Evidence-Based Ethics and Mental Health Research with Prisoners

描述（由申请人提供）：关于人类受试者保护的伦理和联邦法律已经发展到保护一般的研究参与者，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。根据伦理学家的说法，弱势群体还包括因精神疾病、被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。鉴于这些定义，患有精神疾病的囚犯更容易受到伤害。由于患有严重精神疾病的囚犯人数超过了精神病医院的病人人数，监狱和监狱已成为“美国新的精神病医院”（Torrey，1995年），对于许多精神病患者来说，监狱和监狱现在提供住院精神病治疗（Lamb和Weinberger，2005年）。对囚犯的研究，特别是对那些更易患精神疾病的囚犯的研究，提出了伦理挑战和责任，但还没有对参与囚犯精神健康研究的研究人员和IRB解释和应用伦理原则和监管保障措施的实证研究。本申请的重点是1）研究人员和IRB成员如何解释和应用自主，正义和慈善的道德原则在囚犯的心理健康研究; 2）研究人员和IRB成员如何解释和应用监管保障囚犯的心理健康研究; 3）惩教系统的政策和结构环境（包括监狱和监狱）创造了必须由心理健康研究人员和IRB解决的道德挑战;以及4）道德保障和监督影响囚犯心理健康研究的方式。该项目将使用连续的定性和定量阶段来研究道德挑战，责任和解决方案，有关囚犯心理健康研究的进行和监督。第一阶段涉及与对囚犯进行心理健康研究的个人进行的关键线人访谈; 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，第二阶段侧重于构建有关伦理挑战和解决方案的定量调查。在第三阶段，这项调查是管理的心理健康研究人员，IRB主席和成员，以及IRB囚犯代表的国家样本。在第四阶段，将前几个阶段的调查结果提交给监狱管理人员、安全官员、医务官员和监狱倡导小组成员，以收集他们对这些调查结果的意义和影响的看法。第五阶段的重点是通过向重要的利益攸关方群体传播研究结果，启动数据驱动的对话，包括研究人员、IRB主席、成员和监狱代表;以及监狱管理人员、医务人员和安全人员，以加强道德和监管保障措施在囚犯心理健康研究中的应用，目的是减少对流行病学和干预研究的障碍，重点是囚犯中的精神疾病。 公共卫生相关性：监狱已经成为“美国新的精神病院”，收容但很少治疗精神障碍患者，其人数相当于美国所有精神病院的总和。通过提供一个经验基础，加强惩教系统中精神健康研究的道德保障，该项目将有助于加强对患有精神疾病的囚犯的基于研究的治疗。我们的工作与公共卫生密切相关，将为研究人员、IRB和监狱官员提供道德指导;提高监狱人群心理健康研究的质量、行为和范围;并最终提高囚犯及其获释后返回的社区的健康和安全。

DESCRIPTION (provided by applicant): 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 application 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. PUBLIC HEALTH RELEVANCE: Prisons have become "America's new mental hospitals", housing, but rarely treating, as many individuals with mental disorders as all psychiatric hospitals in the US combined. By providing an empirical basis with which to strengthen ethical safeguards for mental health research in correctional systems, this project will contribute to the enhancement of research-based treatment for prisoners with mental illness. Of great relevance to public health, our work will provide ethical guidance to researchers, IRBs, and prison officials; enhance the quality, conduct, and range of mental health research in prison populations; and, ultimately, enhance the health and safety of prisoners and the communities to which they return upon release.