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Except for human research studies that have been determined to be Exempt, U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations require the Institutional Review Board (IRB) to continually review ongoing research at intervals appropriate to the potential risk to participants, but at least annually [45 CFR 46.109(e) and 21 CFR 56.109(f)].
Investigators are responsible for submitting a continuing review application and maintaining current IRB approval until all of the following occur:
- Subject recruitment has concluded (i.e., no subject recruitment is in progress or anticipated),
- All subject specimens, records, data have been collected (i.e., no further collection of data/information from or about living individuals is needed),
- All interactions or interventions with subjects are completed (i.e., no further contact with subjects is necessary or anticipated), and
- Analyses of subject identifiable data, records, specimens are finished (i.e., use or access to subject identifiable data is no longer necessary).
Expiration and Lapses in Protocol Approval
When continuing review of a research protocol does not occur prior to the end of the approval period stated in the IRB approval letter, the IRB approval expires automatically. If the IRB has not reviewed and approved a research study by the study expiration date, all research activities must stop:
- No recruitment or enrollment of new subjects
- No further collection of data/information from or about living individuals
- No further research-related interventions or interactions with currently enrolled subjects (unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions)
- No further data analysis
Failure to maintain current approval may disqualify data intended for submission to the FDA (e.g., studies of investigational drugs and devices), other federal agencies, and sponsors.
For this reason, it is strongly recommended that investigators submit their continuing review in eIRB at least 60 days prior to expiration for review.
Log in to eIRB.
Click on My Home in the upper right corner.
In the My Home workspace, click the Studies Tab.
Click on the Study Name for the study you want for Continuing Review.
Select New Continuing Review in the Study workspace.
Complete the Continuing Review Smart Form. Note: You can no longer do a modification to a study at the time of continuing review. All Modifications to the study must be done prior to your continuing review.
After the Smart Form is completed, the PI can submit it to the IRB for review.
Log in to eIRB.
From the My Home space, select the relevant study.
Click on the “New Modification” button in the study workspace.
Select the appropriate sections on the modification form that correspond to the changes requested by the IRB. For example, if changes to the consent form were requested, check “consent form” in question 1.1 of the modification form. If the information requested by the IRB does not fall into one of these categories, please select “other.”
Complete the modification form. Please insert “Response to IRB requested changes” in the fields where a description of the change is being requested.
Revised redlined documents (i.e., Consent, HIPAA Authorizations, Protocols, etc.) may be uploaded in the new modification workspace. To modify the Smart Form, click on the Smart Form tab on the last page of the modification workspace.
When the modification is complete, the PI will then submit the form back to the IRB for approval.
Note: The CR will remain in the workspace until the IRB has approved the continuing review related modification. When the related modification has been approved, the PI may then re-submit the CR back to the IRB for final approval.
- Office of Human Research Protections (OHRP), section 45 CFR 46.109(e)
- Food and Drug Administration (FDA), section 21 CFR 56.109(f)
- Food and Drug Administration (FDA): “IRB Continuing Review after Clinical Investigation Approval”