Learning Session 6: Responsible Conduct of QI and QI Research


PRESENTER: Jonathan Finkelstein, MD, MPH, Boston Children's Hospital


Participants will be able to:

  1. Describe two or more ways in which typical QI projects differ from human subjects research;
  2. Assess whether your own project should require IRB review from an ethical perspective, and whether it does require IRB review in your own institution; and
  3. In two minutes or less, make a logical argument for why local IRBs should create an alternate and simplified pathway for review and approval of QI projects.


  1. Joshua R, Downing NL, Shieh L, Heidenreich P, and Cho MK. “Ethical Oversight of Quality Improvement and the Research- QI Boundary: A New Common Rule Changes Little,” Hasting Center Report 39 (2017): 2-10.  
  2. Office for Human Research Protections (OHRP) Website. Quality Improvement Activities FAQs.


Learning Session 6_Responsible Conduct of QI