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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

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

Software Programmer

  1. Mr. Sandeep Kalsekar

Clerical Staff :

  1. Mr. Ramchandra Patil, Sr. Asstt.
  2. 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 second Thursdays of every month at 2:00 p.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)

  1. Initial project submission                                       -   Rs. 40,000/- + applicable GST
  2. 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 Thursdays of every month at 2:00 pm. (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 1st April, 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.
Prof. Nasreen Rustomfram Member Ex –Professor, Centre for Lifelong Learning, TISS, 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. Rahul Raghunath Ganoo Member Advocate High Court, 72/6, Vishnu Prasad Society, M. G. Road, Vile – Parle (East), Mumbai – 400 057
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.

 

!--

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. Punit Jain

Member

Consultant Hematologist/ Hemato-Oncologist &  Bone Marrow Transplant Physician, Apollo Hospitals, Belapur, Navi Mumbai    

 Non Affiliated
Male
Clinician (Medical Oncology)
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)

 

हमसे संपर्क करें

टाटा स्मारक अस्पताल
डॉ ई बोर्जेस रोड, परेल, मुंबई - 400 012 भारत 
फ़ोन: +91-22- 24177000, 24146750 - 55
फैक्स: +91-22-24146937
ईमेल : msoffice@tmc.gov.in (रोगी देखभाल और प्रश्नों के लिए) / hrd@tmc.gov.in(प्रशासनिक के लिए - HRD मायने रखता है)

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