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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-16
  • IEC-II :      ECR/414/Inst/MH/2013/RR-16
  • 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 Wednesday 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. 20,000/- + applicable GST
  2. Protocol amendment (major) for ongoing study       -   Rs.   5,000/- + 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

Tata Memorial Centre- Institutional Ethics Committee-I have been reconstituted from
1st April 2018 – 31st March 2020

Sr. No.

Name

Position

Affiliation

Gender

Expertise

1.
Dr. S.K. Shrivastava Chairperson Director, Radiation Oncology, Apollo Hospital
Male
Radiation Oncologist
2.
Dr. Nithya Gogtay Co- Chairperson Professor, Dept of Clinical Pharmacology, KEM Hospital
Female
Basic Medical Scientist (Clinical Pharmacologist)
3.
Dr. Umesh Mahantshetty
Member Secretary Professor, Dept. of Radiation Oncology,TMH
Male
Radiation Oncologist
4.
Mr. KV Ganpathy Member CEO, Jeet Association for Support to Cancer Patients (JASCAP)
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
Female

Social scientist

6.
Ms. Tanu Mehta Member

Legal Counsel and Mediator, High Court, Mumbai

Female
Legal expert
7.
Dr. Sanjeev Waghmare Member

Scientific Officer, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male
Basic Scientist
8.

Dr. Rajiv Sarin

Member Professor, Dept. of Radiation Oncology & PI & OIC, Cancer Genetics Unit, TMH
Male
Radiation Oncologist
9.
Dr. Gouri Pantvaidya Member & Secretary, Data Safety Monitoring Unit (DSMU)

Professor, Dept. of Surgical Oncology,TMH

Female
Surgeon
10.
Dr. Sheila Myatra Member Professor, Dept. of Anesthesiology, Critical Care and Pain, TMH
Female
Anesthetist
11.

Dr. Sudhir Nair

Member Associate Professor, Dept. of Surgical Oncology, Tata Memorial Centre
Male
Surgeon
12.
Dr. Amit Joshi Member Professor, Dept. of Medical Oncology, Tata Memorial Hospital
Male
Medical Oncologist
13.
Dr. Santosh Menon Member

Professor, Dept. of Pathology,TMH

Male
Basic  Medical Scientist (Pathologist)
14.
Dr. Sneha Shah Member

Professor, Nuclear Medicine, Bio-imaging Unit, TMH

Female
Nuclear Medicine Physician
15.
Dr. Palak Popat Member Assistant Professor, Dept. of Radiodiagnosis, TMH
Female

Radiologist

The IEC-I will meet  on last Wednesday 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 DSMSC will be  Members of TRAC.

 

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IEC- II

-->

Institutional Ethics Committee- II

Tata Memorial Centre- Institutional Ethics Committee-II have been reconstituted from
1st April 2018 to 31st March 2020

Sr. No.

Name

Position

Affiliation

Gender

Expertise

1.
Dr. Sudeep Shah Chairperson Consultant in Gastroenterology surgery, Hinduja Hospital
Male

Surgeon

2.

Dr. Arun Bhatt

Co-Chairperson Consultant – Clinical Research and Development
Male
Clinician
3.

Dr.Girish Chinnaswamy

 
Member Secretary Professor, Dept. of Medical Oncology, TMH
Male
Medical Oncologist(Paediatrician)
4.
Dr. Yashashri Shetty Member Associate Professor, Department of Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital
Female
Clinical Pharmacologist
5.
Mrs. Manisha Naikdalal Member Member of Ethics Committees at Hinduja Hospital (IEC-1),IITB,Global Hospital, Nair Hospital and IIT-B Alternate Member (Layperson) with ISBEC(InterSystems Biomedica Ethics Committee) and KEM Hospital
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
Female

Social scientist

7.
Ms. Tanisha Doshi Member Associate, Hariani & Co, Mumbai
Female
Legal expert
8.
Dr. Neelam Shirsat Member Scientific Officer, ACTREC Female
Basic Scientist
9.
Dr. Ashwini Budrukkar Member Professor, Dept. of Radiation Oncology, TMH
Female
Radiation Oncologist
10.
Dr.Priya Ranganathan

Member & Jt.Secretary Data Safety Monitoring Unit (DSMU)

Professor & Anaesthetist F, Dept. of Anaesthesia, Tata Memorial Hospital
Female
Anesthetist
11.

