Central IRB review of local context in emergency research: empirical ethics study Using empirical ethics to understand and optimize Central IRB review of local context: a model based on community consultation in emergency research conducted with exception from informed consent Project Summary / Abstract Institutional Review Boards (IRBs) provide oversight to clinical research involving human subjects to protect participants and ensure ethical research conduct. Local IRBs review research performed just at their own site, while Central Institutional Review Boards (CIRBs) review research being conducted at many sites. Regardless of whether reviews are performed locally or centrally, they must take into account any local context specific to the site where the research will be performed. CIRBs may provide more effective, equitable, and efficient review of large multicenter clinical trials, but whether CIRBs can effectively consider local context is unknown. Local context review is especially important in a kind of research called exception from informed consent for emergency research. In this kind of research, patients who are comatose or otherwise critically ill and unable to consent for themselves may still participate in trials if their condition is life-threatening and the experimental therapy is only effective if given right away. To perform this kind of trial, researchers must also consult with the community and publically disclose information about the study. Information about those consultations must then be considered by an IRB as part of local context review. The purpose of this project is to explore, revise, and test measures of local context review of community consultation for this type of research, by local and central IRBs. We will work with key stakeholders to identify goals and processes, use these data to develop measures in domains such as trustworthiness and acceptability, and then use these measures to compare local IRB reviews to those of a simulated CIRB for a real trial. This project will be conducted within the Neurological Emergencies Treatment Trials (NETT) network and the Pediatric Emergency Care Applied Research Network (PECARN). These networks will serve as an “empirical ethics lab” in which best practices are developed.

Central IRB review of local context in emergency research: empirical ethics study Using empirical ethics to understand and optimize Central IRB review of local context: a model based on community consultation in emergency research conducted with exception from informed consent Narrative / Relevance The ethical conduct of research involving human subjects requires that we continually try to improve the manner in which clinical trial oversight is performed. Centralizing the review of research performed by Institutional Review Boards may make the protection of human subjects more consistent and more effective, but there is no consensus on how to ensure that community views and other local context are considered. This project will engage various stakeholders to learn about their perceived goals and concerns, revise metrics relevant to those goals, and then determine the comparative effectiveness of local and central IRB's on those metrics. The goal is safer, respectful, and ethical research oversight.