The big Cs of the informed consent form: compliance and comprehension.

ABSTRACT

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.