Institutional Officials and HRPP Leadership Track
2019 AER Conference
B06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I
Director, Human Research Protection Program, Yale University
Michele Kennett, JD, MSN, CIP
Associate Vice Chancellor for Research, University of Missouri
Associate Vice Chancellor for Research, University of Missouri
Speaker(s)
Changes to NIH policies, the 21st Century Cures Act, and the 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 HRPP. This session will review the logistical details of work-load reallocation and departmental staffing and budget requirements at academic medical centers, universities, and hospitals. Before attending this session, attendees should have an understanding of the revised Common Rule, familiarity of the revised Common Rule’s impact on IRB operations, and an understanding of operational and compliance considerations related to sIRB. During this session, speakers and attendees will:
Learning Objectives:
- Review the various operational changes that are required to comply with the evolving research regulatory environment, and discuss the budgetary and structural impact
- Share examples of revised job descriptions, and approaches to staffing levels in response to changing operational systems
- Discuss resource allocation related to reliance oversight, limited IRB review, broad consent, and other newly created procedural requirements
- Provide practical strategies to assist organizations in re-evaluating their own staffing structures