A study is normally conducted in compliance with the most recent version of the protocol, which has been previously approved by the REB. At times, study procedures can deviate from the approved protocol. The investigator can implement a protocol deviation without the approval of the REB when necessary to eliminate an immediate risk or hazard to the research participant. As soon as possible, however, after the implemented deviation or change, this form and, if appropriate, the proposed protocol amendment(s) should be submitted to the Board for review in Romeo.
Protocol deviations may impact the participant’s rights, safety or welfare, or that can affect the integrity of the study data; as such should be reported to the REB using in Romeo.
Please note that the following are examples of deviations, however, not limited to those listed below:
- Failure to obtain informed consent;
- Enrolment of a patient not meeting inclusion criteria;
- Failure to report a serious adverse event;
- Study medication dispensing or dosing error;
- Study procedure omitted;
- Failure to file REB Annual Renewal and/or Modifications
- Study procedures conducted out of sequence, but with no impact on participant safety or welfare;
- The use of the same recruitment materials in a new venue (community vs. local newspaper).