title: Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations.
abstract: Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants' cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research.
authors.affiliation: Sr. Research Scientist, Medical Affairs and Clinical Research, Fresenius Kabi India Pvt. Ltd., Gurgaon, India.
authors.forename: Umesh Chandra
authors.initials: UC
authors.lastname: Gupta
authors.forename: Saifuddin
authors.initials: S
authors.lastname: Kharawala