AIDS and Behavior

, Volume 14, Issue 6, pp 1313–1319

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

  • Sohini Sengupta
  • Bernard Lo
  • Ronald P. Strauss
  • Joseph Eron
  • Allen L. Gifford
Brief Report

DOI: 10.1007/s10461-010-9785-x

Cite this article as:
Sengupta, S., Lo, B., Strauss, R.P. et al. AIDS Behav (2010) 14: 1313. doi:10.1007/s10461-010-9785-x

Abstract

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.

Keywords

HIV AIDS Vulnerable populations Ethics Clinical trials 

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Sohini Sengupta
    • 1
  • Bernard Lo
    • 2
  • Ronald P. Strauss
    • 3
  • Joseph Eron
    • 4
  • Allen L. Gifford
    • 5
    • 6
  1. 1.Center for Faculty ExcellenceThe University of North Carolina at Chapel Hill (UNC-Chapel Hill)Chapel HillUSA
  2. 2.Department of MedicineUniversity of California, San Francisco (UCSF)San FranciscoUSA
  3. 3.Executive Associate Provost, School of Dentistry and School of MedicineUNC-Chapel HillChapel HillUSA
  4. 4.Department of Medicine, Division of Infectious Diseases, Center for AIDS Research (CFAR)UNC-Chapel HillChapel HillUSA
  5. 5.VA New England Healthcare System, Center for Healthcare Quality, Outcomes and Economic ResearchBedfordUSA
  6. 6.Department of Health Policy and Management and Department of MedicineBoston UniversityBostonUSA

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