Retroactive IRB approval

No we do not EVER do retroactive IRB approval.  If the study met one of the Exempt Categories then it should have been initially reviewed by the IRB.  If it wasn't then it is considered non-compliance.   

Depending on how you define "exempt," I can see circumstances where it really wouldn't be non-compliance.  A QI activity has an interesting result, the people who've done it think it is worth publishing, and the journal demands evidence that it had IRB approval.  After the fact, we'd be willing to look at it and say, "This wasn't research, and therefore didn't need IRB review."

We use words like Public Health Non-Research or non-human subjects research and not Exempt for projects that do not require IRB review.  It leads to less confusion.  We still review studies that meet the Exempt Criteria to ensure it does fall under Exempt.

At our institution, if a PI thinks they may publish they ask us to review it before starting so they can get a Non-Human Subjects or Public Health Non-Research determination letter so there is no issue.

Also if it is not human subjects research, then just write a letter stating that so it can be submitted to the Publisher.  There does not need to be a retroactive IRB approval if it does not fall under Human Subjects Research.    

I agree with Robin - the IRB should not ever grant retroactive approval.  I've worked at hospital, university, and public health IRBs and have not ever seen this allowed.  Our IRB policies and members are available for questions regarding if a project constitutes human subjects research.  Our IRB also allows a "minimal administrative" submission to determine if a project is human subjects research with a formal determination by the IRB.  As IRB Administrator, I repeatedly encourage our employees to ask questions about research and privacy BEFORE the project begins.  A project conducted without prior review runs the risk of non-compliance, misconduct, and not being publishable. 

To add to Robin's second comment - there is a wide misconception regarding what EXEMPT means.  (Research) Exempt means that a project is human subjects research, but is of such low risk that it is research exempt from complying with the requirements of 45 CFR 46.  Exempt does not mean that IRB review and approval is not required.  Exempt does not mean a project is not human subjects research.  

Our IRB allows the first option of getting a determination from the IRB if a project is "human subjects research" as defined at 45 CFR 46.102(e) and (l).  If the IRB determines that a project does not meet the definition, then no further action is taken.  The IRB provides a letter that a review occurred and the determination so that if journels ask, the project has a formal determination.

Respectfully, if a project is exempt from the requirements of 45 CFR 46, any requirement that it receive IRB review or approval is purely an institutional one, not based on federal regulation.  We, like most institutions, require that investigators submit their studies to the IRB so that we can confirm that they are exempt.  But that process involves the IRB administrator, not the Board members, and I would not describe it as "IRB review" or "IRB approval."  Since this process is not defined by regulation, how it occurs is purely an institutional decision.  All that said, making that determination often requires a complex analysis, requiring digging pretty deeply into the study's intentions, design details, etc.  

Joni Koenig - that is what we do as well.  Thank you for adding to my response.

Jessica Robbins - Our IRB Chair reviews all Exempt Category research submissions.  IRB Administrators do not do it because as you said, it requires a complex analysis and it should occur by someone that is able to look at the project, understand the design and have a scientific background and first-hand research experience, as well as, in our case familiarity, with all the Department of Health's programs. There have been projects over the years have been marked exempt by PIs (because they like the exempt category due to lack of IRB oversight) that actually fell under the Expedited Criteria.