Approval of the Institute Review Board, Ethics Committee and Registering with the Clinical Trial Registry
Submission of research protocol with necessary documents to the Institutional Ethics Committee (IEC) for approval.
Proposals with more than minimal risk where invasive and/or non-invasive procedures are carried out should be submitted for full ethics Committee Review.
Patient information sheet and written informed consent forms should be submitted in both English and local language for ethics committee review.
Registration of clinical trials at Clinical Trial Registry of India.
World Health Organization has developed International Clinical Trial Registry Platform (ICTRP), which is a network of Primary Clinical Trial Registers.
- 1.Ethical guidelines for biomedical and health research involving human participants. New Delhi: Indian Council of Medical Research; 2017.Google Scholar
- 2.Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research. Indian Council of Medical Research. http://icmr.nic.in/ethics_SOP.pdf. Accessed on 21st June 2017.
- 3.Recommended format for a Research Protocol. Research Policy. World Health Organization. http://www.who.int/rpc/research_ethics/format_rp/en/. Accessed on 30 June 2017.
- 4.Implementation research toolkit. Workbook on special Programme for research and training in tropical diseases. Geneva: World Health Organization; 2014.Google Scholar
- 5.Frequently Asked Questions. Clinical Trials Registry of India. National Institute of Medical Statistics. Indian Council of Medical Research. http://ctri.nic.in/Clinicaltrials/faq.php. Accessed on 10 July 2017.
- 6.Primary Registries. International Clinical Trials Registry Platform (ICTRP). World Health Organization. http://www.who.int/ictrp/network/primary/en/. Accessed on 17 October 2017.