What are Protocol Exception Requests and how do I submit one?
Protocol Exception Requests are planned, one-time deviations from the IRB-approved protocol such as enrollment of a subject that does not meet inclusion criteria or one-time dose changes for a single subject. These must receive IRB approval prior to implementation.
* Please note that rescheduling of research appointments due to holidays, vacations or accommodation of research subjects do not require the submission of an exception request.
As with all eIRB submissions, the PI will have to submit the protocol exception request for IRB review. In order to submit an exception request, log in to eirb.med.cornell.edu and click on "All Active Protocols." Open the protocol in question and then click "Submission Options" to bring up the "Other Submission" option. Click on "Other Submissions" and choose "Protocol Exception Request." Complete the required form and submit it for review.
Why does the IRB require Protocol Exception Requests?
Protocol Exception Requests are required to ensure our institution's compliance with the Code of Federal Regulations, which: does not allow principal investigators to initiate changes in research without IRB approval, except when eliminating an apparent immediate hazard to a research subject.
Note: If a PI has taken action to eliminate an apparent immediate hazard to a research subject, then notifying the IRB within 24 hours is required, by our Immediate Reporting Policy. An Immediate Report must be submitted. Like Exception Requests, this can be done in the "Other Submissions" area of eIRB.
How is this different from an amendment?
Amendments are changes in the research that the PI intends to be an ongoing part of the protocol. In contrast, Protocol Exception Requests are one-time changes, after which the PI intends to follow the IRB protocol as usual. Both must be submitted to the IRB for approval prior to implementation.
How is this different from a protocol deviation?
A protocol deviation is a failure to follow the IRB-approved protocol or reporting requirements due to the action or inaction of the principal investigator or research staff and must be reported in accordance with the our Immediate Reporting Policy. An Immediate Report must be submitted. Like Exception Requests, this can be done in the "Other Submissions" area of eIRB.
Human gene transfer trials must also submit Exception Requests to the Institutional Biosafety Committee for achknowledgment at firstname.lastname@example.org, as per Section IV-B-7-c-(3) of the NIH Guidelines For Research Involving Recombinant DNA Molecules.