Substitute Consent for Research Involving the Elderly: A Comparison Between Quebec and France

Abstract

The authors first describe the rules enacted in Quebec and France to protect adults with decisional impairment who may be approached by investigators to participate in research protocols. They then present two consecutive postal surveys conducted among Quebec and French researchers in aging and designed to (1) assess their knowledge of the legal provisions implemented to protect decisionally incapable adults, (2) elicit their opinions regarding the person best suited to provide substitute consent for research participation, and (3) document their conduct related to obtaining consent for prospective subjects with impaired decisional capacity. Knowledge of the legislation governing substitute consent was poor, even more so among French than Quebec researchers (p < 0.001). In both samples, the majority of respondents felt that the substitute decision-maker does not have to be legally appointed when the study poses little risk to the participant. Practice data revealed a certain discrepancy between the conduct of researchers in aging and the legal provisions regarding consent for research purposes that prevail in their jurisdictions. These findings underscore the need to better educate clinical investigators about existing measures to protect prospective subjects who lack decisional capacity. They also provide some support for allowing close relatives to consent to research participation on behalf of older adults who are unable to consent by themselves and have not been appointed a legal representative.

Informed consent in dental care and research for the older adult population

“…Of the 80 articles, 16 were essay-type articles 16,20,23,27,30,33,37,42,64,65,67,68,71,72,81,91 ; 7 were surveys 18,19,46,47,73,75,85 ; and 57 were research articles consisting of case studies and case reports, follow-up studies, cross-sectional studies, case-control and cohort studies, randomized trials, and systematic reviews. 13–15,17,21,22,24–26,28,29,31,32,34–36,38–41,43–45,48–63,66,69,70,74,76–80,82–84,86–90,92 The studies reviewed were from a variety of international settings: United States (n = 33); United Kingdom (n = 7); France (n = 5); the Netherlands (n = 5); Spain (n = 3); and Canada, Sweden, Finland, Germany, Switzerland, Turkey, Hong Kong, Scotland, Norway, Italy, South Africa, Israel, Korea, Austria, and Nigeria.…”

Comfort with proxy consent to research involving decisionally impaired older adults: do type of proxy and risk-benefit profile matter?

“…The reality is that it is uncommon for decisionally incapacitated persons to have either court-appointed guardians (Kim et al ., 2004) or research-specific advance directives (Bravo et al ., 2003a). Restricting participation to those few would likely result in skewed samples, thereby invalidating study results (Kim et al ., 2004; Bravo et al ., 2008). Moreover, guardianship proceedings are both time-consuming and costly in financial and emotional terms.…”