Institutional Review Board
Policies for On-going Actions Post-Approval

Continuing Review or Downgrade to Exempt

  • 9b. Continuing Review and Downgrade Application

    Researchers must file either a Continuing Review/Downgrade to Exempt Application (CRA) or a Closeout Report prior to the expiration date indicated on the approval letter.

    The IRB does not have the authority to extend the approval period without a CRA. If approval expires, research activities must cease, and data collected without IRB approval may be subject to restrictions.  For non-federally funded studies, PIs who have completed data collection and are engaged in data analysis only may apply for “Downgrade to Exempt” status.

    Circumstances for Continuing Review

    A Primary Investigator must submit a Continuing Review Application (CRA) for IRB approval if:

    • The PI will or may continue to interact or intervene with subject participants for the purposes of research data collection for the current approved study.  AND/OR
    • The PI will or may continue to enroll subjects in the current approved research study.

    Minor Modification Requests

    A PI may request any or all of the following three changes on the Continuing Review form:

    • New study title
    • Removal of key personnel. (Follow instructions on the application form for listing names and reasons.)
    • Correction of typos on the informed consent form(s). (Attach corrected form with application.)

    Note: For all other changes, you must submit a separate Modification Request Form with the CRA.

    Circumstances for Downgrading to Exempt

    For non-federally funded studies, if the PI has completed all data collection but will or may continue to work with identifiable data, the PI may request that the protocol be downgraded to “exempt” status. If approved, the downgraded protocol is exempt from further Continuing Review, and IRB oversight concludes.

    Important Information

    • Always use current forms downloaded from the IRB website:  www.seattleu.edu/irb . Submit signed hard-copies to IRB, Hunthausen 125, or send signed, scanned PDFs to irb@seattleu.edu.
    • Prior to leaving SU, the PI must submit to the IRB either an Adverse Effects–Modification Form to request changing PIs or a Closeout Report.
    • Lapses in IRB approval represent non-compliance with Federal regulations and the requirements of the Seattle University IRB, and are handled according to SU IRB policy and procedures.
    • Note: As a courtesy, the PI will be sent a reminder email approximately one month before IRB approval expiration. The responsibility lies with the PI to submit forms so that no lapse in IRB approval occurs.