Genuine informed consent a challenge in clinical trials

The informed consent document (ICD) is the most important document in a clinical trial. Prospective participants sign the ICD after they have been informed of all the aspects of the trial relevant to their decision, thus allowing them to make an express choice to voluntarily participate in the trial. The principle underlying informed consent is the right to self-determination of every adult of sound mind.

Informed consent is not just a signature on a form but an ongoing process of exchange of information between the investigator and the participant. For a legally effective informed consent by the participant or their legally authorized representative (LAR), the consent should be freely given and not obtained by coercion, undue influence, fraud, mistake or misrepresentation.

ICD contents

In trials conducted in India, the ICD is set out in the Drugs and Cosmetics Rules, 1945, in Appendix V of Schedule Y, with an ethics committee (EC) or institutional review board (IRB) having the final authority for ensuring the adequacy of the information in the ICD. In clinical trial studies that are subject to US Food and Drug Administration regulations, the ICDs should meet the requirements of title 21 of the Code of Federal Regulations (CFR) 50.20 and contain the information required by each of the basic elements of 21 CFR 50.20(a) and each of the six elements of 21 CFR 50.20(b) that is appropriate to the study.

Dr Rachna Bharadwaj is an associate at Krishna & Saurastri Associates and an advocate registered with the Bar Council of India.