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Frequently Asked Questions - FAQs

FAQs on the Research Monitor

DoDI 3216.02 requires the Institutional Review Board (IRB) to approve an independent research monitor by name for DoD-conducted and select DoD-supported human subjects research that is more than minimal risk. In addition, a research monitor may be identified by an investigator or appointed by the IRB or Institutional Official (IO) for minimal risk research. IAW DoDI 3216.02, Enclosure 3, section 8.a.(3), an IRB must approve a written summary of the research monitor’s duties, authorities, and responsibilities, and the IRB or Human Research Protection Program (HRPP) official shall communicate with research monitors to confirm the research monitor’s duties, authorities, and responsibilities.

Q: Must research monitors be approved or appointed by a formal letter or memorandum of appointment?

A: No. This approval and communication may be documented in a variety of ways. Acceptable forms include a formal letter or memorandum, a named reference in the IRB minutes, or as a part of the protocol documentation that is approved by the IRB. However documented, approval or appointment of research monitors must be part of the study records and readily accessible to internal and external auditors.

Q: Under what circumstances might the appointment of a research monitor be appropriate for minimal risk research?

A: Generally, a research monitor is not required for minimal risk research. "Minimal risk" indicates that the study procedures present risk that is no greater than that ordinarily encountered in daily life activities, or during the performance of routine physical or psychological examinations or tests. If a research monitor is appointed for a minimal risk protocol the rationale should be clearly documented. For example, the convened IRB may determine that the specific duties of the research monitor are likely to have the effect of lowering risk to subjects, which may reduce the overall risk level of the protocol from what would otherwise be more than minimal risk, to minimal risk.