All studies that were previously approved by expedited or full board review and that continue beyond one year must undergo continuing review once per year until inactivated (45 CFR #46.109(e); Investigator Responsibilities). Studies with a high degree of risk may be reviewed more frequently at the IRB’s discretion. Your original approval letter from the IRB provides information about when your study expires and must be re-reviewed. Please submit the continuing review materials at least 30 days (but no sooner than 60 days) prior to expiration to firstname.lastname@example.org per the submission instructions.
If your study expires before you obtain re-approval, you must halt all research activity on that protocol until approval is received or unless the IRB determines it is in the interest of participant safety to continue.
If you have completed all research activities on a particular protocol, please inactivate that protocol.
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