The Food and Drug Administration has released a draft guidance about children in FDA-regulated research. This draft guidance is intended to describe the FDA’s current thinking about including children in research that involves medical drugs, devices, or biologics. Note that this is a draft guidance only; it may change when (and if) it is finalized. The FDA is currently accepting comments on this draft guidance.
Although it’s only a draft, the guidance contains some good information. For example, we at the Institutional Review Board have struggled with the notion of “component analysis,” which refers to the need to consider that different study arms may pose different levels of risk to child participants. This draft gives more information about what to consider when assessing risk.
Please take a look at the draft guidance. You’re also encouraged to read the Federal Register notice about the draft guidance, accessible via the link above.