Breaking Down Continuing Review
I think the number one question we get at the IRB is about the annual review/check-in process for minimal risk projects and how to handle an approaching expiration or “Next Report Due” date. Here are some things to bear in mind:
- There have been a few changes to both regulations and IRB procedure in the last year, so we understand current expectations may be different from what you’re used to.
- Brooke Wainwright has been helping the IRB to keep on top of expiring studies, so you may be hearing from her if you need to act on your study.
- Automated emails regarding ‘Next Report Due’ from IRBNet are inaccurate for ceded studies. We regret the confusion and are working with our national KP partners to get these revised to differentiate between ceded studies and those that do not require action.
Generally, minimal risk studies fall into one of three categories that affect the annual review/check-in process:
- Expedited studies with an expiration date – Prepare an IRBNet package and create a Continuing Review Form from the Designer page. The package should be submitted 4-6 weeks prior to the study expiration date.
- Exempt and expedited studies with no expiration date - If no changes to study or staff are requested, no action is required by study staff. The study team only needs to update the IRB regarding proposed changes to the approved study plan. After three years, the IRB will check in with the study team to make sure that the study is still active and unchanged.
- Ceded studies overseen by an external IRB - Upon receipt of the continuing review approval letter from the reviewing IRB*, prepare a package in IRBNet and upload the approval letter. If the protocol or any other locally relevant documents were also modified in the last year, include the most recent versions of the revised materials in the package. If the reviewing IRB does not issue approval letters (this is rare), a screen shot of the new expiration date will suffice.
*We realize that in certain situations the CR approval letter may not be available until close to or even after the ‘Next Report Due’ date. If you anticipate a delay in making the submission deadline, please contact the IRB to make them aware.