Researchers in the Department of Bioethics at the National Institutes of Health invite IRB members to participate in a short study related to pediatric research ethics. The purpose of the study is to explore and compare the views of members of the general public and the views of members of IRBs on various types of medical research with children. The information collected is intended to inform how IRBs evaluate the ethical acceptability of proposed medical research in the future. Read more
TAG ARCHIVES FOR pediatric risk
Webinar Follow-Up: Pediatric Risk Determination – IRB Considerations and Cases
Tags:Pediatric subjects participating in HHS-funded or FDA-regulated studies are afforded additional protections not codified in subpart A of the Federal Policy for the Protection of Human Subjects (the Common Rule). On September 18, 2019, PRIM&R hosted a webinar, Pediatric Risk Determination: IRB Considerations and Cases. Presented by Rich Gormon, MD, and Donna L. Snyder, MD, this webinar helped attendees understand pediatric subpart D regulations, identify criteria for pediatric approvable research, and evaluate if the interventions or procedures in a protocol hold the prospect of direct benefit. After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more