This two-year competing-renewal application will extend a program of research aimed at improving the ethics of informed consent to participate in research studies. The initial 3-year grant examined the effects of a corrected feedback procedure and a neutral intermediary procedure in the context of a real-world drug court study. Participants in the corrected feedback condition were given consent quizzes with corrected feedback at regular intervals. Participants in the intermediary condition met with a neutral intermediary (not associated with the treatment or research teams) to ask questions and review their rights prior to providing informed consent. Findings revealed that corrected feedback led to significant increases in recall of consent information. The intermediary procedure led to reductions in perceived coercion but had no effect on understanding or recall. Despite the significant effects of corrected feedback, participants receiving this intervention recalled an average of only 65% of the consent information. This is consistent with numerous reports in the research literature in which consent interventions have been shown to elicit significant improvements, but the effect sizes have been small to moderate and relatively small proportions of the participants achieved mastery levels of 80% to 90% of the consent information. Essentially all of the interventions that have been studied have been remedial and designed to compensate for intellectual deficits or simplify the cognitive task. Cognitive and intellectual factors explain only a portion of the variance in consent recall (Festinger et al., 2007). This suggests remedial interventions alone may be insufficient to facilitate adequate learning and recall of consent information. However, some participants may not be motivated to learn and recall consent information. In a preliminary pilot study (Festinger et al., 2008;Festinger et al., in press), we addressed this issue by using monetary incentives. Participants were randomly assigned to a standard consent procedure or to an incentivized condition in which they received $5.00 for every question they answered correctly on a consent quiz one week later. Results revealed the incentivized group recalled significantly more information with a large effect size (exceeding 1 standard deviation). The primary aim of the proposed two-year project is to conduct a two group study comparing the efficacy of a combined incentivized feedback and incentivized consent procedure to a consent as usual control group. We hypothesize that the combined condition result in greater consent recall and may lead to mastery of the information because it addresses both cognitive limitations in the population as well as motivation to learn the consent material. Importantly, this study will also assist in achieving ARRA aims by stimulating economic growth through the hiring and continued funding of entry and upper level personnel in Philadelphia, PA and Wilmington, DE.
To our knowledge, this will be the first randomized, controlled evaluation to examine the efficacy of an incentive-based procedure for improving consent recall. Despite the numerous investigations of potential consent enhancement strategies, none have specifically examined methods of improving participants'motivation to understand or remember consent information. Determining effective strategies for ensuring the knowing and voluntary aspects of informed consent, may lead to a new standard in human subject protections, and will most certainly provide empirical evidence to assist in more adequately informing drug abusing research participants.
