Suspension of IRB Initial Approvals Over Winter Break

The federal regulations governing human subjects research are set to change on January 19, 2018. To meet the deadline, the IRB will be revising submission forms, informed consent form templates, and review procedures. The transition will take place over the Winter break and the IRB will not be granting initial approvals from December 18- January 18. After January 19th, the new regulatory requirements will apply. Investigators with pending initial submissions are encouraged to submit applications with enough time for review and approval prior to December 18th. Active protocols with pending modification reports will not be affected by this suspension.

Initial applications submitted prior to and during the Winter break should expect significant delay for approval. Submission of outdated application forms will not be turned away, however additional requirements and revisions may be required. Some initial applications that have not yet been submitted and are not near completion will be administratively removed to encourage the use of the new application, which will be available on December 12.

Studies approved before December 18th will follow the regulations under which they received approval and will not be affected by these changes. However, the IRB may determine that a study can be closed under the new regulations.

In the coming weeks, a comprehensive list of changes to the review process and requirements will be posted here and will be announced to the campus.

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Leah Vargas

Research Integrity and Compliance Officer
Office of Research, Innovation, and Economic Development
Division of Academic Affairs
Hornet Bookstore, Suite 3400
leah.vargas@csus.edu
(916) 278-5674