Implementing Evidence-based Informed Consent Practices to Address the Risk of Alzheimer's Dementia and Cognitive Impairment in Clinical Trials

项目摘要 知情同意是研究道德行为的基石。这对研究提出了挑战。 涉及患有阿尔茨海默病或认知障碍的参与者。一方面，认知 障碍可能会干扰理解、欣赏和推理信息的能力，潜在地 损害了同意的质量。另一方面，研究掌握着治疗进展的关键 那些患有阿尔茨海默氏症和认知障碍的人。将个人排除在研究之外可能会阻碍 进步。它通常也是不必要的，因为遵循知情同意的最佳实践通常可以 个人或其代理人提供同意，同时充分保护参与者。 1级证据表明以下每个最佳实践在涉及患者的研究中都有好处 老年痴呆症：(A)在同意书或同意书中使用通俗易懂的语言和数字；(B)评估 参与者使用有效措施对同意信息的理解；(C)讨论同意信息 在评估过程中被误解的个人；及(D)评估任命代理决定的能力- 制造者或学习伙伴。 我们的初步研究表明，这些最佳实践并没有得到常规遵循，一些研究 在临床试验中发现同意过程中持续存在的问题。因此，拟议项目的目的是 在临床研究协调员(CRC)和主要研究人员之间实施同意最佳实践 (PIS)在美国。 该项目将使用对CRC、PI、阿尔茨海默病家庭成员和IRB的调查和访谈 成员或工作人员，以确定当前的做法和实施同意最佳做法的障碍。知情者 通过调查和访谈数据，我们将测试基于Web的工具包的有效性，并使用资源解释 并促进使用同意的最佳做法。我们将在实施中将工具包推送到CRC/PI 使用Twitter、Facebook和LinkedIn等社交媒体平台的小组(n=600)，并将审查 实施小组的结果(例如，态度、采用意图和采用最佳做法)是否 优于对照组(n=300)。 通过更多地使用同意最佳做法，这项创新的研究将对 对患有阿尔茨海默病或认知障碍的参与者进行临床试验的道德行为，并将 减少招募阿尔茨海默病患者的门槛。它还将增进我们对 如何在研究伦理中实施最佳实践，这一点很重要，因为目前的方法是 效果不佳。

Project Summary Informed consent is a cornerstone of the ethical conduct of research. This poses a challenge for research involving participants with Alzheimer's disease or cognitive impairments. On the one hand, cognitive impairment can interfere with the capacity to understand, appreciate, and reason with information, potentially compromising the quality of consent. On the other hand, research holds the key to treatment advances for those with Alzheimer's dementia and cognitive impairment. Excluding individuals from research can impede progress. Its is also often unnecessary, because following best practices for informed consent can often enable individuals or their surrogates to provide consent while adequately protecting participants. Level 1 evidence indicates benefits of each of the following best practices in research involving patients with Alzheimer's disease: (a) Use plain language and figures in consent forms or consent aids; (b) assess participants' understanding of consent information using a validated measure; (c) discuss consent information that individuals misunderstood during assessment; and (d) assess ability to appoint a surrogate decision- maker or study partner. Our preliminary research indicates that these best practices are not routinely followed, and some studies find persistent problems with the consent process in clinical trials. Accordingly, the proposed project aims to implement consent best practices among clinical research coordinators (CRCs) and principal investigators (PIs) in the United States. This project will use surveys and interviews of CRCs, PIs, Alzheimer's Disease family members, and IRB members or staff to identify current practices and barriers to implementing consent best practices. Informed by survey and interview data, we will test the effectiveness of a web-based toolkit with resources that explain and facilitate the use of consent best practices. We will push the toolkit to CRCs/PIs in the implementation group (n=600) using social media platforms such as Twitter, Facebook, and LinkedIn and will examine whether implementation group outcomes (e.g., attitudes, intent to adopt, and adoption of best practices) are superior to those of the control group (n=300). By increasing use of consent best practices, this innovative study will have a significant impact on the ethical conduct of clinical trials with participants with Alzheimer's disease or cognitive impairments, and will reduce barriers to enrolling participants with Alzheimer's disease. It will also advance our understanding of how to implement best practices in research ethics, which is important because current approaches are ineffective.