Newer Practice of Informed Consent Process of Clinical Trials in India

Abstract

Informed consent encompasses imparting information related to risks, rights and benefits of participation to human participants in clinical research studies. This is followed by exercising the right to participate or not in the research study. Consent can be illicitly obtained by means of inducement, force, fraud, or other forms of coercion. Because of the lack of transparency in informed consent process in clinical trials, the Union Health Ministry of India has made audio-visual recording of the informed consent of each participant mandatory in 2013. This study aims to analyse the newly implemented practice of audio-visual recording of the informed consent process in clinical trials. It is a qualitative study based on an in-depth analytical description. The data included notes taken by the researcher and video recordings of the setting being studied. The new process appears to be a better documented process than that of written informed consent, with greater clarity of imparting relevant information of the trial. But elements of anonymity and confidentiality of trial participants, voluntariness in decision-making process and appropriateness of settings were found to be a few limitations of the process. It is necessary to get a better understanding of the challenges following implementation of the new policy in other parts of the country.