TMC-IEC III (ACTREC IEC)

Re-registered with DCGI, Registration No. ECR / 149 / Inst. / MH / 2013 / RR / 2016

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).

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 -

a. In vitro study on established cell lines (other than embryonic stem cells)

b. Physics / Equipment / Software R&D studies not involving animal or human subjects

2. Studies involving Human subjects: Such studies could be

a. 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.

b. 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.

c. Observational studies, surveys, questionnaires, audits for various demographic, symptoms, Quality of life , Knowledge Attitude Practice, dietary variable etc.

d. Cross sectional or longitudinal cohort studies for response, toxicity and other outcomes in patients undergoing standard of care (as listed in TMH EBM guidelines).

e. 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).

  1. Research on Embryonic Stem Cells.
  2. 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.

As per DCGI registration dated 20th April 2013, Institutional Review Boards (IRBs) are renamed as “Institutional Ethics Committees” and are reconstituted from 1st April 2016 till 31st March 2018

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

 

Meeting Schedule :

The IEC-III meets on Third Friday of every month at 10.00 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".

Contact IEC staff :

 

IEC-III Administrator : Ms. Kasturi Awatagiri

 

DSMU Coordinator : Mr. Bhavesh Bandekar

 

Clerical Staff : Ms. Nilam Sawant

 

Name and Address of the IEC:

 

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 id: irb@actrec.gov.in

 

List of Members (IEC-IEC III)  01.04.2018 to 31.03.2020


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

Associate 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

Female

Clinical Pharmacologist (Basic Medical Scientist)

5. 

Mrs. Deepa Ramani
Member

Ex-play group teacher, store and purchase in-charge, Zenith Spinners Ltd.

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, Teni Lab, 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 DSMU Secretary

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, Shilpee Lab, 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 mandate of the committee is 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

Data Safety and Monitoring Unit (DSMU):

The Data Safety and Monitoring Unit (DSMU) is a subcommittee of the IEC, supported by well staffed DSMU whose primary responsibility is to review annual reports and safety issues (SAES, PSUR etc) related to projects approved by the IEC. The DSMU comprises of a Physician, an intensivist, basic scientists and medical, surgical and radiation oncologists. The Members of DSMU are trained in causality assessment as per WHO criteria and routinely implement them in assessing the relatedness of adverse events.

List of DSMU Members:

TMC IEC-III, Data Safety and Monitoring Unit (DSMU) have been reconstituted from 1st April 2018 for 2 years.

Sr No.

Names

Affiliation

Gender

Expertise

1

Dr.  Reshma Ambulkar

Secretary

Professor, Dept. of Anaesthesia, Critical Care and Pain, ACTREC, TMC

Female

Clinician (Intensivist)

2

Dr.  Jayant Goda

Joint Secretary

Professor, Dept. of Radiation Oncology, ACTREC, TMC

Male

Clinician Scientist

3

Dr. Vikram Gota

Member

Associate Professor and Scientific officer ‘F’, Dept. of Clinical Pharmacology, ACTREC, TMC

Male

Clinical Pharmacologist

4

Dr. Jyoti Kode

Member

Scientific officer ‘F’, Chiplunkar Lab,ACTREC, TMC

Female

Basic Scientist

5

Dr. Shalaka Joshi

Member

Associate Professor, Dept of Surgical Oncology, Room No. 1207, Homi Bhabha Block, Tata Memorial Hospital, TMC

Female

Surgeon

6

Dr. Sachin Punatar

Member

Assistant Professor, Medical Oncology, Tata Memorial Hospital, TMC

Male

Clinician

7

Dr. Malini Joshi

Member

Professor, Dept. of Anaesthesia, Critical Care and Pain, ACTREC, TMC

Female

Clinician

8

Dr. Vijay Patil

Member

Assistant Professor, Medical Oncology, Tata Memorial Hospital, TMC

Male

Clinician

9

Dr. Amit Dutt

Member

Principal Investigator, Dutt Lab, ACTREC, TMC

Male

Basic Scientist

10

Dr. Ashok Varma

Member

Principal Investigator, Varma Lab, ACTREC, TMC

Male

Basic Scientist

 

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

  1. Monitor the overall progress of institutional clinical trials and for ensuring adherence to clinical trial and procedural requirements.
  2. Ensure the safety of participants, validity of data, projected accrual goals is maintained.
  3. Ensure that eligibility and evaluation criteria that are followed and risks are not excessive.
  4. Adverse events are appropriately monitored and reported to the appropriate agencies.
  5. Enhance the quality of the research by providing the investigator with constructive criticism.
  6. Provide regular reports to the Institutional Ethics Committee.

The TMC IEC-III, DSMU will meet  on Third Friday of every month at 9 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai.

 

List of IEC Forms for Principal Investigators/ Research Staffs/Patients Effective from 03.10.2018 (Version 5)

1a Project submission form 7a CRA/ASR Form A Interventional studies
1b Revised submission template 7b CRA/ASR Form B Basic Research
1c Classification of Project-ACTREC 8 Deviation (D) Violation (V) Form
2 Checklist of Documents 9 SAE Form
3a Informed Consent Document Template 10 Off-site Safety Reports Classification Form and Report Log
3b Child Assent Form 11 Document Request Form
3c Parent Consent Form 12 Study Completion Report
3d Consent for Prospective Audit Study Patients 13 Premature Termination Suspension Discontinuation Report
3e Parent/LAR Consent for Prospective Audit Study 14 Waiver of Consent Request Form
3f Child assent form for Prospective Audit Study 15 Study Monitoring Form
3g Audio Visual Recording ICF Template 16 Instructions for Submission of Projects for IEC Approval
4 Review Exemption Application Form 17 Summary list of changes (along with form 1b)
5 Expedited Review Application form 18 Request for Formulation of new SOP/ Revision of SOP
6 Amendment reporting form 19 Dealing with Patients Requests Complaints Form

 

Link for IEC SOPs V5 effective from 3.10.2018

 


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)

Mr. Bhavesh Bandekar (For queries in processing submission)

Contact No: 022 2540 5126

 

 

Last updated on 04.04.2018