As an investigator, you may decide, for one subject (or more if they are seen on the same day as the discovery of the protocol error), to follow a procedure different from that set forth in your protocol. Reasons may include subject safety or a change in circumstances of the study. The sponsor may be involved in the decision to deviate.
Whenever you judge that a deviation or change from the approved research plan is necessary to eliminate apparent immediate hazards to the subject or others, you should implement the change. An amendment to the protocol and, if needed, to the informed consent document must then be submitted to IRBMED within 7 days (or as soon as possible if the revised protocol is coming from a sponsor). You must obtain IRBMED approval before implementing a deviation or change that does not serve to eliminate an immediate hazard. In some situations, it may be most appropriate for you to cease enrollment until the needed change is requested and approved. Contact the IRBMED office for further guidance.
Examples where a deliberate deviation IS permissible:
- An investigator realizes that a diagnostic blood test was not described in the protocol but is needed to regulate serum levels of the study drug.
Since this scenario involves a compromise to subject safety, the investigator may deviate from the protocol and then immediately report the deviation to the IRBMED.
- Newly published information indicates that one of the drugs used on a study has the same efficacy, with significantly fewer side effects, when administered at a lower dose than had been the previous standard of care (and the dose approved in the protocol).
If the higher dose poses significant hazards to subjects, the investigator may decrease it and then promptly report the change to IRBMED. The investigator should ensure that the decision is in keeping with all principles of good clinical and research practice.
If, on the other hand, the study will maintain a favorable risk/benefit ratio without a change in dosage, and the investigator decides not to change the protocol, s/he must submit an ORIO, notifying IRBMED of the new information, and a consent amendment, notifying subjects of the new information, and await IRBMED approval before proceeding.
Examples where a deliberate deviation IS NOT permissible:
- The protocol indicates that a nurse will conduct intake interviews and review the consent document with subjects. The nurse retires, so the study coordinator will carry out the procedure instead.
Since this scenario involves no compromise to subject safety, the investigator must submit an amendment and await IRBMED approval before proceeding.
- A sponsor believes that study data to date indicate that a potential participant could safely participate but doesn’t meet currently approved eligibility criteria.
Since this scenario involves no compromise to subject safety, the investigator must submit an amendment and await IRBMED approval before proceeding.
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