This week’s Research Ethics Roundup examines new findings from the FDA on juvenile animal studies for pediatric clinical development, the research community’s response to Apple’s ResearchKit, and why experts think more funding is needed for tuberculosis research. Read more
TAG ARCHIVES FOR FDA
While many agree that increased data sharing is an ethical imperative given the risks that clinical trial participants are asked to undertake, the question many institutions are now struggling with is how they can meet that imperative with their current resources and while protecting the privacy of study subjects. Read more
PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more
On May 14, PRIM&R hosted a webinar titled IRB Oversight and FDA Review of Studies that Include In-Vitro Diagnostics (IVDs), presented by Jonathan M. Green, MD, professor of medicine, pathology, and immunology, associate dean for human studies, and executive chair of the institutional review board (IRB) at Washington University School of Medicine in St. Louis, MO, and E. David Litwack, PhD, personalized medicine staff at the Office of In Vitro Diagnostics and Radiological Health at the US Food and Drug Administration (FDA).
At the conclusion of the webinar, Dr. Green and Dr. Litwack shared additional insight in response to questions from webinar attendees, and [...] Read more