At the University of Michigan, research studies routinely undergo not-for-cause reviews by the Office of Research Compliance Review (ORCR). Not-for-cause audits are conducted to verify the research is being conducted appropriately, and recommends process improvements when necessary. ORCR's mission is to facilitate safe, ethical, efficient, and high quality research.
Research teams should develop internal quality assurance (QA) processes for their studies to ensure compliance with both the protocol and government regulations. These QA processes may be performed randomly or as targeted internal audits performed by qualified individuals on a routine basis. The comprehensiveness and frequency of these audits can be a judgment based on study population vulnerabilities, study risk level, protocol complexity, and/or history of previous compliance/noncompliance by the research teams.
Decisions regarding which studies are reviewed and what type of follow-up is necessary should be outlined in the process itself, or at the study level. In addition, it is important to document the resolution of problems or issues found within these activities.
Contact us at MICHR-SPGSupport@umich.edu.