Brief Report

AIDS and Behavior

, Volume 14, Issue 6, pp 1313-1319

First online:

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

  • Sohini SenguptaAffiliated withCenter for Faculty Excellence, The University of North Carolina at Chapel Hill (UNC-Chapel Hill) Email author 
  • , Bernard LoAffiliated withDepartment of Medicine, University of California, San Francisco (UCSF)
  • , Ronald P. StraussAffiliated withExecutive Associate Provost, School of Dentistry and School of Medicine, UNC-Chapel Hill
  • , Joseph EronAffiliated withDepartment of Medicine, Division of Infectious Diseases, Center for AIDS Research (CFAR), UNC-Chapel Hill
  • , Allen L. GiffordAffiliated withVA New England Healthcare System, Center for Healthcare Quality, Outcomes and Economic ResearchDepartment of Health Policy and Management and Department of Medicine, Boston University

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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.


HIV AIDS Vulnerable populations Ethics Clinical trials