An Interactive Web-Based Tool to Enhance Consent for Mental Health Research

描述（由申请人提供）：获得精神病临床试验知情同意书的标准方法的局限性已得到充分证明。经验数据表明，借助多媒体学习方法，精神病患者可以被教导或“启动”有关临床试验和知情同意本身的一般知识，这种启动促进每个人的能力，以有效地和有效地参与同意过程期间和之后的同意书审查特定的临床试验协议。本申请是通过行为技术研究公司，一个在开发和销售基于网络的多媒体健康教育材料方面具有专业知识的小企业，以及加州大学圣地亚哥分校（UCSD）的研究人员，他们在决策能力和加强精神病学研究的知情同意方面具有专业知识。目前第1阶段申请的具体目标如下。目标1：开发一种基于网络的多媒体工具，可用于在开始审查方案特定信息之前对受试者进行研究和知情同意方面的教育。这一工具还将纳入对参与者对披露信息的理解的标准化评估。目标二：在参加精神分裂症或双相情感障碍III期药物临床试验的30名患者中进行同意援助原型（与常规同意）的随机对照比较。关于同意援助的有效性的数据以及参与者的意见/反应和专家咨询小组的反馈将为进一步完善原型同意工具提供信息。第二阶段（我们将在第一阶段成功完成后申请）将集中于更大规模的适应/改进和测试，以便随后进行营销和广泛传播。 公共卫生相关性：显然需要进行临床试验，以确定对严重精神疾病患者更安全和更有效的治疗方法。然而，从人道主义和道德的角度来看，同样至关重要的是，那些自愿参加临床试验的人只有在自愿和有能力的知情同意下才能参加。该项目将开发和验证一个网络媒体同意工具，旨在评估参与者的理解。它还将促进潜在的临床试验参与者对精神病临床试验和知情同意过程本身的更深入理解，以帮助每个人更积极有效地参与个人临床试验方案的同意过程。

DESCRIPTION (provided by applicant): The limitations of standard means of obtaining informed consent for psychiatric clinical trials have been well documented. Empirical data suggests that, aided by multimedia learning methods, psychiatric patients can be taught or "primed with" general knowledge about clinical trials and about the informed consent itself and that such priming facilitates each person's ability to efficiently and effectively participate in the consent process during and after review of consent forms for specific clinical trial protocols. The present application is being proposed through a partnership between Behavioral Tech Research, Inc., a small business concern with expertise in developing and marketing web-based multimedia health educational materials, and investigators at the University of California, San Diego (UCSD) who have expertise in issues of decisional capacity and enhancing informed consent for psychiatric research. Specific aims for the present Phase 1 application are as follows. Aim 1: to develop a web-based multimedia tool that can be used to educate subjects about research and informed consent prior to beginning review of protocol specific information. This tool will also incorporate standardized assessment of participant comprehension of disclosed information. Aim 2: to conduct a randomized controlled comparison of the consent aid prototype (versus routine consent) among 30 patients participating in phase III pharmacologic clinical trials for schizophrenia or bipolar disorder. Data on the effectiveness of consent aid, as well as participant opinions/reactions, and feedback from an expert advisory panel will inform further refinement of the prototype consent tool. Phase II (for which we will apply upon successful completion of Phase I) will focus on larger scale adaptation/refinement and testing for subsequent marketing and widespread dissemination. PUBLIC HEALTH RELEVANCE: There is a clear need for clinical trials to identify safer and more effective treatments for persons with serious mental illness. Yet, it is also critical from a humanitarian and ethical standpoint that those volunteering for participation in the clinical trials only be enrolled with their voluntary and capable informed consent to do so. This project will develop and validate a web-media consent tool designed to assess participant comprehension. It will also foster deeper comprehension among potential clinical trials participants about psychiatric clinical trials and the informed consent process itself, to aid each person in more actively and effectively engaging in the consent process for individual clinical trial protocols.