Substitute Decision Making About Research: Identifying the Legally Authorized Representative in Four Canadian Provinces

Abstract

Canada's aging population presents new incentives for research on Alzheimer's and other forms of dementia. But the public interest in advancing knowledge about these diseases must be partnered with a concern for exploitation, in particular where a potential research subject is deemed legally incapable of making a decision about research participation. The Tri-Council Policy Statement requires that the research participation of subjects deemed incapable of consent be contingent upon authorization obtained from their legally authorized representative ("LAR"). However, where the prospective research subject is an adult, the question of who, if anyone, may act as an LAR is often uncertain. While some provinces and territories provide a clear statutory basis for identifying LARs, others do not. We identified four provincial regimes that differ in their legislative approach to LAR identification. Of the four, British Columbia's health care consent legislation explicitly addresses the question of who, if anyone, may act as LAR for the purpose of authorizing an adult's participation in research, even in the absence of an advance directive or guardian. At the time of our study, Alberta's laws only addressed this question clearly where an ad- vance directive was in place. Legislative reforms in that province have since expanded the circumstances in which an LAR for research may be identified. In contrast, both Nova Scotia and Ontario lacked (and continue to lack) any legislation ex- plicitly addressing who, if anyone, may act as LAR for research. Indeed, Ontario's health care consent and substitute decision making laws explicitly state that they do not apply to procedures undertaken for the primary purpose of research. A postal survey of five sub-populations (older adults, informal caregivers, physicians, researchers in aging, and REB members) was conducted in each of the four provinces. Respondents were pre- sented with hypothetical scenarios and asked who, if anyone, had legal authority to make decisions about research participation. The most common re- sponse across provinces, scenarios, and population groups was that a close family member could act as an LAR, regardless of whether provincial laws clearly supported, clearly contradicted, or were un- certain with regard to that result. We conclude that the combined lack of clarity in, and lack of knowledge about, provincial laws relating to LAR identification that our study exposes indicates a fundamental gap in the system of research regula- tion. There is a need for increased legal clarity and public education on this important aspect of research governance.