title: Incapacity in Canada: review of laws and policies on research involving decisionally impaired adults.
abstract: OBJECTIVE
  In Canada, as in the United States, the legal frameworks governing research involving adults incapable of providing informed consent are beset by gaps and ambiguities. In both countries, federal laws and policies relevant to the regulation of research involving decisionally incapable adults interact in complex ways with provincial or state laws. To alert researchers to these complexities and to urge law reform, this review provides a comprehensive account of the federal and provincial/ territorial legal frameworks relevant to research involving decisionally incapable adults in Canada.
  
  
  METHODS
  We identified the federal and provincial/territorial laws and policies pertinent to this review by updating previous work on substitute decision-making about research in Canada and then performing keyword searches on a Canadian legal information database (CanLii) to identify further laws of relevance. Our analysis of identified laws focused on three questions: 1) What (if any) preconditions-including permissible risk and/or benefit thresholds-are imposed on research involving persons who lack capacity to consent? 2) What provisions (if any) are in place for identification of the legally authorized representative for research decision making? and 3) What factors, if any, are stipulated as mandatory relevant considerations for the legally authorized representative's decision-making process?
  
  
  RESULTS
  Across Canada, laws relating to substitute decision-making are highly variable, and often ambiguous or uncertain, on each of the matters targeted in our analysis.
  
  
  CONCLUSIONS
  Researchers and research institutions should be aware of federal and provincial/territorial legal requirements for research involving persons who lack capacity to consent in Canada. The relevant governments should undertake coordinated efforts at law reform to clarify, and potentially harmonize, these requirements.
authors.affiliation: Schulich School of Law, Dalhousie University, Halifax, Canada. Electronic address: sheila.wildeman@dal.ca.
authors.forename: Sheila
authors.initials: S
authors.lastname: Wildeman
authors.forename: Laura B
authors.initials: LB
authors.lastname: Dunn
authors.forename: Cheluchi
authors.initials: C
authors.lastname: Onyemelukwe
mesh_terms: D002170:Canada; D003704:Dementia / Q000523:psychology*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence* / Q000523:psychology; D016743:Mental Competency / Q000331:legislation & jurisprudence* / Q000523:psychology; D020458:Third-Party Consent / Q000331:legislation & jurisprudence