Institutional Ethics Committee

Institutional Ethics Committee (IEC) Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India. 400012. Office address: UG/PG Hostel Building, Ground Floor, KEM Hospital Campus, Dr. S. S. Rao Road, Parel, Mumbai. Office Mobile No.: 8779221293, Telephone No.: 022 2410 7515, Extension No.: 7515, Email ID:iec-1@kem.edu, iec-2@kem.edu, iec-3@kem.edu
IEC-I	IEC-II	IEC-III
Established on 6th January 1987 Composition/Member list effective from 10th July 2024	Established on 14th November 2008 Composition/Member list effective from 1st August 2024	Established on 12th October 2019 Composition/Member list effective from 22nd April 2024
Related to: Clinical trial, bioavailability and bioequivalence and academic clinical trial as per NDCT Rule 2019	Related to: Biomedical health research as per NDCT Rule 2019
Registered with CDSCO: Govt of India, DGHS, CDSCO, Drugs Controller General (I) & Licensing Authority: Re‐Registration No. ECR/229/Inst./MH/2013/RR‐24 Valid from 22.04.2024 to 21.04.2029 DHR: Govt of India, Ministry of Health & Family Welfare, Dept of Health Research (DHR), Registration no. EC/NEW/INST/2021/MH/0008, Valid from 22nd Oct 2021 to 21st Oct 2026.	Registered with Govt of India, Ministry of Health & Family Welfare, Dept of Health Research (DHR), Registration No.EC/NEW/INST/2021/MH/0002, Valid from 22nd October 2021 to 21st October 2026.	Registered with Govt of India, Ministry of Health & Family Welfare, Dept of Health Research (DHR), Registration No. EC/NEW/INST/2021/ MH/0003, Valid from 22nd October 2021 to 21st October 2026.
Recognized by SIDCER & FERCAP: Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) for its compliance with international and local standards in ethical review, awarded on Nov 20, 2016
Accredited by NABH: National Accreditation Board for Hospitals & Healthcare Providers (Constituent Board of Quality Council of India) Valid from May 19, 2021, thru May 18, 2024 Certificate No. EC‐CT‐ 2018‐0027

History of Institutional Ethics Committee (IEC)

1987: Dr. G. B. Parulekar Dean, Seth G. S. Medical College and K. E. M. Hospital, Mumbai constituted the Ethics Committee on 6th Jan 1987. Dr. S. M. Karandikar was the first Chairperson and Dr. S. A. Dahanukar was the first Member Secretary of this committee.
1999: The committee was reformulated in 1999 with the chairperson from outside the institution.
2002: it was renamed as Ethics Committee for Research on Human Subjects (ECRHS).
2008, the Director ME & MH, Dr. Sanjay Oak constituted and launched an additional committee, Committee for Academic Research Ethics (CARE) on 14th Nov 2008 to oversee ethical review of thesis and investigator initiated projects.
2009: The IEC received international recognition from Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)
2009: A new SAE Subcommittee of the ECRHS was formulated on 24th March 2009 with Dr. Urmila Thatte as Head of the SAE Subcommittee and Dr. Raakhi Tripathi as Executive Secretary
2012: The IEC received international re-recognition from Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)
2013: Keeping with recommendations of the SIDCER surveyors, the ECRHS and CARE were dissolved on 31st December 2012 by the Dean Dr. Sandhya Kamath and two new boards were constituted with same SOPs Institutional Review Board–I and II (IRB-I and IRB-II) from 1 st January 2013. The SAE Subcommittee was also reconstituted from 1st January 2013.
2013: As per GSR 53-E dated 30 Jan 2013, following registration with Drugs Controller General (India) [DCGI], the IEC–I was registered with DCGI with registration no. ECR/229/Inst./MH/2013 on 22nd April 2013 and IEC-II was registered with DCGI with registration no. ECR/417/lnst./MH/2013 on 6th August 2013.
2016: The IEC received international re-recognition from Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)
2018: IEC-I & II accredited by NABH (National Accreditation Board for Hospitals & Healthcare Providers (Constituent Board of Quality Council of India) and IEC-I received Certificate no.: EC-CT-2018-0027 and IEC-II Certificate no.: EC-CT-2018-0057.
2019: As per GSR 227-E (NDCTR-2019): Three separate committees formulated with the SAE Subcommittee in March 2019.
2019: The IEC-I and IEC-II have been re-registered with CDSCO on 15th Oct 2019 also the IEC-I, IEC-II and IEC-III have been registered with Dept. of Health Research (DHR) provisionally on 12th Oct 2019.
2020: The IEC-I underwent re-accreditation audit by NABH on 4 th & 5th Feb 2020 and received Certificate no.: ECCT-2018-0027, May 19, 2018 to May 18, 2021
2021: The IEC-I underwent re-accreditation audit by NABH on 18th May 2021 and received Certificate no.: EC-CT2018-0027, May 19, 2021 to May 19, 2024
2021: The IEC-I, IEC-II and IEC-III sought approval from Dept. of Health Research (DHR) having validity for five years from 22nd Oct 2021 to 21st Oct 2026.
2022: The IEC-I, IEC-II and IEC-III have started their functioning for which the members have been appointed by the Dean, Seth GSMC and KEMH (as per NDCT Rule 2019) for the tenure of 16th October 2022 to 16th Oct 2025
2023: The IEC-I underwent re-accreditation audit by NABH and received Certificate no.: EC-CT-2018-0027 which was valid from May 19, 2019 to May 19, 2024
2024: The IEC-I received re-registration approval from CDSCO having registration number ECR/229/Inst./MH/2013/RR-2024 valid from 22nd April 2024 to 21st April 2029.