B03 - Assessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?

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People with disabilities, including those with impaired decision-making capacity, have the right to equal access and opportunity to consider participation in clinical research. The Common Rule identifies individuals with impaired decision-making capacity as being "vulnerable to coercion or undue influence" and specifies the expectation of "additional safeguards to protect the rights and welfare" of these participants (45 CFR 46.111). Researchers and IRBs often rely on assessments for capacity to consent to research participation as the required additional safeguard provided to these participants. Yet, capacity assessments for research participation are highly variable and fraught with problems, including implicit and explicit bias, unfamiliarity regarding the capacity of people with cognitive disabilities, and a failure to provide necessary accommodations, among others. This session will present case examples to illustrate the varying ways in which capacity to consent for participation can be incorporated in research.