Title

More than meets the IRB – Conversation with FDA: “Scientific necessity” and the vulnerability of children in research

Authors

Robert Nelson, Federal Food and Drug Administration
Michael Leary, Washington University School of Medicine in St. Louis

Document Type

Digital

Publication Date

5-2013

Notes

In this second installment of "More than Meets the IRB," Robert "Skip" Nelson (MD, PhD, Senior Pediatric Ethicist at the Food and Drug Administration) talks with us about the vulnerability of children in research. Topics include looking at the risk/benefit balance in this context through the lens of "scientific necessity," the difference between the high and low-risk review pathways, and "equitable selection" as a criterion for IRB review of research that involves children. We conclude by talking about the successes of the Pediatric Research Equity Act and Better Pharmaceuticals for Children Act. (22:10).

“Additional Safeguards For Children In Clinical Investigations”

Component Analysis: Presentation to the Secretary’s Advisory Committee on Human Research Protections

Streaming Media

Recommended Citation

Nelson, Robert and Leary, Michael, "More than meets the IRB – Conversation with FDA: “Scientific necessity” and the vulnerability of children in research" (2013). HRPO Podcasts. Paper 2.
https://digitalcommons.wustl.edu/hrpopods/2