What is a necessary step before conducting research on a new formulation of a drug for children under a specific age?

Submitting both the research protocol to an Institutional Review Board (IRB) and an Investigational New Drug (IND) application to the FDA is a crucial step when conducting research involving new drug formulations, particularly for vulnerable populations such as children. The IRB review process ensures that the proposed research meets ethical standards and safeguards the rights and welfare of child participants. The IND application is required by the FDA to ensure that the drug formulation is safe for testing in humans and to obtain clearance to begin clinical trials.

This regulatory oversight is particularly significant in pediatric research, where additional considerations about consent, the risks versus benefits of the study, and ethical considerations in working with children come into play. These steps are necessary to uphold the integrity of the research process and to ensure that it is conducted responsibly, thus protecting the well-being of the minor participants involved.