Institutional Ethics Committees

HRPP Manual at TMC Recognitions IRB Staff Mandate Terms of Reference Responsibility institution Meeting Schedule Composition IEC-I IEC- II IEC- III FAQs-ver1.0 SOPs

The IEC is established to formalize and specify Institution's commitment to the promotion of high scientific and ethical standards in patient care, professional education, clinical research, and community interests.

Timely review and the safeguarding of high ethical standards formed the basis of the IRB review process. These are essential for clinical research including student research, investigator initiated research, extramural, intramural funded research and multi-centric multinational research.

Institutional Review Boards (IRBs) became functional in February 2012. TMC-ACTREC Institutional Ethics Committee (IEC III) was established in December 2009.

As per DCGI registration dated May 2013, Institutional Review Boards (IRBs) are renamed as Institutional Ethics Committees (IEC-I,II,III). Institutional Ethics Committees function with the same purpose and SOPs.

The Institutional Ethics Committees (IECs) are constituted by the Director, Tata Memorial Centre (TMC) under authority vested by the Governing Council of the TMC.

The Data Safety Monitoring Subcommittee (DSMSC) is a subcommittee of the IEC, and is essentially responsible for monitoring patient safety and assessing data during the course of the study in a manner that contributes to the scientific and ethical integrity of the study.

DCGI Registration under Rule 122DD of the Drugs & Cosmetic Rules 1945.

IEC-I : ECR/170/Inst/MH/2013/RR-22
IEC-II : ECR/414/Inst/MH/2013/RR-19
IEC-III: ECR/149/Inst/MH/2013/RR-16

IEC has a Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS) through the Office for Human Research Protections (OHRP). The assurance number is FWA00006143. This is periodically renewed as required. IEC is also registered with HHS and has IORG Nos. IRB00003414 & IRB00007802 for IEC-I & IEC-II respectively. This is periodically renewed as required.

Recognitions / Award

WHO/The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)

WHO/The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in collaboration with the Forum for Ethical Review Committees in Asia and the Western Pacific Region Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) has awarded recognition to the Tata Memorial Centre Human Ethics Committee (TMC-HEC) in November 2009. The recognition of IRB was renewed in Nov 2012.

Human Research Protection Program (HRPP)

Tata Memorial Centre has been awarded accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in June 2014.

Award

National Accreditation Board for Hospitals and Healthcare Providers (NABH) Validity- December 11, 2020 to December 10, 2023

WHO/The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in collaboration with the Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)

TMC–IEC-I/II: 2009-2012, 2012-2016, 2016-2019.
TMC–IEC-III: 2016-2019
Association for the Accreditation of Human Research Protection Programs (AAHRPP)

2014-2017, 2017-2022

Contact IRB staff

IRB Administrators

Mrs. Abhidnya V. Desai
Mrs. Uthara H. Iyer

Software Programmer

Mr. Sandeep Kalsekar

Clerical Staff :

Mr. Ramchandra Patil, Sr. Asstt.
Mrs. Megha Chalke, Sr. Private Secretary

Address
IRB office, Main Building
3rd Floor, Tata Memorial Hospital,
Parel, Mumbai-400012
Tel No-022-24177262 (extn-4267/68)
Email id- tmhethics@gmail.com

Mandate

The IEC through its delegated sub-committees functions independently for maintaining a consistent scientific and ethical framework for patient care and research, and for integrating ethical values into practice, policy relationships, and organizational activities.

The purpose of the IEC is to cultivate a pluralistic and democratic exchange of scientific and ethical values and concerns, and to critically analyze them while looking for opportunities to enhance the scientific and ethical integrity of Institution.

The mandate of the IEC essentially is to promote patient care through a scientific and ethical approach to research and education.

The terms of reference for the IEC are as follows

1	Ensure the highest scientific and ethical standards of research at TMC
2	Review and approve, proposals for clinical, basic or translational research projects (Intra and Extra mural) for scientific and ethical content
3	Improve ethical standards and issue guidelines on ethical dilemmas related to patient care services
4	To function as a forum to advise the administration in case of any ethical issues that may arise from patients, families or public
5	To maintain our leadership as a national standard of reference in all fields
6	To issue and periodically, update and revise SOP s and guidelines for effective functioning of IEC as and when necessary
7	Continuing education in clinical research bioethics and ethical aspects of clinical practice by seminars, workshops and interactive discussions for all categories of staff members including nursing and paramedical staff
8	To initiate and commission research studies on ethical aspects of practice in TMC
	The IEC endeavors to provide guidance on a broad range of topics such as disclosures of diagnosis, diagnosis of brain death, indications for stopping resuscitation, true informed consent, etc
	The committee does not address or interfere in matters of administration, nor does the committee function as a grievance cell for staff members.

