Decisionally Impaired Persons*

HHS Regulations

Though once proposed, federal regulations governing research with the decisionally impaired have not been adopted. Nevertheless, IRBs are required to include additional safeguards in studies where "some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as..., mentally disabled persons, or economically or educationally disadvantaged persons" (see 45 CFR 46.111(b)).

IRB Considerations

Temporary or permanent decisional impairment may result from a variety of conditions (e.g., stroke, brain injury, delirium resulting from illness, mental illness). The IRB should attempt to distinguish between people who have a condition that might cause temporary impairment and people who are impaired. Regardless of the reason for impairment, the IRB should apply the same safeguards when considering approval of research involving persons who might not be able to make informed decisions.

Generally agreed upon principles hold that (a) research involving decisionally impaired persons should not be done if the research question(s) could be answered by involving capable persons; (b) mentally incapable persons should not be involved in more than minimal risk research unless the research holds out the prospect of direct benefit to the subject; (c) decision making capacity should be tested and documented in studies involving impaired persons; (d) persons who might lose the capacity to consent during the research should appoint a surrogate who can approve continuing participation.

OHRP Guidebook

OHRP's IRB Guidebook addresses research involving cognitively impaired persons in Chapter 6, Part D.

*In the preparation of this page, some material has been adapted from Institutional Review Board, Management and Function by Robert Amdur and Elizabeth Bankert, Copyright 2002 by Jones and Barlett Publishers Canada.