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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.

Tata Memorial Centre- IECs are registered with Drug Controller General of 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.

Recognitions

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.

 

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 meets on last Wednesday of every month at 8.30 a.m. (unless otherwise notified) in the IRB Meeting Room, 3rd Floor, Main Bldg., Tata Memorial Hospital

IEC- II meets on second Friday of every month at 8.30 a.m. (unless otherwise notified) in the IRB Meeting Room, 3rd Floor, Main Bldg., Tata Memorial Hospital

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/-
  2. Protocol amendment (major) for ongoing study       -   Rs.   5,000/-

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 2016 – 31st March 2018

Sr. No.

Name

Position

Affiliation

Gender

Expertise

1.
Dr. Tapan Saikia Chairperson Head, Dept of Medical Oncology & Research Director
Male
Medical Oncologist
2.
Dr. Nithya Gogtay Co- Chairperson Professor, Dept of Clinical Pharmacology, KEM Hospital
Female
Clinical Pharmacologist
3.
Dr. George Karimundackal
Member Secretary Professor, Dept. of Surgical Oncology, Tata Memorial Hospital
Male
Surgeon
4.
Dr. Prachi Patil Member & Secretary, DSMSC Associate Professor, Dept. of Digestive Diseases & Clinical Nutrition, Tata Memorial Hospital
Female
Gastroenterologist
5.

Ms. Manisha Naikdalal

Member Member of Ethics Committees at KEM Hospital (ECRHS) & Hinduja Hospital(CREC)
Female
Lay Person
6.
Prof. Bindhulakshmi P Member Associate Professor, Advanced Centre for Women’s Studies, School of Development Studies, Tata Institute of Social Sciences
Female
Social scientist
7.
Dr. Suganthi Iyer Member

Dy. Director (Legal & Medical) Hinduja Hospital

Female
Medicolegal expert
8.
Dr. Sanjay Gupta Member Scientific Officer, CRI- Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Basic Scientist
9.
Dr. J P Agarwal Member Professor, Dept. of Radiation Oncology, Tata Memorial Hospital
Male
Radiation Oncologist
10.
Dr. Vijaya Patil Member Professor, Dept. of Anesthesia Critical Care and pain, Tata Memorial Hospital
Female
Anesthetist
11.
Dr. Devendra Chaukar Member Professor, Dept. of Surgical Oncology, Tata Memorial Hospital
Male
Surgeon
12.
Dr. Amit Joshi Member Professor, Dept. of Medical Oncology, Tata Memorial Hospital
Male
Medical Oncologist
13.
Dr. Tanuja Shet Member Professor, Dept of Pathology, Tata Memorial Hospital
Female
Pathologist
14.
Dr. Seema Kembhavi Member Associate Professor, Dept of Radiodiagnosis, Tata Memorial Hospital
Female
Radiologist
15.
Mr. Sanjay Talole Member Scientific Officer, Dept of Medical records, Tata Memorial Hospital
Male
Statistician

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

 

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IEC- II

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Institutional Ethics Committee- II

Tata Memorial Centre- Institutional Ethics Committee-II Member list from
1st June 2017 to 31st March 2018

Sr. No.

Name

Position

Affiliation

Gender

Expertise

1.
Dr.(Mrs) Urmila Thatte Chairperson Professor & Head, Dept. of Clinical Pharmacology, KEM Hospital
Female
Clinical Pharmacologist
2.

Dr. Rajesh C. Mistry

Co-Chairperson Director, Department of Oncology, 
Centre for Cancer, Kokilaben Dhirubhai Ambani Hospital.
Male
Surgeon
3.

Dr.Sarbani Ghosh Laskar

 
Member Secretary Professor, Dept. of Radiation Oncology, Tata Memorial Hospital
Female
Radiation Oncologist
4.
Dr. Yashashri Shetty Basic Medical Scientist Associate Professor, Department of Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital
Female
Clinical Pharmacologist
5.
Mr.K.V.Ganpathy Layperson CEO,  JASCAP, Jeet Association for Support to Cancer Patients since 1996
Male
Human Resource Management
6.
Dr. Mrunal Marathe Social Scientist Freelance Counselor and Trainer associated with NGO-St.Jude’s Childcare Centre and Adoption Group, Asha Sadan Orphanage, Byculla
Female

Counselor for pediatric cancer patients/ Adoption counselor

7.
Dr.Leena Gangolli Legal expert Member, Institutional Ethics Committee, Nirmala          Niketan College of Home Science, Consultant, Children’s Palliative Care Program, Consultant, Silver Innings Foundation
Female
Medico-Legal expert
8.
Dr. Ashok K Varma S Scientific Member Scientific Officer ‘F’, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Male Basic Scientist
9.
Dr.Umesh Mahantshetty Clinician Professor, Dept. of Radiation Oncology, Tata Memorial Hospital
Male
Radiation Oncologist
10.
Dr.Priya Ranganathan Clinician Associate Professor, Dept. of Anaesthesia, Tata Memorial Hospital
Female
Anesthetist
11.

