HIV, Drugs, and Prisoners: Barriers to Epidemiologic and Intervention Research

描述(由申请人提供)：研究伦理和关于人类受试者保护的联邦法律已经演变为保护研究参与者的一般，特别是弱势群体。根据联邦法律，弱势群体包括孕妇、胎儿和新生儿、囚犯和儿童；根据伦理学家的说法，弱势群体还包括因滥用药物、精神疾病、污名化疾病(如艾滋病毒/艾滋病)和其他使人衰弱的疾病而受损的个人。研究参与者中一个特别脆弱的群体是被监禁的携带艾滋病毒/艾滋病或有感染艾滋病毒/艾滋病风险的吸毒者。这三种脆弱性(即吸毒、监禁和艾滋病毒+状态并存)在文献中得到了仔细的记录：80%-90%的美国囚犯有吸毒史，囚犯中的艾滋病发病率是普通人群的三倍。对囚犯的研究，特别是那些药物使用和/或艾滋病毒/艾滋病易感性增加的人的研究，带来了伦理挑战和责任，超出了对较不脆弱的人群进行研究所需的伦理挑战和责任。尽管惩教环境中艾滋病毒/艾滋病研究的增长和迫切需要，但还没有关于参与艾滋病毒/艾滋病监狱研究的研究人员和监管机构对道德原则和监管保障措施的解释和适用的实证研究。这项建议侧重于1)研究人员和IRB成员如何在囚犯艾滋病毒/艾滋病研究中解释和应用自主、公正和仁慈的伦理原则；2)研究人员和IRB成员如何解释和应用艾滋病毒/艾滋病囚犯研究的管理保障措施；3)惩教系统(包括监狱和监狱)的政策和结构环境如何造成必须由艾滋病毒/艾滋病研究人员和监狱管理机构解决的伦理挑战；4)伦理保障和监督如何影响艾滋病毒/艾滋病囚犯研究的发展。该项目将使用连续的定性和定量阶段来审查与对囚犯，特别是有吸毒史的囚犯进行和监督艾滋病毒/艾滋病研究有关的伦理挑战、责任和解决方案。第一阶段涉及75个关键的线人访谈，访谈对象包括曾在囚犯中进行艾滋病毒/艾滋病研究的个人；IRB主席、成员和囚犯倡导者；以及监狱管理人员。第二阶段将使用第一阶段的定性数据来构建和试行一项关于道德挑战和解决方案的量化调查。在第三阶段，将对全国2500名艾滋病毒/艾滋病研究人员和IRB成员、IRB主席和IRB囚犯倡导者进行定量调查。该项目将增进对囚犯艾滋病毒/艾滋病研究中的道德挑战和解决办法的了解，目的是减少以艾滋病毒/艾滋病和囚犯为重点的迫切需要的流行病学和干预研究的障碍。

DESCRIPTION (provided by applicant): Research ethics and federal laws about human subject protections have evolved to protect research participants in general, and vulnerable groups in particular. According to federal law, vulnerable groups include pregnant women, fetuses and neonates, prisoners, and children; according to ethicists, vulnerable groups also include individuals who suffer from impairment due to substance abuse, mental illness, stigmatized medical illness (e.g., HIV/AIDS), and other debilitating disorders. One particularly vulnerable group of research participants is imprisoned drug users with or at risk for HIV/AIDS. This triad of vulnerability (i.e., coexistence of drug use, imprisonment, and HIV+ status) has been carefully documented in the literature: 80-90% of US prisoners have drug abuse histories and AIDS rates are three times greater in prisoners than in the general population. Research with prisoners, especially those with added vulnerabilities of substance use and/or HIV/AIDS, poses ethical challenges and responsibilities beyond those required for research with less vulnerable populations. Despite the growth in and urgent need for HIV/AIDS research in correctional settings, there have been no empirical studies of the interpretation and application of ethical principles and regulatory safeguards by researchers and IRBs involved in HIV/AIDS prison research. This proposal focuses on 1) how researchers and IRB members interpret and apply ethical principles of autonomy, justice, and beneficence in HIV/AIDS research with prisoners; 2) how researchers and IRB members interpret and apply regulatory safeguards for HIV/AIDS 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 HIV/AIDS researchers and IRBs; and 4) ways in which ethical safeguards and oversight affect the growth of HIV/AIDS 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 HIV/AIDS research with prisoners, particularly prisoners with drug abuse histories. Phase 1 involves 75 key informant interviews with individuals who have conducted HIV/AIDS research with prisoners; IRB Chairs, members and prisoner advocates; and prison administrators. Phase 2 will use qualitative data from Phase 1 to construct and pilot-test a quantitative survey on ethical challenges and solutions. In Phase 3, the quantitative survey will be administered to a national sample of 2500 HIV/AIDS researchers and IRB members, IRB chairs, and IRB prisoner advocates. The project will result in increased understanding of the ethical challenges and solutions in HIV/AIDS research with prisoners, with the goal of reducing barriers to much needed epidemiologic and intervention research focused on HIV/AIDS and prisoners.