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Marginalized Populations and Drug Addiction Research: Realism, Mistrust, and Misconception

This study explored drug users’ attitudes toward and understanding of randomized controlled trials testing addiction therapies. A video portraying a fictional consent conference for a randomized controlled trial with placebo arm was shown to poor male and female drug users of diverse ethnic status and sexual orientation. The video stimulated focus group discussion in which participants’ comments often reflected “experimental realism”—a realistic view of the trial—and adequate understanding of the uncertain efficacy of the treatment being tested, as well as the concepts of randomization and placebo control. However, participants’ comprehension of the nature of placebos was compromised by the widespread view that placebos are a way of testing a subject’s willpower and personal control over his or her addiction. Comments also showed a mistrust of the video investigator’s integrity and competence and signs of therapeutic misconception and misestimation. The study’s findings underscore the importance of tailoring informed consent encounters to the personal and sociohistorical context of participants’ lived experiences.

Key words/concepts: experimental realism, mistrust, therapeutic misconception, therapeutic misestimation, informed consent, randomized controlled trials, drug addiction research

This study explored drug users’ attitudes toward and understanding of randomized controlled trials testing addiction therapies. A video portraying a fictional consent conference for a randomized controlled trial with placebo arm was shown to poor male and female drug users of diverse ethnic status and sexual orientation. The video stimulated focus group discussion in which participants’ comments often reflected “experimental realism”—a realistic view of the trial—and adequate understanding of the uncertain efficacy of the treatment being tested, as well as the concepts of randomization and placebo control. However, participants’ comprehension of the nature of placebos was compromised by the widespread view that placebos are a way of testing a subject’s willpower and personal control over his or her addiction. Comments also showed a mistrust of the video investigator’s integrity and competence and signs of therapeutic misconception and misestimation. The study’s findings underscore the importance of tailoring informed consent encounters to the personal and sociohistorical context of participants’ lived experiences.

Key words/concepts: experimental realism, mistrust, therapeutic misconception, therapeutic misestimation, informed consent, randomized controlled trials, drug addiction research

Celia B. Fisher, Matthew Oransky, Meena Mahadevan, Merrill Singer, Greg Mirhej, and Derrick Hodge, “Marginalized Populations and Drug Addiction Research: Realism, Mistrust, and Misconception,” IRB: Ethics & Human Research 30, no. 3 (2008): 1-9.