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.

项目摘要 在美国和国际研究伦理守则中，知情同意是 研究的道德行为。我们当前父母R01的应用程序，“实施基于证据的 知情同意惯例，以应对临床中阿尔茨海默氏症的痴呆症和认知障碍的风险 试验”（AG058254）回顾了大量文献，得出的结论是有几种基于证据的文献 改善同意过程的实践：使用普通语言并优化同意文档布局； 使用经过验证的工具评估对信息的理解；与任何参与者进行审查 误解的信息；并在必要时涉及替代决策者。我们的目前 家长R01具有3个具体目标 - 包括基于网络的工具包和社交媒体推动的开发 - 共同旨在增加这些基于证据的同意惯例（EBCP）的实施。 在大流行时期，实施EBCP变得更加困难。严重患者可能无法 同意，但是隔离会阻止使用替代物。可能需要使用电子同意书， 因为可能不允许研究人员与患者一起进入房间。这些电子同意书可能 需要很快生产，而很少关注普通语言和格式。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 大流行可能导致人们拥抱一种更加重视共同利益的研究道德 （公共卫生）比个人权利。这使我们提出以下目标 对COVID19进行研究的补充。 1。分析IRB成员和COVID19研究人员的定性（开放式）调查数据 道德，法规和机构要求可能对紧急Covid19研究构成障碍，什么 住宿将有助于此类研究。与当前R01相关，我们将进行文本挖掘 和模型建设，以探索因需要知情同意，同意的惠觉者或 使用人类受试者数据和生物测量的权限。 2。审查IRB成员和COVID19研究人员调查的发现，以指导适应和 扩展父R01的EBCP工具包和实施试验。我们预计这将需要 提供有关电子知情同意程序和合法授权的替代方案的指导 代表患者缺乏同意研究的能力。 3。探索项目的政策含义，并广泛传播数据和发现。我们将发布 《生物伦理学的叙事探究》期刊特刊，在同行评审期刊上发布我们的发现， 并在密歇根大学的ICPSR数据存储库中进行匿名并存放数据。