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?

The correct answer is Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

Explanation:

A research protocol describes the objectives, design, methodology and considerations taken in itself for the implementation and organization of a research or scientific experiment. It includes the design of the procedures to be used for the observation, analysis and interpretation of the results. In addition to the basic conditions for carrying out the described research, a protocol provides the background and reasons why such research is being carried out and defines the parameters under which its results will be measured. Research protocols are usually used in the field of natural sciences, such as physics, chemistry, biology or medicine, although they can also be used in other experimental fields and in the social sciences.