Ethics Committee
Name of the Committee
The name of the Ethics Committee of KIMSHEALTH is Institutional Human Ethics Committee (IHEC) of KIMSHEALTH.
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 under Central Drugs Standard Control Organization (CDSCO), No. ECR/284/284/KIMS/Inst/Ker/2013
2016 – IHEC reregistered under Central Drugs Standard Control Organization (CDSCO), ECR/284/KIMS/Inst/Ker/2013-Re-Registration-2016
2019 – IHEC reregistered under Central Drugs Standard Control Organization (CDSCO), ECR/284/KIMS/Inst/Ker/2013-Re-Registration-2019
2021 – IHEC provisionally registered under the Department of Health Research (DHR), EC/NEW/INST/2020/1432
2022 – IHEC reregistered under Central Drugs Standard Control Organization (CDSCO), No. ECR/184/KIMS/Inst/Ker/2013/RR-22
Accreditation
Constitution of the IHEC
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 | Affiliation with the Institution |
|---|---|---|---|
| 1 | Dr. M. Radhakrishna Pillai FRCPath, PhD, FAMS, FASc, FNASc, FNA | Chairman | Non-affiliated |
| 2 | Dr. P.M. Saffia MS, MCh | Member Secretary | Affiliated |
| 3 | Dr. Naveen Jain MD, DM | Clinician | Affiliated |
| 4 | Dr. K.K, Narayanan Namboodiri MD, DM (Cardiology) | Clinician | Non-affiliated |
| 5 | Dr Rejnish Kumar R MBBS, MD (RT), DNB (RT) | Clinician | Non-affiliated |
| 6 | Dr. M. N. Rema MD (Pharmacology) | Basic Medical Scientist | Non-affiliated |
| 7 | Dr. Reneega Gangadher MD (Pharmacology), PGDBE | Basic Medical Scientist | Non-affiliated |
| 8 | Prof. Jameela Beegum MA (Eng), PhD | Lay person | Non-affiliated |
| 9 | Mr. Sreekanth Pooyappally Krishnan BE, AMIETE | Lay person | Non-affiliated |
| 10 | Adv. Asha S.V. LLB | Legal Expert | Non-affiliated |
| 11 | Adv Sajad Kharim LLB | Legal Expert | Non-affiliated |
| 12 | Dr. Joseph K.A. MSW, PhD | Social Scientist | Non-affiliated |
| 13 | Dr. Usha Kandaswamy MSW, PhD | Social Scientist | Non-affiliated |
| 14 | Dr. Aleyamma Mathew MSc, PhD | Scientific member | Non-affiliated |
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/V2 |
| 2 | Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC | KIMS/SOP-02/V2 |
| 3 | Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC | KIMS/SOP-02/V2 |
| 4 | Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC | KIMS/SOP-02/V2 |
| 5 | Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC | KIMS/SOP-02/V2 |
| 6 | Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC | KIMS/SOP-02/V2 |
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.
