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，他根据经验研究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构成一个重要的一步，帮助我实现这些目标，通过提供必要的培训和指导，在道德研究，成瘾研究，生物统计学和仪器仪表，和刑事司法研究。目前的联邦指导方针对所有高于最低风险的囚犯研究施加了严格的限制，因为担心囚犯可能会被强迫参加。这种限制对于阿片类药物依赖性研究领域尤其成问题，因为阿片类药物成瘾率高，相关的健康问题（例如，艾滋病毒/艾滋病、肝炎、其他成瘾和精神疾病），迫切需要开发监狱启动的治疗方法，有效解决释放后类阿片复吸和刑事累犯相关的高发病率和死亡率。K23奖项的主要研究目的是开发和验证一种工具，衡量囚犯在多大程度上认为他们同意阿片类药物依赖的最低风险研究是自愿的。该工具的初步开发（目标1）将通过以下方式实现：a）批判性评价关于非自愿性的文献，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价这些数据，以开发工具项目的结构定义和初步集，以及d）对该仪器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 通过因子分析、Rasch模型分析以及在参与阿片类药物依赖治疗的两项临床试验之一的囚犯中进行收敛和判别效度测试来评估概念效度。该工具应该引起临床阿片类药物研究人员、其他NIDA和NIH研究人员、机构审查委员会和刑事司法当局的极大兴趣，因为它将允许识别和排除可能非自愿招募的受试者。这反过来又将支持急需的临床研究的伦理进步。 研究囚犯对阿片类药物的依赖和相关状况。

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.