Perspectives of Patients With Schizophrenia and Psychiatrists Regarding Ethically Important Aspects of Research Participation
ABSTRACT 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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ABSTRACT: Objective The authors sought to compare investigators’ predictions of clinical research participants’ attitudes regarding ethically important considerations in serious illness research with attitudes expressed by participants (“attunement”), to compare the personal attitudes of investigators and clinical research participants (“alignment”), and to explore the association between views expressed and covariates. Method The authors queried clinical research participants with either physical or mental illness (n=100) and faculty investigators conducting the clinical research protocols in which these participants were enrolled (n=77). Outcomes included attitudes regarding importance of medical research, attributes of seriously ill people in the research situation, and influences on enrollment decisions by seriously ill people. Generalized estimating equations and linear regression models were used. Results Investigators underestimated the importance of research about physical illness, mental illness, and healthy people to participants (βPI = 0.59, 95% CI [0.36, 0.83]; βMI = 0.60, 95% CI [0.27, 0.92]; βH = 0.93, 95% CI [0.57, 1.29]). Investigators incorrectly predicted that participants would assess seriously ill people as more vulnerable in the research situation than participants did (β =- 0.68, 95% CI [-1.11, -0.25]). Investigators and participants were aligned on the importance of illness research. Participants expressed greater agreement than investigators regarding the influences of ill individuals indicative of will and cognition in their enrollment decisions (β = 0.69, 95% CI [0.25, 1.13]). Conclusions Investigators are attuned to and aligned with research participants in many, but not all, respects. Investigators may bring a protective bias in their predictions of the vulnerabilities of ill volunteers.Journal of Psychiatric Research 05/2014; 52. DOI:10.1016/j.jpsychires.2014.01.012 · 4.09 Impact Factor
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ABSTRACT: There are important benefits to including adults with intellectual disabilities in research. Calls for their increased participation in research co‐occur with notable discussion about how to conduct ethically strong research with adults with intellectual disabilities, a population widely considered vulnerable in the context of research. The authors systematically researched the peer‐reviewed literature on ethical practices in research with adults with intellectual disabilities to identify and analyze conceptually and empirically supported ethical approaches to research in the area of research with adults with intellectual disabilities. They conducted a thematic analysis of the 37 articles that met inclusion criteria. They identified three overarching themes: (1) guiding frameworks and approaches; (2) strategies to promote accountability to ethics; and (3) making decisions about participation, including considerations for coercion, capacity to consent, surrogate decision‐making, and promoting understanding. From the review, they noted diverse recommendations for ethical research practices, characterized by a lack of consensus, entrenched tensions in value orientations, and gaps in knowledge and practice. Attention to promising strands of scholarship that emphasize attention to strengths, autonomy, dignity of risk, and a contextually based framing of consent capacity may be particularly fruitful. Similarly, bringing to the forefront the role of accommodations in promoting participation, systematically studying diverse ethical aspects of research, and identifying and considering the perspectives of persons with intellectual disabilities may represent critical next steps. They suggest that research collaborations between academics and persons with intellectual disabilities present opportunities to further strengthen the ethical integrity of research in the field.A video abstract of this article can be viewed at .Journal of Policy and Practice in Intellectual Disabilities 03/2012; 9(1). DOI:10.1111/j.1741-1130.2011.00319.x · 0.97 Impact Factor
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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.BMC Psychiatry 02/2014; 14(1):28. DOI:10.1186/1471-244X-14-28 · 2.24 Impact Factor