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调查员，对与药物滥用治疗研究相关的伦理问题进行实证研究，特别关注刑事司法人群。这个K23奖项提供的时间和支持将成为帮助我实现这些目标的重要一步，通过在伦理研究、成瘾研究、生物统计和工具以及刑事司法研究方面提供必要的培训和指导。目前的联邦指导方针对所有上述最低风险囚犯研究施加了严格限制，因为担心囚犯可能被强迫入伍。考虑到监狱中阿片成瘾和相关的健康问题(如艾滋病毒/艾滋病、肝炎、其他成瘾和精神疾病)的高比率，以及迫切需要开发监狱发起的疗法，有效解决释放后阿片类药物复发和犯罪累犯相关的高发病率和高死亡率，这种限制对于阿片依赖研究领域尤其成问题。这项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进行阿片类药物依赖的上述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)对关于自愿的文献进行批判性评估，b)对同意或拒绝参加NIDA资助的阿片依赖临床试验的囚犯进行概念启发访谈，c)与一个多学科小组一起评估这些数据，以制定一个构思定义和初步的一套工具项目，以及d)对该工具的可读性和理解性进行试点测试。确定该工具的结构有效性(目标2)将是 通过因子分析、Rasch模型分析评估概念有效性，以及通过参与阿片依赖治疗的两个临床试验之一的囚犯的会聚和区分有效性测试来实现。临床阿片类药物研究人员、NIDA和NIH的其他调查人员、机构审查委员会和刑事司法当局应该对这一工具非常感兴趣，因为它将允许识别和排除可能非自愿登记的受试者。反过来，这将支持急需的临床医学的道德进步。 服刑人员阿片类药物依赖及相关情况研究。

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.