Through the community looking glass: How street drug users perceive ethical issues in randomized clinical trials for drug addiction

Making a reasoned decision to participate in a randomized clinical trial (RCT) requires understanding the uncertain efficacy and risks of the experimental treatment, random assignment, and use of placebos or other control conditions. Such concepts are often unfamiliar to and confused by middle income, educated patients participating in RCTs for a broad spectrum of medical disorders. Even when such concepts are understood, prospective participants may incorrectly hold a “therapeutic misconception” characterized by the (a) belief that individualized needs will be taken into account in RCT condition assignment and (b) the unreasonable expectation of medical benefit from research participation. The consent problem is compounded when RCT recruitment involves poor, less educated and socially marginalized groups of active drug users who, because of their experience with economic and social barriers to quality healthcare and distorted beliefs about addiction, may appraise consent information differently than groups with histories of access to effective medical care and health disorders that do not compromise their understanding of their disease. Moreover, the unfortunate history of scientific exploitation experienced by marginalized groups in the United States may lead to experimental mistrust and an overestimation of risk. This presentation will identify ethical issues associated with RCT research in general and with illicit drug users in particular, provide data generated through a NIDA funded study on how active street drug users perceive these issues, and discuss implications for research ethics planning.