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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA020357-04
Application #
7841730
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Deeds, Bethany
Project Start
2007-07-01
Project End
2012-04-30
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
4
Fiscal Year
2010
Total Cost
$634,276
Indirect Cost
Name
University of Alaska Anchorage
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
076664986
City
Anchorage
State
AK
Country
United States
Zip Code
99514
Hanson, Bridget L; Faulkner, Sherilyn A; Brems, Christiane et al. (2015) Key Stakeholders' Perceptions of Motivators for Research Participation Among Individuals Who Are Incarcerated. J Empir Res Hum Res Ethics 10:360-7
Johnson, Mark E; Kondo, Karli K; Brems, Christiane et al. (2015) HIV/AIDS Research in Correctional Settings: A Difficult Task Made Even Harder? J Correct Health Care 21:101-11
Johnson, Mark E; Brems, Christiane; Bergman, Aaron L et al. (2015) Knowledge of Federal Regulations for Mental Health Research Involving Prisoners. AJOB Empir Bioeth 6:12-18
Johnson, Mark E; Brems, Christiane; Hanson, Bridget L et al. (2014) Conducting Ethical Research with Correctional Populations: Do Researchers and IRB Members Know the Federal Regulations? Res Ethics 10:6-16
Kondo, Karli K; Johnson, Mark E; Ironside, Erica F et al. (2014) HIV/AIDS research in correctional settings: perspectives on training needs from researchers and IRB members. AIDS Educ Prev 26:565-76
Eldridge, Gloria D; Robinson, Rebecca Volino; Corey, Staci et al. (2012) Ethical challenges in conducting HIV/AIDS research in correctional settings. J Correct Health Care 18:309-18
Back, Sudie E; Book, Sarah W; Santos, Alberto B et al. (2011) Training physician-scientists: a model for integrating research into psychiatric residency. Acad Psychiatry 35:40-5