[IN-PERSON/LIVESTREAMED] Plenary Session: From Compliance to Embracing the Belmont Report Tenets as the Framework for the Operations of the HRPP

This plenary session will be held in-person, livestreamed for the Virtual Meeting, and recorded for on-demand access by attendees registered for PRIMR23 on this day.

Federal regulations (e.g., Revised Common Rule, FDA, DOD, etc.) provide regulatory frameworks meant to ensure the ethical treatment of people who participate in research. Although these regulatory frameworks can be seen as extensions of the principles of the Belmont report—Respect for Person, Beneficence, and Justice—they are often applied in ways that reflect a more compliance approach. They can become check boxes that are used by HRPPs and IRBs to guarantee adherence to the literal language of the regulation or law rather than guiding principles that inform the approach to the application of the regulations. As a result, IRBs are often seen as gatekeepers that arbitrarily constrain research activities instead of ethics boards that focus on the protection of human research participants. In addition, a compliance approach can interfere with the development of a partnership between HRPPs and IRBs and the research community as they stand behind the regulations as their explanation for their decisions (e.g., 'the regulations made me do it'). By adopting a more principal based approach to the implementation of the regulations, HRPPs and IRBs can reframe the conversation with the research community, increase transparency, and cultivate a collective accountability to the review process. This shift in orientation requires organizational change that is both structural (e.g., processes that are in place) as well as human (e.g., how people understand their work).