3.11 - Monitoring and Observation

Continuing monitoring and observation of research is the responsibility of both the researcher and the IRB. Monitoring of the research by the researcher is important because preliminary data may signal the need to (a) change the research design, (b) change the information presented to the subjects, or even (c) terminate the project before the scheduled date. Concurrent monitoring by the IRB helps ensure the protection of subjects and continued compliance with federal regulations. IRB monitoring is related to the degree of risk posed by the research and the history of compliance demonstrated by researchers. When risk to subjects is minimal, the IRB usually will ask for an annual progress report for a given study. However, when risks are more than minimal or when researchers have a history of serious noncompliance with IRB guidelines, the IRB may ask for detailed progress reports at intervals specified by the IRB. The IRB has the authority to observe all research procedures first hand or to assign monitoring of research to another individual or group of individuals (45 CFR 46.109).