Perspectives of Patients With Schizophrenia and Psychiatrists Regarding Ethically Important Aspects of Research Participation

Psychiatric Empirical Ethics Group, Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque 87131, USA.
American Journal of Psychiatry (Impact Factor: 12.3). 01/2000; 157(1):67-74. DOI: 10.1176/ajp.157.1.67
Source: PubMed


Significant controversy surrounds the ethics of psychiatric research. Nevertheless, few data have been gathered to improve our understanding of how individuals with serious mental illness and psychiatrists view ethically important aspects of biomedical research participation.
The authors assessed views of clinically diagnosed patients with schizophrenia from three sites by means of structured interviews and views of psychiatrists at two sites with written surveys regarding attitudes affecting motivation to participate in biomedical research, attitudes related to autonomy and influences on participation decisions, and attitudes toward the inclusion of vulnerable populations in research. The schizophrenia patients were asked to indicate their personal views; the psychiatrists were asked to provide their personal views and to predict schizophrenia patients' views. Responses were compared by using repeated measures multivariate analysis of variance.
Sixty-three patients with schizophrenia and 73 psychiatry faculty and residents participated. Overall, responses to 23 rated attitudes revealed remarkably similar rank orders and several areas of agreement between patients and psychiatrists. Both groups strongly supported schizophrenia research and autonomous decision making by participants. They saw helping others and helping science as important reasons for protocol participation. Patients endorsed the feeling of hope associated with research involvement, a perspective underestimated by psychiatrists. Psychiatrists also underestimated the patients' acceptance of physician, investigator, and family influences on participation decisions. Psychiatrists agreed more strongly than patients that vulnerable populations should be included in research.
This study helps to characterize previously neglected attitudes of psychiatric patients and clinicians toward ethically important aspects of biomedical research participation. Schizophrenia patients offered highly discerning views, and interesting similarities and differences emerged in comparing responses of patients and psychiatrists.

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Available from: Teddy D Warner, Jan 05, 2016
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    • "Challenges and barriers regarding participation in research have been connected with timing of approach, practical barriers, conceptualization of mental health problems, concerns of potential harm, and negative influence of other patients [16,17]. Regarding reasons for participating in research Chong et al. [15] found two main reasons for volunteering; 1) the possibility that I might get well, 2) I’m helping other patients like myself, and a similar study Roberts et al. [18] found three main reasons; 1) helping other people, 2) helping science, 3) gaining a sense of hope. "
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    ABSTRACT: Recruitment is one of the most serious challenges in performing randomized controlled trials. Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time, funding, and the participants' efforts. Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians' concerns regarding individuals diagnosed with schizophrenia as participants in research. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark. GSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia. Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams. Three types of recruitment challenges not related to patients were identified and met during the trial: 1) organizational challenges, 2) challenges with finding eligible participants and 3) challenges with having professionals invite patients to participate. These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study. Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%). Distinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention.
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    • "They found that in several instances respondents' views varied, in some cases substantially, from those reflected in the assumptions articulated by the U.S. Supreme Court in opinions regarding the application of the Fourth Amendment. In a study more on point for the present research, Roberts et al. (2000) found a number of significant differences between psychiatric patients' views and values concerning research participation and the views and values that psychiatrists predicted would be held by those patients. These findings suggest that policymakers would be more informed, and thus better positioned to develop regulations, if the voices of prisoners were represented in the debate concerning the ethics of research with prisoners – a view congruent with the principle underlying the current requirement in 45 CFR 46 that at least one IRB member be a prisoner advocate, if not a current or former prisoner, to ensure that there is a prisoner " voice " in the proceedings. "
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    ABSTRACT: A major ethical concern in research with criminal offenders is the potential for abuse due to coercive influences that may adversely affect offenders' capacity to give voluntary consent to participate in research conducted in correctional settings. Despite this concern, to date there have been almost no systematic scientific investigations of the extent to which offenders themselves perceive that coercion occurs in these settings or that it is likely to influence their decisions about research participation. In a sample of over 600 ethnically diverse men and women recruited from various prisons and community corrections facilities in Texas and Florida, we used a vignette-based survey concerning a hypothetical research project to measure and compare offenders' global perceptions of coercive processes, as well as the differential salience and perceived coercive influence of specific factors (e.g., coercion by other inmates, inducements from staff). Somewhat surprisingly, across multiple outcome measures our participants on average reported relatively little in the way of significant coercive influences on their capacity to make voluntary decisions concerning research participation. Implications and directions for future research on coercive influences in offender research are discussed.
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    • "Of course, research can not be seen to provide any form of alternative to participants' standard care. The current study also supports past findings that patients with diagnoses of schizophrenia predominantly express positive views about mental health research, viewing it as an important and valuable endeavor (Roberts et al., 2000), and rating the possible benefit to others as an important reason for participating (Roberts et al., 2000, 2004). This motivation for participation in mental health research has also been endorsed by other populations, such as bereaved parents (Dyregrov, 2004). "
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    ABSTRACT: Mental health research may pose a risk to those who participate in it, especially for potentially vulnerable groups such as those diagnosed with schizophrenia. The current study aimed to investigate the subjective experience of research participation in this group. Seventy-nine individuals with diagnoses of schizophrenia spectrum disorders who had taken part in research looking at suicide were asked to provide feedback about their experiences. Responses were analyzed using qualitative and quantitative methods. Results indicate that negative feedback concerning participation was rare, occurring in 2.5% to 15.2% of responses. Positive feedback was more frequent, occurring in 45.6% to 60.8% of responses. Qualitative thematic analysis identified 5 key themes in participants' responses: Altruism, Value of being involved in research, Therapeutic effect, Enjoyable experience and Negative experiences. The results support the view that mental health research in this group can be ethically viable.
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