Democratic deliberation softens attitudes toward surrogate consent for dementia research
MedWire News: Democratic deliberation involving older members of the general public increases support for surrogate consent for Alzheimer's disease (AD) research, say researchers.
Patients with mild AD may be able to provide consent, but, as one characteristic symptom of the disease is decisional incapacity, surrogate consent is often needed for research, explain Scott Kim (Center for Bioethics and Social Sciences in Medicine, Ann Arbor, Michigan, USA) and colleagues.
"When to allow surrogate consent for research involving decisionally impaired adults has been debated for several decades with little progress in policy," they say.
Their study, published in the journal Neurology, used deliberative methods to help gauge public opinion on the matter. It involved 503 people over 50 years of age who were randomly assigned to participate in one of three research groups: the deliberation group, the education group, and the control group.
Deliberation consisted of attending an all-day session where the attendees were shown a video presentation, and participated in question and answer sessions with experts and decision-making via peer-discussion groups. The education group only received written information on the issue.
Each participant completed three surveys: one prior to randomization, one at the end of the deliberation day (or sent by mail around a similar time for those in the other two groups), and one sent by mail 1 month later. They were asked for their opinions in terms of surrogate consent in four possible research scenarios: a lumbar puncture study, a drug randomization trial, a vaccine protocol, and a gene transfer protocol.
The results showed that, at baseline, 55-91% of all the participants supported a policy of surrogate consent for AD research. The degree of total support depended on the scenario; the greatest support was for a randomized drug trial scenario, and the lowest was for the gene transfer protocol.
Over the course of the study there was a significant increase in support among the deliberation day group for all four scenarios; for example, the support for surrogate consent for the vaccine protocol increased from 65% to 75%, and from 33% to 76% for the lumbar puncture protocol. The education group saw an increase in support for surrogate consent for a vaccine trial (from 60% at baseline to 73%) and the control group showed no change in attitude from baseline.
They also all completed a knowledge questionnaire element of the survey and the three groups' scores did not differ at baseline. Both the education and deliberation groups showed significant increases in their mean scores at surveys 2 and 3, whereas the control group mean score did not change.
"Our study shows not only majority support for a policy of surrogate consent for dementia research at baseline, but as citizens become more informed and deliberate with one another, they become significantly more supportive," write Kim and team.
The conclude: "Institutional review boards, other research oversight bodies, and future policy-making panels may find it useful to know what happens when citizens spend a day learning about and then deliberating the complex issues in ethics of surrogate consent for dementia research."
By Chloe McIvor