IRB: Ethics & Human Research

Advance Directives for Research: How Do They Compare with Surrogates’ Predictions of Older Adults’ Preferences?

Abstract: Surrogates’ decisions and advance directives currently offer the best opportunities for people to participate in research at times of decisional incapacity. We investigated which of these options better reflects an older adult’s willingness to engage in research should he or she be solicited to enroll in a study after losing the capacity to consent. Data were drawn from a recently completed trial in which older adults were invited to record their research advance directives in a booklet designed for that purpose. Three vignettes describing hypothetical studies were later used to elicit older adults’ willingness to engage in these studies. Statistical analyses involved comparing surrogates’ and advance directives’ ability to predict the older adults’ answers. No significant differences in agreement with older adults’ hypothetical choices were found between surrogates and advance directives (p-values ranged from 0.164 to 0.720). Future studies could test whether more specific forms of research advance directives would assist surrogates in making research-related decisions for their loved ones.

Key words: human subjects research, surrogate decision-making, substitute decision-making, decision-making capacity, research advance directives, dementia