Meeting Schedule

IEC- I second Tuesday of every month at 9:00 a.m. (unless otherwise notified)

IEC- II last Thursdays of every month at 2.00 p.m. (unless otherwise notified)

The IEC-III meets on Third Friday of every month at 9.30 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC

IEC processing fees (applicable for all pharmaceutical sponsored studies)

Initial project submission - Rs. 40,000/- + applicable GST
Protocol amendment /revision for ongoing studies - Rs. 10,000/- + applicable GST

The fees will be accepted as cheque/demand draft drawn in favour of “Tata Memorial Centre".

Composition

Each IEC will be multidisciplinary and multi-sectorial in composition. Each IEC is composed of a minimum of 7, and maximum of 15 members. The members are selected so as to have an equitable representation of all specialties in TMC. It includes scientific and non-scientific members, clinicians and non - clinicians, a clinical pharmacologist, members of the community, a lawyer-expert in ethics, a social worker / layperson / patient representative to represent different points of view.

Each committee will comprise of a Chairperson, Co-Chairperson, a Member Secretary, and 4-12 other active members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community interests.

The committee should have adequate representation of age, gender, community, etc. to safeguard the interests and welfare of all sections of the community / society. Members are expected to be aware of local, social and cultural norms, as this is the most important social control mechanism.

The members should have various backgrounds to promote complete and adequate review of research activities commonly conducted by TMC.

Composition of IEC

Institutional Ethics Committee- I ( Please click here for PDF )

IEC-I Re-registration - I ( Please click here for PDF )

Tata Memorial Centre- Institutional Ethics Committee-I have been reconstituted
from 1st April 2022 to 31st March 2024

Sr. No.	Name	Position	Affiliation	Affiliation Status	Gender	Expertise
1.	Dr. Nithya Gogtay	Chairperson	Professor & Head Department of Clinical Pharmacology, KEM Hospital	Non Affiliated	Female	Basic Medical Scientist (Clinical Pharmacologist)
2.	Dr. Sangeeta Mudaliar	Co-Chairperson	Full Time Consultant & Head of The Department, Paediatric Hemato-Oncology B J Wadia Hospital	Non Affiliated	Female	Medical Oncologist (Pediatrician)
3.	Dr. Rajiv Sarin	Member Secretary	Professor, Radiation Oncology & PI & OIC, Cancer Genetics Unit, Tata Memorial Hospital	Affiliated	Male	Clinician (Radiation Oncologist)
4.	Mr. KV Ganpathy	Member	CEO, Jeet Association for Support to Cancer Patients (JASCAP)	Non Affiliated	Male	Lay Person
5.	Mrs. Nivedita Sinha	Member	Freelance patient volunteer	Non Affiliated	Female	Lay Person
6.	Dr. Mrunal Marathe	Member	Freelance Counselor and Trainer associated with NGO-St.Jude’s- Childcare Centre and Adoption Group, Asha Sadan Orphanage	Non Affiliated	Female	Social scientist
7.	Dr. Astrid Lobo-Gajiwala	Member	Director & CEO Novo Tissue Bank and Research Centre Pvt. Ltd.CSM Road, Vakola, Santa Cruz	Non Affiliated	Female	Social scientist
8.	Mr. N. D. Jay want	Member	Advocate, High court, Mumbai	Non Affiliated	Male	Legal expert
9.	Mr. Rajiv Talashikar	Member	Advocate & Legal Consultant Rajeev & Associates, Mumbai	Non Affiliated	Male	Legal expert
10..	Dr. Sachin Satpute	Member	Asst. Professor, Dept. of Pharmacology, Topiwala National Medical College & BYL Nair Ch. Hospital	Non Affiliated	Male	Basic Medical Scientist (Clinical Pharmacologist)
11.	Dr. Uma Dangi	Member	Senior Consultant, Dept of Medical Oncology, Fortis Hospital, Mulund	Non Affiliated	Female	Clinician (Medical Oncologist)
12.	Dr. Seema Gulia	Member	Professor, Dept of Medical Oncology, Tata Memorial Hospital	Affiliated	Female	Clinician (Medical Oncologist)
13.	Dr. Swapnil Parab	Member & Secretary, Data Safety Monitoring Unit	Professor, Dept of Anaesthesiology, Tata Memorial Hospital	Affiliated	Male	Clinician (Anesthesiologist)
14.	Dr. Prakash Nayak	Member	Associate Professor, Dept. of Surgical Oncology, Tata Memorial Centre	Affiliated	Male	Clinician (Surgeon)
15.	Dr. Rahul Krishnatry	Member	Associate Professor, Radiation Oncology ,Tata Memorial Hospital	Affiliated	Male	Clinician (Radiation Oncologist)

