Question

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 and submit an IND application to the FDA before conducting the research
Discard the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
All of the above
none of the above

Answer 1

A). Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research.

Step-by-step explanation:

As per the question, the most appropriate course of action for the investigator would be to 'Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research.' The investigator would be able to conduct the research only after receiving the necessary permissions as it concerns the lives of young children. Thus, study could be taken forward only after seeking the permission which requires the submission of protocols of the research to IRB and IND application to FDA. Hence, option A is the correct answer.