Informed consent: Are we doing enough?

The process of informed consent is an ethical mandate for all clinical trials. The principles of ethics in research involving human beings decrees the conduct of a process where the prospective research subjects should be informed of all aspects of the research study and after complete comprehension of all the features involved, should express willingness to be a part of the study, and the same should be duly documented. The consent should be fully informed and autonomous. However, with subject populations that are mostly medically naïve and for whom the whole concept of clinical research and the umpteen terms and concepts associated with it are alien; the true essence of an "informed" and "autonomous" decision is largely lost. The consent process thus gets reduced to mainly a "narration-followed-by-signature" process. Over the last few years, this gap in principles and practices of ethics and consent has been acknowledged and innovative concepts and attempts are being fostered, to make the informed consent process more "ethical". The article discusses the loopholes associated with the informed consent process and the innovative concepts to make it more authentic.