Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

Abstract

Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics.

A New Brief Instrument for Assessing Decisional Capacity for Clinical Research

“…The final version included 4 items for examining understanding, 5 for appreciation, and 1 for reasoning. We chose not to assess the expression of choice because this aspect is usually not impaired in most neuropsychiatric populations 7,8 and a deficit in this area tends to be obvious during the consent process without a specific formal evaluation. We have previously found that persons with schizophrenia have greater difficulty with openended questions than with those requiring answers of the yes or no type.…”

“…[16][17][18][19][20] In terms of divergent validity, UBACC scores should not be strongly associated with severity of positive symptoms. 8,[18][19][20] …”

Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized, Controlled Educational Intervention

“…Furthermore, awareness that people often decide quickly about participating in research could lead to a greater awareness by researchers and research policymakers of the need for safeguards beyond the requirement of signed informed consent-an argument we and others have made elsewhere (Appelbaum, 1996;Dunn, Candilis, & Roberts, 2006;Dunn & Gordon, 2005;Moreno, Caplan, & Wolpe, 1998;Roberts, 1998;Roberts, Hammond, Warner, & Lewis, 2004;Shore, 2006;Verheggen, Nieman, & Jonkers, 1998). It is thus encouraging that our straightforward and brief educational intervention shows promise in promoting awareness and attitudes among medical professionals.…”

“…Embedded within this concept is the importance of regard for the autonomy, dignity, and unique strengths and vulnerabilities of each individual who participates in the research endeavor (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Honoring the full meaning of this ethical principle in clinical research involves affirming the rights and safeguarding the well-being of clinical research volunteers, and it also entails understanding participants' personal values, motivations, and experiences (Dunn & Roberts, 2005;Dunn, Candilis, & Roberts, 2006;Roberts & Roberts, 1999).…”

Ethics and the payment of research subjects

“…A comprehensive review of the ethics of schizophrenia research has recently been published in the literature (Dunn et al 2006). …”