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63. Additional DoD Requirements for Research Monitors

A medical monitor will be appointed for research involving more than minimal risk and may be required for a portion of and for all aspects of studies involving no more than minimal risk.

  • The medical monitor is appointed by name.
  • University and affiliate PIs must name the medical monitor in the application.
  • The monitor may be an ombudsman or a member of the data safety monitoring board.
  • The medical monitor shall be independent of the team conducting the research.
  • There may be more than one research monitor if different skills or experiences are needed.

The IRB must approve a written summary from the Principle Investigator regarding the monitors' duties, authorities, and responsibilities. The duties of the research monitor are determined on the basis of specific risks or concerns about the research and may include the following:

  • Observing recruitment, enrollment, and consent processes;
  • Overseeing study interventions and interactions;
  • Reviewing monitoring plans and unanticipated problems involving risks to participants or others;
  • Overseeing data collection and analysis;
  • Discussing the research protocol with investigators;
  • Interviewing human participants;
  • Consulting with others outside of the study; and
  • Reporting observations and findings to the IRB or a designated official.

The research monitor may take any steps necessary to protect the safety and well-being of participants until the IRB can assess the situation or incident including

  • Stopping a research study in progress, or
  • Removing individuals from the study.

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