Improving the Ethics of Consent in Drug Abuse Research

描述(由研究人员提供)：知情同意是伦理研究的基石，但我们还没有发现经验性地检验了提高药物滥用患者对同意信息的理解或减少他们被强迫进入研究研究的方法的研究。许多药物滥用研究的参与者缺乏参与研究的意识，没有回忆起研究的潜在风险，没有意识到他们有权退出研究，也不知道如果参与伤害了他们该怎么办。这些缺陷很可能在参与刑事司法系统的吸毒者中放大。特别是，参与刑事司法系统的吸毒者可能认为，他们的自由、生计或声誉取决于与当局合作和参与研究。 这是对题为“改进药物滥用研究中的同意伦理”的拨款申请#R01-DA-016730-01的第一次修订，该申请是针对PA-02-103“人类研究中的伦理问题研究”提交的。我们提议对两种不同的知情同意干预措施进行2乘2的随机实验研究，这些干预措施适用于被要求参与毒品法庭研究的客户：更正的反馈程序，在该程序中，我们将以不同的间隔测试参与者对同意信息的回忆，并纠正他们的错误反应；以及使用研究中间人来监督同意过程，并代表受试者与研究人员进行VISA宣传。潜在受试者将被随机分配到四种条件之一：(1)照常同意过程；(2)照常同意过程加上多次试验校正反馈程序；(3)与第三方研究中介机构照常同意过程；以及(4)照常同意过程加上多次试验校正反馈和第三方研究中介。结果变量将包括参与者对同意信息的理解和保留、对进入研究的胁迫的感知、对研究的感知满意度、对研究的感知伤害、同意率和流失率。此外，我们将评估某些客户层面的特征，包括言语智力、记忆力和抽象推理，是否可能与其中一种或两种同意干预措施的效果相互作用或起到调节作用。据我们所知，这将是第一次对罪犯或药物滥用人群中的同意干预进行随机、受控评估。

DESCRIPTION (provided by investigator): Informed consent is the comerstone of ethical research, yet we have uncovered no study that has empirically examined methods for improving drug abuse clients' understanding of consent information or reducing their perceptions of coercion to enter research studies. Many participants in drug abuse studies lack awareness of being in a study, fail to recall potential risks of the research, do not realize they have a right to withdraw from the study, and are unaware of what to do if they are harmed by participation. These deficiencies are likely to be magnified among drug abusers involved with the criminal justice system. In particular, drug abusers involved in the criminal justice system may believe that their liberty, livelihood, or reputation depend on cooperating with authorities and participating in research. This is the first revision of grant application #R01-DA-016730-01 entitled "Improving the Ethics of Consent in Drug Abuse Research," which was submitted in response to PA-02-103, Research on Ethical lssues in Human Studies. We are proposing to conduct a 2-by-2, randomized experimental study of two different informed consent interventions for clients being asked to participate in a study of drug courts: a corrected feedback procedure, in which we will test participants' recall of consent information at various intervals and correct their erroneous responses; and the use of a research intermediary who will be available to monitor the consent process and to advocate on behalf of subjects visa vis research staff. Potential subjects will be randomly assigned to one of four conditions: (1) consent process as usual; (2) consent process as usual plus a multi-trial corrected feedback procedure; (3) consent process as usual with a third party research intermediary; and (4) consent process as usual plus both multi-trial corrected feedback and a third party research intermediary. Outcome variables will include participants' comprehension and retention of consent information, perceptions of coercion to enter the study, perceived satisfaction with the study, perceived injuries from the study, consent rates, and attrition rates. In addition, we will assess whether certain client-level characteristics including verbal intelligence, memory, and abstract reasoning may interact with or mediate the effects of either or both of the consent interventions. To our knowledge, this will be the first randomized, controlled evaluation of these consent interventions in a criminal offender or drug-abusing population.