Beginning February 17, 2014, the IRB is launching a new pilot initiative to facilitate the process of determining which projects are QI/QA and which projects are considered research. According to the Office of Human Research Protections (OHRP), quality improvement (QI) and quality assurance (QA) initiatives may or may not be considered research.
The IRB, in collaboration with faculty of the Perelman School of Medicine, is working to develop parameters to clearly outline which projects may be considered strictly QI/QA and do not require IRB review, and which projects qualify as human subjects research and require IRB review.
To assist with this initiative we encourage individuals working on QA/QI projects to submit to the IRB for an assessment. Your participation will result in the following:
- The IRB and faculty will provide prompt feedback about whether the project should be submitted for formal IRB review or you will be provided with a letter from the IRB that can be used for publication.
- You will assist the IRB in creating an efficient process for determining IRB review of projects that have QI/QA goals.
A new abbreviated submission form for QI/QA is available on the IRBs Forms page here:
If you have a QI/QA project, please email your completed submission form to the following dedicated QI/QA email address: email@example.com
Submitters will receive a formal determination that their project qualifies as QI/QA not requiring IRB review or will receive additional instructions on submitting to the IRB.
Please feel free to contact the QI review team with any questions at firstname.lastname@example.org.