Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. This week’s IRB message will discuss protocol deviations.
What is a protocol deviation?
During a research study, a principal investigator (PI) may run into situations where a change to the protocol is necessary to meet the needs of a specific subject. Federal regulations allow the IRB to grant approval through an expedited process under certain conditions.
The IRB will grant approval for a protocol deviation from a protocol for one subject in the following situations:
- To enroll an ineligible subject in an IRB-approved protocol, where the change in eligibility criteria is a minor change.
- To allow a minor deviation in the research procedures for a single subject.
What does the Principal Investigator need to do?
1. Contact the IRB Chair (Dr. Bruce Gordon) or the IRB Vice-Chair (Dr. Kris Kratochvil) to receive verbal approval. If you cannot reach either physician, call the Office of Regulatory Affairs for assistance (559-6463).
2. Following verbal approval, immediately call Gail Paulsen (559-3853) to report that you have received verbal approval of a protocol deviation. Be prepared to provide a short description of the deviation, the protocol number, the date of the deviation, was sponsor approval required, and if Dr. Gordon or Dr. Kratochvil indicated that a change to the consent form for this subject was required. This step was added to assure that the IRB file contained written documentation that the protocol deviation was reviewed and approved by the designated IRB official before the deviation occurred.
3. Within five (5) business days, complete the IRB form, “Single Subject Protocol Deviation,” and attach a copy of the consent form signed by the subject. The consent form must have the subject name removed to protect subject confidentiality. Subject study numbers and subject initials at the bottom of each page may be retained on the consent form for tracking purposes. The signature page should keep the dates and signatures of the witness and investigator.
4. Make one (1) copy of the completed form “Single Subject Protocol Deviation” and the consent form signed by the subject.
5. Send the original and copy to the IRB. The Board will be notified of the event and a formal letter of approval will be returned to you.
If the plan is to use this deviation for other subjects as well, a formal “Request for Change in the Protocol and/or Consent” must be submitted.