KING EDWARD MEMORIAL HOSPITAL

Seth Gordhandas Sunderdas Medical College

Acharya Donde Marg, Parel,
Mumbai 400 012. India.
Tel.: 91-22-2410 7000 Fax: 91-22-2414 3435

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).

Annual Reports

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

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

1.Addendum 1

2. Addendum 2

3.Addendum 3

4.IEC Protocol review processing fees

5. SOPs-V_6.1-Index

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

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

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

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

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

11. 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….

Annexures
A. Annexures for initial submission
B. Vulnerable Group Annexures
C. Other Annexures
D. SAE Annexures

Important Links Guidelines

Click here to view complete table

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

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

Notices :

For Investigators:

1. Sample format Cover Letter for thesis dissertations & investigator initiated Other Academic (OA) studies

2. Sample format Cover Letter for Pharmaceutical & GOVT sponsored Funded studies

3. For online GCP training certification follow website link : gcp.nihtraining.com

4.Sample format of Memorandum of Understanding(MOU)

5.Circular : who should be the Principal investigator

6.Revised sample format of DRB Approval letter Dated 21st March 2023

7.Revised Departmental Review Board Guidance Document dated 21st March 2023

8.Investigator Undertaking format