Measuring Prisoners' Voluntary Consent to Clinical Research for Opioid Dependence

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DESCRIPTION (provided by applicant): My career goal is to become an independent investigator who empirically examines ethical issues relevant to substance abuse treatment research with a particular focus on criminal justice populations. The time and support provided by this K23 award will constitute a major step in helping me achieve these goals by providing the necessary training and mentorship in ethics research, addictions research, biostatistics and instrumentation, and criminal justice research. Current federal guidelines impose strict limitations on all above minimal risk prisoner research out of concern that prisoners may be coerced into enrolling. Such restrictions are particularly problematic for the field of opioid dependence research given the high rate of opioid addiction and related health problems (e.g., HIV/AIDs, hepatitis, other addictions, and mental illness) in prisons, and the urgent need to develop prison-initiated therapies that effectively address the high morbidity and mortality associated with post-release opioid relapse and criminal recidivism. The primary research aim of this K23 award is to develop and validate an instrument that measures the extent to which prisoners perceive their consent to above minimal risk research for opioid dependence as voluntary. Initial development of the instrument (Aim 1) will be achieved by a) critically evaluating the literature on voluntariness, b) conducting concept elicitation interviews with prisoners who have either consented or declined to enroll in a NIDA-funded clinical trial for opioid dependence, c) evaluating these data with a multi-disciplinary group to develop a construct definition and preliminary set of instrument items, and d) pilot testing the instrument for readability and comprehension. Establishing the instrument's construct validity (Aim 2) will be achieved by evaluating concept validity with factor analyses, Rasch model analyses, and by convergent and discriminant validity testing among prisoners participating in one of two clinical trials for opioid dependence treatment. This instrument should be of great interest to clinical opioid researchers, other NIDA and NIH investigators, Institutional Review Boards, and criminal justice authorities because it will allow for the identification and exclusion of subjects who migh enroll non-voluntarily. This, in turn, will support the ethical advancement of much-needed clinical research on opioid dependence and related conditions among prisoners.