Dr. Nita Nair

Member

Associate Professor, Dept. of Surgery, TMH
Female
Surgeon
12.
Dr. Suyash Kulkarni Member Professor & Head, Division of Interventional Radiology, TMH
Male
Interventional Radiologist
13.
Dr. Vikas Ostwal Member Associate Professor, Dept. of Medical Oncology, TMH
Male
Medical Oncologist
14.

Dr. Mukta Ramadwar

Member

Professor, Dept. of Pathology, TMH

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

Professor, Dept. of Nuclear Medicine

Male
Radiologist

The IEC-II will meet on Second Wednesdays 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 DSMSC will be Members of TRAC.

 

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IEC- III

-->

Institutional Ethics Committee- III

Tata Memorial Centre- Institutional Ethics Committee-III have been reconstituted from
1st April 2018 – 31st March 2020

Sr. No.

Name

Position

Affiliation

Gender

Expertise

1.
Dr. Rita Mulherkar
Chairperson
Former Scientist, Genetic Engineering Unit, ACTREC
Female
Basic Scientist
2.
Dr. Rabindranath Mukhopadhya
Co- Chairperson
Former Scientist, Virology Lab, ACTREC
Male
Basic Scientist
3.

Dr Prafulla Parikh

 
 
Member Secretary
Assistant Professor, Dept. of General Medicine , ACTREC, TMC
Female

Clinician (Physician)

4.

Dr. Padmaja Marathe

Member

Prof. (Additional), Dept of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai

Female

Clinical Pharmacologist
(Basic Medical Scientist)

5.
Mrs. Deepa Ramani
Member
Ex-play group teacher, store and purchase in-charge, Kharghar
Female
Layperson
6.
Mrs. Lakshmi. R.
Member
Co-ordinator, Sanjeevani life beyond cancer Trust, Mumbai.
Female

NGO Representative

7.
Dr. B.B. Singh
Member
Advocate, Mumbai High Court
Male
Legal Expert
8.

Dr. Tanuja Teni

Member
Principal Investigator,  ACTREC, TMC
Female
Basic Scientist
9.

Dr. Supriya Chopra

Member
Professor, Dept. of  Radiation Oncology,  ACTREC, TMC
Female
Clinician (Radiation Oncology)
10.

Dr. Reshma Ambulkar

Member and Secretary Data Safety Monitoring Unit (DSMU)
Professor, Dept. of Anaesthesia, Critical Care and Pain, ACTREC, TMC.
Female
Clinician (Intensivist)
11.
Dr. Amita Maheshwari
Member
Professor, Dept. of Surgery,Tata Memorial Hospital, TMC.
Female
Clinician (Surgical oncology)
12.

Dr. Gaurav Narula

Member
Professor, Dept. of Medical Oncology (Pediatric), Tata Memorial Hospital, TMC.
Male
Clinician (Medical Oncology)
13.

Dr. Shilpee Dutt

Member
Principal Investigator, ACTREC, TMC
Female
Basic Scientist
14.

Dr. Bhausaheb Bagal

Member
Associate Professor, Dept. of Medical Oncology, Tata Memorial Hospital, TMC
Male
Clinician (Medical Oncology)
15.

Dr. P.G. Subramanian

Member
Professor, Dept. of Hematopathology, ACTREC, TMC
Male
Clinician (Pathology, Basic Medical Scientist)

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

-->

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

Contact Us

TATA MEMORIAL HOSPITAL
Dr. E Borges Road, Parel, Mumbai - 400 012 India
Phone: +91-22- 24177000, 24146750 - 55
Fax: +91-22-24146937
E-mail : msoffice@tmc.gov.in (for patient care and queries) / hrd@tmc.gov.in(for administrative - HRD matters)

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