What do people at risk for Alzheimer disease think about surrogate consent for research?
BACKGROUND
Research involving decisionally incapable adults remains an unsettled and controversial policy issue, especially for protocols that involve significant risk to participants. Few data exist to guide policymakers and IRBs


OBJECTIVE
Survey the views of persons at heightened risk for dementia regarding the acceptability of surrogate consent for biomedical research of varying levels of risks and potential benefits.


METHODS
Using a mail survey, the authors surveyed the participants at one of the sites of the Alzheimer's Disease Anti-inflammatory Prevention Trial (all participants are 70 years old or older with at least one first-degree relative with dementia) and measured responses regarding the acceptability of surrogate consent for 10 research scenarios of varying degrees of risks and benefits (ranging from an observation study to a gene transfer protocol), given from the perspectives of social policy, personal preferences for self, and preferences when deciding on behalf of a loved one.


RESULTS
Two hundred twenty-nine of 259 eligible participants responded (88%). A large majority (>90%) found minimal risk studies as well as randomized clinical trials of new medications acceptable for surrogate consent. A smaller majority found the more invasive studies acceptable. Participants were more cautious when deciding for a loved one. General attitude toward biomedical research and scenario-specific risk perception were strong independent predictors. Demographic and personal history variables had relatively little effect.


CONCLUSIONS
Laypersons at heightened risk of Alzheimer disease discriminate among research scenarios of varying risks and burdens. They are supportive of surrogate consent-based research even when the risks and burdens are significant to the subjects; these opinions appear to be based in part on their assessment of risks as well as on their general attitude toward biomedical research.
Kim
Scott Y H
SY
Department of Psychiatry, Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. scottkim@umich.edu
Kim
Hyungjin Myra
HM
McCallum
Colleen
C
Tariot
Pierre N
PN
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000503:physiopathology / Q000517:prevention & control / Q000628:therapy*; D001290:Attitude; D017028:Caregivers / Q000941:ethics / Q000592:standards; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D008297:Male; D016743:Mental Competency / Q000592:standards*; D018579:Patient Selection / Q000941:ethics*; D012307:Risk Factors; D011795:Surveys and Questionnaires; D036302:Therapeutic Human Experimentation / Q000941:ethics