When reviewing research that is more than minimal risk, the IRBs are responsible for determining the protocol includes adequate provisions for monitoring the data collected to ensure the safety of participants.
For U.S. Department of Defense-sponsored research:
- Appointment of a research monitor.
- Required for research involving greater than minimal risk, although the IRB can require for a portion of the project or for studies involving no more than minimal risk if appropriate.
- Independent research monitor must be appointed by name.
- The research monitor has the authority to:
- Stop a research study in progress.
- Remove individuals from a study.
- Take any steps to protect the safety and well being of participants until the IRB can make an assessment.