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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 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

  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 fourth Tuesday 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)

  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 )

Tata Memorial Centre- Institutional Ethics Committee-I have been reconstituted from
1st July 2020 – 30th June 2022

Sr. No.

Name

Position

Affiliation

Affiliation
Status

Gender

Expertise

1.
Dr. Nithya Gogtay Chairperson Professor, Dept 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. Gouri Pantvaidya Member Secretary Professor, Department of Surgical Oncology, Tata Medorial Hospital Affiliated
Female
Surgeon
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.
Mr. N. D. Jay want Member

Advocate, High court, Mumbai

Non Affiliated
Male
Legal expert
7.
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)

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. Tushar Vora Member & Secretary, Data Safety Monitoring Unit (DSMU)

Professor, Dept. of Medical Oncology, Tata Memorial Hospital

Affiliated
Male
Medical Oncologist
( Pediatrician)
10.
Dr. Santosh Menon Member

Professor, Dept. of Pathology,Tata Memorial Hospital

Affiliated
Male
Basic  Medical Scientist (Pathologist)
11.

Dr. Prakash Nayak

Member Associate Professor, Dept. of Surgical Oncology, Tata Memorial Centre
Affiliated
Male
Surgeon
12.
Dr. Jeson Doctor Member Associate Professor, Dept. of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital
Affiliated
Male
Anesthesiologist
13.
Dr. Sabita Jiwnani Member

Associate Professor, Dept. of Surgical Oncology, TMH

Affiliated
Female
Surgeon
14.
Dr. Tabassum Wadasadawala Member

Associate Professor, Dept. of Radiation Oncology, TMH

Affiliated
Female
Radiation Oncologist

The IEC-I fourth Tuesday 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 DSMU 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 2020 to 30th June 2022

Sr. No.

Name

Position

Affiliation

Affiliation
Status

Gender

Expertise

1.
Dr. Shyam Kishore Shrivastava Chairperson Director, Radiation Oncology, Apollo Hospitall Non Affiliated
Male

Radiation Oncologist

2.
Dr. Sudeep Shah Co-Chairperson Consultant, Surgical Gastroenterology, Hinduja Hospital Non Affiliated
Male

Surgeon

3.
Dr.Priya Ranganathan

Member Secretary

Professor, Dept. of Anaesthesia, Tata Memorial Hospital
Affiliated
Female
Anesthetist
4.
Dr. Padmaja Marathe Member Prof. (Additional) Dept of Pharmacology and Therapeutics, Seth G S Medical College and KEM Hospital, Mumbai Non Affiliated
Female
Clinical Pharmacologist
5.
Mrs. Manisha Naikdalal Member Member of Ethics Committees at Hinduja Hospital (IEC-1),IITB,Global Hospital, Nair Hospital ISBEC (InterSystems Biomedica Ethics Committee) , Altemate Member (Layperson) at and KEM Hospital and Lilavati 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. Gaurav Narula Member Professor, Dept. of Medical Oncology ( Pediatric), TMH
Affiliated
Male
Medical Oncologist
9.
Dr. Nehal Khanna Member Associate Professor, Dept. of Radiation Oncology, TMH
Affiliated
Female
Radiation Oncologist
10.
Dr.Shivakumar Thiagarajan

Member

Associate Professor, Head and Neck Oncology, Tata Memorial Hospital
Affiliated
Male
Surgeon
11.

Dr. Nita Nair

Member

Professor, Surgical Oncology ( Breast Service ), TMH
Affiliated
Female
Surgeon
12.
Dr. Nilesh Lokeshwar Member Consultant, Asian Cancer Institute, Sion (E), Mumbai  Non Affiliated
Male
Medical Oncologist
13.
Dr. Sewanti Limaye Member Consultant, Medical Oncology, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai Non Affiliated
Female
Medical Oncologist
14.

Dr. Munita Bal

Member

Professor, Dept. of Pathology, TMH

Affiliated
Female
Basic Medical Scientist (Pathologist)
15.
Dr. Nilendu Purandare Member

Professor, Dept. of Nuclear Medicine, TMH

Affiliated
Male
Radiologist

The IEC-II second Wednesday 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
01st July 2020 for 2 years.

Sr. No.

Name

Position

Affiliation

Gender

Expertise

1.
Dr. Surekha Zingde
Chairperson
Trustee, Indian Women Scientists' Association (IWSA), Former Deputy Director, CRI, Scientific Officer ‘H’
Female
Basic Scientist
2.
Dr. Siby K. George
Co- Chairperson

Professor of Philosophy, Department of Humanities & Social Sciences, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, India

Male
Philosopher
3.
Dr Sudhir Nair    
Member Secretary
Prof. Head and Neck Surgical Oncology, ACTREC., TMC
Male

Clinician (Surgical oncology)

4.

Dr. Pramila Yadav

Member

Prof, Dept of Pharmacology,  Dr D Y Patil   Medical college, Nerul, Navi Mumbai

Female

Clinical Pharmacologist
(Basic Medical Scientist)

5.
Mrs. Deepa Ramani
Member
Ex-play group teacher, store and purchase in-charge, Zenith Spinners Ltd. Member of IC-SCR, ACTREC
Female
Layperson
6.

Mr Akil Hirani

Member

Head of the Transactions Practice and Managing Partner  Majmudar & Partners, International Lawyers, India

Male

Legal Expert

7.

Dr. Punit Jain

Member
Consultant Hematologist/ Hemato-Oncologist & Bone Marrow Transplant Physician, Apollo Hospitals, Belapur, Navi Mumbai Member of IC-SCR, ACTREC
Male

Clinician (Medical Oncology)

8.

Dr Uma Dangi

Member

Consultant Medical Oncology Fortis Hospital, Mulund, Vashi and Kalyan

Female
Clinician (Medical Oncology)
9.

Dr. Tanuja Teni

Member
Principal Investigator and Scientific Officer ‘G’  ACTREC, TMC
Female
Basic Scientist
10.

Dr Naveen Mummadi

Member
Asst. Professor, Dept. of  Radiation Oncology,  ACTREC, TMC
Male
Clinician (Radiation Oncology)
11.

Dr. Reshma Ambulkar

Member and DSMU Secretary
Professor, Dept. of Anaesthesia, Critical Care and Pain, ACTREC, TMC..
Female
Clinician
(Anaesthetist and Intensivist)
12.

Dr. Shalaka Joshi

Member
Associate Professor, Dept. of Surgery, Tata Memorial Hospital, TMC.
Female
Clinician (Surgical oncology)
13.

Dr. Bhausaheb Bagal

Member
Professor and Consultant, , Dept. of Medical Oncology, Tata Memorial Hospital, TMC
Male
Clinician (Medical Oncology)
14.

Dr. Nitin S Shetty

Member

Prof. Interventional Radiology Tata Memorial  Hospital, TMC

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)

 

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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

हमसे संपर्क करें

टाटा मेमोरियल अस्पताल
डॉ ई बोरगेस रोड, परेल, मुंबई - 400 012 इंडिया
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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