Document Type

Digital

Publication Date

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

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