Improving the Ethics of Consent in Drug Abuse Research

这项为期两年的竞争续签申请将延长一项旨在提高参与研究的知情同意伦理的研究计划。最初为期3年的赠款在现实世界毒品法庭研究的背景下审查了纠正的反馈程序和中立的中介程序的效果。在纠正的反馈条件下，参与者会定期接受带有纠正的反馈的同意测验。中间人条件的参与者在提供知情同意之前会见了中立的中间人(与治疗或研究小组无关)，询问问题并审查他们的权利。结果显示，正确的反馈导致同意信息回忆的显著增加。中介程序减少了被认为的胁迫，但对理解或回忆没有影响。 尽管纠正后的反馈效果显著，但接受这种干预的参与者平均只回忆起65%的同意信息。这与研究文献中的许多报告是一致的，在这些报告中，同意干预被证明能够带来显著的改善，但效果的大小一直是小到中等，相对较小的比例的参与者达到了80%到90%的同意信息掌握水平。基本上，所有已研究的干预措施都是补救性的，旨在弥补智力缺陷或简化认知任务。认知和智力因素只能解释同意回忆差异的一部分(Festinger等人，2007年)。这表明，仅靠补救干预可能不足以促进对同意信息的充分学习和回忆。 然而，一些参与者可能没有学习和回忆同意信息的动机。在初步试点研究中(Festinger等人，2008年；Festinger等人，正在出版中)，我们通过使用货币激励措施解决了这个问题。参与者被随机分配到标准同意程序或激励条件下，在一周后的同意测试中，他们回答正确的每一个问题都会得到5美元。结果显示，受激励组回忆的信息显著更多，效应大(超过1个标准差)。 拟议的为期两年的项目的主要目标是进行一项两组研究，比较激励反馈和激励同意程序与通常同意的控制组的效果。我们假设，联合条件导致更大的同意回忆，并可能导致对信息的掌握，因为它既解决了人群中的认知限制，也解决了学习同意材料的动机。 重要的是，这项研究还将通过招聘和继续资助宾夕法尼亚州费城和得克萨斯州威尔明顿的初级和高级人员来刺激经济增长，从而帮助实现ARRA的目标。

This two-year competing-renewal application will extend a program of research aimed at improving the ethics of informed consent to participate in research studies. The initial 3-year grant examined the effects of a corrected feedback procedure and a neutral intermediary procedure in the context of a real-world drug court study. Participants in the corrected feedback condition were given consent quizzes with corrected feedback at regular intervals. Participants in the intermediary condition met with a neutral intermediary (not associated with the treatment or research teams) to ask questions and review their rights prior to providing informed consent. Findings revealed that corrected feedback led to significant increases in recall of consent information. The intermediary procedure led to reductions in perceived coercion but had no effect on understanding or recall. Despite the significant effects of corrected feedback, participants receiving this intervention recalled an average of only 65% of the consent information. This is consistent with numerous reports in the research literature in which consent interventions have been shown to elicit significant improvements, but the effect sizes have been small to moderate and relatively small proportions of the participants achieved mastery levels of 80% to 90% of the consent information. Essentially all of the interventions that have been studied have been remedial and designed to compensate for intellectual deficits or simplify the cognitive task. Cognitive and intellectual factors explain only a portion of the variance in consent recall (Festinger et al., 2007). This suggests remedial interventions alone may be insufficient to facilitate adequate learning and recall of consent information. However, some participants may not be motivated to learn and recall consent information. In a preliminary pilot study (Festinger et al., 2008; Festinger et al., in press), we addressed this issue by using monetary incentives. Participants were randomly assigned to a standard consent procedure or to an incentivized condition in which they received $5.00 for every question they answered correctly on a consent quiz one week later. Results revealed the incentivized group recalled significantly more information with a large effect size (exceeding 1 standard deviation). The primary aim of the proposed two-year project is to conduct a two group study comparing the efficacy of a combined incentivized feedback and incentivized consent procedure to a consent as usual control group. We hypothesize that the combined condition result in greater consent recall and may lead to mastery of the information because it addresses both cognitive limitations in the population as well as motivation to learn the consent material. Importantly, this study will also assist in achieving ARRA aims by stimulating economic growth through the hiring and continued funding of entry and upper level personnel in Philadelphia, PA and Wilmington, DE.