Philip J. Candilis

A direct comparison of research decision-making capacity: Schizophrenia/schizoaffective, medically ill, and non-ill subjects

To characterize predictors of impairment in research decision-making capacity, we undertook a direct comparison of schizophrenia/schizoaffective (n=52), medically ill (diabetic; n=51), and non-ill (n=57) subjects. Scores on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Positive and Negative Syndrome Scale (PANSS), Mini-Mental State Examination (MMSE), and Short-Form-36 (SF-36). Across diagnoses, cognitive capacity, physical functioning, and a diagnosis of mental illness had the greatest impact on decision-making capacity, with level of education also having an impact. 69-89% of schizophrenia/schizoaffective subjects attained MacCAT-CR subscale scores achieved by almost all comparison (98-100%) and medically ill (94-100%) subjects. Positive, negative, and general psychotic symptoms correlated with poorer scores. Prior research experience, number of queries used during interview, and emotional functioning also predicted MacCAT-CR scores. These data suggest that investigators and IRBs should consider a number of variables, many of which reach across diagnoses, as they decide which populations and individual subjects may require more intensive screening for decisional impairment or educational interventions to improve their abilities to make capable decisions about research participation.

How Closely Do Institutional Review Boards Follow the Common Rule

Purpose To determine how closely institutional review board (IRB) discussions reflect the ethical criteria specified in the Common Rule federal regulations. Method Between November 2006 and July 2009, the authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic medical centers. They also reviewed each of the applications discussed to identify the Common Rule criteria—(1) risk minimization, (2) risk/benefit comparison, (3) equitable subject selection, (4) informed consent, (5) data monitoring to ensure safety, (6) privacy protection and confidentiality, and (7) protection of vulnerable subjects—that were both relevant to the study and not adequately addressed in the application. They then determined if the IRB addressed each of the relevant and not-discussed Common Rule criteria in their discussions. Results IRBs made no mention of many of the Common Rule criteria that required their discussion—In 17/82 (21%) reviews, they failed to address risk minimization; in 52/91 (57%), risk/benefit comparison; in 31/52 (60%), equitable subject selection; in 32/59 (54%), data monitoring; in 13/52 (25%), privacy and confidentiality; and in 7/55 (13%), protection of vulnerable populations. However, they discussed informed consent in 102/104 (98%) reviews and raised questions about, or requested changes about, informed consent for 92/104 (88%) protocols. Conclusions These findings suggest that essential elements of human subjects protection are not implemented uniformly across IRBs. Although not directly addressing this issue, the current proposed changes to the Common Rule offer an opportunity to improve, in general, the effectiveness of IRBs to protect human subjects.

The Revolution in Forensic Ethics: Narrative, Compassion, and a Robust Professionalism

For 5 decades modern forensic psychiatry has struggled with the seminal question of which master it serves: is it a field that answers chiefly to the law or to psychiatry? It is the law, after all, that privileges forensic experts in the courtroom, but it is psychiatry that grounds them in the medical ethics of care and cure. In reviewing the historical narrative of modern forensic ethics, this article explores whether the field has developed to the point that it is insufficient to apply legal or medical ethics alone. Rather, a more robust professionalism of broader perspectives, mixed theories, and basic ethical habits and skills may foster better understanding of the complex intersection of psychiatry and the law.

The participation of community members on medical institutional review boards

The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.

End-of-life care and mental illness: a model for community psychiatry and beyond

End-of-life care is often influenced by the stereotyping of patients by age, diagnosis, or cultural identity. Two common stereotypes arise from the presumed incompetence of many patients to contribute to end-of-life decisions, and the fear that the discussions themselves will be de-stabilizing. We present a model for end-of-life discussions that combines competence assessment with healthcare preferences in a psychiatric population that faces identical stereotypes. The model, which draws on clinical research in competence and suicide risk assessment, has important implications for all patients in the community who are marginalized or stereotyped during discussions of end-of-life treatment.

Capacity to make medical treatment decisions in multiple sclerosis: a potentially remediable deficit.

