Ethics of Participant Payment in Drug Abuse Research

描述（由申请人提供）：药物滥用治疗结果研究 通常依靠对客户的后续评估来评估 临床干预。在许多情况下，给受试者现金或 现金等价凭证，以补偿他们的时间和精力， 完成研究措施。道德上的反对意见通常会被提出， 然而，给受试者大量的现金用于他们的研究， 参与，因为这可能会促使复发药物使用或可能 不适当地影响受试者参与方案。很少有研究， 然而，已经实证研究了对受试者的实际影响， 不同的激励机制。研究者和IRB成员通常必须依靠 或者他们自己对可能的 不同的支付安排的影响时，从事道德 风险/收益分析。拟定的研究将涉及一项2x 3、随机、 不同模式的参数分析（现金与礼券）， 受试者的报酬幅度（10.00美元vs 40.00美元vs 70.00美元） 完成研究后续评估。后续行动的所有其他方面 协议（例如，工作人员与患者互动的程度，提醒信和 电话，交通援助）将被仔细监测和举行 在所有付款条件下保持不变。受试者将参与成瘾 严重性指数（ASI; McLellan，Luborsky，奥布莱恩，& Woody，1980; McLellan， Metzger，& Kushner，1991; McLellan，et al.，1992年），并将 计划在6个月时完成随访研究评估 入院后接受治疗。后续电池将包括一个ASI，以及 作为其他几种旨在评估受试者对 胁迫、满足、利益、伤害和与之相关的不便 参与研究。在6个月随访时，受试者将 随后被要求在3天后再次前来完成简报， 随访后满意度调查，并提供额外的尿液 试样这将是第一个随机，对照的努力， 有系统地审查学科薪酬的具体参数，并 经验性地评估与不同激励措施相关的风险和收益 安排这些结果将有助于研究人员和IRB的任务， 制定和实施有效的、经过验证的和符合道德规范的后续行动 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.