Schizophrenia Bulletin Advance Access published online on October 27, 2005
Schizophrenia Bulletin, doi:10.1093/schbul/sbj016
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* To whom correspondence should be addressed. Greater attention is being focused on the willingness and motivations of potential subjects who are recruited for research protocols. Given the importance of subjects' abilities to choose freely and reason through their decisions about entering psychiatric research, empirical researchers have been developing assessment and education tools that address the potential vulnerabilities of research subjects. In this study subjects' responses and reasons for or against participation were elicited as part of an assessment of their research decision making. Fifty-two persons diagnosed with a thought disorder were asked to consider a hypothetical research study using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Their responses were documented, coded for content, and correlated with demographic characteristics and scores on scales rating psychosis, cognition, and health-related quality of life. Subjects expressed common considerations that have been identified by other psychiatric investigators, as well as by those studying nonpsychiatric protocols. In general, reasons were both appropriate to the study being considered and appropriately linked to common considerations that flowed logically from the study. However, elements of the therapeutic misconception were evident as well. Willingness to participate was correlated with higher MacCAT-CR scores on certain scales, better education, and lower levels of psychosis and cognitive impairment. These findings highlight both the strengths and weaknesses of the decision making of research subjects with thought disorder. Research protections and assessments may consequently be appropriately targeted to specific vulnerabilities. Because of differences in severity of illness, cognition, and reasoning among subjects who decline to participate in research, greater attention to this population appears warranted.
Article
Willingness of Subjects With Thought Disorder to Participate in Research
1 Department of Psychiatry, University of Massachusetts Medical School
2 University of New Mexico Health Sciences Center, Department of Psychiatry and Religious Studies Program, University of New Mexico
Philip J. Candilis, E-mail: philip.candilis{at}umassmed.edu
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