Questions: An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action? Submit the research protocol to the IRB for review, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication Submit the research protocol to the Office for Human Research Protections (OHRP) for their review Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research Submit an Investigational Device Exemption (IDE) application to the FDA

The answer is the third one: Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research.

Explanation for each option:

1. Submit the research protocol to the IRB for review, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication: This option is incorrect because, although the drug is approved for treating high blood pressure in individuals over age 12, using it in a different population (children under age 12) and in a different formulation (liquid) constitutes a new use. This requires an IND application to ensure safety and efficacy in the new population.

2. Submit the research protocol to the Office for Human Research Protections (OHRP) for their review: This option is incorrect because the OHRP is not the appropriate body for reviewing drug research protocols. The OHRP oversees the protection of human subjects in research, but the FDA is responsible for the regulation of drug studies.

3. Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research: This is the correct option. The IRB review is necessary to ensure the ethical conduct of the study, and an IND application is required because the study involves a new use of an existing drug in a different population and formulation.

4. Submit an Investigational Device Exemption (IDE) application to the FDA: This option is incorrect because an IDE is applicable to medical devices, not drugs. Since the study involves a drug, an IND application is appropriate.

In summary, the investigator should submit the research protocol to the IRB for ethical review and submit an IND application to the FDA to ensure regulatory compliance for the new use of the drug in a different population.