Evidence-Based Ethics and Mental Health Research with Prisoners

描述（由申请人提供）：有关人类受试者保护的伦理和联邦法律已经发展到保护一般研究参与者，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。伦理学家认为，弱势群体还包括因精神疾病、耻辱性医疗疾病和其他使人衰弱的疾病而受到损害的人。鉴于这些定义，患有精神疾病的囚犯非常容易受到伤害。随着患有严重精神疾病的囚犯人数超过精神病院的患者人数，看守所和监狱已成为“美国新的精神病院”（Torrey，1995），并且对于许多患有精神疾病的人来说，监狱和监狱现在提供住院精神病护理（Lamb＆Weinberger，2005）。对囚犯，特别是那些更容易患精神疾病的囚犯的研究，提出了伦理挑战和责任，但目前还没有对参与囚犯心理健康研究的研究人员和IRB对伦理原则和监管保障措施的解释和应用进行实证研究。此应用程序重点关注 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、正义和仁慈的道德原则； 2）研究人员和IRB成员如何解释和应用囚犯心理健康研究的监管保障措施； 3）惩教系统（包括监狱和看守所）的政策和结构环境造成道德挑战的方式，必须由心理健康研究人员和IRB解决； 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研究有关囚犯心理健康研究的实施和监督的道德挑战、责任和解决方案。第一阶段包括对对囚犯进行心理健康研究的个人进行关键知情人访谈； IRB 主席和成员； IRB 囚犯代表；监狱管理人员；和研究伦理学家。第二阶段的重点是利用这些数据构建有关道德挑战和解决方案的定量调查。在第三阶段，这项调查的对象是心理健康研究人员、IRB 主席和成员以及 IRB 囚犯代表的全国样本。在第四阶段，先前阶段的调查结果将提交给监狱管理人员、安全官员、医疗官员以及监狱宣传小组成员，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包括研究人员在内的重要利益相关群体传播研究成果来启动数据驱动的对话； IRB 主席、成员和监狱代表；以及监狱管理人员、医务人员和保安人员，以加强对囚犯心理健康研究的道德和监管保障的应用，以减少针对囚犯精神疾病的流行病学和干预研究的障碍。 公共健康相关性：监狱已成为“美国新的精神病院”，收容但很少治疗的精神障碍患者数量相当于美国所有精神病院的总和。通过为加强惩教系统中心理健康研究的伦理保障提供实证基础，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；提高监狱人口心理健康研究的质量、行为和范围；最终，加强囚犯及其释放后返回社区的健康和安全。

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.