Informed consent is central to ethical research but often impossible to obtain in emergency medicine, trauma, and critical care research. When available treatments are unsatisfactory and participation may offer direct benefit, federal regulations 21 CFR 50.24 allow an exception from informed consent (EFIC) to permit enrolling subjects in a life-threatening situation who are unable to consent. Fulfilling the additional requirements for EFIC studies, including "community consultation" (CC) and "public disclosure" (PD), is difficult, expensive, and often unsuccessful because of the inadequacy of data to guide investigators and institutional review boards (IRB) on best practices for performing CC and PD, the absence of a definition of the appropriate community, and the lack of appropriate metrics to gauge the success of different CC methods. To address these gaps, the exceptionally qualified Community VOICES study team at Mount Sinai has partnered with multiple sites conducting EFIC studies within the NHLBI-funded Resuscitation Outcomes Consortium (ROC), and the NINDS-funded Neurological Emergencies Treatment Trials Network (NETT). This study will be the first to 1) prospectively and systematically, using multiple EFIC studies and sites, observe CC activities, pre-study public disclosure, "opt-out" mechanisms, post-enrollment notification of participants/surrogates, and post-study public disclosure;2) use explicit criteria developed in VOICES 2, (of which the current application is a competing renewal), to assess the effectiveness of various strategies for CC with respect to the five VOICES domains: feasibility, participant composition, quality of communication, participant perceptions, and investigator/IRB perceptions;and 3) gather detailed qualitative and quantitative data on how IRBs implement Part 50.24 in their review and oversight of EFIC studies. The research will use a convergent mixed-methods design with concurrent use of quantitative and qualitative methods in a trans-disciplinary conceptual framework with merged analysis of both types of data. The findings will allow improved implementation of EFIC clinical trials on new treatments for a range of life-threatening conditions by providing practical guidance on meeting the ethical and regulatory requirements for EFIC research.
Saving lives in emergencies requires testing new treatments on patients whose critical condition means they cannot agree to be part of a research study. Federal guidelines allow such research to be conducted but require certain additional protections. This study will discover the best ways for researchers and institutional review boards to meet these guidelines, reducing delay and expense for emergency clinical trials.
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