Though now we can do larger genetic tests faster and cheaper, it doesn’t always make sense. Time constraints and lack of genetic providers put a limitation on the ability to consent or educate a family before they decide on clinical or research genetic testing, making true informed consent difficult to obtain, and there are ethical considerations for secondary findings. Read more
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
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
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 On May 13, PRIM&R submitted comments in response to the draft guidance.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
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
