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.