Ability to make decisions about medical treatment is compromised in significant numbers of people with neurological and psychiatric illness, and this incapacity frequently corresponds with compromised neuropsychological function. Although cognitive deficits occur often in people with multiple sclerosis (MS), no research has studied decisional capacity in that disease. The present investigation examined ability to understand treatment disclosures, which is a core component of decisional capacity, in 36 people with MS and 16 normal controls. MS patients with diminished neuropsychological function showed poor understanding of treatment disclosures compared to the control group, and diminished new learning and executive function correlated with poorer understanding. Nonetheless, with sufficient cuing, the MS patients with diminished neuropsychological function were able to display understanding that was equivalent to that of the control group. Implications of these results for clinical practice and medical research involving people with MS are discussed.

Early intervention in schizophrenia: three frameworks for guiding ethical inquiry

Psychiatric research is making important strides toward early detection and treatment of schizophrenia. Discovery of genetic markers, identifiable prodromes, and low-risk interventions fuel this vital scientific movement. At the same time, investigators and clinicians are studying the ethical questions that arise whenever the bounds of diagnosis and treatment are evolving rapidly. This ethical analysis generally falls within three dominant frameworks of bioethics: the conceptualization of disease, scientific uncertainty, and risk-factor ethics. These frameworks are explored as potential guides for directing ethical inquiry in early intervention.

Pain is associated with prospective memory dysfunction in multiple sclerosis

Prospective memory (PM) pertains to the execution of a future goal or behavior. Initial research implies that people with multiple sclerosis (MS) are apt to show impaired prospective memory for activities of daily living. Yet, PM impairment does not occur in all people with MS. Thus, some other variable besides disease status alone may contribute to PM dysfunction in people with MS. Chronic pain may be such a variable. Approximately 50–70% of people with MS experience significant pain, and such pain has been thought to diminish memory function. To investigate this possibility, 96 patients with MS and 29 healthy subjects were administered the Memory for Intentions Screening Test (MIST; Woods, S. P., Iudicello, J. E., Moran, L. M, Carey, C. L., Dawson, M. S., & Grant, I. (2008). HIV-associated prospective memory impairment increases risk of dependence in everyday functioning. Neuropsychology, 22, 110–117.), a well-validated measure of prospective memory, and the Medical Outcomes Study Pain Effects Scale (PES; Fischer, J. S., Rudick, R. A., Cutter, G. R., & Reingold, S. C. (1999). The multiple sclerosis functional composite measure (MSFC): An integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Multiple Sclerosis, 5, 244–250.) to assess chronic pain. After controlling for demographic variables and disability severity, subjective pain accounted for significant variance in PM, particularly for time-based intentions over sustained delay periods. These data accord well with assertions that pain may degrade ability to remember new intentions and suggests that pain is associated with PM dysfunction in people with MS.

An Empirical Ethics Agenda for Psychiatric Research Involving Prisoners

In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nations most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic.

Motivations of Patients With Diabetes to Participate in Research

Background: While research on the motivations of research participants has focused primarily on vulnerable populations at risk of exploitation, there is little research on the motivations and reasons of general medical patients participating in research. Given a significant increase in research studies recruiting participants with diabetes, we sought to understand better the motivations of patients with diabetes considering a general medical research protocol. Methods: The analyses presented here compare the reasoning and willingness to participate in a hypothetical research study of medically ill subjects (patients with diabetes, n = 51) with non-ill (n = 57) subjects. Responses on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Mini-Mental State Examination (MMSE) and Short-Form 36 (SF-36). Results: Overall, 44% of the group with diabetes and 56% of the comparison group indicated a willingness to participate in the research study. The reasons diabetic and comparison groups offered for willingness or unwillingness to participate in research did not differ significantly: 75% mentioned reasons related to treatment, 63% altruism; none mentioned money. Of those patients with diabetes who would not participate in research, 94% cited risk, and 89% expressed an aversion to research. Conclusions: The present study suggests that when research is not related to their diagnosis, persons with diabetes do not differ significantly from non-ill comparison subjects in their motivations to participate in research. Given the similarity of our subjects’ motivations to those of other medically ill populations, it may be that investigators can now focus more closely on the decision-making characteristics of their patients involved in clinical research rather than on their diagnoses.