Institutional Review Board (IRB)
CIHSR Institute Ethics Committee (CIHSR IEC) was set up in 2014 to oversee all the research activities within the hospital premises and jurisdiction. The CIHSR IEC only approves and allows research that qualifies as Biomedical and health research.
Biomedical and health research as defined in Chapter I of the New Drug and Clinical Trials Rules-2019 means research including studies on basic, applied, and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or social-behavioral); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not include clinical trials.
Under the above rule, all ethical committees in India are required to register with the Department of Health Research (DHR) which is under the Ministry of Health and Family Welfare.
Ethical clearance for any research by an independent group is absolutely necessary regardless of any mandate. The core lies in respecting the individual and protecting them from potential exploitation.
ICMR ethical guidelines for research involving human subjects have a strict criterion for the make-up of an ethical committee composed of various individuals from multi-disciplinary and multi-sectoral areas. There should be adequate representation of age and gender. Preferably 50% of the members should be non-affiliated or from outside the institution. The number of members in an EC should preferably be between seven and fifteen and a minimum of five members should be present to meet the quorum requirements. The ethical committee should have a balance between medical and non-medical members/technical and non-technical members.