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- W2016335692 abstract "Despite promising scientific advances in managing Alzheimer's disease, further research is required, especially in patients at later stages of the disease process. Involving such patients in clinical trials raises complex ethical, legal, and social issues due to their progressive incapacity to provide valid consent for participation in research. Researchers in aging and Institutional Review Boards (IRB) should be knowledgeable of the rules enacted in their jurisdiction to protect this vulnerable population. Using a pre-tested postal questionnaire, we surveyed all French researchers in aging and IRB members to 1) assess their knowledge of the legislation governing proxy consent for research in decisionally-incapacitated subjects, and 2) elicit their opinions regarding the person best suited to provide proxy consent for research purposes. Knowledge and opinions were measured with vignettes describing hypothetical research situations involving Alzheimer's disease patients. 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 consent. The sample comprised 122 researchers and 332 IRB members, for an overall response rate of 31.4%. Knowledge was worse for vignettes describing incompetent adults who had not been appointed a legal representative. In these situations, the correct answer rates ranged from 15.4% to 41.6%. In hypothetical studies presumed to carry little risk for the subjects, 59% of researchers and 55% of IRB members favored consent from close relatives. As the postulated risks became serious, the proportions gradually decreased (p<0.001) to 18% and 13%, respectively. In such instances, one out of three respondents preferred excluding cognitively impaired older adults, regardless of their legal status. The observed lack of knowledge strongly argues for better educating French researchers in aging and IRB members about legal provisions that may limit the participation of Alzheimer's disease patients in clinical research. Survey findings also provide some support for recent changes to the French legislation which now allows close relatives to consent on behalf on incapable subjects for low-risk studies." @default.
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- W2016335692 date "2009-07-01" @default.
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- W2016335692 title "P1-197: Knowledge and opinions regarding proxy consent for participation in research on Alzheimer's disease: The eppicore study" @default.
- W2016335692 doi "https://doi.org/10.1016/j.jalz.2009.04.203" @default.
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