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

项目摘要 在所有美国和国际研究伦理准则中，知情同意是 研究的道德行为。对我们当前父项R01的应用，"实施循证医学 知情同意实践，以解决阿尔茨海默氏痴呆症和认知障碍的风险，在临床 试验”（AG058254）回顾了大量文献，并得出结论，有几个基于证据的 改进同意过程的实践：使用简单的语言和优化同意文件的布局; 使用经验证的工具评估对信息的理解;与参与者一起审查任何 被误解的信息;以及在必要时让代理决策者参与。我们目前 父R01有3个具体目标-包括开发基于Web的工具包和社交媒体推送- 共同致力于增加这些循证同意实践（EBCP）的实施。 在大流行时期，实施EBCP变得更加困难。重症患者可能无法 同意，但隔离阻止接触代理人。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病人的房间。这些电子同意书可能 需要非常迅速地制作，很少注意简单的语言和格式。同意 信息可能不完整，因为有关风险的信息可能非常有限。最后，研究期间， 大流行可能会导致人们接受一种更强烈地关注共同利益的研究伦理 （公共卫生）高于个人权利。这导致我们在行政管理中提出以下目标 审查Covid 19研究的补充。 1.分析来自IRB成员和Covid 19研究人员的定性（开放式）调查数据， 伦理、监管和制度要求可能对紧急Covid 19研究构成障碍， 住宿将有助于这种研究。与当前的R01相关，我们将从事文本挖掘 和模式建设，以探讨问题所产生的需要知情同意，放弃同意，或 允许使用人类受试者数据和生物标本。 2.审查IRB成员和Covid 19研究人员的调查结果，以指导适应和 扩展R01母公司的EBCP工具包和实施试验。我们预计，这将需要 就电子知情同意程序和合法授权的替代办法提供指导 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，并广泛传播数据和调查结果。我们将发布一个 期刊的特刊，生物伦理学的叙事研究，在同行评议的期刊上发表我们的研究结果， 并将数据匿名化和存款在密歇根大学的ICPSR数据存储库中。

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.