Institutional Ethics Committee

Institutional Ethics Committee – I (IEC-I)

Registered by : DCGI & Licensing Authority with Re-Registration

No.ECR/229/Inst/MH/2013/RR-19 issued under

NewDrugs and Clinical Trials Rules, 2019 and

the Drugs and Cosmetics Act, 1940.

Valid from April 22, 2019 thru April 21, 2024

Recognized by : The Strategic Initiative for Developing Capacity in

Ethical Review (SIDCER),Forum for Ethical committees in Asia and

the Western Pacific Region (FERCAP) for its compliance with

international and local standards in ethical review.

Accredited by : National Accreditation Board for Hospitals (NABH) &

Healthcare Providers (Constituent Board of Quality Council of

India).

Valid from May 19, 2021 thru May 18, 2024 Certificate No. EC-

CT- 2018-0027

Institutional Ethics Committee – II (Relating to Biomedical Health Research)

Registered By: Biomedical and Health Research (NECRBHR),

Department of Health Research (DHR).

Recognized by: The Strategic Initiative for Developing Capacity in Ethical

Review (SIDCER), Forum for Ethical committees in Asia and

the Western Pacific Region (FERCAP) for its compliance with

international and local standards in ethical review.

Institutional Ethics Committee – III (Relating to Biomedical Health Research.)

Registered By: Biomedical and Health Research (NECRBHR),

Department of Health Research (DHR).

Dr. G. B. Parulekar Dean, Seth G. S. Medical College and K. E. M. Hospital, Mumbai constituted the Ethics Committee in 1987. Dr. S. M. Karandikar was the first Chairperson and Dr. S. A. Dahanukar was the first Member Secretary of this committee. The committee was reformulated in 1999 with the chairperson from outside the institution. In 2002 it was renamed as Ethics Committee for Research on Human Subjects (ECRHS). In November 2008, the Director ME & MH, Dr. Sanjay Oak constituted and launched an additional committee, Committee for Academic Research Ethics (CARE) to oversee ethical review of thesis and investigator initiated projects. The first meeting of CARE was held on 3rd December 2008.

The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) conducted a survey visit in February 2009. In keeping with recommendations of the SIDCER surveyors, on 24th March 2009 a new SAE Subcommittee of the ECRHS was formulated with Dr. Urmila Thatte as Head of the SAE Subcommittee and Dr. Raakhi Tripathi as Executive Secretary. The first meeting of the SAE Subcommittee was held on 21st April 2009.

The Committees underwent a survey by the SIDCER and FERCAP on September 2012 for confirmation of recognition and both committees received the SIDCER rerecognition award for compliance to international standards in November 2012.

In keeping with recommendations of the SIDCER surveyors, the ECRHS and CARE were dissolved on 31st December 2012 by the Institutional head Dr. Sandhya Kamath and two new boards were constituted Institutional Review Board–I and II (IRB-I and IRB-II) from 1st January 2013. The SAE Subcommittee was also reconstituted from 1st January 2013.

Following registration with Drugs Controller General (India) [DCGI], the Institutional Review Boards (IRBs) I & II are renamed as Institutional Ethics Committee (IEC) I & II. 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.

IEC-I & IEC-II presently function according to the requirements laid down in Schedule Y and are guided by the ICH GCP guidelines, Ethical Principles set forth in the Declaration of Helsinki and the Ethical Guidelines for Biomedical Research on Human Participants laid down by the Indian Council of Medical Research.

2020|2019|2018 |2017 | 2016| 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 |

2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001

6.IEC Protocol review processing fees

7. SOPs-V_6.1-Index

7. Standard operating procedures (SOP 1 to 22) V6.1 dated 29th June 2020.

8. Standard operating procedure 23 Emergency or compassionate use of drugs version V1.0 dated 14 th May 2021

9. SOP 24 Version 1 (Review of Case Report and Case Series)

10.SOP 25 Version 1 Audio Visual (AV) Recording of Informed Consent Process

11.Standard operating procedure Addendum 1 dated 21 May 2021 effective from 15th July 2021 to SOP2,5.11-B,12 & 17 version 6.1

12. Member list

12.Notice – CDSCO Dated 25-02-2021 for SAE reporting

13.Circular dated 21st March 2023 regarding protocol submission

14.Important circular for Investigators regarding Submissions

15.Revised SOP coming soon....

