On August 2, 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more
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In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, PRIM&R Executive Director Elisa Hurley explores the complex issue of clinical trial data sharing and its implications for the protection of human research subjects.
Though not a new issue, clinical trial data sharing has over the past several months taken center stage within the medical research community. In December 2015, a STAT [...] Read more
In this week’s Research Ethics Roundup, a collection of articles explore debates on regulations and regulators: NPR covers a critique of revisions to the Common Rule, a Nature editorial responds to legislation that would loosen FDA regulations, and former FDA commissioners ask Congress to make the agency more independent. Read more
From the role of women in research to a poll that found the majority of Americans don’t approve of an expedited drug approval process in exchange for lower standards, this week’s Research Ethics Roundup examines some of the latest controversial issues occurring in research. Read more
This week’s Research Ethics Roundup focuses on the ethical arguments for conducting Zika research on pregnant women, Public Citizen’s challenge of the Food and Drug Administration's (FDA's) redaction policy, and the official investigation on why a phase I trial in France left one dead. (more…) Read more