If your research includes cognitively impaired adults, or adults with potentially absent, diminished or fluctuating capacity to consent, review the HRP 417-CHECKLIST-Cognitively Impaired Adults to see the categories of research in which those with impaired decision-making may be involved. Use this checklist to ensure you are providing sufficient justification in your protocol or application for enrollment of these individuals. See also HRP 013-SOP-Legally Authorized Representatives, Children and Guardians, and HRP 090-SOP-Informed Consent.

Your protocol or application should specify the validated assessment tool that will be used for assessing capacity to consent to research and a copy should be provided with your application. If a standard assessment tool will not be used the IRB may require documentation to determine whether the tool is appropriate in the context of the study and population.

For studies involving non-English speaking participants, your protocol or application must describe how the assessment will conducted. The assessment tool does not need to be translated unless the assessor will assess the participant’s capacity to consent by speaking in the participant’s language. For studies where the assessment will be conducted in English but will include the involvement of an interpreter, the assessment tool does not need to be translated.

Your protocol or application should be explicit regarding the use of a legally authorized representative if one may potentially be utilized to consent on behalf of a participating adult.

As a matter of subjects’ protection, assent should be obtained from incompetent or incapacitated adults for research participation to the extent they are able to provide assent. Even where a legally authorized representative has consented to the research participation, an incompetent or incapacitated adult should, except in rare cases, not be included over their objection (known as dissent). The IRB will consider instances in which superseding considerations may affect this guidance.