740244 JREXXX10.1177/1556264617740244Journal of Empirical Research on Human Research EthicsEyal and Holtzman research-article2017 Ethical Issues in Clinical Trials Journal of Empirical Research on Human Research Ethics 2018, Vol. 13(1) 18 –22 Invited Commentary on Dubé et al. © The Author(s) 2017 Reprints and permissions: (Perceptions of Equipoise, Risk/Benefit sagepub.com/journalsPermissions.nav https://doi.org/10.1177/1556264617740244 DOI: 10.1177/1556264617740244 Ratios, and “Otherwise Healthy Volunteers” journals.sagepub.com/home/jre in the Context of Early-Phase HIV Cure Research in the United States—A Qualitative Inquiry): Are HIV-Infected Candidates for Participation in Risky Cure-Related Studies Otherwise Healthy? 1 1 Nir Eyal and Lisa G. Holtzman Keywords HIV/AIDS, HIV Cure Research, Ethics, Healthy Volunteers, Clinical Trials personal communication, August 29, 2017, emphasis added). Background While later that year the FDA approved the study with pro- Much of Dubé et al.’s (2017) article is dedicated to the U.S. tocol modifications and more stringent eligibility require- Food and Drug Administration (FDA) reference to people ments, we shall focus on the FDA’s initial decision to put the living with HIV (PLWHIV) and well-managed on antiretro- ACTIVATE study on clinical hold as it was originally pro- viral therapy (ART) as “otherwise healthy volunteers.” They posed, because we believe there are general lessons to be focus on that reference in FDA’s
Journal of Empirical Research on Human Research Ethics – SAGE
Published: Feb 1, 2018
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