“Deliberative democracy” is an increasingly popular method for soliciting public input on health care policies. There are a number of ways of organizing deliberative democracy (DD) sessions, but they generally involve gathering a group of citizens, supplying them with information relevant to the policy in question, giving them time to interact with each other and with experts in the policy area, and collecting their informed and considered opinions. As the method has become more widely used, some have questioned the quality of the public input it generates. Although theorists of DD agree that “good” input – i.e., input that is the product of careful and thorough reflection – is an essential aspect of useful and effective deliberation, few have actually measured the quality of deliberative sessions. As part of a DD project organized to help guide policies on the morally complex question of allowing surrogate permission to enroll persons with dementia in medical research, we developed and tested measures of “quality of deliberation.” After a brief discussion of the substantive results of our research – survey data from participants in the DD sessions and control groups showed a significant change in participants' attitudes toward surrogate consent – we examine the process by which this change occurred, describing and assessing the characteristics of our DD sessions. We use both quantitative and qualitative data from our DD sessions, conducted in southeastern Michigan, United States, to examine four dimensions of the quality of deliberation: 1) equal participation by all members of the session, 2) respect for the opinions of others, 3) a willingness to adopt a societal perspective on the issue in question (rather than a focus on what is best for participants as individuals), and 4) reasoned justification of one's positions. We demonstrate that DD can be reliably used to elicit opinions of the public and show how analysis of the quality of deliberations can offer insight into the ways opinions about ethical dilemmas are formed and changed.

An approach to develop fully human monoclonal antibodies in a human/mouse radiation chimera, the Trimera system, is described. In this system, functional human lymphocytes are engrafted in normal strains of mice which are rendered immuno-incompetent by lethal total body irradiation followed by radioprotection with severe combined immunodeficient (SCID) mouse bone marrow. Following transplantation, human lymphocytes colonize murine lymphatic organs and secrete human immunoglobulins. We have established this system as a tool to develop fully human monoclonal antibodies, and applied it for the generation of monoclonal antibodies specific for hepatitis B virus surface antigen. A strong memory response to hepatitis B surface antigen was elicited in Trimera engrafted with lymphocytes from human donors positive for antibodies to hepatitis B surface antigen. The human specific antibody fraction in the Trimera was 10(2)-10(3)-fold higher as compared with that found in the donors. Spleens were harvested from Trimera mice showing high specific-antibody titres and cells were fused to a human-mouse heteromyeloma fusion partner. Several stable hybridoma clones were isolated and characterized. These hybridomas produce high-affinity, IgG, anti-hepatitis B surface antigen antibodies demonstrating the potential of the Trimera system for generating fully human monoclonal antibodies. The biological function and the neutralizing activity of these antibodies are currently being tested.

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.

Diagnostic study, level III.