TY - JOUR
T1 - Deliberative assessment of surrogate consent in dementia research
AU - Kim, Scott Y.H.
AU - Uhlmann, Rebecca A.
AU - Appelbaum, Paul S.
AU - Knopman, David S.
AU - Kim, H. Myra
AU - Damschroder, Laura
AU - Beattie, Elizabeth
AU - Struble, Laura
AU - De Vries, Raymond
N1 - Funding Information:
Michael Neblo served as political-science consultant. John Creswell served as qualitative-research methodology consultant. Sid Gilman, Roger Tyslan, and Gary Chadwick contributed to the development of study materials. S.Y.H.K. is a Greenwall Foundation Faculty Scholar in Bioethics. The project was supported with additional funding by grant R01-AG029550 from the National Institute on Aging. This study's contents are solely the responsibility of the authors, and do not necessarily represent the official views of the National Institutes of Health.
PY - 2010/7
Y1 - 2010/7
N2 - Background: Research involving incapacitated persons with dementia entails complex scientific, legal, and ethical issues, making traditional surveys of layperson views on the ethics of such research challenging. We therefore assessed the impact of democratic deliberation (DD), involving balanced, detailed education and peer deliberation, on the views of those responsible for persons with dementia. Methods: One hundred and seventy-eight community-recruited caregivers or primary decision-makers for persons with dementia were randomly assigned to either an all-day DD session group or a control group. Educational materials used for the DD session were vetted for balance and accuracy by an interdisciplinary advisory panel. We assessed the acceptability of family-surrogate consent for dementia research ("surrogate-based research") from a societal policy perspective as well as from the more personal perspectives of deciding for a loved one or for oneself (surrogate and self-perspectives), assessed at baseline, immediately post-DD session, and 1 month after DD date, for four research scenarios of varying risk-benefit profiles. Results: At baseline, a majority in both the DD and control groups supported a policy of family consent for dementia research in all research scenarios. The support for a policy of family consent for surrogate-based research increased in the DD group, but not in the control group. The change in the DD group was maintained 1 month later. In the DD group, there were transient changes in attitudes from surrogate or self-perspectives. In the control group, there were no changes from baseline in attitude toward surrogate consent from any perspective. Conclusions: Intensive, balanced, and accurate education, along with peer deliberation provided by democratic deliberation, led to a sustained increase in support for a societal policy of family consent in dementia research among those responsible for dementia patients.
AB - Background: Research involving incapacitated persons with dementia entails complex scientific, legal, and ethical issues, making traditional surveys of layperson views on the ethics of such research challenging. We therefore assessed the impact of democratic deliberation (DD), involving balanced, detailed education and peer deliberation, on the views of those responsible for persons with dementia. Methods: One hundred and seventy-eight community-recruited caregivers or primary decision-makers for persons with dementia were randomly assigned to either an all-day DD session group or a control group. Educational materials used for the DD session were vetted for balance and accuracy by an interdisciplinary advisory panel. We assessed the acceptability of family-surrogate consent for dementia research ("surrogate-based research") from a societal policy perspective as well as from the more personal perspectives of deciding for a loved one or for oneself (surrogate and self-perspectives), assessed at baseline, immediately post-DD session, and 1 month after DD date, for four research scenarios of varying risk-benefit profiles. Results: At baseline, a majority in both the DD and control groups supported a policy of family consent for dementia research in all research scenarios. The support for a policy of family consent for surrogate-based research increased in the DD group, but not in the control group. The change in the DD group was maintained 1 month later. In the DD group, there were transient changes in attitudes from surrogate or self-perspectives. In the control group, there were no changes from baseline in attitude toward surrogate consent from any perspective. Conclusions: Intensive, balanced, and accurate education, along with peer deliberation provided by democratic deliberation, led to a sustained increase in support for a societal policy of family consent in dementia research among those responsible for dementia patients.
KW - Alzheimer's disease
KW - Bioethics
KW - Deliberative democracy
KW - Impaired decision-making capacity
KW - Informed consent
KW - Research ethics
KW - Surrogate-based research
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U2 - 10.1016/j.jalz.2009.06.001
DO - 10.1016/j.jalz.2009.06.001
M3 - Article
C2 - 20188635
AN - SCOPUS:77956647705
SN - 1552-5260
VL - 6
SP - 342
EP - 350
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 4
ER -