ETHICS COMMITTEE

Name of the Committee
The name of the Ethics Committee of Kerala Institute of Medical Sciences (KIMS) is Institutional Human Ethics Committee (IHEC) of KIMS.

Aim of the Ethics Committee
To review proposed studies with human participants to ensure that they conform to internationally and nationally accepted ethical guidelines, monitor studies once they have begun and, where relevant, take part in follow-up action and surveillance after the end of the research

Scope of the Ethics Committee

  • To advise and recommend on ethical matters arising in relation to research involving human participants.
  • To ensure research is designed and conducted in accordance with the ICMR and CDSO rules and regulations for the responsible conduct of research and the National Statement on Ethical Conduct in Human Research.
  • To consider the ethical implications of all research proposals received by the Committee approve, request amendment of, or reject a research proposal on ethical grounds.
  • To monitor and audit approved research to verify that the conduct of research conforms to the proposal that is approved by the Committee.
  • To adopt measures to identify and manage any real, potential and/or perceived conflicts of interest of HREC members and or researchers.
  • To handle any complaints about research or the conduct of research on humans.

Registration History of the IHEC
2003 – Established
2013 – IHEC registered by Central Drugs Standard Control Organization (CDSCO), No. ECR/284/284/KIMS/Inst/Ker/2013
2016 – EC CIMS reregistered by Central Drugs Standard Control Organization (CDSCO), ECR/284/KIMS/Inst/Ker/2013-Re-Registration-2016

Constitution of the IHEC

The IHEC will be established by the Head of the Institution (HOI). The IHEC is multidisciplinary and multi-sectoral in composition. The IHEC will be composed of at least 7 members and up to a maximum of 15. It includes a combination of medical and non-medical, scientific and non-scientific persons including lay persons to represent the different points of differing backgrounds to promote complete and adequate review of research, the required qualifications as prescribed by applicable regulations and guidelines from time to time and the expertise, time and commitment to perform all functions. The representation of the members is varied in terms of gender, age and social background to safeguard the interests and welfare of all sections of the community / society.

Responsibilities of the Ethics Committee

  • To ensure protection of the dignity, rights, safety and well-being of the research participants
  • To make sure ethical conduct of research by the investigator team
  • To carry out competent initial and continuing review of all scientific, ethical, medical and social aspects of research proposals as per universal ethical values and international and national scientific and ethical standards
  • To assist in the development and education of the research community in the given Institute
  • To protect the privacy of the individual and confidentiality of data including the documents of EC meetings is protected.
  • To review progress reports, final reports and AE/SAE and gives needful suggestions regarding care of the participants and risk minimization procedures
  • To recommend appropriate compensation for research related injury, wherever required.

Ethics Committee members

Sl. No Name & Qualifications Designation

 

1 Dr. C.C.Kartha
MD,FRCP (London), FAMS, FASc, FNASc, FICPath, FIACS
Chairman
2 Dr. P.M. Saffia
MS, MCh
Member Secretary
3 Dr. Naveen Jain
MD, DM
Clinician
4 Dr. M. N. Rema
MD, DME (Retd)
Basic Medical Scientist
5 Dr. Reneega Gangadher
MD, PGDBE
 Basic Medical Scientist
6 Prof. Jameela Beegum
MA (Eng), PhD
 Lay person
7 Mr. Sreekanth Pooyappally Krishnan
BE, AMIETE
Lay person
8 Adv. P. A. Dev  
LLB
Legal Expert

 

9 Adv. A. Abdul Kharim
LLB
Legal Expert
10 Ms. J. Lalithambika
MA, MBA, IAS (Retd)
Social Scientist

 

11 Mrs. Rose Mary
MA(ENG), Dip in Journalism and Public Relations
Social Scientist

 

12 Prof. A. Joseph
M.Sc, FRES, D. Med En
Scientific member
13 Dr. Aleyamma Mathew
MSc, PhD
Scientific member

Ethics Committee Protocols

Sl.No Title of the Standard Operating Procedures (SOPs) SOP No.
1 Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC KIMS/SOP-02/V1
2 Selection and Responsibilities of Representatives of Vulnerable Population KIMS/SOP-05/V1
3 Management of Submission of Research Study Protocol and Study Related Documents KIMS/SOP-07/V1
4 Initial Full Board Review of Research Study Protocols KIMS/SOP-08A/V1
5 Dealing with Participants’ Requests and Complaints Coming to Ethics Committee KIMS/SOP-18/V1
6 Reviewing Proposals involving Vulnerable Populations KIMS/SOP-20/V1

Note: If you are interested in referring to any of the SOPs not available on the website, a request can be sent to : iheckims.tvm@kimsglobal.com for getting the SOPs.