The federal regulations do not allow the IRB to approve a study for more than one year. For multi-year research, the principle investigator is responsible for completing a written progress report. The continuation of research after an IRB approval expires is a violation of the regulations [21 CFR 56.103(a)]. If the IRB has not reviewed and approved a research study by the study's current expiration date, IRB approval is considered to have expired, and research activities must stop. No new subjects may be enrolled in the study.
Approximately 8 weeks prior to the expiration of the current IRB approval period, a Progress Report/Continuing Review Form is mailed to the investigator.
If the investigator plans to renew the study, the Progress Report/Continuing Review Form should be completed and returned to the Office of Research Affairs as soon as possible, but no less than four weeks before the approval period expires.
The Progress Report/Continuing Review Form requests specific information about the progress of the study:
- A list of key study personnel
- The enrollment status of the study
- Continued enrollment
- Enrollment closed, subjects still undergoing treatment, subjects in follow-up, or data analysis only
- Study terminated
- Information regarding adverse events
- Information regarding the number of subjects enrolled
- A summary of changes made to the study since the last review
If the study has closed, but research subjects are still being following, the study must be renewed. If the study is closed, but the study is still undergoing data analysis through the sponsor, the study must be renewed. If you have questions, contact the Office of Research Affairs staff at 614-546-4325 or email@example.com
Once the Progress Report/Continuing Review is received by the Office of Research Affairs, it will be reviewed by the staff for completeness. It will then be assigned to the IRB agenda. It is not necessary for the principal investigator to attend the IRB for a study renewal.
Once the Progress Report/Continuing Review has been reviewed by the IRB, the investigator will receive the form back, signed by the IRB Chairman. The form will indicate whether the study has been renewed, and, if so, the form will contain the next review date.