Psychopharmacological research ethics: special issues affecting US ethnic minorities.
ABSTRACT This article is intended to explore how minority status and cultural factors affect the participation of subjects in clinical psychopharmacology research.
A literature review was performed using key words "clinical psychopharmacology trials", "psychiatric ethics" and "minority groups". Major goals of this review were to examine current knowledge base and identify existing gaps in this fairly new area of psychiatric research.
We found extremely few papers addressing the issue directly. Most references to minority groups were made peripherally, and many of these were extrapolated to psychiatric patients from work done on medical populations. We found no empirical studies done in psychiatric populations.
Systematic, well-designed research studies are needed to elucidate how culture, race and ethnicity impact on such issues as accrual, retention, informed consent and safeguards against the potential exploitation of minority research subjects. On the basis of the literature review and our personal experience doing clinical research with minority patients, we provide several recommendations and specific suggestions to clinical researchers who include minority patients in their clinical trials.
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ABSTRACT: Participants’ understanding of consent information has been subject to rather intensive studies. This review was undertaken with the aim of exploring how understanding has been defined and measured in empirical studies of trial participants’ understanding of consent information. The databases Medline, Embase, ISI Web of Science, and PsycINFO were used to identify relevant literature published until October 2007. The following search terms were used: (informed consent OR consent forms) AND (clinical trials OR clinical research) AND (comprehension OR understanding). Thirty-five papers fulfilled the inclusion criteria and were reviewed in detail. Different terms were assigned to the variable: “understanding,” “comprehension,” “retention,” “awareness,” or “recognition.” A definition of what these terms implied was seldom given. Most of the studies used questionnaires for measuring the subjects’ understanding. The instruments differed substantially with regard to time of measurement, number of questions and which topics were covered. Most of the instruments were developed specifically for each study. The variation in definitions and measurements hinders comparisons of findings and thus improvement of consent forms based upon empirical studies.AJOB Primary Research. 06/2010; 1(2).
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ABSTRACT: There has been considerable discussion in the research ethics literature concerning special researcher responsibilities in studying vulnerable populations, including whether or not drug addicts, as a result of their health condition and craving for drugs, constitute a vulnerable group from a human subject perspective. In the assessment of ethical issues, researchers in recent years have begun to recognize the critical importance of hearing the subject's voice and learning the concerns and attitudes of those who participate in research. To date, however, despite a significant increase in studies of not-in-treatment drug users, little attempt has been made to determine the perspectives of drug users about participation in research, especially ethnic minority drug users, and in particular, Hispanic drug users. Based on recent findings of a study of drug user attitudes and perspectives on research, this paper reports on the perceived risks and benefits of participation in research of a subsample of Hispanic street drug users from Hartford, ConnecticutJournal of drug issues 01/2009; 38:351-372. · 0.38 Impact Factor