Pinals D A, Appelbaum P S
Department of Psychiatry, University of Massachusetts Medical School, Worcester 01655, USA.
Isr J Psychiatry Relat Sci. 2000;37(2):82-94.
Informed consent to research has recently become a focus of public attention as questions have been raised about the adequacy of information disclosed to potential research subjects and about the competence of psychiatric research subjects to provide valid informed consent to participate in potentially high risk studies. Around the world, policies and position statements have been written to address these concerns and to offer suggestions to protect potentially vulnerable research subjects, such as persons with neuropsychiatric disorders. Relevant literature has demonstrated that a subset of persons with such disorders have significant competence-related deficits, and thus may require specific means of protection with regard to informed consent to research. Recent guidelines offered to improve the informed consent process include review of potential studies for scientific merit and potential risk, assessment of subject competence to consent to research, and the use of proxy decision-makers when subjects are deemed incompetent.
随着人们对向潜在研究对象披露的信息是否充分以及精神病学研究对象参与潜在高风险研究提供有效知情同意的能力提出质疑，研究中的知情同意最近已成为公众关注的焦点。在世界各地，已经制定了政策和立场声明来解决这些问题，并为保护潜在的弱势研究对象（如患有神经精神疾病的人）提供建议。相关文献表明，患有此类疾病的一部分人存在与能力相关的重大缺陷，因此在研究知情同意方面可能需要特定的保护措施。最近为改进知情同意程序提供的指导方针包括审查潜在研究的科学价值和潜在风险、评估研究对象同意参与研究的能力，以及在研究对象被认为无能力时使用代理决策者。
