Clinical trials are essential to advance therapeutics in AD. Yet the nature of the disease makes patients with AD highly vulnerable research subjects, as their capacity for self-determination is lost early in the illness. This ethical dilemma defies easy solutions, but an acceptable societal policy should incorporate the views of citizens, elicited in a way that provides confidence that those opinions are considered and informed—as we tried to do in this study using democratic deliberation as a vehicle for eliciting such opinions.
There are several notable findings. First, prior to deliberation, the baseline survey revealed that a majority of the respondents supported a policy of surrogate consent for dementia research (combining “probably” and “definitely” allow responses). This majority support is consistent with previous surveys, including a survey of persons at increased risk for AD,12
and is consistent with our national survey of older Americans in which the response categories were “yes” or “no.”10
Second, the initial level of support for a policy of allowing surrogate consent increased when the respondents were given thorough and balanced information and a chance to deliberate with peers. Given that the information presented included a detailed history of human subject abuses (see appendix e-1), this is a significant finding. This sample of the lay public became significantly more supportive of a societal policy of surrogate consent and increased support was sustained even after 1 month, even for the higher risk research scenarios such as a first-in-human gene transfer trial. 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.
Several factors support the validity of the impact of DD found in this study, including the experimental design and successful randomization. The quality of deliberative sessions was high, as reflected in participants' self report (). Further, qualitative analyses of the audiotaped DD deliberations from a previous study showed equality of participation, respectful dialogue among subjects, and use of reasoned justifications—all markers of high-quality deliberation.19
Moreover, the key materials used in this study—the experts' presentations on AD clinical research and on the ethics of surrogate consent for research—were developed and vetted in collaboration with an interdisciplinary panel of experts and laypersons. Thus, there is good reason to believe that post-DD session opinions were more informed, thoughtful, and considered than opinions solicited via traditional surveys.
The study has several potential limitations. First, because the DD sessions require a considerable time commitment from volunteer participants, there is inevitable self-selection. Based on the 52% of decliners who answered our follow-up questions, the decliners were slightly younger and less likely to know or to have cared for someone with AD. Although this does not affect the internal validity of the DD effect, it is possible that a more representative sample may show more or less change in their attitudes regarding surrogate consent following DD. Second, although there is self-report evidence from this study and published evidence of similar DD sessions that deliberations are of high quality, there may have been undetected group dynamics or subtle influences from the experts during the session that affected the deliberations. Qualitative analyses of the session transcripts are ongoing and will be reported elsewhere. Third, it is possible that some of the immediate effects found in survey 2 may have been due to nonspecific effects of the DD group completing their surveys on site, compared to the other groups completing them by mail. This may account for the decrease in the DD session effect at survey 3, although we note that an increase in support for surrogate consent by the DD group was sustained for all 4 scenarios. Fourth, because the attitudes elicited were based upon information unique to dementia research, findings may not be generalizable to other research, e.g., research involving comatose subjects or incapacitated persons with mental illness.
Finally, we note that the use of DD in bioethics research is still relatively new and further discussions of the method will be needed. For example, the educational materials were developed by an interdisciplinary panel mostly comprising persons not involved in dementia research. However, with the exception of a few laypersons, most were academics, and academics in general are likely to be favorably disposed to research. This could have led to unintended bias in the materials used (appendix e-1).
Our results may have significant policy implications. Enrolling persons in research when they are incapable of providing their own informed consent remains controversial, especially when the research involves significant risks.8
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. This is particularly striking for the higher risk research scenarios (the lower risk scenarios may not have shown dramatic changes due to ceiling effects) in which, for example, the public's support for a policy of surrogate consent for a gene transfer protocol rose from 56% to 68%, with the increase largely retained even after a month. Although there are no simple rules for translating levels of public support into policy, 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 deliberating the complex issues in ethics of surrogate consent for dementia research.