Background

The objective of this standard operating procedure is to contribute to the effective functioning of the Institutional Ethics Committee of B. J. Medical College & Civil Hospital, Ahmedabad to ensure a competent and consistent ethical review mechanism for health and biomedical research proposals dealt by the committee as prescribed by the Ethical guidelines for biomedical research on human subjects of Indian Council of medical research (ICMR). The Ethics Committee of B. J. Medical College & Civil Hospital Ahmedabad is an Institutional Ethics Committee (IEC). IEC will review and approve all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of research participants. The goal of  research, however important would never be permitted to override the health and well being of the

research subjects. Independence and competence will be the two hall marks of Ethics Committee. The IEC will take care of all cardinal principles of research ethics viz. Autonomy, Beneficence, Non-maleficence and Justice in planning, conduct and reporting of the proposed research. For this purpose, it will look into the aspects of informed consent process, risk benefit ration, distribution of burden and benefit and provisions for appropriate compensations whenever required. It will review the proposals before start of the study as well as monitor the research throughout the study until and after the completion of the study through appropriate well documented procedures. The committee will also examine compliance with all regulatory requirements, applicable guidelines and laws.