Institutional Officials and HRPP Leadership Track

Breakout Session Series C

C09 - Use It or Lose It: Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate

Speaker(s)

• 

  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:

Learning Objectives:

• Review the operational changes that are required to comply with the evolving regulatory environment and potential budgetary and structural impact
• Explore operational solutions to manage sIRBs, including presentation of case examples from the perspectives of a reviewing IRB and relying institution, and how existing IRB staff roles may be re-purposed or re-defined in the era of sIRB review to avoid loss of staff
• Discuss other proposed changes to IRB review processes independent of sIRBs, such as limited IRB review, broad consent, and other newly created procedural requirements
• Illustrate examples of revised job descriptions and staffing levels in response to the changing operational systems
• Provide practical strategies to assist organizations in re-evaluating their own staffing structures
• Note: This session will end at 1:30 PM. Attendees should get their boxed lunch in the exhibit hall before going to the session room.