C11 - [IN-PERSON ONLY] An Adult Lacks Capacity to Consent to Research... Now What Do I Do?

This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

Some adult participants are unable to provide consent to research participation for themselves, leading to a set of complex decisions regarding whether it is ethical to allow that person to enroll in the study. While the regulations address the requirements for research and assent with minors, beyond requiring the use of a legally authorized representative to provide consent, there are no such regulatory requirements for adults unable to consent for themselves. Therefore, institutions and researchers are left to determine how to best balance the multitude of considerations, including whether there should be limitations on acceptable levels of research risk, designation of a proxy, whether the prospective participant can consent for some aspects of the study, and the need for assent when consent cannot be obtained. In this session, speakers will discuss these and other issues related to enrolling cognitively impaired adults in research studies, and discuss ways IRBs and researchers can ensure the ethical and meaningful participation in research of those that cannot consent for themselves.