UCSD Human Research Protections Program

How to Submit information for Continuing Review

  1. Federal Regulation required that projects undergo Continuing Review at intervals not greater than 365 days. Courtesy reminders regarding upcoming expiration dates may be sent electronically at intervals set by users of the HRPP system. The default reminders are sent 75, 60 and 45 days before a project expires, but these intervals, and the entire reminder service, can be set to a user's preference using our e-IRB services . However, this courtesy notification should not substitute for the researcher's own internal tracking of expiration dates. Ultimately, it is the PI's responsibility to submit documentation within the due dates provided.
  2. A Continuing Review submission has three or more components:
    • A cover letter for submission of Continuing Reviewdocuments
    • Continuing Review Facepages. There are two different Facepages, one for a Biomedical project\ and one for a SBS project . The Facepages must be signed by the PI and submitted to HRPP at mailcode 0052, if provided as a hardcopy document, or uploaded as a .PDF file through eIRB services .
    • A Narrative Summary of Progress made since the most recent IRB review. This is a Word document that can be downloaded and saved on your workstation. There are two different Narrative Summary forms, one for a Biomedical project and one for a SBS project .
    • A copy of the IRB-stamped, approved blank consent/assent form currently in use by the project. (Note: although HRPP has a copy of this on file, federal regulations require that you send us the current consent/assent so that the IRB can determine that you are using the correct version.) Do not send a consent/assent that has been signed by a study participant.
    • A "clean" copy of the consent/assent form, as a Word document, for "restamping."
    • Associated study documentation, including a copy of any site monitoring reports, progress reports, audits, communication to/from the FDA, and/or publications associated with the project, as applicable, since the most recent IRB review.
  3. the items should be uploaded to the HRPP not less than 45 days before expiration of the current IRB approval.

Contact the Human Research Protections Program Office