Deliberative assessment of surrogate consent in dementia research

Abstract

Background-Research involving incapacitated persons with dementia involves complex scientific, legal, and ethical issues, making traditional surveys of layperson views regarding 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-178 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' or SBR) 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 Corresponding author: Scott Kim, MD, PhD, Bioethics Program, 300 North Ingalls St, 7C27, Ann Arbor, MI 48109. scottkim@umich.edu, 734-936-5222, 734-936-8944 (fax). Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author ManuscriptAlzheimers Dement. Author manuscript; available in PMC 2011 July 1. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript perspectives), assessed at baseline, immediately post-DD session, and a month after DD date, for 4 research scenarios of varying risk-benefit profiles.Results-At baseline, a majority in both DD and control groups supported a policy of family consent for dementia research for all research scenarios. The support for a policy of family consent for SBR increased for the DD group, but not for the control group; the change in the DD group was maintained one 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 leads to a sustained increase in support for a societal policy of family consent for dementia research among those responsible for dementia patients.

Impact of Non-Welfare Interests on Willingness to Donate to Biobanks

“…For example, follow-up is needed on our findings that suggest disclosure of certain NWIs pertaining to issues of trust and fairness (i.e., commercial profits and insurance risk assessment) are of more concern to donors than other historically controversial issues (e.g., reproductive research). One way this could be accomplished is through engaging the public in a democratic deliberation to ascertain their preferences (Kim et al, 2011; Kim et al, 2010; Kim, Wall, Stanczyk, & De Vries, 2009) regarding policy options to determine how to best address the NWIs of biobank donors. Finally, a more representative national survey to assess public attitudes and preferences about NWIs is needed.…”

Effect of public deliberation on attitudes toward surrogate consent for dementia research

“…This finding is consistent with a previous study of caregivers of patients with AD using similar DD methods. 18 Third, these changes in attitude appear to be the effect of the deliberative process rather than simply of additional knowledge. Although the education group showed similar shifts in knowledge as the DD group, there was little change in their attitudes regarding surrogate consent.…”

“…This ratio was based on a previous study 18 and a pilot study that estimated the no-show rate in the group assigned to DD, with the goal of achieving approximately similar numbers of respondents in each group. As described below, the DD group attended an all-day education and deliberation session.…”

“…This study's survey has been used in previous studies. 18 It contains an introduction to AD and to the ethical dilemma of involving decisionally impaired subjects in research, and presents 4 research scenarios of approximately 120 words each: a study involving a lumbar puncture to develop a diagnostic test, a randomized clinical trial of a new drug, a randomized clinical trial of an AD vaccine, and an early-phase neurosurgical gene-transfer trial. Respondents are then asked: "If patients cannot make their own decisions about being in studies like this one, should our society allow their families to make the decision in their place?"…”

Public's Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism

“…(12–14, 26) Among our participants, we found that the older general public strongly supports a policy of surrogate consent for dementia research and that this support increased after in-depth education and peer deliberation; for example, at baseline, support for a policy of surrogate consent for a dementia research protocol involving gene transfer neurosurgery increased from 56% to 68% after deliberation. (22) Our thematic analysis of participants’ deliberations provides important insights into what this overall support means.…”