Gupta Umesh Chandra, Kharawala Saifuddin
Sr. Research Scientist, Medical Affairs and Clinical Research, Fresenius Kabi India Pvt. Ltd., Gurgaon, India.
Perspect Clin Res. 2012 Jan;3(1):8-15. doi: 10.4103/2229-3485.92301.
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.
在涉及精神能力减退和同意能力受损受试者的精神病学临床研究中获取知情同意，一直是研究人员面临的一项挑战，由于参与者存在认知缺陷以及判断现实的能力受损，这引发了许多伦理问题和程序障碍。相关法规似乎并不完善，提供的指导有限，不足以解决与从决策能力受损者处获取同意相关的不同情况下所固有的所有伦理问题。研究人员正在努力在风险效益比、研究进展和研究对象的自主性之间找到平衡。受启发于改进精神病学临床研究中的同意程序，人们开展了许多研究，聚焦于各种与知情同意相关的伦理问题，目的是制定适当策略并优化精神病学临床研究中的知情同意程序，克服伦理问题。本文批判性地审视了各种伦理问题和同意挑战、其潜在原因，并探讨了在从同意能力受损的受试者处获取知情同意以参与精神病学临床研究时需要采用的适当策略和做法。
