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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

TMCThe 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.

Tata Memorial Centre- IECs are registered with Drug Controller General India.
IEC-I Registration No. ECR/170/Inst/MH/2013 issued under Rule 122DD of the Drugs & Cosmetic Rules 1945 
IEC-II Registration No. ECR/414/Inst/MH/2013 issued under Rule 122DD of the Drugs & Cosmetic Rules 1945.
IEC-III Registration No. ECR/149/Inst/MH/2013 issued under Rule 122DD of the Drugs & Cosmetic Rules 1945

.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.



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.
 
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.
 
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
1.
Dr. Tapan Saikia,
Chairperson
Head of Medical Oncology & Research Director, Prince Aly Khan Hospital, Mazagaon, Mumbai
Male
Medical
Oncologist
2.
Dr. Nithya Gogtay,
Co- Chairperson
Professor, Clinical Pharmacology, KEM Hospital
Female
Clinical Pharmacologist
3.
Dr. George Karimundackal,
Member Secretary
Associate Professor, Dept. of Surgical Oncology, Tata Memorial Hospital
Male
Surgeon
4.
Mrs. Manisha Naikdalal,
Member
Member of Ethics Committees at KEM Hospital (ECRHS) & Hinduja Hospital (CREC)
Female
Lay Person
5.

Ms. Sandhya Vora
Member

Managing Trustee V Care Foundation
Female
Social scientist/ NGO representative
6.
Dr. Pradnya Talawadeker,
Member
Country Coordinator for India Association Children Pallative Care Project
Female
Medico-legal expert
7.
Dr. Sanjay Gupta,
Member
Scientific Officer, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Basic Scientist
8.
Dr. Sarbani Ghosh Laskar,
Member
Professor, Dept. of Radiation Oncology, TMH & Member-Secretary, Data Safety and Monitoring Subcommittee, Tata Memorial Hospital
Female
Radiation Oncologist
9.
Dr. J. V. Divatia
Member
Professor and Head, Department of Anaesthesia, Critical Care & Pain, Tata Memorial Hospital
Male
Anaesthetist
10.
Dr. Vani Parmar
Member
Professor, Dept. of Surgical Oncology , Tata Memorial Hospital
Female
Surgeon
11.
Dr. Umesh Mahanshetty,
Member
Professor, Dept. of Radiation Oncology, Tata Memorial Hospital
Male
Radiation Oncologist
12.
Dr. Girish Chinnaswamy,
Member
Associate  Professor, Dept. of Medical Oncology, Tata Memorial Hospital
Male
Medical Oncologist
13.
Dr. Manju Sengar,
Member
Professor, Dept. of Medical Oncology, Tata Memorial Hospital
Female
Medical Oncologist
14.
Dr. Mukta Ramadwar,
Member
Professor, Dept. of Pathology, Tata Memorial Hospital
Female
Pathologist
15.
Dr. Seema Kembhavi,
Member
Associate Professor, Dept of Radiodiagnosis, Tata Memorial Hospital
Female
Radiologist
 
IEC- II
1.
Dr.(Mrs) Urmila Thatte,
Chairperson
Professor & Head, Dept. of  Clinical Pharmacology,  KEM Hospital
Female
Clinical pharmacologist
2.
Dr. Vinay Deshmane,
Co-Chairperson
Consultant in Surgical Oncology & Breast Diseases, P.D. Hinduja National Hospital & Medical Research Centre
Male
Surgeon
3.
Dr. Siddhartha Laskar,
Member Secretary
Professor, Dept. of Radiation Oncology, Tata Memorial Hospital
Male
Radiation Oncologist
4.
Mr. P. K. Rao,
Member
Founder/ Trustee of JASCAP, Jeet Association for Support to Cancer Patients since 1996
Male
Lay person
5.
Dr. A. Lobo Gajiwala,
 Member
Head, Dept. of Tissue Bank, Tata Memorial Hospital
Female
Theologian
6.
Dr. Swati Gadgil,
Member
Anaesthesiologist & Medico-legal Consultant,  Director,Ishwar Hospitals
Female
Medico-legal Expert
7.
Dr. Renuka Munshi,
Member
Head, Dept. of Clinical Pharmacology
TN Medical College & BYL Nair Hospital
Female
Clinical Pharmacologist
8.
Dr. Rajiv Kalraiya,
Member
Scientific Officer,  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Basic Scientist
9.
Dr. Prachi Patil,
Member
Associate Professor, Dept. of Digestive Diseases and Clinical Nutrition,Jt. Secretary, Data Safety and Monitoring Subcommittee, Tata Memorial Hospital
Female
Gastroenterologist
10.
Dr. Devendra Chaukar,
Member
Professor, Dept. of Surgical Oncology, Tata Memorial Hospital
Male
Surgeont
11.
Dr. Hari Menon,
 Member
Professor, Dept of Medical Oncology, Tata Memorial Hospital
Male
Medical Oncologist
12.
Dr. Priya Ranganathan , Member Associate Professor, Dept. of Anaesthesia, Tata Memorial Hospital
Female
Anesthesiologist
13.
Dr. Kedar Deodhar,
Member
Professor, Dept. of Pathology, Tata Memorial Hospital
Male
Pathologist
14.
Dr. M H Thakur,
 Member
Professor & Head, Dept. of Radio-diagnosis, Tata Memorial Hospital
Female
Radiologist
15.
Ms. Rohini Hawaldar,
Member
Scientific Officer, Tata Memorial Hospital
Female
Statistician

The IEC-I will meet on last Friday of every month at 8.30 a.m. and IEC II will meet on second Friday of every month at 8.30 a.m. (unless otherwise notified) in the IEC Meeting Room, 3rd Floor, Main Bldg., and TMH

IEC- III
1.
Dr. R Mulherkar
Chairperson
Ex -ACTREC Scientist
Female
Basic Scientist
2.
Dr. Nobhojit Roy,
Co- Chairperson
Head, Dept of Surgery, BARC Hospital, Anushakti Nagar, Mumbai 94
Male
Surgeon
3.
Dr. Vedang Murthy,
Member Secretary
Associate Professor, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Radiation Oncologist
4.
Dr. Aliasgar Moiyadi, Member
Associate Prof, Neuro-Surgery, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) & Member Secretary DSMSC
Male
Surgeon
5.
Dr. Vikram Gota, Member
Associate Professor, Dept of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Clinical Pharmacologist
6.
Dr. Tejpal Gupta, Member
Associate Professor, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Radiation Oncologist
7.
Dr. Kumar Prabhash,  
Member
Prof. Dept of Medical Oncology, Tata Memorial Hospital
Male
Medical Oncologist
8.
Dr. Navin Khattry, 
Member
Asst  Professor, Dept of Pathology,  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Medical oncologist
9.
Dr. Bharat Reiki, Member
Prof. Dept of Pathology, Tata Memorial Hospital, Mumbai.
Male
Pathologist
10.
Dr. Prasanna Venkataraman, Member
Scientific Officer F, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Female
Basic Scientist
11.
Dr. B.B. Singh, Member
Advocate, Mumbai High Court
Male
Legal Expert
12.
Dr. Manoj Mahimkar, Member
Scientific Officer F, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Basic Scientist
13.
Mrs. Sadhana Kannan, Member
Scientific Officer E Data Manager, ACTREC
Female
Bio-statistician
14.
Mrs. Lakshmi. R, Member
Co-ordinator, Sanjeevani life beyond cancer, Mumbai. Trust
Female
NGO Representative
15.
Mrs. Deepa Ramani, Member
Ex-play group teacher, store and purchase in-charge, Vishwakarma Tower,
Female
Layperson

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



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