What should an investigator do to study a marketed high blood pressure product for use in children under age 12?

When an investigator aims to study a marketed high blood pressure product for use in children under age 12, it involves a careful consideration of regulatory requirements due to the specific population and the nature of the research.

Submitting the research protocol to the Institutional Review Board (IRB) for review is essential as it ensures that the study meets ethical standards and safeguards the rights and welfare of the child participants. However, since the product is already marketed, the research likely seeks to explore new indications (in this case, use in a pediatric population) rather than just general use.

Submitting an Investigational New Drug (IND) application to the FDA is also necessary. An IND application is required when the investigational research involves a drug that is being used in a manner not specified in the approved labeling, which would apply to studying the product in a pediatric population where it has not been previously assessed. This process allows for the collection of safety and efficacy data in this new demographic, complying with regulatory standards.

Therefore, the combination of IRB review and the IND application submission is critical for conducting this research ethically and legally, ensuring both participant safety and scientific integrity.