Shore D
Division of Clinical and Treatment Research, National Institute of Mental Health, Rockville, MD 20857, USA.
Psychopharmacol Bull. 1996;32(1):7-10.
In conclusion, several points are worth emphasizing at this juncture: 1. Clinical researchers must attend to a set of ongoing concerns in new ways and reconsider how best to explain research protocols to potential subjects. Consent procedures and documents 5 or 10 years old may not be considered adequate by current standards. It is clearly important to ensure that consent documents, and the process by which informed consent is obtained and maintained, are state-of-the-art. 2. Many valuable sources of information are available to help researchers, family members, and potential participants learn about proper informed consent. NIMH is taking steps to improve this educational process. Members of IRBs are educated through conferences, newsletters, case books, etc. OPRR (May 1994) has also provided considerable information relevant to informed consent in clinical research. OPRR and NIMH staff may be useful sources of information concerning informed consent. 3. Research on competency and the consent process itself is needed so we can compare what was explained with what was understood and learn what research subjects want to know, what they believe has occurred, and why. 4. Progress in discovering the underlying causes of schizophrenia and other severe mental disorders, and improving their treatment, will require scientifically rigorous studies involving people affected by these disorders. Attempts to prohibit competent people with mental disorders from making decisions about participating in research protocols seem misguided, paternalistic, and stigmatizing. If we are to improve the treatment of severe mental disorders, clinical research is essential, including research that is not likely to directly benefit each individual participating. 5. This is a time of great opportunity for clinical research. New medications being tested have the potential to revolutionize the treatment of severe mental disorders. During recent years, a number of large scale projects have been focusing on underlying genetic vulnerability factors that may shed light on the etiology of these disorders, with profound implications for diagnosis, treatment, and eventually even prevention. Unfortunately, clinical research is also under attack on several fronts, including concerns about consent and the protection of human subjects with mental disorders. If we do not take steps now to ensure that the process by which we protect and inform research participants is state-of-the-art, the very progress we seek will be at risk.
总之，在这个关头有几点值得强调：1. 临床研究人员必须以新的方式关注一系列持续存在的问题，并重新思考如何最好地向潜在受试者解释研究方案。按照当前标准，5年或10年前的同意程序和文件可能不被认为是充分的。确保同意文件以及获得和维持知情同意的过程是最新的，这显然很重要。2. 有许多宝贵的信息来源可帮助研究人员、家庭成员和潜在参与者了解适当的知情同意。美国国立精神卫生研究所正在采取措施改善这一教育过程。机构审查委员会的成员通过会议、时事通讯、案例书籍等接受教育。保护研究风险办公室（1994年5月）也提供了与临床研究中的知情同意相关的大量信息。保护研究风险办公室和美国国立精神卫生研究所的工作人员可能是有关知情同意的有用信息来源。3. 需要对能力以及同意过程本身进行研究，以便我们能够比较所解释的内容与所理解的内容，并了解研究受试者想知道什么、他们认为发生了什么以及原因。4. 发现精神分裂症和其他严重精神障碍的潜在病因并改善其治疗方法的进展，将需要涉及受这些疾病影响的人的科学严谨的研究。试图禁止有能力的精神障碍患者就参与研究方案做出决定似乎是错误的、家长式的且带有污名化的。如果我们要改善对严重精神障碍的治疗，临床研究至关重要，包括那些不太可能直接使每个参与个体受益的研究。5. 这是临床研究的一个绝佳机遇期。正在测试的新药物有可能彻底改变对严重精神障碍的治疗。近年来，一些大型项目一直专注于潜在的遗传易感性因素，这些因素可能有助于揭示这些疾病的病因，对诊断、治疗乃至最终的预防都具有深远意义。不幸的是，临床研究也在多个方面受到攻击，包括对同意以及对精神障碍患者的保护等问题的担忧。如果我们现在不采取措施确保我们保护和告知研究参与者的过程是最新的，我们所追求的进展将面临风险。
