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

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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.

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Acknowledgments

The French survey was funded through the International Opportunities Program of the Canadian Institutes of Health Research (Grant # 200310OPD-131002). The first author holds a National Researcher’s Award from the Fonds de la recherche en santé du Québec. The authors thank Jean-Louis Albarède, Alain Grand, and Thierry Lang for their constructive comments on the preliminary version of the French questionnaire, as well as Geneviève Laroque and Jacques Tréton for their letter of endorsement that we included in the survey packets.

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Correspondence to Gina Bravo.

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Bravo, G., Duguet, AM., Dubois, MF. et al. Substitute Consent for Research Involving the Elderly: A Comparison Between Quebec and France. J Cross Cult Gerontol 23, 239–253 (2008). https://doi.org/10.1007/s10823-008-9070-x

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