A05 - [IN-PERSON/RECORDED] Finding the Path Forward: Research that Faces a Difficult Route to Approval

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

A researcher with federal funding wants to do a study involving current criminal activity of pregnant people to help society better understand what contributes to criminal behavior and to test interventions that might alleviate pressures to commit crimes. The study doesn't directly affect the fetus, but the data, if subpoenaed, could lead to criminal charges or jail time for the pregnant participants. How does that work with 45 CFR 46 subpart B? Or, a research center wants to study methods to promote the adoption of evidence-based practices by randomizing clinics to different implementation strategies – but the practices may impact patients, and it is not clear which institutions are engaged and who is considered a human subject. How does this work for assurance and informed consent requirements? A researcher wants to compare a novel intervention to a sham intervention in a greater than minimal risk study. Although the sham arm poses few risks, the overall study is greater than minimal risk. Is this possible to do if the sham arm requires deception for scientific purposes? Society could benefit from outcomes of the research if they result in a more flexible organ supply chain. Is this approvable? In our current regulatory context, some types of potentially beneficial research face a difficult path to approval. This session will identify some of these regulatory gray areas and discuss how stakeholders can come together to create a path to approval in the context of the Common Rule and other governing statutes or regulations. Come prepared for collaboration!