Improving the Ethics of Consent in Drug Abuse Research

描述（由研究者提供）：知情同意是伦理研究的基石，但我们还没有发现任何研究已经经验性地检查了改善药物滥用客户对同意信息的理解或减少他们对强制进入研究的看法的方法。许多药物滥用研究的参与者缺乏参与研究的意识，无法回忆研究的潜在风险，没有意识到他们有权退出研究，并且不知道如果他们因参与而受到伤害该怎么办。这些缺陷在刑事司法系统所涉吸毒者中可能会更加突出。特别是，刑事司法系统中的吸毒者可能认为，他们的自由、生计或声誉取决于与当局合作和参与研究。 这是资助申请#R01-DA-016730-01的第一次修订，标题为“改善药物滥用研究中的同意伦理”，该申请是为了回应PA-02-103，人类研究中的伦理研究而提交的。我们建议进行一项2乘2的随机实验研究，对被要求参加药物法庭研究的客户进行两种不同的知情同意干预：一种纠正反馈程序，我们将在不同的时间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;以及使用研究中介，该中介将可用于监测同意过程并代表受试者维斯研究人员进行辩护。潜在受试者将被随机分配至以下四种情况之一：（1）常规知情同意程序;（2）常规知情同意程序加多项试验校正反馈程序;（3）常规知情同意程序加第三方研究中介;（4）常规知情同意程序加多项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知情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、知情同意率和损耗率。此外，我们将评估某些客户层面的特征，包括语言智力，记忆力和抽象推理是否可能相互作用或介导的一个或两个同意干预的影响。据我们所知，这将是第一个随机，对照评估这些同意干预在刑事犯罪或吸毒人群。

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.