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
It’s your single place to instantly
discover and read the research
that matters to you.
Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.
All for just $49/month
Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly
Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.
Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.
Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.
All the latest content is available, no embargo periods.
“Hi guys, I cannot tell you how much I love this resource. Incredible. I really believe you've hit the nail on the head with this site in regards to solving the research-purchase issue.”Daniel C.
“Whoa! It’s like Spotify but for academic articles.”@Phil_Robichaud
“I must say, @deepdyve is a fabulous solution to the independent researcher's problem of #access to #information.”@deepthiw
“My last article couldn't be possible without the platform @deepdyve that makes journal papers cheaper.”@JoseServera