IRB: Ethics & Human Research

Informed Consent for Dementia Research: The Study Enrollment Encounter

The basic elements of informed consent are well known in the research community, but how they are discussed during the consent process for persons with dementia is seldom examined.  We audiotaped and analyzed consent discussions with forty-six potential subjects and their surrogates during enrollment visits for six dementia studies and discovered that how the consent form was used, how subjects and surrogates were engaged in discussion, and how the discussion was conducted varied widely.  Explanations of study procedures dominated most discussions, and there was less focus on participants’ rights.  Discussions for drug studies were more consistent and comprehensive than for those studies that did not involve drugs.  Investigators were also more likely to assess subjects’ understanding or consent capacity for drug studies, although this happened in a minority of cases overall.  Investigators were more likely to seek a subject’s assent to participation without explicitly asking for it (for example, by asking if the explanation was straightforward, or if it was okay to sign the consent form).  These findings suggest that investigators should be more deliberate in covering critical study information, assessing capacity, confirming understanding, and seeking assent.

Key words/concepts: informed consent, dementia research, decisional capacity, assent, surrogate decision-makers