[Comparing ethics committees from France and Quebec with respect to incapacity to consent to research]

French and Quebec legislation allow the inclusion of decisionally-incompetent subjects in research, provided certain conditions are met. In both jurisdictions, ethics committees are charged with ensuring that research protocols meet these conditions. We investigated committee members' knowledge and opinions regarding substitute consent for research purposes.

Two consecutive postal surveys were conducted among all members of ethics committees from France and Quebec. Knowledge and opinions about proxy consent were measured with clinical vignettes describing hypothetical situations involving incapable adults. For each vignette, respondents were asked to either identify the person legally authorized to consent or choose the substitute decision-maker whom they considered best suited to do so.

Knowledge of the legislation governing substitute consent was poor in both samples, especially in situations involving an incompetent person who did not have a legal representative. Knowledge was worse among French ethics committee members (p<0.001). In hypothetical clinical studies that involved no risk to the subject's health, 59% of respondents favored consent from a close relative. As the risk increased, the proportion gradually decreased to 14.2%, while the proportion against soliciting the cognitively impaired older adult tended to increase (from 5.8 to 31.2%). These trends were observed in both samples.

These findings underscore the need to better educate ethics committee members about legislation regarding prospective subjects who lack decisional capacity. Such efforts could improve both knowledge of and compliance with legal provisions that enable or restrict the participation of cognitively-impaired patients in research projects. Moreover, study findings provide some support for enlarging the category of persons who are authorized to consent to low-risk research on behalf of incapacitated adults who lack legal representation.