The structure of informed consent in psychiatric research

The manner in which the informed consent process is structured was explored by means of intensive interviews with 17 experienced psychiatric researchers. Despite differing views on informed consent, investigators displayed a commonality of practice. Most investigators were themselves not usually involved in obtaining consents, relegating the process to lower-level assistants. They did not closely monitor the process and generally were unaware of problems that may have arisen. Most protocols called for repeat contact with patients so that a relationship would develop and information could be provided before obtaining a formal consent. The actual signing of a consent form often reflected a decision that had been made much earlier in the process. These findings have significance for both sides in the dispute over informed consent in research. Those who favor tighter controls over psychiatric research will have to consider the implications of monitoring, without destroying, a prolonged and complicated process. Those who argue for a reliance on investigators' integrity must deal with the apparent lack of involvement most investigators have in the consent process.     

The capacity to appoint a proxy and the possibility of concurrent proxy directives

With the projected increase in the number of persons with dementia (who eventually lose their capacity to give informed consent to treatment and research), third-party decision-making will become even more common than it is today. We argue that, because there are situations in which an appointed proxy is preferred over a de facto surrogate, it is ethically important to understand the capacity of persons with dementia to delegate their decision-making authority regarding treatment and research decisions.In this paper, focusing mainly on the research consent context, we examine the idea that persons suffering from neurodegenerative disorders may retain significant abilities-including sufficient capacity for delegating one's authority for giving consent to research-even if they are not capable of giving independent consent themselves. We first propose a rationale for assessing the capacity to appoint a proxy and then describe a novel interview instrument for assessing the capacity to appoint a proxy for research consent.     

Statistical constraints on the use of single cases in neuropsychological research

In a recent study by Miceli, Silveri, Romani, and Caramazza (Brain and Language, 1989, 36, 447-492), free speech records for 20 unselected Italian-speaking agrammatic patients were analyzed along a variety of linguistic parameters, with particular emphasis on substitution and omission errors within traditional "part of speech" categories. The authors draw two strong conclusions: (1) the variability observed in this sample is too great to justify grouping these patients (or any coherent subset of the patients) into the "same" clinical category; (2) the extensive variability displayed by these patients reflects meaningful and very specific patterns of dissociation that would be lost if patients were grouped together in a common category called "aggrammatism." In a reanalysis of the Miceli et al. data, we conclude that the evidence does not justify either of these conclusions. First, we provide a set of mathematical simulations demonstrating that the dissociations claimed by Miceli et al. could have occurred entirely by chance, if samples of speech were drawn randomly from a "universe of discourse" characterized by error rates similar to those displayed by patients in this study. This randomization method has considerable generality, and could prove useful to other investigators interested in determining the number and type of dissociations that are likely to occur by chance in individual and/or group studies. Second, we demonstrate that there are many confounding factors that could account for the variability observed by Miceli et al., including differences in neurological status, education, and the strategies that patients elect to deal with their limitations.     

The Evolving Position of the American Psychiatric Association on Firearm Policy (1993–2014)

Before the Supreme Court's 2008 decision in District of Columbia v. Heller, the American Psychiatric Association's position on gun policy reflected the strong gun control perspective championed by the nation's public health establishment. After Heller declared that an individual's right to bear arms is constitutionally protected, the APA refocused its attention on the specific aspects of firearm policy that implicate the interests and rights of persons with mental illness. Psychiatrists are mindful of the need to curtail firearm access by persons with mental disorders that elevate the risk of suicide or violence to others, but they are also opposed to stigmatization, discrimination, and unfair treatment of individuals based on mental illness. Although civil commitment is an acceptable basis for prohibiting access to firearms, other adjudications of conduct indicative of elevated risk should also be included. Every state should provide a fair and reasonable process for restoring firearm rights after a suitable waiting period based on individualized assessment of whether the person remains at an elevated risk. However, restricting firearm rights of persons solely on the basis of a diagnosis of a mental disorder or voluntary treatment, whether in-patient or outpatient, discourages treatment and would be counterproductive. Copyright © 2015 John Wiley & Sons, Ltd. (original adopted by the American Psychiatric Association 2014).     

Resource Document on Access to Firearms by People with Mental Disorders

The American Psychiatric Association, (“APA”), with more than 36,000 members at present, is the Nation's leading organization of physicians who specialize in psychiatry. APA provides for education and advocacy and develops policy through Position Statements. It promotes enhanced knowledge of particular topics relevant to psychiatric practice and patient care through Resource Documents. Since 1993, the APA has developed various positions and resource materials related to firearms and mental illness, incorporating evolving themes as new issues emerge. This paper reflects the APA's 2014 Resource Document on “Access to Firearms by People with Mental Disorders.” This article is derived from work done on behalf of American Psychiatric Association and remains the property of APA. It has been altered only in response to the requirements of peer review. Copyright © 2015 American Psychiatric Association. Published with permission (original adopted by the American Psychiatric Association 2014).