The IEC-I will meet on the second Tuesday of every month at 9:00 a.m. (unless otherwise notified) in the IRB Meeting Room, 3rd Floor, Main Bldg., TMH. The Member Secretaries of the IECs and DSMU will be Members of TRAC.

IEC- II

Institutional Ethics Committee- II ( Please click here for PDF )

IEC - II-Re-registration ( Please click here for PDF )

Tata Memorial Centre- Institutional Ethics Committee-II have been reconstituted
from 15^th June, 2022 to 31st March, 2024

Sr. No.	Name	Position	Affiliation	Affiliation Status	Gender	Expertise
1.	Dr. Shyam Kishore Shrivastava	Chairperson	Director, Radiation Oncology, HCG-ICS-Khubchandani Cancer Centre	Non Affiliated	Male	Radiation Oncologist
2.	Dr. Padmaja Marathe	Co-Chairperson	Prof. (Additional) Dept of Pharmacology and Therapeutics, Seth G S Medical College and KEM Hospital, Mumbai	Non Affiliated	Female	Basic Medical Scientist (Clinical Pharmacologist)
3.	Dr. Sarbani Ghosh-Laskar	Member Secretary	Professor, Radiation Oncologist Tata Memorial Hospital	Affiliated	Female	Clinician (Radiation Oncologist)
4.	Dr. Shyamal R. Sinha	Member	Associate Professor, Dept. of Pharmacology, Grant Govt. Medical College, Mumbai.	Non Affiliated	Male	Basic Medical Scientist (Clinical Pharmacologist)
5.	Mrs. Mainsha Naikdalal	Member	Member of Ethics Committees at Hinduja Hospital (IEC-1), Nair Hospital, IITB Global Hospital, ISBEC, Altemate Member, (Layperson) at KEM Hospital and Lilavati Hospital	Non Affiliated	Female	Lay Person
6.	Dr. Anand Parihar	Member	Managing Trustee, Madat Charitable Trust, 48 Swastik Park, Chembur, Mumbai 400071	Non Affiliated	Male	Lay Person
7.	Dr. Archana Diwate	Member	Assistant Professor, Centre for Health and Mental Health, School of Social Work, Tata Institute of Social Sciences, Mumbai	Non Affiliated	Female	Social Scientist
8.	Dr. Srilatha Juvva	Member	Professor, School of Social Work, Tata Institute of Social Sciences, Mumbai	Non Affiliated	Female	Social scientist
9.	Mr. Agnel Cameiro	Member	Advocate Associate, Mulla & Mulla & Craigie Blunt & Caroe, Mulla House, 51 Mahatma Gandhi Road, Fort, Mumbai 400 001.	Non Affiliated	Male	Legal expert
10.	Mr.Shyam B. Iyer	Member	Associate, Solomon & Co., Advocates & Solicitors, 3rd floor, Calcot House, M.P. Shetty Marg (Tamarind Street),Fort, Mumbai -400 023, Maharashtra, India	Non-Affiliated	Male	Legal expert
11.	Dr.Nilesh Lokeshwar	Member	Consultant, Asian Cancer Institute, Sion (E), Mumbai	Non-Affiliated	Male	Clinician(Medical Oncologist)
12.	Dr.Sabita Jiwnani	Member	Professor, Dept. of Surgical Oncology, Tata Memorial Hospital	Affiliated	Female	Clinician (Surgeon)
13.	Dr.Anant Ramaswamy	Member	Professor, Dept.of Medical Oncology, Tata Memorial Hospital	Affiliated	Male	Clinician (Medical Oncologist)
14.	Dr.Lavanya G	Member	Associate Professor, Radiation Oncology, Tata Memorial Hospital	Affiliated	Female	Clinician (Radiation Oncologist)
15.	Dr.Richa Vaish	Member	Associate Professor, Tata Memorial Hospital, Mumbai	Affiliated	Female	Clinician (Surgeon)