Sr.No.	Guidelines
1.	CDSCO-Guidance For Industry
2.	DCGI registration approval of IEC-II
3.	Declaration_Helsinki 1964
	Declaration-of-helsinki
	Declation of Helsinki October 2013
4.	Draft guidelines multicentre common review (2)
5.	Draft Guidelines on AV recording of ICD process in clinical trial 06-012014,09.01.2014
6.	E6_R1_Guideline
7.	GUIDELINES FOR INTERNATIONAL COLLABORATION
8.	ICH GCP E6_R1_Guideline …. 10th June 1996
9.	ICH GCP
10.	ICMR 2006
11.	ICMR 2018 National ethical guidelines on biomedical and health research
12.	ICMR DBT Guidelines
13.	ICMR_ethical guidelines 2000
14.	ICMR_Ethical_Guidelines_2017
15.	Indian Good Clinical Practices
16.	NFI_2011 (1)
17.	Regulations_Dr.Bangaruranjan Well drfine Drug ministry
18.	Salient features of CT Rules _27-3-2019
19.	whozip13e gcp FOR Pharmaceutical trial
20.	ICMR Guidelines for Ethics Committee review during Pandemic COVID-19
21.	FDA guidance doc Clinical Trial Conduct during COVID-19 March 2020
22.	Revised National Clinical Management Guideline for COVID19 31-03-2020
23.	SAE User Manual (Online & Offline)

Sr.No.	Gazttes Circular & Order
1.	Medical Device Rule gsr78E English version
2.	Image of MDR Pg. 159
3.	224 (E)
4.	237(E) Special Order
5.	289 (E)
6.	918 (E)PHYTOPHARMACEUTICAL DRUG IN THE COUNTRY
7.	2019-03-19- MoH GSR 227 – New drugs and clinical trial approval regulations 2019
8.	Academic trials Order
9.	CDSCO compensation formula for non death SAE
10.	Circular dated 10-11-2015 Requirement of permission for conductd (1)
11.	Circular for Restricion removal of conducting three clinical trial for PI
12.	Circular- Requirement of 50 bedded
13.	Compensation formula for SAEs_2013
14.	DCGI Order dated 2013-11-19 on AV recording of Informed Consent
15.	Draft CT Rules sent for Publication
16.	G.S.R (E) 889 dated 12 Dec 2014 SAE timeline
17.	G.S.R 72(E) dated 08.02.2013
18.	G.S.R 292(E) dated 24th April 2014 (1 Draft Rules on compensation)
19.	G.S.R 821(E) 08-112011 (Draft Rules)compensation_during_clinicaltrial
20.	GSR 63(E) dated 01 .02.2013
21.	GSR 287 (E)
22.	GSR 313 (E) dated 16_03_2016
23.	GSR 364(E) 7th June 2013
24.	GSR 611(E) 31 July 15 Audio for vulnerable pop
25.	GSR 640 (E)
26.	GSR 918(E)-dated-30-11-2015
27.	GSR-826-E-30-October-2015 NCE
28.	Notification GSR NO 53 (E) Dated 30-01-2013
29.	Schedule Y(ammended version) – CDSCO Compensation
30.	Schedule_Y
31.	System of Pre-screening for submission of reports of SAEs to CDSCO
32.	The drugs and cosmetics bill no. LVIII of 2013

IEC-I

IEC-II

IEC-III

Member Secretary

Dr. Raakhi Tripathi

Associate Professor Pharmacology & Therapeutics

Intercom no. 7444,7482

Mobile no. 9821724700

Dr. Priyanka Prasad

Associate Professor

Microbiology

Intercom no. 7552

Mobile no. 9930923115

Dr. Swapna Kanade

Associate Professor

Microbiology

Intercom no. 7827

Mobile no. 9004377725

Jt. Member Secretary

Dr. Nithya Gogtay

Prof. and Head,

Clinical Pharmacology

Intercom no. 7715

Mobile no. 9820495836

Dr. Mona Agnihotri

Associate Professor (Additional)

Pathology

Intercom no. 7566, 7555

Mobile no. 9987810111

Dr. Shirish Joshi

Professor (Additional)

Pharmacology & Therapeutics

Intercom no. 7444

Mobile no. 9820338456

Office Address:

Institutional Ethics Committee (IEC) I, II & III

Dr Sangeeta Ravat- Dean

New UG-PG Hostel, 20 Storey Hostel Building, Ground Floor,Seth G.S. Medical College & K.E.M. Hospital, Parel, Mumbai 400 012.

Telephone no: 2412 2188, 24107515

Intercom no. 7515

E-mail: iec-1@kem.edu
E-mail: iec-2@kem.edu
E-mail: iec-3@kem.edu

The IEC Office timing for correspondence and communication is as follows: The office hours for submission of documents, enquiries and telephonic communication with the IEC staff are as follows:

Monday to Friday – 1.30 p.m. to 4.30 p.m.

Saturday – 10.30 a.m. to 12.30 p.m.

The office will remain closed on Sundays and all the public holidays.
The IEC office remains closed for the last working day of every month for monthly data update of IECs.
You are requested to follow the office timings strictly for submission and telephonic enquiries and kindly cooperate with the IEC staff.

News and Updates:

Notice:This is regarding the IECs approval of dissertations topics of MD (Pediatrics) postgraduate students of Seth GSMC & KEMH. Kindly note it has come to IECs notice that dissertations from BJJWHC are being directly sent to IEC without them being forwarded by HOD (Pediatrics) Seth GSMC.
Institutional Ethics Committee Circular