There is a new guidance document adopted for research reviewed by the JHM IRBs. Over the past two years, we have received an increasing number of inquiries from faculty who try to discern when an activity involving patients represents quality improvement/quality assurance (QA/QI) and when an activity meets the definition of human subjects research. The distinction is important, as QI/QA projects do not require JHM IRB review and approval, whereas all human subjects research projects do require JHM IRB review and approval. We have been working with the JHU Vice Provost for Research in developing a guidance document that would be applicable to all components of the University. The University-wide policy is under active review and a decision should be made by the end of this year. In order to provide clarification to JHUSOM faculty and staff at this time, we are providing on the JHM IRB website (http://irb.jhmi.edu/Guidelines/QI_QA.html) the document "Definition of Research As It Applies to Clinical Practice, Quality Improvement/Quality Assurance, and Public Health Activities." This document will be replaced when the JHU-wide policy is available.

Please note that the guidance states faculty should request an IRB opinion in cases where it is not clear whether or not an activity meets the definition of research requiring IRB review. I believe the guidance will be useful to the community of researchers here. Questions about the document should be referred to the Office of Human Subjects Research senior staff or regulatory staff for assistance.

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