The IEC-II will meet on the last Thursdays of every month at 2.00 p.m. (unless otherwise notified) in the IEC Meeting Room, 3rd Floor, Main Bldg., TMH. The Member Secretaries of the IECs and DSMU will be Members of TRAC.

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IEC- III

Institutional Ethics Committee- III ( Please click here for PDF )

Tata Memorial Centre- Institutional Ethics Committee-III have been reconstituted from
01st April 2022 for 2 years.

Sr. No.	Name	Position	Affiliation	Affiliation Status	Gender	Expertise
1.	Dr. Surekha Zingde	Chairperson	Trustee, Indian Women Scientists' Association (IWSA), Former Deputy Director, CRI, Scientific Officer ‘H’	Non Affiliated	Female	Basic Scientist
2.	Dr Shona Nag	Member	Director, Oncology, Sahyadri Super Speciality Hospitals, Hadapsar, Survey No. 163, Bhosale Nagar, Pune, 400 028, Maharashtra	Non Affiliated	Female	Clinician (Medical oncology)
3.	Dr. Pravesh Golay	Member	Associate Professor, Department of Humanities and Social Sciences, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, India	Non Affiliated	Male	Philosopher
4.	Dr Sudhir Nair	Member Secretary	Prof. Head and Neck Surgical Oncology, ACTREC., TMC	Affiliated	Male	Clinician (Surgical oncology)
5.	Dr. Sangita Sukumaran	Member	Prof and Head, Department of Pharmacology, Terna Medical College Navi Mumbai, 400706	Non Affiliated	Female	Clinical Pharmacologist (Basic Medical Scientist)
6.	Mrs. Deepa Ramani	Member	Zenith Spinners Ltd. Ex-play group teacher, store and purchase in-charge, Zenith Spinners Ltd., Member of IC-SCR, ACTREC	Non Affiliated	Female	Layperson
7.	Mr Akil Hirani	Member	Head of the Transactions Practice and Managing Partner Majmudar & Partners, International Lawyers, India	Non Affiliated	Male	Legal Expert
8.	Dr. Girish Maru,	Member	Former Principal Investigator and Scientific Officer ‘H’, CRI.	Non Affiliated	Male	Basic Scientist
9.	Dr. Syed Hasan	Member	Principal Investigator and Scientific Officer ‘E’ ACTREC, TMC	Affiliated	Male	Basic Scientist
10.	Dr Naveen Mummadi	Member	Asst. Professor, Dept. of Radiation Oncology, ACTREC, TMC	Affiliated	Male	Clinician (Radiation Oncology)
11.	Dr. Sachin Punatar	Member and DSMU Secretary	Prof. Medical Oncology, E (Adult Hematolymphoid) ACTREC, TMC	Affiliated	Male	Clinician (Medical Oncology)
12.	Dr. Shalaka Joshi	Member	Associate Professor, Dept. of Surgery, Tata Memorial Hospital, TMC.	Affiliated	Female	Clinician (Surgical oncology)
13.	Dr. Prashant Tembhare	Member	Clinician Scientist and Prof in Hematopathology Laboratory (SO F) ACTREC, TMC	Affiliated	Male	Basic Medical Scientist (Hemato Pathology)
14.	Dr. Nitin S Shetty	Member	Prof. Interventional Radiology Tata Memorial Hospital, TMC	Affiliated	Male	Clinician (Interventional Radiology)

The IEC-III will meet on third Friday of every month at 10.00 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai. The Member Secretary of IEC -III will be Member of TRAC..

Link for TMC-IEC III (ACTREC IEC)

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