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Making Consent More Informed: Preliminary Results From a Multiple-Choice Test Among Probation-Referred Marijuana Users Entering a Randomized Clinical Trial

Mr. Rounsaville is Doctoral Candidate, University of Maryland–Baltimore County, Baltimore, MD. Ms. Hunkele is Research Associate, Dr. Easton is Associate Professor of Psychiatry, Ms. Nich is Statistician, and Dr. Carroll is Professor of Psychiatry, Yale University School of Medicine, New Haven, CT. Support was provided by the National Institute on Drug Abuse awards K05-DA 00457 and P50-DA09241. Address correspondence to: Kathleen M. Carroll, PhD, Yale University School of Medicine, 950 Campbell Avenue, 151D, West Haven, CT 06516. E-mail: kathleen.carroll{at}yale.edu

Although individuals who use illicit drugs are a potentially vulnerable population, there have been no objective evaluations of the effectiveness of standard informed consent procedures in assuring that prospective participants entering drug abuse treatment trials fully understand the nature of the research and treatments in which they have agreed to participate. Young, marijuana-dependent adults referred by the criminal justice system who were enrolling in a randomized treatment trial were asked to complete a multiple-choice quiz concerning basic elements of the trial before providing written informed consent. Participants were assigned to standard drug counseling or motivational interviewing/skills-building therapy, delivered alone or with incentives for attending sessions and submitting marijuana-free urine specimens. Only 55 percent of the 130 participants correctly answered all four questions, and 20 percent incorrectly answered a question concerning their right to refuse to participate. An unexpected finding was that quiz scores were modestly associated with marijuana use outcome measures. These preliminary findings highlight the importance of systematically evaluating the understanding of research participants, particularly those in vulnerable populations, of their rights and key aspects of the trials in which they agree to participate.