E04 - [IN-PERSON/RECORDED] Leveraging Logic Tools for Not Human Subjects Research and Exemption Determinations

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.

On the one hand, by its nature, exempt human subjects research carries little risk. The research community expects streamlined review process for research that carries minimal risk, and as the revised Common Rule suggests, the regulators agree with this view. This expectation for an efficient review process extends to the assessment of whether projects meet the definition of human subject research and require regulatory oversight, including IRB review. On the other hand, just because a project is determined to be exempt does not mean institutions do not have an obligation to ensure that the research meets high ethical standards. Further, the determination of whether activities constitute research involving human subjects can be difficult and incorrect determinations can increase regulatory risks. The goal of this session is to show how to streamline exemption determinations through automated tools while maintaining regulatory compliance and robust ethical standards. Speakers will look at the pros, cons, and challenges of using tools to automate the decision processes for not human subjects research and exemption determinations present, including how to ensure these tools are accurate and compliant and how they can encourage research teams to take an active role in and ownership of the review process.