The informed consent process is a shield which protects subjects from harms that may be caused by a scientific enquiry. Only a competent participant with a complete understanding of the trial can give informed consent. Although the content of a valid informed consent form (ICF) has been established, the Drugs and Cosmetics (First Amendment) Rules, 2013 have stipulated that ICFs must fulfil the requirements of Appendix V of Schedule Y. We considered 50 ICFs and analysed whether they complied with Appendix V. Our analysis reveals a gloomy picture, with 70% of the ICFs deviating from the requirements of the law. We have identified the elements most commonly overlooked in the ICFs analysed. We recommend certain points which must be incorporated into ICFs to help participants better understand the trial. Our findings indicate that adequate action needs to be taken to ensure the protection of the rights of research participants.

All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal.