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 IEC- Forms

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-19
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- Dec 11, 2017 - Dec 10, 2020

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, 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 fourth Wednesday of every month at 8.30 a.m. (unless otherwise notified)

IEC- II second Wednesday of every month at 8.30 a.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. 20,000/- + applicable GST
Protocol amendment (major) for ongoing study - Rs. 5,000/- + 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 )

Tata Memorial Centre- Institutional Ethics Committee-I have been reconstituted from
1st July 2019 – 31st March 2020

Sr. No.	Name	Position	Affiliation	Affiliation Status	Gender	Expertise
1.	Dr. S.K. Shrivastava	Chairperson	Director, Radiation Oncology, Apollo Hospital	Non Affiliated	Male	Radiation Oncologist
2.	Dr. Nithya Gogtay	Co- Chairperson	Professor, Dept of Clinical Pharmacology, KEM Hospital	Non Affiliated	Female	Basic Medical Scientist (Clinical Pharmacologist)
3.	Dr. Umesh Mahantshetty	Member Secretary	Professor, Dept. of Radiation Oncology,TMH	Affiliated	Male	Radiation Oncologist
4.	Mr. KV Ganpathy	Member	CEO, Jeet Association for Support to Cancer Patients (JASCAP)	Non Affiliated	Male	Lay Person
5.	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
6.	Ms. Tanu Mehta	Member	Legal Counsel and Mediator, High Court, Mumbai	Non Affiliated	Female	Legal expert
7.	Dr. Sangeeta Mudaliar	Member	Full Time Consultant & Head of the Department, Dept. of Paediatric Hemato-Oncology B. J. Wadia Hospital	Non Affiliated	Female	Medical Oncologist (Pediatrician)
8.	Dr. Bharatsinha Bhosale	Member	Senior consultant Oncologist, Bombay Hospital Medical and Research Institute Visiting Consultant Oncologist Jaslok Hospital Medical & Research Institute, SL Raheja Fortis group of Hospital	Non Affiliated	Male	Medical Oncologist
9.	Dr. Gouri Pantvaidya	Member & Secretary, Data Safety Monitoring Unit (DSMU)	Professor, Dept. of Surgical Oncology,TMH	Affiliated	Female	Surgeon
10.	Dr. Sheila Myatra	Member	Professor, Dept. of Anesthesiology, Critical Care and Pain, TMH	Affiliated	Female	Anesthetist
11.	Dr. Sudhir Nair	Member	Associate Professor, Dept. of Surgical Oncology, Tata Memorial Centre	Affiliated	Male	Surgeon
12.	Dr. Amit Joshi	Member	Professor, Dept. of Medical Oncology, Tata Memorial Hospital	Affiliated	Male	Medical Oncologist
13.	Dr. Santosh Menon	Member	Professor, Dept. of Pathology,TMH	Affiliated	Male	Basic Medical Scientist (Pathologist)
14.	Dr. Sneha Shah	Member	Professor, Nuclear Medicine, Bio-imaging Unit, TMH	Affiliated	Female	Nuclear Medicine Physician

The IEC-I will meet on last Wednesday of every month at 8.30 a.m. (unless otherwise notified) in the IRB Meeting Room, 3rd Floor, Main Bldg., TMH. The Member Secretary of IECs and DSMSC will be Members of TRAC.

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IEC- II

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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
1st July 2019 to 31st March 2020

Sr. No.	Name	Position	Affiliation	Affiliation Status	Gender	Expertise
1.	Dr. Sudeep Shah	Chairperson	Consultant in Gastroenterology surgery, Hinduja Hospital	Non Affiliated	Male	Surgeon
2.	Dr. Arun Bhatt	Co-Chairperson	Consultant – Clinical Research and Development	Non Affiliated	Male	Clinician
3.	Dr.Girish Chinnaswamy	Member Secretary	Professor, Dept. of Medical Oncology, TMH	Affiliated	Male	Medical Oncologist(Paediatrician)
4.	Dr. Yashashri Shetty	Member	Associate Professor, Department of Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital	Non Affiliated	Female	Clinical Pharmacologist
5.	Mrs. Manisha Naikdalal	Member	Member of Ethics Committees at Hinduja Hospital (IEC-1),IITB,Global Hospital, Nair Hospital and IIT-B Alternate Member (Layperson) with ISBEC(InterSystems Biomedica Ethics Committee) and KEM Hospital	Non Affiliated	Female	Lay Person
6.	Dr. Bindulakshmi P	Member	Associate Professor, Advanced Centre for Women’s Studies, School of Development Studies, Tata Institute of Social Sciences	Non Affiliated	Female	Social scientist
7.	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
8.	Dr. Neelam Shirsat	Member	Scientific Officer, ACTREC	Affiliated	Female	Basic Scientist
9.	Dr. Ashwini Budrukkar	Member	Professor, Dept. of Radiation Oncology, TMH	Affiliated	Female	Radiation Oncologist
10.	Dr.Priya Ranganathan	Member & Jt.Secretary Data Safety Monitoring Unit (DSMU)	Professor, Dept. of Anaesthesia, Tata Memorial Hospital	Affiliated	Female	Anesthetist
11.	Dr. Nita Nair	Member	Associate Professor, Dept. of Surgery, TMH	Affiliated	Female	Surgeon
12.	Dr. Nilesh Lokeshwar (1st June 2019 - 31st March 2020)	Member	Consultant, Asian Cancer Institute, Sion (E), Mumbai	Non Affiliated	Male	Medical Oncologist
13.	Dr. Sewanti Limaye (1st June 2019 - 31st March 2020)	Member	Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai	Non Affiliated	Female	Medical Oncologist
14.	Dr. Mukta Ramadwar	Member	Professor, Dept. of Pathology, TMH	Affiliated	Female	Basic Medical Scientist (Pathologist)
15.	Dr. Nilendu Purandare	Member	Professor, Dept. of Nuclear Medicine	Affiliated	Male	Radiologist

