Effective on January 21, 2019, Continuing Review will no longer be required for:
- Most studies that qualify for the expedited review process.
- Studies (regardless of review path) that have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care.
Eliminating continuing review for qualifying minimal-risk research reduces administrative burden for both the study team and IRB staff without impact to the human subjects.
For existing minimal risk studies (expedited) and exemptions that are approved on or before January 20, 2019, the pre-2018 Common Rule will apply. If an existing study is federally funded after January 20, 2019, it will be transitioned to the 2018 Common Rule.
For new expedited studies approved on or after January 21, 2019 (January 22 due to holiday on the 21st), the UC Merced IRB will determine the need for continuing review. Most expedited studies will not require continuing review. Reasons a study might maintain continuing review:
- The projects is regulated by a sponsor that requires continuing review (FDA)
- The project involves additional regulatory oversight, such as COI
- The research will be conducted internationally and/or research with a reliance agreement
- The investigator has had previous serious non-compliance or a pattern of non-compliance
New Process: 10-Year Expiration
In order to close-out studies that are no longer active, all studies (not assigned an annual expiration date) will undergo a post-approval review at the 10 year mark.
Although, in most cases, continuing review will not be required, the researchers are still responsible for:
- Submitting modifications for project changes,
- Report Adverse Events; and,
- Terminate the project once it ends, or when personal identifiers are removed from the data/biospecimens and all codes and keys are destroyed.