While protocol deviations are not defined by the Code of Federal Regulations (45CFR46 or 21CFR50), for Solutions IRB, a protocol deviation occurs when the activities occurring within a study stray from the Institutional Review Board-approved protocol. Deviations may be minor or major. They may be known to the PI prior to their occurrence or after they occur. Some deviations can be prevented through good protocol and consent form writing. If a deviation should happen in your study, there are specific steps that you should follow to report it quickly to the IRB.

Some deviations are minor, such as a subject signing the consent form wrong, or a survey being administered differently than was originally described. Generally, deviations like these can be quickly dealt with. Major deviations may require revisions to the study protocol, or other study documents, some may even raise the overall level of risk in the study, or rise to the level of an adverse events or noncompliance.

Some protocol deviations are known to the researcher before they occur (for example, providing life-saving treatment to a subject who becomes seriously ill while participating in study activities); others are only discovered after the fact (a signature was left off of a consent form). Whether the deviation is known prior to its occurring or after does not necessarily impact how serious that deviation is.

Not all potential protocol deviations can be anticipated ahead of time, some can be addressed through good protocol writing that anticipates where problems might occur. For example, if multiple office visits are required in the protocol, the researcher will want to make sure that the timing of such visits is reasonable. Potential deviations can also be avoided by creating a clear and comprehensive consent document. When a researcher wants subjects to complete multiple surveys, that needs to be explained in detail. Finally, many deviations can be avoided through adequate training of the research team. Make sure all of your people understand what is expected of them and what the details for the study are.

When a protocol deviation happens, it is very important to report the deviation to the IRB. This should be done as soon as it is identified, or within 5 business days of knowledge of the event. Please follow these steps:

1. Log into your profile and access your protocol ID.
2. Scroll to the bottom of the page and you should see a “protocol deviation” tab.
3. Select the tab, then select “new protocol”
4. Fill out the necessary information.
5. Once this is all completed, Solutions IRB will review the submission
6. Solutions IRB will walk you through any remaining processes.
7. In some instances, you may be instructed to make certain changes—for example to your consent form, or more education for your staff may be required.
8. Finally, the Chair will send a notification that the Protocol Deviation has been acknowledged.

Authors: Ayn O’Reilly & Josephine Rudy