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TMC-ACTREC IEC

Registered with DCGI, Registration No. ECR/149/Inst./MH/2013

The TMC-ACTREC Institutional Ethics Committee (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 was reconstituted in January 2012.The present committee comprises of 15 members. In addition, the IEC seeks the help of domain experts from time to time to deliberate on projects where in–house expertise not available. The committee is well rounded with representation from clinical faculty, basic sciences, lay community and legal profession. The committee has met 24 times in the last four years and more than 125 projects have been discussed so far. The entire spectrum of studies involving human subjects including epidemiological studies, biological studies on human tissues, observational studies, surveys, questionnaires, audits,  studies on Quality of Life, Knowledge Attitude Practice (KAP) studies, cross sectional or longitudinal cohort studies, for response, toxicity and other outcomes in patients undergoing standard of care and human clinical trials using drugs or additional invasive intervention  have been discussed and approved by the committee. ACTREC has a two- bedded dedicated phase I clinical trials unit.  Five phase I clinical trial projects have been discussed in the committee so for of which two are approved. In addition to studies involving human subjects, the committee also provides critical scientific review for in vitro studies and those involving evaluation of physics/equipments/software etc not involving animal or human subjects,  at the behest of the Directors of ACTREC / Tata Memorial Centre, especially for such projects being submitted for grants from intramural agencies. The  Committee has currently applied for accreditation of the prestigious Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Mandate:

The TMC-ACTREC IEC provides combined scientific and ethics review of research projects being conducted at ACTREC with or without a component at Tata Memorial Hospital. Research studies may involve small or large animals or human subjects.  These projects involve participation of human subjects including but not restricted to retrospective chart reviews, observational studies, questionnaires, audits, epidemiological studies, and all kinds of interventional studies including clinical trials of novel drugs/devices/procedures. The IEC will also provide critical scientific review for selected studies involving animals, before forwarding them to Institutional Animal Ethics Committee (IAEC)

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

1. Studies not involving living subjects:

These studies would normally not require IEC approval and as per the requirement of the extramural funding agency (e.g. DBT), they would be forwarded by Director ACTREC to the funding agencies. However, in certain situations, Director ACTREC may refer any new, ongoing or completed studies to this IEC for critical scientific review before considering them for competitive Intramural grants; before forwarding for extramural funding or if there is a concern regarding some IPR issue or its scientific credibility. 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

2Studies involving non human living subjects

a. In vivo studies on small animal models (before forwarding to Institute Animal Ethics Committee): These studies  normally not require IEC approval and will be  directly reviewed by the IAEC. However, in certain situations, Director ACTREC may refer any new, ongoing or completed studies on small animals to this IEC for critical scientific review before considering them for competitive Intramural grants, before forwarding for extramural funding or if there is a concern regarding some IPR issue or its scientific credibility.

b. Biological or Clinical studies and trials in naturally occurring cancers and other conditions in dogs, cats or other animals (experimental studies in primates / healthy dogs / other large animals will not be considered by this IEC).

3. 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.

Name and Address of the IEC:

Tata Memorial Centre- Advanced Centre for Treatment, Research & Education in Cancer Institutional Ethics committee (TMC-ACTREC IEC),

Paymaster Shodhika, First floor,

ACTREC,  Kharghar, Sector 22

Navi Mumbai 410210

Contact no: 27405154,   email id: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

As per DCGI registration dated 20th April 2013, Institutional Review Boards (IRBs) are renamed as “Institutional Ethics Committees” and are reconstituted from 15th October 2013 till 31st  December 2013

Members list  (IEC-III)  01.04.2014 to 31.03.2016

Sr. No.

IEC-III

Registration No. ECR/149/Inst/MH/2013

Affiliation

Gender

Expertise

 

Dr. Rita Mulherkar

Chairperson

Kharghar, Navi Mumbai.

