Institutional Ethics Committee

Human Research Ethics Committee, Indian Institute of Liver and Digestive Sciences (HREC, IILDS)

Sitala East, Sonarpur, Kolkata – 700150

About HREC, IILDS: The Institutional Ethics Committee (IEC) of IILDS is known as Human Resource Ethics Committee, Indian Institute of Liver and Digestive Sciences whose main purpose is to maintain a quality and consistent ethical review mechanism for health and biomedical research for all of the proposals dealt by the committee as prescribed by the Ethical guidelines for biomedical research on human subjects of ICMR, ICH, GCP, Indian GCP and applicable regulatory requirements. HREC-IILDS is located in Sitala East, Sonarpur, Kolkata – 700150.

The committee will ensure a strict concordance with the statements of General principles on Research using Human subjects in specific areas of biomedical research, as laid down by Indian Council of Medical Research (ICMR) and New Drugs Clinical Trials Rules 19th March, 2019 Ministry of Health & Family Welfare, Government of India.

The general purposes of the HREC, IILDS includes:

• The purpose of the ethics committee is to safeguard the dignity, right, safety and wellbeing of all the actual and potential research participants before approving the research proposals. The goals of research proposals however important, should not take precedence to the health and well being of potential human participants.
• The purpose of the research should be directed towards the increase in knowledge about human beings.
• Research should be conducted under the conditions that no one person/persons becomes a mere means for the betterment of other.
• Research is subjected to a regime of evaluation at all stages of proposal which includes design experimentation, statistical validity, declaration and use of result thereafter.
• The mandate of the IEC shall be to review all research projects conducted at the Institution involving human beings directly or indirectly irrespective of whether the research project is funded or non-funded and if funded irrespective of funding agency.
• The study procedures should be conducted under the supervision of medical persons with adequate expertise in clinical trial.
• The clinical study should include patients who have given voluntary and informed consent non-coercively to participate in the clinical study.
• The HREC, IILDS will provide advice to the researchers and Investigators in all aspects of the welfare and safety of the research participants.
• If the HREC, IILDS revoke the approval accorded to the study protocol, reason for the same will be recorded and communicated to the Investigator and licensing authority.
• In case of any SAE or death of the research participants, the committee shall forward its opinion on SAE or death after due analysis and opinion on the financial compensation, if any to be paid by the sponsor with a copy of the report to the licensing authority within prescribed timelines.
• The HREC, IILDS will review both the amount and the method of payment to the research participants to defray expenses and compensation for any loss of income of the participants, and to ensure that this does not amount to coercion, undue influence, misinterpretation or fraud on the trial subjects.
• The HREC, IILDS will perform its responsibilities by prior registration to the Drug Controller General (India) as per the amended Drug & Cosmetic Act 1945, by Ministry of Health & Family Welfare, Government of India.
• The HREC, IILDS will apply for re-registration to the Licensing authority prior to three months of its expiry of the registration and will inform the CDSCO for any change in the member and composition.
• The HREC, IILDS will maintain the list of audits and inspections it has hosted.
• The HREC, IILDS will ensure strict confidentiality of all the documents related to study protocol and its proceedings.

IEC Membership List: The following table contains IEC membership list with name, qualification & role in IEC, specialty, contact details, gender and affiliation: