How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials
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In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers’ ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations’ group-based approach to defining vulnerable populations.
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- How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials
AIDS and Behavior
Volume 14, Issue 6 , pp 1313-1319
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
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- Vulnerable populations
- Clinical trials
- Industry Sectors
- Author Affiliations
- 1. Center for Faculty Excellence, The University of North Carolina at Chapel Hill (UNC-Chapel Hill), 316 Wilson Library, 3470, Chapel Hill, NC, 27599-3470, USA
- 2. Department of Medicine, University of California, San Francisco (UCSF), San Francisco, CA, USA
- 3. Executive Associate Provost, School of Dentistry and School of Medicine, UNC-Chapel Hill, Chapel Hill, NC, USA
- 4. Department of Medicine, Division of Infectious Diseases, Center for AIDS Research (CFAR), UNC-Chapel Hill, Chapel Hill, NC, USA
- 5. VA New England Healthcare System, Center for Healthcare Quality, Outcomes and Economic Research, Bedford, MA, USA
- 6. Department of Health Policy and Management and Department of Medicine, Boston University, Boston, MA, USA