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Except for human research studies that have been determined to be Exempt, DHHS and FDA regulations require the 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. This includes:
• No new subject recruitment or enrollment;
• 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 the individual subjects to continue participating in the research interventions or interactions.); and
• 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 paperwork to the IRB at least 60 days prior to expiration for review.
 Continuing Review Full Board – More than Minimal Risk
Continuing Review Expedited Review – Minimal Risk
IRB Meeting Schedule
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What to Submit for Continuing Review Full Board Review – More than Minimal Risk
Submission of studies for review will be "first come, first served". Once your study has been assigned to a meeting, you will be notified via email the week before the meeting date.
IRB Meeting Schedule
Please submit the materials outlined below:
Submit two copies copy of:
- The current approved protocol, which should reflect all approved amendments
Submit one original (signed by the Principal Investigator) and 25 (collated) copies of the following packet:
- IRB Form CR;
- Progress report;
- Data Safety Monitoring Board Reports (if applicable);
- Project summary;
- Consent Form (if enrollment is ongoing) with approval and expiration dates left blank;
- HIPAA Forms (Exception: If you are submitting an updated HIPAA form, it is not necessary to submit a copy of the previously approved version.); and
- Modification Form (if applicable) If you need to make any changes or additions to the approved documents at the time your study is due for continuing review, please submit IRB Form MOD for the proposed changes together with IRB Form CR.
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What to Submit for Continuing Review Expedited Review – Minimal Risk
Submission of studies for expedited continuing review will be reviewed in expiration date order.
Please submit one copy the materials outlined below:
- IRB Form CR original (signed by the Principal Investigator);
- Progress report;
- Project summary;
- Consent Form (if applicable) with approval and expiration dates left blank;
- HIPAA Forms (Exception: If you are submitting an updated HIPAA form, it is not necessary to submit a copy of the previously approved version.); and
- Modification Form (if applicable) If you need to make any changes or additions to the approved documents at the time your study is due for continuing review, please submit IRB Form MOD for the proposed changes together with IRB Form CR.
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