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

项目总结

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.