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TMC-IEC III

Overview

Tata Memorial Centre- Institutional Ethics Committee –III

Re-registered with DCGI, Registration No. ECR/149/Inst/MH/2013/RR-24
Registered with DHR: EC/NEW/INST/2020/934

The TMC- Institutional Ethics Committee-III (IEC) was established in December 2009 as per the ICMR and ICH- GCP guidelines for Ethics Committees, with a mandate for combined scientific and ethics review of research projects being conducted at ACTREC and Tata Memorial Hospital. The Committee has currently accredited by the prestigious Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Tata Memorial Centre, Institutional Ethics Committee has been accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of Quality Council of India (QCI) in 2017 Validity: Dec 11, 2017 - Dec 10, 2020

The research studies which are eligible for review by this IEC and their categorization is as follows:

  1. Studies not involving living subjects:

    Studies requiring Intra-Mural/Extra-Mural grant or those in collaboration with other sites/institutes will be reviewed by IEC. Such studies could be -

    • In vitro study on established cell lines (other than embryonic stem cells)
    • Physics / Equipment / Software R&D studies not involving animal or human subjects
  2. Studies involving Human subjects: Such studies could be
    • Epidemiological, Molecular epidemiology or Pharmacological studies using questionnaires, with or without physical examination and or additional blood / saliva / urine / hair / nail / other samples or follow up.
    • Biological studies on human tissues obtained as part of diagnostic or therapeutic procedures with or without physical examination and or additional blood / saliva / urine / hair / nail /other samples or follow up.
    • Observational studies, surveys, questionnaires, audits for various demographic, symptoms, Quality of life , Knowledge Attitude Practice, dietary variable etc.
    • Cross sectional or longitudinal cohort studies for response, toxicity and other outcomes in patients undergoing standard of care (as listed in TMH EBM guidelines).
    • Human Clinical trials using experimental approaches or involving additional invasive intervention, including gene and cell based therapies.

TMC-ACTREC IEC will not review the following research studies (Investigators can seek IEC guidance about the possible routes of obtaining scientific and ethical approval at local and national level).

  • Research on Embryonic Stem Cells.
  • Experimental invasive studies on non human primates or healthy pets or other animals in captivity or wild that are not being investigated or treated as patients.

Meeting Schedule

The IEC-III meets (Virtual) on Third Friday of every month at 09.15 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC

IRB Processing fee for Pharma initiated projects

IEC processing fees (applicable for all pharmaceutical sponsored studies)

  1. Initial project submission                    -   Rs. 40,000/-  +applicable GST
  2. Protocol amendment (major) for ongoing study   -   Rs. 10,000/-  + applicable GST

The fees will be accepted as cheque/demand draft drawn in favour of “Tata Memorial Centre".

Organogram

Organization Chart

Scope of Authority of IEC-III

Members IEC - III

Tata Memorial Centre- Institutional Ethics Committee –III, ACTREC has been reconstituted from 01st June 2026 to 31st May 2028

