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；和囚犯。根据伦理学家的说法，弱势群体还包括因精神疾病、被污名化的医学疾病和其他使人衰弱的疾病而遭受损害的个人。根据这些定义，患有精神疾病的囚犯非常容易受到伤害。由于患有严重精神疾病的囚犯人数超过了精神病院的病人人数，监狱和监狱已成为“美国的新精神病院” （Torrey， 1995年），现在监狱和监狱为许多患有精神疾病的人提供住院精神护理（Lamb和Weinberger， 2005年）。对囚犯的研究，特别是对那些更容易患精神疾病的囚犯的研究，带来了伦理挑战和责任，但参与囚犯心理健康研究的研究人员和内部审查委员会对伦理原则和监管保障的解释和应用尚未进行实证研究。本应用程序侧重于1)研究人员和IRB成员如何在囚犯心理健康研究中解释和应用自主、正义和仁慈的伦理原则；2)研究人员和内部审查委员会成员如何解释和应用囚犯心理健康研究的监管保障；3)惩教系统（包括监狱和拘留所）的政策和结构环境如何造成精神卫生研究人员和伦理委员会必须解决的伦理挑战；4)道德保障和监督影响囚犯心理健康研究的方式。该项目将采用连续的定性和定量阶段来审查与囚犯心理健康研究的开展和监督有关的道德挑战、责任和解决办法。第一阶段涉及与曾对囚犯进行心理健康研究的个人进行关键举报人访谈；IRB主席和成员；IRB囚犯代表；监狱管理员;以及研究伦理学家。利用这些数据，第二阶段的重点是构建关于道德挑战和解决方案的定量调查。在第三阶段，本调查在全国范围内进行，包括心理健康研究人员、内部审查委员会主席和成员以及内部审查委员会囚犯代表。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团体成员，收集他们对这些调查结果的意义和影响的看法。第五阶段侧重于通过向包括研究人员在内的重要利益攸关方群体传播研究成果，发起数据驱动的对话；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，加强对囚犯心理健康研究的道德和监管保障，目标是减少以囚犯精神疾病为重点的流行病学和干预研究的障碍。与公共卫生相关：监狱已成为“美国的新精神病院”，关押着精神障碍患者，但很少治疗，其数量相当于美国所有精神病院的总和。本项目为加强惩教系统内精神健康研究的道德保障提供经验基础，有助加强以研究为基础的精神病囚犯治疗。我们的工作与公共卫生密切相关，将为研究人员、内部审查委员会和监狱官员提供伦理指导；提高监狱人口心理健康研究的质量、开展和范围；并最终加强囚犯的健康和安全，以及他们获释后返回的社区。

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.