1. Central Drugs Standard Control Organization (CDSCO) – The New Drugs and Clinical Trial rules; 2019. Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ==. [Last accessed on 2022 Jan 18].
2. Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants; 2017. Available from: https://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf. [Last accessed on 2022 Jan 18].
3. Accreditation of ethics committees: Experience of an ethics committee;Kulkarni;Indian J Med Ethics,2015
4. Ethical issues in clinical research;Muthuswamy;Perspect Clin Res,2013
5. Projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital;Kuyare;J Postgrad Med,2014