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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-19
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 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 09.30 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".

Members IEC - III

Tata Memorial Centre- Institutional Ethics Committee –III

Sr. No.Name & PositionAffiliationGenderExpertise
1.Dr. Surekha Zingde
Chairperson
Trustee, Indian Women Scientists' Association (IWSA),
Former Deputy Director, CRI, Scientific Officer ‘H’
FemaleBasic 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
MalePhilosopher
3.Dr Sudhir Nair
Member Secretary
Prof. Head and Neck Surgical Oncology,
ACTREC., TMC
MaleClinician (Surgical oncology)
4.Dr. Sangita Sukumaran
Member
Prof and Head, Department of Pharmacology, Terna Medical College Navi Mumbai, 400706FemaleClinical 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
FemaleLayperson
6.Mr Akil Hirani
Member
Head of the Transactions Practice and Managing Partner Majmudar & Partners,
International Lawyers, India
MaleLegal Expert
7.Dr. Punit Jain
Member
Consultant Hematologist/ Hemato-Oncologist & Bone Marrow Transplant Physician,
Apollo Hospitals,Belapur, Navi Mumbai Member of IC-SCR, ACTREC
MaleClinician (Medical Oncology)
8.Dr Uma Dangi
Member
Consultant Medical Oncology Fortis Hospital,
Mulund, Vashi and Kalyan
FemaleClinician (Medical Oncology)
9.Dr. Tanuja Teni
Member
Principal Investigator and Scientific Officer ‘G',
ACTREC, TMC
FemaleBasic Scientist
10.Dr Naveen Mummadi
Member
Asst. Professor, Dept. of Radiation Oncology,
ACTREC, TMC
MaleClinician (Radiation Oncology)
11.Dr. Reshma Ambulkar
Member and DSMU Secretary
Professor, Dept. of Anaesthesia, Critical Care and Pain,
ACTREC, TMC
FemaleClinician (Anaesthetist and Intensivist)
12.Dr. Shalaka Joshi
Member
Associate Professor, Dept. of Surgery,
Tata Memorial Hospital, TMC
FemaleClinician (Surgical oncology)
13.Dr. Bhausaheb Bagal
Member
Professor and Consultant, Dept. of Medical Oncology,
Tata Memorial Hospital, TMC
MaleClinician (Medical Oncology)
14.Dr. Nitin S Shetty
Member
Prof. Interventional Radiology,
Tata Memorial Hospital, TMC
MaleClinician (Interventional Radiology)

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 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 oncology and in allied specialties
  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-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 Members of TRAC.

Data Safety and Monitoring Unit (DSMU)

The Data Safety Monitoring Unit (DSMU) 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 Data Safety Monitoring Unit 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.

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

DSMU Members

TMC IEC-III, Data Safety and Monitoring Unit (DSMU) have been reconstituted from 1st July 2020 for 2 years.

Sr. No.Name & PositionAffiliationGenderExpertise
1.Dr. Reshma Ambulkar
Member Secretary
(IEC-III Member)
Professor & Anaesthetist ‘F’, Dept. Of Anaesthesia, Critical Care & Pain, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC) & Tata Memorial Hospital, TMC.FemaleClinician (Anaesthetist & Intensivist)
2.Dr. Sachin Punatar
Member-Joint Secretary
Assistant Professor & Medical Oncology ‘E’, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)MaleClinician (Medical Oncology)
3.Dr. Ashok Varma,
Member
Scientific Officer ‘G’, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)MaleBasic Scientist
4.Dr. Vikram Gota
Member
Associate Professor & Clinical pharmacologist ‘F’, Department Of Clinical Pharmacology, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)MaleBasic Medical Scientist (Clinical- Pharmacologist)
5.Dr. Purvi Thakkar
Member
Assistant Professor ’E’, Consultant Surgeon, Tata Memorial Hospital, TMCFemaleClinician (Surgical Oncology)
6.Dr. Anant Gokarn
Member
Asst. Professor, Medical Oncology (Adult HL) Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)MaleClinician (Medical Oncology)
7.Dr. Madhavi Desai
Member
Associate Professor & Anaesthetist F, Dept. Of Anaesthesia, Critical Care & Pain, Tata Memorial Hospital, TMCFemaleClinician (Anaesthetist & Intensivist)
8.Dr. Sonam Mehrotra
Member
Scientific Officer D, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)FemaleBasic Scientist
9.Dr. Syed Hasan
Member
Scientific Officer E, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)MaleBasic Scientist
10.Dr. Sharayu Mhatre
Member
Scientific Officer D, CCE, Advanced Centre For Treatment, Research & Education In Cancer (ACTREC)FemaleBasic Scientist(Epidemiologist)

The mandate of the TMC-IEC III Data Safety and Monitoring Unit (TMC IEC-III, DSMU) are to:

As a national cancer centre, the TMC needs to ensure that research data generated by the investigators are of high quality, reliable and verifiable. To accomplish this objective, the DSMU is charged with the mission of developing and implementing quality assurance procedures to monitor the overall progress of institutional clinical trials and ensuring adherence to procedural requirements.

This includes -

  • Review of overall progress of IEC approved clinical trials/studies to ensure the safety of participants.
  • Checking the enrollment to ensure that the projected accrual goals are met on a timely basis and do not fall below minimum acceptable standards.
  • Serious adverse events and off-site serious adverse events are appropriately monitored and reported to the IEC.
  • Ensure that eligibility criteria are followed as per IEC approved study protocol and risk-benefit ratio to the patient remains acceptable.
  • Enhance the quality of the research by providing the investigator with constructive criticism.
  • Provide regular reports to the Institutional Ethics Committee.

The DSMU will meet on third Wednesday of every month at 02.00 p.m (unless otherwise notified) in the Conference Room, Khalolkar Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai.

List of Forms for PIs / Research staff effective from 28.04.2021 for human study

Sr. No.Title
1.Project Submission Form
2.checklist of document
3.Template for Participant Information Sheet and ICF
4.Template for Child Information Sheet and Assent Form
5.Template for Parent Information sheet and ICF
6.Template for Participant Consent for prospective audit study
7.Template for Parent - LAR Consent for prospective audit study
8.Template for Child Assent for prospective audit study
9.Informed Consent Template for Audio-Visual Recording
10.IEC form for re-review of research proposals
11.instructions for PI for submission of projects
12.Expedited review form
13.Review exemption form
14.Post approval Amendment Reporting Form
15.Continuing Review Application Form
16.Continuing Review Application Form - Basic Human Study
17.Deviation (D) Violation (V) Form
18.Serious Adverse Event Report
19.Off-site Safety Reports Classification Form
20.Off-site safety log
21.Document request form
22.Study Completion Report
23.Premature Termination - Suspension - Discontinuation Report
24.Application form for requesting waiver of consent
25.Monitoring Form
26.Summary list of changes

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:

IEC SOPs effective from 28.04.2021- Kindly request (irb @actrec.gov.in) IRB to provide copy of IEC SOP.

 

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@actrec.gov.in

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