Improving the Ethics of Consent in Drug Abuse Research

这项为期两年的竞争性更新申请将延长一项研究计划，旨在提高参与研究的知情同意的伦理道德。最初的3年补助金在真实世界毒品法庭研究的背景下检查了纠正反馈程序和中立中介程序的效果。在纠正反馈条件下的参与者被给予同意测验与纠正反馈定期。中间条件下的参与者会见了中立的中间人（与治疗或研究团队无关），在提供知情同意之前提出问题并审查他们的权利。研究结果显示，纠正反馈导致显着增加召回的同意信息。中介程序导致减少感知胁迫，但没有影响的理解或回忆。 尽管纠正反馈效果显著，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一致，在这些报告中，同意干预措施已被证明可获得显著改善，但效果大小较小至中等，并且相对较小比例的参与者达到了80%至90%的同意信息的掌握水平。基本上，所有研究过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。认知和智力因素仅解释了同意回忆中的一部分差异（Festinger等人，2007年）。这表明，仅采取补救措施可能不足以促进充分学习和回忆同意信息。 然而，一些参与者可能没有动机学习和回忆同意信息。在初步的试点研究中（Festinger等人，2008; Festinger等人，我们通过使用货币奖励来解决这个问题。参与者被随机分配到一个标准的同意程序或一个激励条件下，他们在一周后的同意测验中回答正确的每一个问题都会得到5美元。结果显示，激励组回忆起显着更多的信息，具有较大的效果大小（超过1个标准差）。 拟议的两年期项目的主要目的是进行一项两组研究，比较联合激励反馈和激励同意程序与常规同意对照组的有效性。我们假设，合并条件导致更大的同意回忆，并可能导致掌握的信息，因为它解决了人口的认知局限性以及学习同意材料的动机。 重要的是，这项研究还将有助于实现ARRA的目标，通过雇用和继续资助宾夕法尼亚州费城和特拉华州威尔明顿的入门级和高级人员来刺激经济增长。

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.