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. ? ? ? ?
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