Female

Basic Scientist

 

Dr. Nobhojit Roy

Co-Chairperson

Dept of Surgery,  BARC Hospital, Mumbai

Male

Surgeon

 

Dr. Vedang Murthy

Member Secretary

Associate Professor, Dept. of Radiation Oncology, ACTREC

Male

Radiation Oncologist

 

Dr.Vikram Gota

Member

Associate  Professor, Dept of Clinical Pharmacology, ACTREC

Male

Clinical Pharmacologist

 

Dr. Aliasgar Moiyadi

Member

Associate  Professor,  Neuro-Surgery, ACTREC

Male

Surgeon

 

Dr. Tejpal Gupta

Member

Associate Professor, Dept. of Radiation Oncology, ACTREC

Male

Radiation Oncologist

 

Dr. Kumar Prabhash

Member

Professor  Dept of Medical Oncology, Tata Memorial Hospital

Male

Medical Oncologist

 

Dr. Navin Khattry

Member

Professor,  Dept of  Medical Oncology, ACTREC

Male

Medical oncologist

 

Dr. Bharat Reiki

Member

Professor, Dept of Pathology, Tata  Memorial  Hospital, Mumbai.

Male

Pathologist

 

Dr. Prasanna Venkataraman

Member

Scientific Officer ‘F’, ACTREC

Female

Basic Scientist

 

Dr. B.B. Singh

Member

Advocate, Mumbai High Court

 

Male

Legal Expert

 

Dr. Manoj Mahimkar

Member

Scientific Officer ‘F’, ACTREC

Male

Basic Scientist

 

Mrs. Sadhana Kannan

Member

Scientific Officer ‘E’ Data Manager, ACTREC

Female

Bio-statistician

 

Mrs. Lakshmi. R.

Member

Co-ordinator, Sanjeevani  life beyond cancer, Mumbai.

Female

Social Scientist

 

Mrs. Deepa Ramani

Member

Ex-play group teacher, store and purchase in-charge, Kharghar.

Female

Layperson

 

The IEC-III will meet  on Third Friday of every month at 10.00a.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.

Data Safety Monitoring Committee (DSMC):

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

The mandate of the TMC-ACTREC Data Safety Monitoring Committee (TMC-ACTREC DSMC) is 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

 

List of DSMC Members:

 

Names

Affiliation

Gender

Expertise

1

Dr.  Aliasgar Moiyadi

Member  Secretary

Associate  Prof, Neuro-Surgery, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Clinician

2

Dr.  Supriya Chopra

Joint Member Secretary

Associate Prof, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Clinician

3

Dr. Tabassum W

Member

Asst Prof, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Clinician

4

Dr. Bhausaheb Bagal

Member

Asst Prof, Dept of Medical Oncology, Tata Memorial Hospital

Male

Clinician

5

Dr. Prafulla  Parikh

Member

Asst Prof, General Medicine, Advanced Centre for Treatment, Research and Education in Cancer, (ACTREC)

Female

Clinician

6

Dr. Amol Kothekar

Member

Asst Prof, Intensive care  Medicine,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Clinician

7

Dr. Sudhir Nair

Member

Asst Prof, and Clinician Scientist E,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Clinician Scientist

8

Dr. Rukmini Govekar

Member

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

Female

Scientist

9

Dr. Sanjay  Gupta

Member

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

Male

Scientist

 

 

 


Human study

Forms for Principal Investigators / Research staffs (Effective from 1.5.2014)

1. Project submission form for human study

9. Protocol deviation form

2. Checklist of documents

10. SAE submission form

3. ICF template

11. Offsite Safety  report classification form

4. Child assent form and parent consent template

12. Off site safety log

5. Review exemption form

13. Document request form

6. Expedited Review Application form

14. Study completion Form

7. Amendment reporting form

15. Premature termination form

8. Continuing Review Application Form 16. Waiver of consent request form

 

 

Link for IEC SOPs effective from 1.5.2014

 

Last updated on 19.08.2014

Contact Us

Advanced Centre for Treatment, Research and Education in Cancer

Kharghar, Navi Mumbai - 410 210, india

Phone:+91-22-2740 5000

Fax: +91-22-2740 5085

E-mail : This email address is being protected from spambots. You need JavaScript enabled to view it.