IRB Study Continuation
Multi-year studies that were approved by the IRB by a Full Board review or Expedited review must be reviewed by the IRB on an annual basis or at a more frequent rate if noted by the IRB. The Institutional Review Board (IRB) conducts substantive and meaningful continuation reviews at intervals appropriate to the degree of risk but not less than once per year. The study must satisfy the criteria set forth in 45 CFR 46.111 and 21 CFR 56.111 for the IRB to approve the study for continuation. The PI must complete and submit a Renewal/Continuation Form in the iRIS platform to report on the study activity that has taken place since the last approval of the study. This applies to studies where the HU IRB is not the IRB of record.
Submission Checklist
A complete submission increases the chance of approval. All requests to continue a study previously approved by the IRB must include the following:
- A complete IRB Renewal/Continuation Form. Responses should be clear and concise to improve readability and understanding. Complete all fields. Fields that are not applicable to the research should indicate this when possible.
Current CITI certifications for ALL study personnel. Missing or expired certificates of completion must be updated and included in the submission.
- Updated study personnel. Any changes to study personnel since the last approval of the study should be reported to the IRB for review using a Modification Form. Visit the IRB Study Modifications page for more information.
A copy of the research study and other documentation previously approved by the IRB. Any changes to these documents should be submitted to the IRB for review using a separate Modification Form.
Clean versions of all previously stamped documents (consent forms, flyers, study protocols, etc.) that will be used in the next approval cycle. These documents will need to be approved and stamped for use in the next approval cycle.
A copy of at least one executed consent and assent form (completed and signed by a participant during the last approval cycle). This is required if at least one participant was consented to participate into the study since the last approval.
- A clean copy of consent and assent forms (blank and clear of any signatures, initials, or stamps). This is required if a consent or assent form was used to consent individuals to participate in the study AND the study will continue to actively enroll new participants. These documents will need to be approved and stamped for use in the next approval cycle.
- An approval letter from the IRB of record. If This is required if the study was reviewed by a central or single IRB that is not the HU IRB.
- An adverse event report. This report should list all adverse events that have occurred throughout the duration of the study.
Any changes to research personnel, the research design, or documents previously approved by the IRB should be submitted to the IRB for review using a separate Modification Form. Visit the IRB Study Modifications page for more information.
Research Study Expiration
Research studies that have not been approved to continue research activities by their expiration date must cease all activity and will be administratively closed by the ORRC. It is recommended that continuation requests are submitted for review at least 90 days of the study expiration date to prevent a lapse in approval or the administrative closure of the research study.