The IEC-II will meet on Second Wednesdays of every month at 8.30 a.m. (unless otherwise notified) in the IEC Meeting Room, 3rd Floor, Main Bldg., TMH. The Member Secretary of IECs and DSMU will be Members of TRAC.

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IEC- III

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Institutional Ethics Committee- III

Tata Memorial Centre- Institutional Ethics Committee-III have been reconstituted from
1st April 2018 – 31st March 2020

Sr. No.	Name	Position	Affiliation	Gender	Expertise
1.	Dr. Rita Mulherkar	Chairperson	Former Scientist, Genetic Engineering Unit, ACTREC	Female	Basic Scientist
2.	Dr. Rabindranath Mukhopadhya	Co- Chairperson	Former Scientist, Virology Lab, ACTREC	Male	Basic Scientist
3.	Dr Prafulla Parikh	Member Secretary	Assistant Professor, Dept. of General Medicine , ACTREC, TMC	Female	Clinician (Physician)
4.	Dr. Padmaja Marathe	Member	Prof. (Additional), Dept of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai	Female	Clinical Pharmacologist (Basic Medical Scientist)
5.	Mrs. Deepa Ramani	Member	Ex-play group teacher, store and purchase in-charge, Kharghar	Female	Layperson
6.	Mrs. Lakshmi. R.	Member	Co-ordinator, Sanjeevani life beyond cancer Trust, Mumbai.	Female	NGO Representative
7.	Dr. B.B. Singh	Member	Advocate, Mumbai High Court	Male	Legal Expert
8.	Dr. Tanuja Teni	Member	Principal Investigator, ACTREC, TMC	Female	Basic Scientist
9.	Dr. Supriya Chopra	Member	Professor, Dept. of Radiation Oncology, ACTREC, TMC	Female	Clinician (Radiation Oncology)
10.	Dr. Reshma Ambulkar	Member and Secretary Data Safety Monitoring Unit (DSMU)	Professor, Dept. of Anaesthesia, Critical Care and Pain, ACTREC, TMC.	Female	Clinician (Intensivist)
11.	Dr. Amita Maheshwari	Member	Professor, Dept. of Surgery,Tata Memorial Hospital, TMC.	Female	Clinician (Surgical oncology)
12.	Dr. Gaurav Narula	Member	Professor, Dept. of Medical Oncology (Pediatric), Tata Memorial Hospital, TMC.	Male	Clinician (Medical Oncology)
13.	Dr. Shilpee Dutt	Member	Principal Investigator, ACTREC, TMC	Female	Basic Scientist
14.	Dr. Bhausaheb Bagal	Member	Associate Professor, Dept. of Medical Oncology, Tata Memorial Hospital, TMC	Male	Clinician (Medical Oncology)
15.	Dr. P.G. Subramanian	Member	Professor, Dept. of Hematopathology, ACTREC, TMC	Male	Clinician (Pathology, Basic Medical Scientist)

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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IEC- FORMS

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Institutional Ethics Committee - Forms wef 03 October 2018

Sr. No.	Forms
1.	Application form for requesting waiver of consent
2.	Assent for prospective audit study
3.	Child Information Sheet and Assent Form
4.	Consent for prospective audit study and Participant Consent
5.	Consent for prospective audit study_Parent_LAR
6.	Continuing review application
7.	Dealing with patients requests complaints form
8.	Deviation (D) Violation (V) Form
9.	Document Checklist
10.	Document Request Form
11.	Expedited Review Application Form
12.	Guidelines for devising Participant Information Sheet and ICF and Sample format of an Informed Consent Document
13.	IEC form for re-review of research proposals
14.	Informed Consent Template for Audio-Visual Recording
15.	Off site Safety Reports Classification Form_Report Log
16.	Parent Information sheet and ICF
17.	Post approval Amendment Reporting Form
18.	Premature Termination Suspension Discontinuation Report
19.	Project Submission Form
20.	Request for Formulation of new SOP or Revision of SOP
21.	Review Exemption Application Form.docx
22.	Serious Adverse Event Reporting Form (SAE Form)
23.	Study Completion Report
24.	Study Monitoring Form

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