical Biology Laboratory
  • Rajiv Gandhi Centre for Biotechnology
  • Trivandrum-695014, Kerala, India.
  • Phone: 0471- 2529520