QA/QI and Postapproval Monitoring Track

2019 AER Conference

Basic

E14 - Impact of the Revised Common Rule on the Work of a QA/QI Program

Speaker(s)

• 

  Mary-Tara Roth, RN, MSN, MPH
  

  Director, Clinical Research Resources Office; Assistant Director Human Research Protection Program, Boston University Medical Campus/Boston Medical Center
  
• 

  Leslie M. Howes, MPH, CIP
  

  Director, Office of Regulatory Affairs and Research Compliance, Harvard T.H. Chan School of Public Health
  

Institutions and universities have changed policies and procedures to be in compliance with the revised Common Rule. Some of the new provisions decrease the oversight and administrative burden of the IRB while simultaneously increasing the investigator’s responsibility. QA/QI programs have long been instrumental in educating and auditing investigator sites to ensure compliance, and this is another opportunity. During this session, speakers and attendees will:

Learning Objectives:

• Identify key changes in the revised Common Rule where QA/QI programs can collaborate with IRBs, or other components of the HRPP, to ensure compliance
• Discuss considerations introduced by the 2018 Requirements that could impact a QA/QI Program
• Use examples to highlight different QA/QI program approaches
• Note: Attendees are encouraged to bring their own case studies (including works in progress) for group discussion and further best practice brainstorming