14. Research Monitor

Research that is greater than minimal risk requires that the IRB approve a research monitor by name. A research monitor is an individual with expertise consonant with the nature of risk(s) identified within the research protocol and whose role is to protect the safety and well-being of human subjects. (DoD Instruction, Glossary) The monitor is independent of the team conducting the research involving human subjects. The monitor’s duties may include observing recruitment, enrollment procedures, and the consent process; reviewing safety monitoring and overseeing data collection and analysis. The monitor may discuss the research protocol with the investigator, interview subjects, and has the authority to take the steps necessary to protect the safety and well-being of human subjects by stopping research in progress until the IRB can assess the monitor’s report. The monitor has the responsibility to promptly report observations and findings to the IRB or other designated official and the HRPO. (DoD Instruction, 8. Research Monitor)

The researcher must identify the monitor by name, provide a written summary of the monitors’ duties, authorities and responsibilities, and the selection must be approved by the IRB.  More than one monitor may be appointed by the IRB for the same project and a monitor may be appointed even if the research is deemed to be no more than minimal risk.