| 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.
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Mandate |
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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
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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.
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The mandate of the IEC essentially is to promote patient care through a scientific and ethical approach to research and education.
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The terms of reference for the IEC are as follows |
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Ensure the highest scientific and ethical standards of research at TMC |
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Review and approve, proposals for clinical, basic or translational research projects (Intra and Extra mural) for scientific and ethical content |
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Improve ethical standards and issue guidelines on ethical dilemmas related to patient care services |
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To function as a forum to advise the administration in case of any ethical issues that may arise from patients, families or public |
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To maintain our leadership as a national standard of reference in all fields |
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To issue and periodically, update and revise SOP s and guidelines for effective functioning of IEC as and when necessary |
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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 |
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To initiate and commission research studies on ethical aspects of practice in TMC |
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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
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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. |
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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 |
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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 |
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The members should have various backgrounds to promote complete and adequate review of research activities commonly conducted by TMC. |
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Institutional Ethics Committee - I |
Sr. No. |
IEC-I |
Affiliation |
Gender |
Expertise |
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Dr. Tapan Saikia,
Chairperson |
Head of Medical Oncology & Research Director, Prince Aly Khan Hospital, Mazagaon, Mumbai |
Male |
Medical
Oncologist |
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Dr. Nithya Gogtay,
Co- Chairperson |
Professor, Clinical Pharmacology, KEM Hospital |
Female |
Clinical Pharmacologist |
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Dr. George Karimundackal,
Member Secretary
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Associate Professor, Dept. of Surgical Oncology, Tata Memorial Hospital |
Male |
Surgeon |
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Mrs. Manisha Naikdalal,
Member |
Member of Ethics Committees at KEM Hospital (ECRHS) & Hinduja Hospital (CREC) |
Female |
Lay Person |
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Managing Trustee V Care Foundation |
Female |
Social scientist/ NGO representative |
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Dr. Pradnya Talawadeker,
Member |
Country Coordinator for India Association Children Pallative Care Project |
Female |
Medico-legal expert |
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Dr. Sanjay Gupta,
Member |
Scientific Officer, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Male |
Basic Scientist |
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Dr. Sarbani Ghosh Laskar,
Member
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Professor, Dept. of Radiation Oncology, TMH & Member-Secretary, Data Safety and Monitoring Subcommittee, Tata Memorial Hospital |
Female |
Radiation Oncologist |
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Dr. J. V. Divatia
Member |
Professor and Head, Department of Anaesthesia, Critical Care & Pain, Tata Memorial Hospital |
Male |
Anaesthetist |
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Dr. Vani Parmar
Member |
Professor, Dept. of Surgical Oncology , Tata Memorial Hospital |
Female |
Surgeon |
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Dr. Umesh Mahanshetty,
Member |
Professor, Dept. of Radiation Oncology, Tata Memorial Hospital |
Male |
Radiation Oncologist |
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Dr. Girish Chinnaswamy,
Member |
Associate Professor, Dept. of Medical Oncology, Tata Memorial Hospital |
Male |
Medical Oncologist |
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Dr. Manju Sengar,
Member |
Professor, Dept. of Medical Oncology, Tata Memorial Hospital |
Female |
Medical Oncologist |
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Dr. Mukta Ramadwar,
Member |
Professor, Dept. of Pathology, Tata Memorial Hospital |
Female |
Pathologist |
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Dr. Seema Kembhavi,
Member |
Associate Professor, Dept of Radiodiagnosis, Tata Memorial Hospital |
Female |
Radiologist |
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Institutional Ethics Committee - II |
Sr. No. |
IEC-II |
Affiliation |
Gender |
Expertise |
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
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Institutional Ethics Committee - III |
Sr. No. |
IEC-III |
Affiliation |
Gender |
Expertise |
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
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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 |
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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.
Upload
File For Ethics Committee Investigators
Standard Operating Procedures (SOPs):
SOP 01/V3 Date:01/05/2014 of Institutional Ethics Committees ( Pdf Format) |
Tata Memorial Hospital, Dr.
E Borges Road, Parel, Mumbai - 400 012 India. 