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

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study. We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy appointed under an advance directive, or non-appointed family member may make a substitute decision about another adult’s participation in health research. Moreover, we find that stakeholders in all five subgroups surveyed are frequently mistaken about the state of the law and tend to believe that a non-appointed family member can make such decisions, even when this is not supported by legislation. Our findings indicate a disturbing gap between assumptions and reality regarding the legality of health research in Canada, and give rise to specific concerns about liability on the part of researchers, REB members, and research institutions