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It is the principal investigator's responsibility to submit a schedule continuing review application before the expiration of the IRB approval of an active project and in ample time for IRB review.
IRB Scheduled Continuing Review (SCR)
The IRB Scheduled Continuing Review is an online form completed in U-M's eResearch Regulatory Management (eRRM) system by a member of the study team to report the current status of the research project, including the number of subjects enrolled, to the IRB and either:
- Initiate the IRB review for the renewal of approval prior to the study's expiration date, or
- Terminate the study upon the completion of the research and the closure of the study
Because of it's multiple uses, the form may be referred to by the following terms: Continuing Review (CR), Scheduled Continuing Review (SCR), or Termination Application.
A human subjects study must retain active IRB approval until the study team has completed the work (e.g., all papers submitted and analyses completed) on the research, or until the data has been completely deidentified, including the destruction of any keys or codes linking the data to subject identifiers. The SCR is used to request an update to the approval period for the study upon IRB review. Study teams receive an automated email from eRRM at 90, 60, and 30 days prior to a study's expiration date as a reminder to submit an SCR, but it is the Principal Investigator's responsibility to ensure that the SCR is submitted in a timely manner for IRB review.
Lapse in IRB Approval
If the study's approval period expires (i.e., lapses), all research activity must stop until IRB approval is re-established. This means no new subjects may be enrolled in the study, no data may be collected, and data analysis is discontinued. The only exception is when stopping the activity would jeopardize the welfare of the subject. This exception is very rare for the type of research reviewed by the IRB-HSBS. If the lapse is less than three (3) months, the Prinicpal Investigator or study team may submit an SCR to initiate an IRB review for approval. If greater than three months, the IRB may require a new application. The IRB has the authority to require a full re-review of the study in cases of lapsed approvals.
Per federal regulations outlined in 45 CFR 46.109(e), the IRB must conduct a continuing review of federally-supported research at least once per year. For research that is not federally-supported, U-M policy allows for the review period to be extended to two years (see HRPP Demonstration for details). When an SCR is submitted, the IRB reviews the:
- Study protocol
- Informed consent and other documentation or materials
- Any adverse events (AEs) or other reportable events (ORIOs) that occurred during the current approval period
The IRB may recommend modifications or updates to a study upon continuing review. An SCR is not used to update an IRB application at the time of renewal. The study team would submit these changes for IRB review via the amendment process.
References and Resources
For questions regarding IRB continuing review requirements (e.g., policy, procedure, science), contact:
For help using eResearch Regulatory Management, contact: