Continuing Review and Annual Updates

Last updated on June 10, 2016 2 min read Working with Human Subjects - Continuing Review and Annual Updates

Quick Reference

    Continuing Review and Annual Updates

    Which studies need continuing approval or annual update?

    • The CRC IRB conducts continuing review of research requiring review by the convened IRB in accordance with 45 CFR 46.109(e), at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.
    • The CRC IRB requires investigators to provide an annual update for research reviewed by expedited procedures.

    How do I know if I need to submit for continuing review or annual update?

    IRB approval letters for research that requires continuing approval or annual update will list the date of approval, and the date of expiration. PIs are responsible for keeping track of approval and expiration dates for their research and submitting materials in a timely manner to assure reapproval prior to expiration, especially for continuing reviews by the convened IRB. As a courtesy, the IRB office will send PIs reminder notices 6 weeks and 2 weeks prior to the expiration date.

    What do I need to submit for continuing approval or annual update?

    Investigators should submit the following materials for review:

    • Completed Continuing Review and Annual Update Form
    • Informed consent forms, assent forms and information sheets
    • Recruitment and screening materials
    • Data collection instruments (e.g., questionnaires, surveys, assessments, )
    • Sponsor progress reports
    • DSMB or other Monitoring Reports

    When do I need to submit my continuing review or annual update materials?

    Ideally, both continuing reviews and annual updates should be submitted four weeks prior to expiration. This is especially important for continuing reviews, as they require review by the convened IRB, which meets once a month. When you receive the courtesy reminder notice from the IRB office, it will provide a submit-by date to help assure reapproval prior to expiration.

    What happens if my IRB approval expires?

    If your study expires, you no longer have IRB approval to conduct your research and you must stop all research activities.

    • If your approval has expired within the last 30 days, please complete the materials outlined above (“What do I need to submit for continuing approval or annual update”) as well as an Event Form to document the expiration and corrective action.
    • If your approval has been expired for longer than 30 days, you may need to submit a new IRB application.
    • In accordance with Federal Regulations and institutional policies, all human subjects related activities (including, but not limited to, enrollment, randomization, recruitment, data collection, study interventions, data analysis and long-term follow-up) must cease until IRB approval is re-obtained. In other words, conducting human subject research without IRB approval is a violation of federal regulations and institutional policy.

    What if I completed my research?

    Human subjects research is ordinarily complete when the following are true (as applicable):

    • The study is permanently closed to enrollment
    • All subjects have completed all study procedures
    • Data collection is complete
    • Analysis of identifiable data is complete
    • Subject identifiers (including codes, links, or key to identifiers) have been destroyed

    If your research is complete, you must submit a Final Report Form to the IRB. The IRB will send a letter confirming the closure of the study with the office.

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