A Single Subject Protocol deviation is a change in an IRB-approved protocol which is permitted for an individual subject when it is in the best interest of that subject and/or is necessary for research purposes (e.g., data completion). Protocol deviations are classified as either “minor” or “more than minor”.
To obtain Single Subject Protocol Deviation approval, a Single Subject Protocol Deviation Request must be submitted PRIOR to the implementation of the deviation. This form can be found under the "Miscellaneous" heading on the FORMS page and in the online system (see instruction manual). Once the form is received, the deviation will be reviewed and processed for further review if necessary by the IRB Compliance Coordinator. Deviations may be approved in one of two ways:
- Deviations that are minor are eligible for expedited review under the provisions of HHS regulations at 45 CFR 46.110(b)(2) and FDA regulations at 21 CFR 56.110(b)(2), as applicable.
- Deviations that are more than minor do not qualify for expedited review and therefore must be reviewed by the full IRB.
Once the deviation is approved, an approval letter for the Single Subject Protocol Deviation will be sent to the PI and lead coordinator via email.