Department of Psychology.
Department of Behavioral Science.
Psychol Addict Behav. 2018 Aug;32(5):552-563. doi: 10.1037/adb0000378. Epub 2018 Jul 12.
Narrow inclusion criteria regarding substance use are commonplace in clinical research. This is due, in part, to assumptions about capacity to make "rational" decisions regarding participation by these populations. This study evaluated decision-making and perceptions surrounding each of the Belmont principles among individuals with cocaine use histories, cigarette smokers without illicit substance use histories, and controls without cigarette or illicit substance use histories. Cocaine ( = 124), cigarette ( = 128), and control ( = 145) groups were recruited using Amazon's Mechanical Turk. Participants completed measures evaluating research participation after reading two hypothetical study vignettes varying in risk. Assays assessed capacity to consent, perceived research burden, and endorsement of research participation by various populations. Individuals reporting cocaine use showed a reduced capacity to consent compared to controls, but this effect was small and largely explained by sociodemographic differences (e.g., race) rather than substance use history. Perceived research burden in the cigarette group was lower than in the cocaine group, but this difference was of a small to medium effect size. All groups reported substantively lower endorsement of research participation by individuals with illicit substance use histories relative to healthy adults, with less support indicated by control and cigarette groups compared to the cocaine group. Few differences were observed by substance use history regarding perceptions of and decision-making surrounding research participation. These data highlight the need for the continued study of evidence-based ethics and support more widespread acceptance of research participation by individuals with substance use histories in clinical research. (PsycINFO Database Record
狭窄的物质使用纳入标准在临床研究中很常见。这部分是由于对这些人群参与的“理性”决策能力的假设。本研究评估了可卡因使用史个体、无非法物质使用史的吸烟者和无吸烟或非法物质使用史的对照者在每个贝尔蒙原则方面的决策和看法。使用亚马逊的 Mechanical Turk 招募可卡因（= 124）、香烟（= 128）和对照组（= 145）。参与者在阅读两个风险不同的假设研究案例后，完成了评估研究参与的措施。测定法评估了各种人群的同意能力、对研究负担的感知以及对研究参与的认可。与对照组相比，报告可卡因使用的个体表现出同意能力降低，但这种影响很小，主要是由于社会人口统计学差异（例如，种族）而不是物质使用史。香烟组的研究负担感知低于可卡因组，但这种差异的效应大小为小到中等。所有组都报告说，与健康成年人相比，有非法物质使用史的个体对研究参与的认可程度明显较低，对照组和香烟组的支持程度低于可卡因组。关于研究参与的看法和决策，物质使用史方面观察到的差异很少。这些数据强调了需要继续研究循证伦理学，并支持在临床研究中更广泛地接受有物质使用史的个体参与研究。
