This week’s Research Ethics Roundup examines new international guidelines that focus on research in low-and middle-income countries, experts’ unease over increasing changes to the FDA’s mission, the academic debate over primate research, and what 21st Century Cures means for public health.
Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans: In this JAMA Viewpoint article, Johannes J. M. van Delden and Rieke van der Graaf summarize the Council for International Organizations of Medical Sciences (CIOMS)’ new International Ethical Guidelines for Health-Related Research Involving Humans. CIOMS created the guidelines with the World Health Organization and they are based on well-known guidance documents like the Declaration of Helsinki. The authors note that one of the big changes to the document is that in low-resource settings, CIOMS now believes that, once an intervention has proven effective, it should continue to be provided to the subject even after the research concludes.
The FDA is Slowly Getting Weaker. Here’s Why that’s Dangerous: In this piece for Vox, Julia Belluz examines public health experts’ increasing concern about what lies ahead for the Food and Drug Administration (FDA). She interviews several prominent researchers who voice concerns about upcoming changes to the FDA’s leadership, the 21st Century Cures Act, and the current way FDA’s drug review process is funded.
Reconsidering Research on Primates: Brandon Keim reports on one primate scientist’s re-evaluation of his work and the increased interest in research on primates’ cognitive abilities for The Chronicle of Higher Education. Keim also reviews how the ongoing debate over primate research played out at the National Institutes of Health’s primate research meeting in September. In this review, he highlights in-coming PRIM&R Board of Directors member F. Claire Hankenson’s remarks on the cognitive abilities of primates and her thoughts on what this means for research housing improvements.
Obama Signs Medical Cures Bill Into Law: Peter Sullivan writes for The Hill that the 21st Century Cures Act was passed with overwhelming bipartisan support. The law includes billions of dollars for new research initiatives, but consumer and public health experts remain concerned that sections accelerating the Food and Drug Administration’s approval process may hurt safety efforts.