Measuring Prisoners' Voluntary Consent to Clinical Research for Opioid Dependence

描述（由申请人提供）：我的职业目标是成为一名独立的调查员，以经验检验与药物滥用治疗研究相关的伦理问题，特别关注刑事司法人群。这个K23奖所提供的时间和支持将通过在伦理学研究、成瘾研究、生物统计学和仪器以及刑事司法研究方面提供必要的培训和指导，帮助我实现这些目标。目前的联邦指导方针严格限制上述最低风险囚犯研究，因为担心囚犯可能被迫加入。鉴于监狱中阿片类药物成瘾和相关健康问题（如艾滋病毒/艾滋病、肝炎、其他成瘾和精神疾病）的高发率，以及迫切需要开发监狱发起的治疗方法，有效解决与阿片类药物释放后复发和犯罪累犯相关的高发病率和死亡率，这种限制对阿片类药物依赖研究领域尤其成问题。K23奖的主要研究目的是开发和验证一种工具，以衡量囚犯认为他们同意上述阿片类药物依赖最小风险研究的程度是自愿的。该工具的初步开发（目标1）将通过以下方式实现：a)严格评估关于自愿性的文献；b)对同意或拒绝参加nida资助的阿片类药物依赖临床试验的囚犯进行概念启发访谈；c)与多学科小组一起评估这些数据，以制定构建定义和初步的工具项目集；d)对工具的可读性和理解性进行试点测试。建立工具的结构效度（目标2）将是

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.