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 01/2014; · 4.09 Impact Factor
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ABSTRACT: Individuals with psychosis are more likely than the general community to develop obesity and to die prematurely from heart disease. Interventions to improve cardiovascular outcomes are best targeted at the earliest indicators of risk, at the age they first emerge. We investigated which cardiometabolic risk indicators distinguished those with psychosis from the general population, by age by gender, and whether obesity explained the pattern of observed differences. Data was analyzed from an epidemiologically representative sample of 1,642 Australians with psychosis aged 18-64 years and a national comparator sample of 8,866 controls aged 25-64 years from the general population. Cubic b-splines were used to compare cross sectional age trends by gender for mean waist circumference, body mass index [BMI], blood pressure, fasting blood glucose, triglycerides, LDL, HDL, and total cholesterol in our psychosis and control samples. At age 25 individuals with psychosis had a significantly higher mean BMI, waist circumference, triglycerides, glucose [women only], and diastolic blood pressure and significantly lower HDL-cholesterol than controls. With the exception of triglycerides at age 60+ in men, and glucose in women at various ages, these differences were present at every age. Differences in BMI and waist circumference between samples, although dramatic, could not explain all differences in diastolic blood pressure, HDL-cholesterol or triglycerides but did explain differences in glucose. Psychosis has the hallmarks of insulin resistance by at least age 25. The entire syndrome, not just weight, should be a focus of intervention to reduce mortality from cardiovascular disease.PLoS ONE 12/2013; 8(12):e82606. · 3.53 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). · 0.97 Impact Factor