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 by submitting the Protocol Exception Request Form and supporting documentation (e.g., sponsor waivers) to submit2irbexception@med.cornell.edu. Response time is typically within 24 hours or less.

* 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.

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, per our policy.

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 using the Protocol Deviation Reporting Form within 7 calendar days of occurrence, per our policy.

Important Notes:

Human gene transfer trials must also CC the form to the Institutional Biosafety Committee for approval at submit2ibc@med.cornell.edu, as per Section IV-B-7-c-(3) of the NIH Guidelines For Research Involving Recombinant DNA Molecules.