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Institutional Officials and HRPP Leadership Track
Breakout Session Series C
Ann Johnson, PhD, MPH, CIP
IRB Director; Adjunct Professor
University of Utah
Michele Kennett, JD, MSN, CIP
Associate Vice Chancellor for Research
University of Missouri
University of Missouri Columbia
Robert Nobles, II, DrPH, MPH, CIP
Associate Vice Chancellor for Research, Responsible Conduct of Research, and Research Integrity Officer
University of Tennessee, Knoxville
Changes to NIH policies, the 21st Century Cures Act, and the pending revisions to the Common Rule, are driving many changes to operational procedures in the HRPP/IRB office. As a result, institutions are busy redefining workflows, job descriptions, and staffing levels. For example, the paradigm shift to single IRB (sIRB) review of multi-site research has resulted in institutions creating reliance departments whose sole responsibility is to oversee studies whose IRB oversight has been ceded to a sIRB and/or have had a re-characterization of existing staff roles, an addition of staff, and redistribution of traditional IRB activities to other components of the human subjects protections program. This session will review the logistical details of work-load reallocation and departmental staffing and budget requirements at academic medical centers, universities, and hospitals. Attendees should have an understanding of the revised Common Rule changes, familiarity of the revised Common Rule’s impact on IRB operations, and an understanding of operational and compliance considerations related to sIRBs before attending this session. During this session, speakers and attendees will: