A Randomized Trial of Incentives for Research Participation

 描述(由申请人提供)：随机临床试验(RCT)中的贫困患者收益是评估新的医疗干预措施的最大障碍。调查人员通常会提供经济奖励来促进招生和留存，但这些做法变数很大，基本上不受监管，而且一直存在争议。鼓励参与研究最常见的伦理问题是，它们可能(1)削弱人们对研究风险的看法，从而阻止完全知情同意，从而代表不正当的诱因；(2)通过鼓励优先在穷人中登记，代表不公正的诱因；以及(3)减少信息的披露，从而威胁到参与者的安全和科学完整性。所有这些担忧都没有在使用假设性激励措施参与假设性随机对照试验的研究中表现出来。但在没有证据表明真正的激励如何影响真正的RCT决策的情况下，实践的可变性仍然存在。一些调查人员在获得机构审查委员会(IRB)批准后使用的激励措施是否阻碍了自主决策和/或违反了正义原则？或者是其他研究人员和IRBs严重利用了一种方法，这种方法可以在不引发这些意想不到的后果的情况下提高医学创新的有效性和效率？研究激励是否真的能通过提醒参与者注意研究风险来促进自主性？激励措施是否具有足够的成本效益，足以证明使用它们是合理的？我们建议的研究将提供 到目前为止，对这些问题的最明确答案。我们将对3项实际激励措施(0美元、500美元或1,500美元)进行随机试验，以参与肺癌的常规放射治疗和质子射线治疗的比较。在患者审阅了包括他们分配的激励在内的知情同意文件后，我们将评估他们的研究态度、人口统计学特征、感知的研究风险、审阅知情同意文件所花费的时间、区分研究与个性化患者护理的能力，以及对关键试验特征的理解。这些量化评估将得到半结构化访谈的补充，这些访谈将更深入地探索患者参与试验的动机，以及激励对这些选择的相对影响。在患者决定是否参加父母的RCT后，我们将听取患者关于随机分配激励措施的情况。这项研究将有足够的力量，使用正式的“非自卑”测试，排除激励规模与风险感知之间的交互作用(即，不正当诱导)，以及激励规模与收入之间的交互作用(即，不公平诱导)。我们还将探索激励措施的潜在好处，例如激励措施通过让人们更彻底地关注研究风险来改善知情同意的可能性，以及它们是否足以加快招聘速度，从而总体上节省成本。这项研究将首次对真正的研究激励的预期和意外后果进行广泛的测试，从而为研究法规提供信息，并指导这种方法的使用，从而加速医学创新和改善健康。

 DESCRIPTION (provided by applicant): Poor patient accrual in randomized clinical trials (RCTs) is the greatest barrier to evaluating new medical interventions. Investigators commonly offer financial incentives to promote enrollment and retention, but these practices are highly variable, largely unregulated, and persistently controversial. The most common ethical concerns with incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; (2) represent unjust inducements by encouraging enrollment preferentially among the poor; and (3) reduce disclosure of information that would preclude entry into studies, thereby threatening participant safety and scientific integrity. None of these concerns have been shown to manifest in studies using hypothetical incentives for participating in hypothetical RCTs. But without evidence of how real incentives influence decision-making for real RCTs, practice variability remains. Are the incentives that some investigators use with institutional review board (IRB) approval thwarting autonomous decision-making and/or violating principles of justice? Or are other investigators and IRBs grossly underutilizing a method that can enhance the validity and efficiency of medical innovation without inciting these unintended consequences? Might research incentives actually promote autonomy by alerting participants to research risks? And are incentives sufficiently cost-effective to justify using them? The study we propose will provide the most definitive answers to date to these questions. We will conduct a randomized trial of 3 real incentives ($0, $500, or $1,500) to participate in a parent RCT comparing conventional radiation therapy with proton beam therapy for lung cancer. After patients review informed consent documents including their assigned incentive, we will assess their research attitudes, demographic characteristics, perceived research risks, time spent reviewing informed consent documents, ability to distinguish research from individualized patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews that more deeply explore patients' motivations for participating in trials, and the relative influence of incentives on those choices. After patients decide to enroll or not in the parent RCT, we will debrief patients about the random assignment of the incentives. The study will have adequate power to rule out, using formal "non-inferiority" tests, interactions between incentive size and risk perception (i.e., undue inducement) and between incentive size and income (i.e., unjust inducement). We also will explore potential benefits of incentives, such as the possibilities that incentives improve informed consent by making people attend more thoroughly to research risks, and that they expedite recruitment enough to be cost-saving on balance. This study will provide the first-ever tests of a broad range of intended and unintended consequences of real research incentives, thereby informing research regulations and guiding the use of this method that could expedite medical innovation and improve health.