Sr. No.Name & PositionPositionAffiliationAffiliation StatusGenderExpertise
1.Dr. Surekha ZingdeChairpersonTrustee, Indian Women Scientists' Association (IWSA),
Former Deputy Director, CRI, Scientific Officer ‘H’
Non-AffiliatedFemaleBasic Scientist
2.Dr. Girish Maru Co-ChairpersonFormer Principal Investigator and Scientific Officer ‘H’, CRI.Non-AffiliatedMaleBasic Scientist
3.Dr. Sachin PunatarMember SecretaryProfessor. Medical Oncology ‘F’ (Adult Hematolymphoid) ACTREC, TMCAffiliated MaleClinician (Medical Oncology)
4.Dr Nidhi DhariwalMember (Stem Cell Expert) Consultant, Pediatric Hemato- Oncology and BMT, Nanavati Max Super Speciality Hospital, Mumbai Non-AffiliatedFemaleClinician (Stem cell Expert)
5.Mrs Swati Parab Member Student counsellor, Changu Kana Thakur College of Science, Commerce and Arts, Khanda colony, Khandeshwar Non-Affiliated FemaleSocial scientist/ NGO Representative
6.Dr. Sharmila Vinayak Jalgaonkar MemberProfessor (Additional) Department of Pharmacology, Seth G S Medical College and KEM Hospital Parel, Mumbai 400012 Non-Affiliated FemaleClinical Pharmacologist (Basic Medical Scientist)
7.Dr Sheela S Hosamani MemberAssistant Prof. M.G.M Law College, Nerul, Navi Mumbai Non-AffiliatedFemaleLegal Expert
8.Dr Varun AggarwalaMemberAssistant Prof, Principal Investigator, Microbiome Therapeutics Laboratory Jio Institute, Ulve Navi Mumbai Non-Affiliated Male Basic Scientist (Computational Biologist)
9.Mrs. Josephine Machado MemberPlaygroup teacher and special educator, Bloomingdale Preschool, Nursery & Day Care, Kharghar, Navi MumbaiNon-AffiliatedFemaleLayperson
10.Dr. Shwetabh SinhaMemberAssociate Professor "E", Radiation Oncology, ACTREC, TMCAffiliatedMaleClinician (Radiation Oncology)
11.Dr. Anant Gokarn MemberProfessor ‘F’ Medical Oncology, (Adult Hematolymphoid) TMH, TMCAffiliatedMaleClinician (Medical Oncology)
12.Dr. Arjun Singh MemberAssociate Professor ‘E’(Oral & Maxillo Facial Surgery), ACTRECAffiliatedMale Clinician (Surgical oncology)
13.Dr. Prashant TembhareMemberClinician Scientist and Prof in Hematopathology (SO G) ACTREC, TMCAffiliatedMaleBasic Medical Scientist (Hematopathology)
14.Dr. Amit Janu MemberProfessor ‘F’ Radiodiagnosis, & OIC - MRI, ULTRASOUND, PCPNDT & PACS, ACTRECAffiliatedMaleClinician (Interventional Radiology)
15.Dr. Syed HasanMemberPrincipal Investigator, Hasan Lab, Associate Professor, Translational Research & Scientific Officer ‘F’ In charge of Clinical Research Lab, ACTREC, TMC AffiliatedMaleBasic Scientist

The mandate of the committee 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 Extramural) 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 the public
  5. To maintain our leadership as a national standard of reference in oncology and in allied specialities
  6. To issue and periodically update and revise SOPs and guidelines for the 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-III will meet on the Third Friday of every month at 09:15 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 a Member of TRAC.

Research Review Committee (RRC)

The Research Review Committee (RRC) is a unit of the IEC comprising of clinicians of varied expertise from the hospital, supported by IEC staff with a primary responsibility to review serious adverse events, safety reports and annual status reports of the projects approved by the IEC. This unit reports to the IEC.

The Research Review Committee is a unit of the IEC essentially responsible for monitoring IEC approved projects, to ensure patient safety and assess data during the course of the study in a manner that contributes to the scientific and ethical integrity of the study.

RRC- I based in TMH will function as a unit of the IEC for TMH (IEC-I & II) and RRC-II based in ACTREC will function as a unit of the IEC for ACTREC (IEC-III).

RRC Members

Tata Memorial Centre-Research Review Committee, ACTREC has been reconstituted from 1st June 2026 to 31st May 2028. The composition of the committee is as follows:

Sr. No.Name & PositionPositionAffiliationGenderExpertise
1.Dr. Shwetabh SinhaChairpersonAssociate Professor "E", Radiation Oncology, ACTREC, TMCMaleClinician (Radiation Oncology)
2.Dr. Tanuj ChawlaMember Secretary Consultant ‘F’ Clinical PharmacologyMaleClinician (Pharmacologist)
3.Dr. Ashwini RaneCo- ChairpersonAssociate Professor ‘E’ AnaesthesiaFemale Clinician (Anaesthesia)
4.Dr. Akanksha ChichraMemberAssociate Professor Medical Oncology ‘F’ (Paediatric) FemaleClinician (Medical Oncology)
5.Dr. Aditya DhanawatMemberAssistant Professor ‘E’ Medical Oncology (Adult Solid Tumour)MaleClinician (Medical Oncology)
6.Dr. Dileep HoysalMemberAssistant Professor ‘E’ Breast SurgeryMaleClinician (Surgical Oncology- Breast Unit)
7.Dr Sayak ChoudhuryMemberAssociate Professor ‘E’ Nuclear Medicine Male Clinician (Nuclear Medicine)
8.Dr. Himangi UndeMemberAssistant Professor ‘E’ RadiodiagnosisFemaleClinician (Radiologist)
9.Dr. Shivani SachdevMemberScientific Officer ‘D’ (Chemical Biology)FemaleBasic Scientist
10.Dr. Gunjan MandalMemberScientific Officer ‘D’ (Tumor Immunology and Immunotherapy)FemaleBasic Scientist
11.Dr. Nandini VermaMemberPrincipal Investigator & Associate Professor ‘F’FemaleBasic Scientist
12.Dr. Sivaranjini KMemberMedical Officer (Scientific Officer ‘E’) at the Centre for Cancer Epidemiology (CCE)FemaleClinician (Community Medicine)

