TY - JOUR
AU - Holtzman, Lisa G.
AB - 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 
TI - Invited Commentary on Dubé et al. (Perceptions of Equipoise, Risk/Benefit Ratios, and “Otherwise Healthy Volunteers” 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?
JF - Journal of Empirical Research on Human Research Ethics
DO - 10.1177/1556264617740244
DA - 2018-02-01
UR - https://www.deepdyve.com/lp/sage/invited-commentary-on-dub-et-al-perceptions-of-equipoise-risk-benefit-5fAObvZIc1
SP - 18
EP - 22
VL - 13
IS - 1
DP - DeepDyve
ER -