TAG ARCHIVES FOR pediatric research

16
Mar2020

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

11
Jun2019

In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients." The guidance is one of the latest moves by the agency to expand eligibility criteria, and hence the knowledge base for how drugs work in various populations, for the clinical trials they regulate. It makes recommendations not only for sponsors but also for IRBs. On May 13, PRIM&R submitted comments in response to the draft guidance. PRIM&R also has an upcoming webinar, Pediatric Risk Determination: IRB Considerations and Cases, on Thursday, September 19 that will review considerations for IRBs in assessing the risks and benefits of pediatric studies. Read more

12
Nov2018

I was very excited to learn of the opportunity to become a member of the Blog Squad for the 2018 Advancing Ethical Research Conference (AER18). I am the Research Director for the Department of the Emergency Medicine and serve as the Vice Chair for the IRB at The Lincoln Medical Center in The Bronx, New York. Initially, I became familiar with the IRB as a Principal Investigator, when I conducted a research project to fulfil the requirement for Pediatric Emergency Medicine (PEM) fellowship training. I quickly realized that research is vitally important to for the advancement of medical science and I also understood that human subjects protections, particularly in children and other vulnerable populations, is critical. As I practiced in a neighborhood of diverse and low-income households, I appreciate the importance that subjects’ rights not be violated, and that they not be unduly coerced to participate in research. It is also important that participants enter into research studies voluntarily and with sufficient information and understanding. Read more

19
Aug2016

This week’s Research Ethics Roundup discusses a study on the low rate of publication of pediatric studies, the ethics of compensating women for eggs donated to research, Senator Elizabeth Warren’s argument for improved data sharing, and a study of standard versus semi-naturalistic caging for lab rats. Read more