Understanding and addressing challenges to informed consent and research compliance during Covid-19 research

项目总结 在所有美国和国际研究道德准则中，知情同意是 研究的道德行为。对我们现在的家长R01的申请，“实施循证的 知情同意做法在临床上解决阿尔茨海默病痴呆和认知障碍的风险 试验“(AG058254)回顾了大量文献，并得出结论：有几个基于证据的 改进同意程序的做法：使用通俗易懂的语言和优化同意文件的布局； 使用经过验证的工具评估对信息的理解；与参与者一起审查 被误解的信息；必要时请代理决策者参与。我们目前的情况 Parent R01有3个具体目标-包括开发基于网络的工具包和推动社交媒体- 共同致力于增加这些循证同意做法(EBCP)的实施。 在大流行时期，实施EBCP变得更加困难。重病患者可能无法 同意，但隔离阻止接触代孕母亲。可能需要使用电子同意书， 因为研究人员可能不被允许进入与患者一起的房间。这些电子同意书可能 需要非常快地产生，几乎不注意简单的语言和格式。同意书 信息可能不完整，因为有关风险的信息可能非常有限。最后，在一个 流行病可能会导致人们接受一种更强烈地关注公共利益的研究伦理 (公共卫生)而不是个人权利。这导致我们在管理中提出以下目标 审查关于Covid19的研究的补充资料。 1.分析来自IRB成员和Covid19研究人员的定性(开放式)调查数据，了解当前 道德、法规和制度要求可能会对紧急Covid19研究构成障碍，以及 住宿将为此类研究提供便利。与当前的R01相关，我们将从事文本挖掘 和模型构建，以探讨因需要知情同意、放弃同意或 人类受试者数据和生物标本的使用许可。 2.审查对IRB成员和Covid19研究人员的调查结果，以指导适应和 母公司R01‘S EBCP工具包的扩展和实施试验。我们预计这将需要 就电子知情同意程序和法律授权的替代方案提供指导 当患者缺乏同意研究的能力时，代表。 3.探讨该项目的政策影响，广泛传播数据和研究结果。我们将出版一份 该杂志的特刊《生物伦理学中的叙事调查》在同行评议的期刊上发表了我们的研究结果， 并将数据匿名化并存储在密歇根大学的ICPSR数据库中。

PROJECT SUMMARY Within all US and international codes of research ethics, informed consent serves as a cornerstone for the ethical conduct of research. The application to our current parent R01, “Implementing Evidence-based Informed Consent Practices to Address the Risk of Alzheimer's Dementia and Cognitive Impairment in Clinical Trials” (AG058254) reviewed a large body of literature and concluded that there are several evidence-based practices that improve the consent process: using plain language and optimizing consent document layout; assessing understanding of information using a validated instrument; reviewing with participants any information that was misunderstood; and involving surrogate decision-makers as necessary. Our current parent R01 has 3 specific aims—including development of a web-based toolkit and a social media push—that collectively aim to increase the implementation of these evidence-based consent practices (EBCPs). Implementing EBCPs is made more difficult in times of pandemic. Severely ill patients may be unable to consent, yet quarantine prevents access to surrogates. Electronic consent forms may need to be used, because researchers may not be allowed to enter rooms with patients. These electronic consent forms may need to be produced very quickly, with little attention given to plain language and formatting. Consent information may be incomplete as information about risks may be very limited. Finally, research during a pandemic may lead people to embrace a research ethic that is more strongly focused on the common good (public health) than individual rights. This leads us to propose the following aims in an administrative supplement that examines research on Covid19. 1. Analyze qualitative (open-ended) survey data from IRB members and Covid19 researchers on how current ethical, regulatory, and institutional requirements might pose barriers to urgent Covid19 research, and what accommodations would facilitate such research. Relevant to the current R01, we will engage in text mining and model building to explore the issues arising from the need for informed consent, waivers of consent, or permissions for use of human subject data and biospecimens. 2. Review findings from the survey of IRB members and Covid19 researchers to guide adaptation and expansion of the parent R01's EBCP toolkit and implementation trial. We anticipate that this will entail providing guidance on electronic informed consent processes and alternatives to legally authorized representatives when patients lack the ability to consent to research. 3. Explore the policy implications of the project, and broadly disseminate data and findings. We will publish a special issue of the journal, Narrative Inquiry in Bioethics, publish our findings in peer reviewed journals, and anonymize and deposit data in the ICPSR data repository at the University of Michigan.