Determining Continuing Review under the Revised Rule
Exempt or Limited Review: For new studies determined to qualify for exempt or limited IRB review under the revised Common Rule, continuing review requirements do not apply.
Expedited Review: For new studies determined to qualify for expedited review under revised Common Rule, the regulations now stipulate that continuing review is not required unless justified by the IRB. Therefore, most expedited studies will not require continuing review. Justifications for continuing review might include:
- The project is regulated by the Food & Drug Administration (FDA) or by another sponsor that requires continuing review
- The project involves additional regulatory oversight
- Study procedures or risks indicate greater oversight is necessary
- Other research specific considerations.
In addition, the IRB may change its determination regarding continuing review for an individual study based on new information it receives via an amendment, event report, or new findings related to the study procedures and/or population.
Full Review: For new studies determined to qualify for full review, Continuing Review requirements continue to apply (annually at minimum) unless the study status has progressed to data analysis only or acquisition of long-term follow-up data collected as part of routine care.
Project Approval Periods
At the time of initial review, new studies reviewed under the revised common rule will be issued a project approval period with an expiration date based on the researcher’s stated anticipated end date for working with human subjects. We will solicit the projected project start and end dates on the initial review form. This date may be amended if necessary through a formal amendment.
At least 45-days in advance of the protocol expiration (researcher’s stated end date), a Progress Report form will need to be submitted to RCS. The Progress Report will serve to either close the protocol or may be used to request a revised project end date. Researchers are required to submit this form when the study is closed.
Reminder of Principal Investigator Responsibilities and Study Closure
Even when continuing review is not required for a project, the Principal Investigator must adhere to the ethical principles of the responsible conduct of research. This includes but is not limited to:
- Being familiar with and adhering to the Principal Investigator Responsibilities
- Submit amendments for study changes
- Report events and unanticipated problems, and
- Close the study once it ends, or when personal identifiers are removed from the data/biospecimens and all codes and keys are destroyed
In the absence of the continuing review process for qualified expedited studies, UO will implement an automated annual email reminding the principal investigator of these responsibilities.