Procedural Changes for Expedited Review of Human Subjects Research
The Charles River Campus Institutional Review Board (CRC IRB) is discontinuing annual progress reports for expedited research and moving instead to a triennial review cycle. For research teams, this will go into effect at the next expedited annual progress report review and will apply to all newly approved expedited research going forward.
Annual continuing review will remain for research reviewed by the full board, per regulatory requirements.
Who does this affect:
Investigators with research that has been approved by expedited review.
What:
The CRC IRB is moving from an annual progress report to a triennial progress report (every three years) for research approved by expedited review.
When:
At the next annual progress report review an IRB analyst will assess the protocol to confirm that it still meets expedited review criteria, and that it is appropriate to move to a triennial review. If appropriate, investigators will receive an approval notice with their next triennial progress report review date – and, if applicable, a stamped consent form with the approval date only. This will also apply to newly approved expedited research.
Why:
With regulatory changes that went into effect several years ago, the requirement for annual continuing review was discontinued. The CRC IRB maintained an annual progress report at that time to assess compliance and has been satisfied with the results to date. Research that is reviewed by expedited procedures are minimal risk. By switching to a triennial review, investigators and the IRB office can better focus on other compliance and quality assurance matters. Additionally, the switch to triennial review is consistent with other compliance committee review schedules at BU and peer institutions for research that is minimal risk.
Important!
- Investigators must continue to submit amendments for changes to their research and receive approval prior to implementation of those changes.
- Investigators must continue to submit incidents (non-compliance, deviations, unanticipated problems, etc.) within five days of learning of the event.
- The only change is from an annual progress report for research approved by expedited review to a triennial review.
- Annual review is still required for research that is reviewed by the full board.