All studies that were previously approved by 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 orsp@acu.edu 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.

Please note that the 2018 Common Rule revisions no longer require Continuing Review for minimal risk studies reviewed by Expedited procedures, unless the IRB determines, justifies, and documents the necessity for such review. You will be notified if Continuing Review is required. Though a Continuing Review is not required for Expedited or Exempt studies approved after January 19, 2018, the IRB may request a study status update annually, simply to determine when to close the file and begin records storage.

If you have completed all research activities on a particular protocol, please inactivate that protocol.

Forms

• Continuing Review Form
• Signed Assurance Form - Faculty
• Signed Assurance Form - Student
• Current Consent Form AND Revised

Also attach, if applicable:

• NIH Training Certificates for any new team members
• Unanticipated Problems/Noncompliance Form

The IRB documents have been revised as of January, 2018, and can be found in the ORSP Canvas Classroom. You may enroll in the classroom by clicking here.