Ethics of Participant Payment in Drug Abuse Research

描述(申请人提供)：药物滥用治疗结果研究 通常依赖于客户的后续评估来评估 临床干预。在许多情况下，受试者会被给予现金或 现金等值代金券，以补偿他们在 完善研究措施。道德上的反对意见通常会被提出， 然而，给受试者一大笔钱用于他们的研究 参与，因为这可能会促使人们重新使用药物，或者 不适当地影响受试者参与议定书。很少有研究， 然而，我已经经验性地调查了 不同的激励安排。调查人员和IRB成员经常必须依靠 关于轶事的描述或他们自己对可能的 不同的付款安排在从事道德行为时的影响 风险/收益分析。拟议的研究将涉及2x3随机、 不同模式的参数分析(现金与礼券)和 给予受试者的报酬数量级(10.00美元对40.00美元对70.00美元) 完成一项研究跟踪评估。后续行动的所有其他方面 礼仪(例如，工作人员与患者之间的互动程度、提醒函和 电话、交通援助)将被仔细监控和扣留 在所有付款条件下都是恒定的。受试者将竞争上瘾 严重程度指数(ASI；McLellan，Luborsky，O‘Brien，&Woody，1980；McLellan， Metzger，&Kushner，1991；McLellan等人，1992)，并将 计划在6个月内完成后续研究评估 入院后接受治疗。后续电池也将包括ASI 就像其他几种工具一样，旨在评估受试者对 胁迫、满足感、利益、伤害和不便 参加研究性学习。在6个月的随访中，受试者将 随后被要求在3天后再次进来完成一份简报， 术后随访满意度调查，并提供额外的尿液 样本。这将是第一次随机、受控的努力 系统审查主体薪酬的具体参数，并 经验性评估与不同激励措施相关的风险和收益 安排好了。这一结果将有助于研究人员和IRB的任务 制定和实施有效、有效和合乎道德的后续行动 程序。

DESCRIPTION (provided by applicant): Substance abuse treatment outcome studies typically rely on follow-up assessments of clients to evaluate the effects of clinical interventions. In many instances, subjects are given cash or cash-equivalent vouchers to compensate them for their time and effort in completing the research measures. Ethical objections are commonly raised, however, to giving subjects substantial sums of cash for their research participation because this might precipitate relapse to substance use or might unduly influence subjects to participate in the protocol. Very few studies, however, have empirically investigated the actual effects on subjects of different incentive arrangements. Investigators and IRB members often must rely on anecdotal accounts or their own preconceived notions about the possible effects of different payments arrangements when engaging in an ethical risk/benefit analysis. The proposed study will involve a 2x3, randomized, parametric analysis of different modes (cash vs. gift certificates) and magnitudes ($10.00 vs. $40.00 vs. $70.00) of remuneration to subjects for completing a research follow-up assessment. All other aspects of the follow-up protocol (e.g., degree of staff-to-patient interaction, reminder letters and phone calls, transportation assistance) will be carefully monitored and held constant across all payment conditions. Subjects will compete an Addiction Severity Index (ASI; McLellan, Luborsky, O'Brien, & Woody, 1980; McLellan, Metzger, & Kushner, 1991; McLellan, et al., 1992) at admission and will be scheduled to complete a follow-up research assessment at 6 months post-admission to treatment. The follow-up battery will include an ASI, as well as several other instruments designed to assess subjects' perceptions of coercion, satisfaction, benefits, harms, and inconveniences associated with being in the research study. At the 6-month follow-up, subjects will subsequently be asked to come in again 3 days later to complete a brief, post-follow-up satisfaction survey, and to provide an additional urine specimen. This will be the first randomized, controlled effort to systematically examine specific parameters of subject remuneration, and to empirically evaluate the risks and benefits associated with different incentive arrangements. The results will assist researchers and IRB's in their task of developing and implementing effective, validated, and ethical follow-up procedures.