The mandate of the TMC-IEC III Research Review Committee (RRC) are to:

The Research Review Committee (RRC) will review Serious Adverse Events (SAEs), monitor research studies, review retrospective studies (as subject experts) and submit a report to the Institutional Ethics Committee-III (IEC III-ACTREC).

The Research Review Committee (RRC) will convene on the second Friday of every month at 02.00 p.m. (unless otherwise notified) in the Paymaster Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai. The Chairperson of RRC will be a Member of the IEC-III, ACTREC.

List of Forms for PIs / Research staff effective from 10.11.2023 for human study

Sr. No.Form NoTitle
1.1aProject Submission Form
2.2Checklist of document
3.3aTemplate for Participant Information Sheet and ICF
4.3bTemplate for Child Information Sheet and Assent Form
5.3cTemplate for Parent Information sheet and ICF
6.3dTemplate for Participant Consent for prospective audit study
7.3eTemplate for Parent - LAR Consent for prospective audit study
8.3fTemplate for Child Assent for prospective audit study
9.3gInformed Consent Template for Audio-Visual Recording
10.3hIEC form for re-review of research proposals
11.3iGeneral instructions for PI for submission of projects
12.4aExpedited review form
13.4bReview exemption form
14.6Post approval Amendment Reporting Form
15.7aContinuing Review Application Form (CRA)/Annual Status Report (ASR)
16.7bContinuing Review Application Form - Basic Human Study
17.8Deviation (D) Violation (V) Form
18.9aSerious Adverse Event Report (SAE) form
19.9bOff-site Safety Reports Classification Form
20.9cOff-site safety log
21.10Document request form
22.12Study Completion Report (SCR)
23.13Premature Termination - Suspension - Discontinuation Report
24.14Application form for requesting waiver of consent
25.15Monitoring Form
26.16Summary list of changes
27.17Advertisement script for healthy volunteer
28.18Script for Telephonic consent
29.19IEC Feedback form
30.20Revised Budget for the Study

Online Submission

Online submission of new projects through IEC web portal

TMC IEC has initiated online web portal for submission/review of research projects w.e.f. 01 Jan 2018
Link: https://www.iecportal.org/login.php

Contact person for creating Login ID:
Mr. Sandeep Kalsekar
Email id: sandeep.kalsekar@gmail.com
Contact No: 022 2417 7000 (Extn: 4267)

Note:

Link for IEC SOPs effective from Version 6.1 dated 10.11.2023


IEC Process

Flow Chart



Link for guidelines and regulations:

1. NDCT guidelines 2019  NDCT 2019 (2021 amendment)

2. ICMR guidelines 2017

3. ICMR Emergency 2020

4. WMA Helsinki 2024 and Taipei 2016

5. US common rules 2018

 

Contact Us

Tata Memorial Centre
Advanced Centre for Treatment, Research & Education in Cancer,
Institutional Ethics Committee (TMC- IEC III),
Room no 128, Paymaster Shodhika, First floor,
ACTREC, Kharghar,
Sector 22 Navi Mumbai 410210
Phone: +91-22-27405154//27405126
Email- irb[at]actrec[dot]gov[dot]in

Feedback

PI/Study team member Feedback Form

Patient Complaint / Query / Feedback form

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