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Institutional Ethics Committees
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-19
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
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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. |
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Human Research Protection Program (HRPP) |
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Award
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Contact IRB staff
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IRB Administrators
Software Programmer
Clerical Staff :
Address |
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. |
The terms of reference for the IEC are as follows
| 1 |
Ensure the highest scientific and ethical standards of research at TMC |
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| 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 |
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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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Meeting Schedule
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IEC- I second Tuesday of every month at 9:00 a.m. (unless otherwise notified) |
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IEC- II last Thursdays of every month at 2.00 p.m. (unless otherwise notified) |
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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)
The fees will be accepted as cheque/demand draft drawn in favour of “Tata Memorial Centre". |
Composition
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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. |
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
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Sr. No. |
Name |
Position |
Affiliation |
Affiliation Status |
Gender |
Expertise |
|---|---|---|---|---|---|---|
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1.
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Dr. Nithya Gogtay | Chairperson | Professor & Head Department of Clinical Pharmacology, KEM Hospital | Non Affiliated |
Female
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Basic Medical Scientist (Clinical Pharmacologist)
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2.
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Dr. Sangeeta Mudaliar
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Co-Chairperson | Full Time Consultant & Head of The Department, Paediatric Hemato-Oncology B J Wadia Hospital |
Non Affiliated
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Female
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Medical Oncologist (Pediatrician)
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3.
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Dr. Rajiv Sarin | Member Secretary | Professor, Radiation Oncology & PI & OIC, Cancer Genetics Unit, Tata Memorial Hospital | Affiliated |
Male
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Clinician (Radiation Oncologist)
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4.
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Mr. KV Ganpathy | Member | CEO, Jeet Association for Support to Cancer Patients (JASCAP) | Non Affiliated |
Male
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Lay Person
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5.
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Mrs. Nivedita Sinha | Member | Freelance patient volunteer | Non Affiliated |
Female
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Lay Person
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6.
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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
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Social scientist |
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7.
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Dr. Astrid Lobo-Gajiwala | Member |
Director & CEO Novo Tissue Bank and Research Centre Pvt. Ltd.CSM Road, Vakola, Santa Cruz |
Non Affiliated |
Female
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Social scientist |
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8.
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Mr. N. D. Jay want | Member |
Advocate, High court, Mumbai |
Non Affiliated |
Male
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Legal expert
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9.
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Mr. Rajiv Talashikar | Member |
Advocate & Legal Consultant Rajeev & Associates, Mumbai |
Non Affiliated |
Male
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Legal expert |
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10..
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Dr. Sachin Satpute | Member |
Asst. Professor, Dept. of Pharmacology, Topiwala National Medical College & BYL Nair Ch. Hospital |
Non Affiliated |
Male
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Basic Medical Scientist (Clinical Pharmacologist) |
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11.
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Dr. Uma Dangi |
Member |
Senior Consultant, Dept of Medical Oncology, Fortis Hospital, Mulund |
Non Affiliated |
Female
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Clinician |
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12.
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Dr. Seema Gulia | Member |
Professor, Dept of Medical Oncology, Tata Memorial Hospital |
Affiliated
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Female
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Clinician
(Medical Oncologist) |
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13.
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Dr. Swapnil Parab | Member & Secretary, Data Safety Monitoring Unit |
Professor, Dept of Anaesthesiology, Tata Memorial Hospital |
Affiliated
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Male
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Clinician (Anesthesiologist)
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14.
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Dr. Prakash Nayak |
Member | Associate Professor, Dept. of Surgical Oncology, Tata Memorial Centre |
Affiliated
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Male
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Clinician (Surgeon)
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15.
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Dr. Rahul Krishnatry | Member | Associate Professor, Radiation Oncology ,Tata Memorial Hospital |
Affiliated
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Male
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Clinician (Radiation Oncologist)
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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 15th June, 2022 to 31st March, 2024
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Sr. No. |
Name |
Position |
Affiliation |
Affiliation Status |
Gender |
Expertise |
|---|---|---|---|---|---|---|
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1.
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Dr. Shyam Kishore Shrivastava | Chairperson | Director, Radiation Oncology, HCG-ICS-Khubchandani Cancer Centre | Non Affiliated |
Male
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Radiation Oncologist |
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2.
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Dr. Padmaja Marathe | Co-Chairperson | Prof. (Additional) Dept of Pharmacology and Therapeutics, Seth G S Medical College and KEM Hospital, Mumbai | Non Affiliated |
Female
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Basic Medical Scientist
(Clinical Pharmacologist) |
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3.
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Dr. Sarbani Ghosh-Laskar | Member Secretary | Professor, Radiation Oncologist Tata Memorial Hospital | Affiliated |
Female
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Clinician (Radiation Oncologist) |
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4.
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Dr. Shyamal R. Sinha | Member | Associate Professor, Dept. of Pharmacology, Grant Govt. Medical College, Mumbai. | Non Affiliated |
Male
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Basic Medical Scientist |
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5.
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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
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Female
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Lay Person
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6.
