Variability of judgments of capacity: experience of capacity evaluators in a study of research consent capacity.

BACKGROUND: Assessment of decision-making capacity is a common and important function of psychiatric consultants. However, the sources of variability in evaluators' judgments have not been well characterized. OBJECTIVE: To examine the degree and potential sources of variability in the categorical capacity judgments of experienced psychiatrists. METHOD: The setting was a study comparing the decision-making capacities of 188 persons with Alzheimer's disease to appoint a research proxy and to consent to two hypothetical randomized controlled trials for dementia (a new drug RCT and a neurosurgical RCT). We compared five experienced consultation psychiatrists' capacity judgments for 555 videotaped capacity interviews. Both quantitative and qualitative data were used. RESULTS: Pair wise kappa statistics ranged from slight agreement (0.17) to substantial agreement (0.64) with group kappa statistics ranging from fair to moderate agreement (0.40 to 0.45) for the psychiatrists' judgments regarding the three capacities. The sources of variability included varying "strictness" among judges, moderate test-retest reliability within judges, the relative novelty of assessing decision-making capacity for research participation decisions, as well as the limitations of the methods used to obtain capacity judgments in the study. DISCUSSION: There is considerable variability in capacity judgments of experienced consultation psychiatrists regarding the capacities to appoint a research proxy and to consent to research. The potential sources of variability identified in this study may provide starting points for more effective training in capacity assessment.

Preservation of the capacity to appoint a proxy decision maker: implications for dementia research.

CONTEXT: Research involving persons with impaired decision-making capacity (such as persons with Alzheimer disease [AD]) remains ethically challenging, especially when the research involves significant risk. If individuals incapable of consenting to research studies were able to appoint a research proxy, it would allow for an appointed surrogate (rather than a de facto surrogate) to represent the subject. OBJECTIVE: To assess the extent to which persons with AD retain their capacity to appoint a research proxy. DESIGN: Interview study. SETTING: Academic research. PARTICIPANTS: One hundred eighty-eight persons with AD were interviewed for their capacity to appoint a proxy for research and to provide consent to 2 hypothetical research scenarios, a lower-risk randomized clinical trial testing a new drug (drug RCT) and a higher-risk randomized clinical trial testing neurosurgical cell implants using a sham control condition (neurosurgical RCT). Categorical capacity status for each subject was determined by independent videotaped reviews of capacity interviews by 5 experienced psychiatrists. MAIN OUTCOME MEASURES: Categorical capacity determinations for the capacity to appoint a research proxy, capacity to consent to a drug RCT, and capacity to consent to a neurosurgical RCT. RESULTS: Data showed that 37.7% (40 of 106) of those deemed incapable of consenting to the drug RCT and 54.8% (86 of 157) of those deemed incapable of consenting to the neurosurgical RCT were found capable of appointing a research proxy. Only 7 of 186 (3.8%) were deemed capable of consenting to the neurosurgical RCT by all 5 psychiatrists. CONCLUSIONS: A substantial proportion of persons with AD who were thought incapable of consenting to lower-risk or higher-risk studies have preserved capacity for appointing a research proxy. Because few persons are found to be unequivocally capable of providing independent consent to higher-risk AD research, providing for an appointed surrogate even after the onset of AD, which might best be done in the early stages of the illness, may help address key ethical challenges to AD research.

Assessing the quality of democratic deliberation: a case study of public deliberation on the ethics of surrogate consent for research.

"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.

David Jenkins Memorial Lecture 2008: Tria Juncta in Uno - the faculty of forensic and legal medicine.

The David Jenkins Memorial Lecture given at the Annual General Meeting of the Faculty of Forensic and Legal Medicine on 6 June 2008 at Maidstone, Kent.

Assessing the public's views in research ethics controversies: deliberative democracy and bioethics as natural allies.

In a liberal democracy, policy decisions regarding ethical controversies, including those in research ethics, should incorporate the opinions of its citizens. Eliciting informed and well-considered ethical opinions can be challenging. The issues may not be widely familiar and they may involve complex scientific, legal, historical, and ethical dimensions. Traditional surveys risk eliciting superficial and uninformed opinions that may be of dubious quality for policy formation. We argue that the theory and practice of deliberative democracy (DD) is especially useful in overcoming such inadequacies. We explain DD theory and practice, discuss the rationale for using DD methods in research ethics, and illustrate in depth the use of a DD method for a longstanding research ethics controversy involving research based on surrogate consent. The potential pitfalls of DD and the means of minimizing them as well as future research directions are also discussed.

Lack of training in custodial medicine in the UK--a cause for concern?

This research demonstrates that forensic physicians in the United Kingdom (UK) who have not received academically approved introductory training in custodial medicine are failing to recognise adverse events in relation to patient safety and are missing forensic evidence. A model for future mandatory introductory training of forensic physicians is suggested.