Evidence-Based Ethics and Mental Health Research with Prisoners

关于人类受试者保护的伦理和联邦法律已经发展到保护研究参与者， 特别是弱势群体。根据联邦法律，弱势群体包括孕妇; 胎儿、新生儿和儿童;以及囚犯。伦理学家认为，弱势群体还包括 因精神疾病、污名化的医疗疾病和其他使人衰弱的疾病而遭受损害的个人 紊乱鉴于这些定义，患有精神疾病的囚犯更容易受到伤害。的数量 患有严重精神疾病的囚犯人数超过精神病医院、监狱和 监狱已经成为“美国新的精神病院”（Torrey，1995年），对许多患有精神疾病的人来说， 在精神病患者中，现在监狱和监狱提供住院精神病治疗（Lamb和Weinberger，2005年）。研究 与囚犯，特别是那些患有精神疾病的人，进行接触，构成了道德挑战， 责任，然而，还没有对道德责任的解释和应用进行实证研究。 参与精神卫生研究的研究人员和IRB的原则和监管保障措施， 囚犯该提案重点关注1）研究人员和IRB成员如何解释和应用伦理 囚犯心理健康研究中的自主、公正和有益原则; 2）研究人员如何 和IRB成员解释和应用监管保障与囚犯的心理健康研究; 3）方法 在这种情况下，惩教系统（包括监狱和看守所）的政策和结构环境创造了道德 心理健康研究人员和IRB必须解决的挑战;以及4）道德伦理 保障和监督影响对囚犯的心理健康研究。该项目将使用顺序 定性和定量阶段，审查道德挑战，责任和解决方案， 开展和监督囚犯心理健康研究。第一阶段涉及关键线人访谈， 对囚犯进行心理健康研究的个人; IRB主席和成员; IRB囚犯 代表;监狱管理人员;和研究伦理学家。利用这些数据，第二阶段的重点是 构建一个关于道德挑战和解决方案的定量调查。在第三阶段，这项调查是 管理的国家样本的心理健康研究人员，IRB主席和成员，和IRB囚犯 各位代表。在第四阶段，将前几个阶段的调查结果提交监狱管理人员、安全官员， 医疗官员和监狱倡导组织成员，收集他们对意义的看法， 这些发现的影响。第五阶段的重点是通过传播 向重要的利益相关者群体提供研究结果，包括研究人员; IRB主席，成员和监狱 代表;监狱管理人员，医务人员和安全人员，以加强 将道德和监管保障措施应用于囚犯心理健康研究，目标是 减少对囚犯精神疾病进行流行病学和干预研究的障碍。

Ethics and federal laws about human subject protections have evolved to protect research participants in general and vulnerable groups in particular. Under federal law, vulnerable groups include pregnant women; fetuses, neonates, and children; and prisoners. According to ethicists, vulnerable groups also include individuals who suffer from impairment due to mental illness, stigmatized medical illness, and other debilitating disorders. Given these definitions, prisoners with mental illnesses are multiply vulnerable. With the number of prisoners with serious psychiatric disorders exceeding the number of patients in psychiatric hospitals, jails and prisons have become "America's new mental hospitals" (Torrey, 1995) and for many individuals with mental illness, inpatient psychiatric care is now provided in jails and prisons (Lamb & Weinberger, 2005). Research with prisoners, especially those with the added vulnerability of mental illness, poses ethical challenges and responsibilities, yet there have been no empirical studies of the interpretation and application of ethical principles and regulatory safeguards by researchers and IRBs involved in mental health research with prisoners. This proposal focuses on 1) how researchers and IRB members interpret and apply ethical principles of autonomy, justice, and beneficence in mental health research with prisoners; 2) how researchers and IRB members interpret and apply regulatory safeguards for mental health research with prisoners; 3) ways in which policies and structural environments of correctional systems (including prisons and jails) create ethical challenges that must be addressed by mental health researchers and IRBs; and 4) ways in which ethical safeguards and oversight affect mental health research with prisoners. This project will use sequential qualitative and quantitative phases to examine ethical challenges, responsibilities, and solutions regarding the conduct and oversight of mental health research with prisoners. Phase 1 involves key informant interviews with individuals who have conducted mental health research with prisoners; IRB Chairs and members; IRB prisoner representatives; prison administrators; and research ethicists. Using these data, Phase 2 focuses on construction of a quantitative survey about ethical challenges and solutions. In Phase 3, this survey is administered to a national sample of mental health researchers, IRB chairs and members, and IRB prisoner representatives. In Phase 4, findings from prior phases are taken to prison administrators, security officials, and medical officials, and prison advocacy group members, to gather their perspectives on the meaning and implications of these findings. Phase 5 focuses on initiating a data-driven dialogue through dissemination of research findings to important stakeholder groups, including researchers; IRB chairs, members, and prison representatives; and prison administrators, medical staff, and security personnel to result in enhanced application of ethics and regulatory safeguards to mental health research with prisoners, with the goal of reducing barriers to epidemiologic and intervention research focused on mental illness among prisoners.