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Dr. Anand Parihar | Member | Managing Trustee, Madat Charitable Trust, 48 Swastik Park, Chembur, Mumbai 400071 | Non Affiliated |
Male
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Lay Person
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7.
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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
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Social Scientist
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8.
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Dr. Srilatha Juvva | Member | Professor, School of Social Work, Tata Institute of Social Sciences, Mumbai | Non Affiliated |
Female
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Social scientist |
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9.
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Mr. Agnel Cameiro | Member | Advocate Associate, Mulla & Mulla & Craigie Blunt & Caroe, Mulla House, 51 Mahatma Gandhi Road, Fort, Mumbai 400 001. | Non Affiliated |
Male
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Legal expert
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10.
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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
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Male
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Legal expert
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11.
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Dr.Nilesh Lokeshwar | Member | Consultant, Asian Cancer Institute, Sion (E), Mumbai |
Non-Affiliated
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Male
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Clinician(Medical Oncologist)
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12.
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Dr.Sabita Jiwnani |
Member |
Professor, Dept. of Surgical Oncology, Tata Memorial Hospital |
Affiliated
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Female
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Clinician (Surgeon)
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13.
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Dr.Anant Ramaswamy |
Member |
Professor, Dept.of Medical Oncology, Tata Memorial Hospital |
Affiliated
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Male
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Clinician
(Medical Oncologist) |
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14.
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Dr.Richa Vaish | Member | Professor, Tata Memorial Hospital, Mumbai | Affiliated |
Female
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Clinician (Surgeon)
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15.
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Dr. Tabassum Wadasadawala | Member | Professor, Radiation Oncology, Tata Memorial Hospital, Mumbai | Affiliated |
Female
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Clinician
(Radiation Oncologist) |
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.
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.
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Sr. No. |
Name |
Position |
Affiliation |
Affiliation Status |
Gender |
Expertise |
|---|---|---|---|---|---|---|
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1.
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Dr. Surekha Zingde |
Chairperson
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Trustee, Indian Women Scientists' Association (IWSA), Former Deputy Director, CRI, Scientific Officer ‘H’ | Non Affiliated |
Female
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Basic Scientist
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2.
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Dr Shona Nag |
Member
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Director, Oncology, Sahyadri Super Speciality Hospitals, Hadapsar, Survey No. 163, Bhosale Nagar, Pune, 400 028, Maharashtra |
Non Affiliated |
Female
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Clinician (Medical oncology)
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3.
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Dr. Pravesh Golay |
Member
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Associate Professor, Department of Humanities and Social Sciences, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, India | Non Affiliated |
Male
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Philosopher |
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4.
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Dr Sudhir Nair |
Member Secretary
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Prof. Head and Neck Surgical Oncology, ACTREC., TMC | Affiliated |
Male
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Clinician (Surgical oncology) |
| 5. | Dr. Sangita Sukumaran |
Member
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Prof and Head, Department of Pharmacology, Terna Medical College Navi Mumbai, 400706 |
Non Affiliated |
Female
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Clinical Pharmacologist
(Basic Medical Scientist) |
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6.
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Mrs. Deepa Ramani |
Member
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Zenith Spinners Ltd. Ex-play group teacher, store and purchase in-charge, Zenith Spinners Ltd., Member of IC-SCR, ACTREC |
Non Affiliated |
Female
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Layperson |
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7.
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Mr Akil Hirani |
Member
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Head of the Transactions Practice and Managing Partner Majmudar & Partners, International Lawyers, India
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Non Affiliated |
Male
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Legal Expert |
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8.
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Dr. Girish Maru, |
Member
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Former Principal Investigator and Scientific Officer ‘H’, CRI. |
Non Affiliated |
Male
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Basic Scientist
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9.
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Dr. Syed Hasan |
Member
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Principal Investigator and Scientific Officer ‘E’ ACTREC, TMC |
Affiliated |
Male
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Basic Scientist
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10.
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Dr Naveen Mummadi |
Member
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Asst. Professor, Dept. of Radiation Oncology, ACTREC, TMC | Affiliated |
Male
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Clinician (Radiation Oncology)
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11.
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Dr. Sachin Punatar |
Member and DSMU Secretary
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Prof. Medical Oncology, E (Adult Hematolymphoid) ACTREC, TMC | Affiliated |
Male
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Clinician (Medical Oncology)
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12.
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Dr. Shalaka Joshi |
Member
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Associate Professor, Dept. of Surgery, Tata Memorial Hospital, TMC. | Affiliated |
Female
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Clinician (Surgical oncology)
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13.
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Dr. Prashant Tembhare |
Member
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Clinician Scientist and Prof in Hematopathology Laboratory (SO F) ACTREC, TMC | Affiliated |
Male
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Basic Medical Scientist (Hemato Pathology)
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14.
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Dr. Nitin S Shetty |
Member
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Prof. Interventional Radiology Tata Memorial Hospital, TMC |
Affiliated |
Male
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Clinician (Interventional Radiology)
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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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टाटा स्मारक अस्पताल
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