Dr. Gouri  Pantvaidya

Clinician & Joint Secretary, DSMSC

Associate Professor & Assistant Surgeon F, Head and Neck Oncology, Tata Memorial Hospital
Female
Surgeon
12.
Dr. Girish Chinnaswamy Clinician Associate  Professor, Dept. of Medical Oncology, Tata Memorial Hospital
Male
Medical Oncologist
13.
Dr. Kedar Deodhar Basic Medical Scientist Professor, Dept. of Pathology, Tata Memorial Hospital
Male
Pathologist
14.

Dr. Suyash Kulkarni

Clinician Associate Professor & Radiologist F Departmental of Radiology, Tata Memorial Hospital
Male
Radiologist
15.
Ms. Rohini Hawaldar Scientific Member Scientific Officer, Tata Memorial Hospital
Female
Statistician

The IEC-II will meet on second Friday 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

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Institutional Ethics Committee- III

Tata Memorial Centre- Institutional Ethics Committee-III have been reconstituted from
1st April 2016 – 31st March 2018

Sr. No.

IEC-III
Registration No. ECR/149/Inst/MH/2013

Affiliation

Gender

Expertise

1.
Dr. Rita Mulherkar Chairperson A/ 103, Park-Dew, Plot no 73, Sector 20, Kharghar, Navi Mumbai 410210
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. Y A Deshmukh Member Professor and Head, Dept of Pharmacology, MGM Medical College, Kamothe, Navi Mumba
Male
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, Mumbai. Trust
Female
Social Scientist
7.
Dr. B.B. Singh Member
Advocate, Mumbai High Court
Male
Legal Expert
8.
Dr. Sanjeev Waghmare Member Scientific Officer ‘E’ & Principal Investigator, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Basic Scientist
9.
Dr. Tejpal Gupta Member Associate Professor, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Male
Radiation Oncologist
10.
Dr. Prafulla Parikh Member Assistant Professor,General Medicine, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Female
Physician
11.
Dr. Amita Maheshwari Member Associate Professor, Dept of Gynecology, Tata Memorial Hospital
Male
Surgeon
12.
Dr. Brijesh Arora Member Professor, Pediatric Oncology, Tata Memorial Hospital
Male
Medical Oncologist
13.
Dr. Bharat Reiki Member Professor, Dept of Pathology, Tata Memorial Hospital, Mumbai.
Male
Pathologist
14.
Dr. Pritha Ray Member Scientific Officer ‘F’ & Principal Investigator, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Female
Basic Scientist
15.
Dr. Navin Khattry Member Professor, Dept of Medical Oncology, ACTREC
Male
Medical oncologist

The IEC-III meets on Second Saturday 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 and DSMC will be Members of TRAC.

Link for TMC-IEC III (ACTREC IEC)

 

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IEC- FORMS

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Institutional Ethics Committee - Forms wef 01 April 2016

Sr. No.

Forms

1.
Amendment Reporting Form
2.
Application form for requesting waiver of consent
3.
Considerations for Genetic Research
4.
Checklist of Documents for IEC submission
5.
Child Information Sheet and Assent Form
6.
Continuing Review Application- Form A
7.
Deviation or Violation Reporting Form
8.
Document Request Form
9.
Expedited Review Application Form
10.
Informed Consent Document Template
11.
Instructions for Submission of Project for Institutional Ethics Committee Approval
12.
Off Site Safety Reports Classification Form
13.
Off Site Safety Reports Log
14.
Parent Information sheet and Informed Consent Form
15.
Premature Termination or Suspension or Discontinuation Report
16.
Project Submission Form
17.
Request or Complaint Record Form
18.
Review Exemption Application Form
19.
Revised Submission Template
20.
Serious Adverse Event Reporting Form
21.
Short Assent for Participation in the study
22.
Short Parental or LAR Consent
23.
Short Participant Consent for Participation in the study
24.
Study Completion Report Form
25.
Study Monitoring Visit Report

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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