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INSTITUTIONAL ETHICS COMMITTEE (IEC): 

Our Hospital has an Institutional ethics Committee with a mix of professionals and lay people as laid down by the ICMR in its guidelines for the Ethics Committee and its Compliance with GCP guidelines and its amendments of schedule Y of Drugs & Cosmetics Act, 1945. As directed by the Govt. of India, the IEC of SGCCRI is registered with CDSCO with Registration number ECR/250/Inst/WB/2013 as per the provisions of Rule 122DD of the Drugs and Cosmetics Rule, 1945.

IRB/IEC & its working procedures:

Objectives
1.1 The Institutional Ethics Committee (IEC) of Saroj Gupta Cancer Centre & Research Institute (SGCC&RI) will review and consider approval of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of all actual and potential research participants. The goal of research, however important, will never be permitted to override the health and well being of the research subjects/volunteers.
1.2 The primary task of IEC, SGCC&RI lies in the review of research proposals and their supporting documents, with special attention given to the informed consent process, documentation, and the suitability, credibility and feasibility of the protocol. IEC may take into account the requirements of applicable laws and regulations as per Schedule Y (2005) provisions of Government of India. IEC may consider review of research proposals intended to be conducted at study sites at Cancer Centre Welfare Home & Research Institute (SGCC&RI) and its related Hospital and other satellite centers.

Members
NAME & Profession DESIGNATION
Honb’le Justice (Retd) Ajit Kumar Nayak
Retd. Justice, High Court, Calcutta
Chairperson
Mr Anjan Gupta
B Arch, M Arch. MCP
Architect
Member Secretary
Dr Arnab Gupta
MBBS, FRCS
Medical Profession, Oncosurgeon
Director, SGCC & RI
Bishop Dr. Dinesh Ch. Gorai
Religious Person
Retired Arch Bishop
Dr Manas Nath Bandyopadhyay
Medical Profession,
Radiation Oncologist
Sr. Radiation Oncologist & Research Officer,
I/C Cancer Control Wing, SGCC & RI 700 063
Dr Samir Bhattacharyya
Medical Profession Oncosurgeon
HOD, Dept. of surgical oncology, SGCC & RI
Dr Chinmoy Bose
Medical Profession
Gynecologist
Consultant Gynaecologist,
Netaji Subhas Chandra Bose Cancer Institute Kolkata.
Prof Susanta Roychowdhury
Basic  Scientist
Dy.Director
IICB, Jadavpur
Dr Madhuchanda Kar
Medical Profession
Consultant Medical Oncologist, SGCC & RI
Mrs Vijaya Mukherjee
Social Worker
Founder, President “Hitaishini”,
Mrs Salony Priya
Ethicist + Councellor
Counseling Psychologist,
Director UMEED- Positive Living Initiative
Ms Debjani Aich
Media Person
Sr. Producer, Akhon Samay

IEC working Procedure
The Investigator shall submit 13 (Thirteen) copies of the detailed project proposal for review of the ethics of proposed biomedical research along with a forwarding letter, the format of which is annexed (Annexure-I). The documents to be enclosed along with are:
The protocol of the proposed research clearly, together with supporting documents;(vide the essential sections of a protocol Annexure III)
A summary flowchart of the protocol procedural steps;
Case report forms and other questionnaires;
A brief summary of study purpose, methods, product information, risks and benefit of participation in the study, described in non-technical parlance, meant for patient information;
A summary of all safety, pharmacological, pharmaceutical , and toxicological data available on the study product, together with a summary of clinical experience with the study product to date e.g., recent investigator's brochure(IB), published data, a summary of the product's characteristics;
Investigators' curriculum vitae, updated, signed, and dated;
A statement by the Investigator detailing the mechanism to be followed in recruiting of potential research participants, including mention of advertisements, if any;
A description of the process to be used to obtain and document consent;
Informed consent form and dated in English and in vernacular.
A statement by the investigator,  of estimated expenditure and the mode of funding/sponsorship;
A statement describing any compensation for study participants including expenses and access to medical care to be given to research participants;
A description of the arrangements for indemnity, or the arrangements for insurance coverage for research participants, if applicable;
A statement of agreement by the investigator to comply with ethical principles set out in GCP & ICMR guidelines;
All significant previous decisions (e.g., those leading to a negative decision or modified protocol by other IECs or regulatory authorities for the proposed study) whether in the same location or elsewhere and an indication of modifications to the protocol made on that account. The reasons for previous negative decisions should be provided.
The investigator must state any conflict of interest on the study and its ethical concern.
The investigator informs IEC of SAE within 24 hours.

Documents to be submitted to the Institutional ethics Committee
Nature of Research [see categories mentioned above]
Phase of Trial
Research proposal in detail including inclusion & exclusion criteria
Research proposal in plain language
Informed consent form (see sample in Appendix – in English, Bengali & Hindi with a translator’s certificate)
Case Record Form (CRF) or electronic Case Record Form (eCRF)
Regulatory Approvals: DCGI Certificate, Ethics committee approval from other participating institutes.
Purity of molecule certificate (for drug pharmacokinetic efficacy evaluation trials)
Plain language summary of the project
Informed consent forms in English & local languages in a way that can be understood by a lay person

IEC meeting
Institutional Ethics Committee Meetings will be held on an as-needed basis. The aim is to hold 4 meetings in a year. The Member Secretary will call the meeting in consultation with the Chairman. The fee structure of IEC meeting and Expedited IEC meeting are mentioned in the downloadable form for clinical trials & for scholars.
The Member Secretary will screen all submitted proposals, arrange dispatch to individual members of IEC and place the same for discussion in the next meeting.
The meeting proceedings will be recorded and the minutes will be deemed approved after concurrence endorsed by the Chairman;
A minimum of 5 (five) members (out of a total members strength of 12) must be present to form a quorum. One of the members must be from non-medical research background.

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