Bio-Smart Independent Ethics Committee

the “bio-smart independent ethics committee” (bio-smart iec) is an independent body constituted of medical/scientific professionals and non-medical/non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving the protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. the bio-smart iec is functioning in accordance with ich- gcp guideline, ethical guideline for biomedical research in human subjects by indian council of medical research, new delhi and as per requirements laid down in the indian gcp and schedule y and its amendments. detailed procedure of iec functioning is defined in the bio-smart iec’s standard operation operating procedures in compliance to requirements of national a