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

了解并应对 Covid-19 研究期间知情同意和研究合规性的挑战

• 批准号: 10164294
• 负责人: James M Dubois
• 金额: $ 23.54万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10164294
• 关键词: Address; Administrative Supplement; Advocate; Alzheimer' s Disease; Alzheimer' s disease risk; Attention; Bioethics; COVID-19; Categories; Clinical Trials; Code; Collection; Common Good; Computer software; Consent; Consent Forms; Data; Data Collection; Data Set; Deposition; Development; Ethicists; Ethics; Evidence based practice; Human Research Ethics; Human Resources; Impaired cognition; Individual; Informed Consent; Institutional Review Boards; International; Journals; Language; Lead; Legal; Literature; MeSH Thesaurus; Michigan; Modeling; Online Systems; Ontology; Parents; Participant; Patients; Peer Review; Policies; Process; Professional Organizations; Public Health; Published Comment; Publishing; Quarantine; Recommendation; Regulation; Research; Research Ethics; Research Personnel; Rights; Risk; Surveys; Time; Universities; data warehouse; evidence base; human subject; implementation trial; improved; instrument; member; model building; novel; pandemic disease; policy implication; prevent; response; social media; surrogate decision maker; symposium; text searching; waiver

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.

项目概要 在所有美国和国际研究道德规范中，知情同意是研究伦理的基石。 研究的道德行为。对我们当前母公司 R01 的应用，“实施基于证据的 解决临床中阿尔茨海默病痴呆和认知障碍风险的知情同意实践 试验”（AG058254）回顾了大量文献并得出结论，有几个基于证据的 改进同意流程的做法：使用简单语言并优化同意文件布局； 使用经过验证的工具评估对信息的理解；与参与者一起审查任何 被误解的信息；并在必要时让代理决策者参与。我们目前的 母公司 R01 有 3 个具体目标，包括开发基于网络的工具包和社交媒体推送 共同目标是加强这些基于证据的同意实践（EBCP）的实施。 在大流行期间，实施 EBCP 变得更加困难。重症患者可能无法 同意，但隔离阻止接触代孕妈妈。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有病人的房间。这些电子同意书可能 需要非常快速地制作，很少关注简单的语言和格式。同意 由于有关风险的信息可能非常有限，因此信息可能不完整。最后，研究期间 大流行可能会导致人们接受更加关注共同利益的研究道德 （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 Covid19 研究的补充。 1. 分析来自 IRB 成员和 Covid19 研究人员的定性（开放式）调查数据，了解当前情况如何 道德、监管和制度要求可能会对紧急的新冠病毒研究构成障碍，以及什么 住宿条件将有助于此类研究。与现在的R01相关，我们会搞文本挖掘 建立模型来探讨因需要知情同意、放弃同意或 使用人类受试者数据和生物样本的许可。 2. 审查 IRB 成员和 Covid19 研究人员的调查结果，以指导适应和 母公司 R01 的 EBCP 工具包的扩展和实施试验。我们预计这将需要 提供有关电子知情同意流程和合法授权替代方案的指导 当患者缺乏同意研究的能力时，代表。 3. 探索项目的政策影响，并广泛传播数据和调查结果。我们将发布一个 期刊特刊《生物伦理学叙事探究》在同行评审期刊上发表我们的研究结果， 并将数据匿名化并存入密歇根大学的 ICPSR 数据存储库。