Substitute consent practices in the face of uncertainty: a survey of Canadian researchers in aging.

ABSTRACT

BACKGROUND: In Canada and elsewhere, research policies require researchers to secure consent from a legally authorized representative (LAR) for prospective participants unable to consent. Few jurisdictions, however, offer a clear legislative basis for LAR identification. We investigated Canadian researchers' practices regarding the involvement of decisionally incapacitated participants and tested whether reported practices were associated with (1) researchers' understanding of the law on third-party authorization of research and (2) their comfort with allowing a family member to consent on behalf of an incapacitated relative. METHODS: We surveyed researchers in aging from four Canadian provinces about their practices with prospective participants deemed incapable of consent, their understanding of relevant law, and comfort with family consent for research purposes. Understanding and comfort were measured with research vignettes that briefly described hypothetical studies in which an adult who lacks the capacity to consent was invited to participate. RESULTS: Many respondents reported soliciting consent from a family member (45.7% for low-risk studies and 10.7% for serious risks studies), even in jurisdictions where such authority is uncertain at law. Researchers' tendency to solicit family consent was associated with their comfort in doing so, but not with their understanding of the law on substitute consent for research. CONCLUSIONS: Findings underscore the need to clarify who may authorize an incapacitated adult's participation in research. Meanwhile, people should inform their relatives of their desire to participate or not in research in the event of incapacity, given researchers' tendency to turn to family for consent, even where not supported by law.