Miskimen Theresa, Marin Humberto, Escobar Javier
University Behavioral HealthCare, University of Medicine and Dentistry of New Jersey, Piscataway, NJ 08855, USA.
Psychopharmacology (Berl). 2003 Dec;171(1):98-104. doi: 10.1007/s00213-003-1630-8. Epub 2003 Nov 18.
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.
本文旨在探讨少数群体身份和文化因素如何影响受试者参与临床精神药理学研究。
使用关键词“临床精神药理学试验”、“精神病学伦理学”和“少数群体”进行文献综述。本次综述的主要目的是审视当前的知识基础，并找出这一相当新的精神病学研究领域中存在的差距。
我们发现极少有论文直接论述该问题。对少数群体的提及大多是间接的，其中许多是从针对医学人群的研究成果推断至精神病患者。我们未发现针对精神病患者群体开展的实证研究。
需要开展系统、精心设计的研究，以阐明文化、种族和民族如何影响诸如招募、留存、知情同意以及防止少数群体研究对象可能受到剥削等问题。基于文献综述以及我们在对少数群体患者开展临床研究中的个人经验，我们为将少数群体患者纳入其临床试验的临床研究人员提供了若干建议和具体意见。
