For IRB purposes
ID:
Date received:
Chair signature:
Institutional Review Board (IRB) – Lapse in approval
Submit all IRB Forms and inquiries to [email protected]
A lapse in IRB approval of research occurs whenever an investigator has failed to provide continuing
review information to the IRB or the IRB has not conducted a continuing review and re-approved the
research – with or without conditions – by the expiration date of the IRB approval.
If the PI has not submitted his or her protocol to the IRB and obtained continuing review approval by
the expiration date, the IRB approval automatically expires.
Once the IRB expires, all research activities must stop, including recruitment, research interventions
or interactions, data sharing/reporting, data collection and analysis of identifiable data, and no new
subjects may be enrolled.
If the lapse represents possible serious or continued noncompliance, the IRB will make a
determination if the OHRP or applicable funding agencies should be notified. The research may
continue only after the PI receives written approval from the IRB.
21 CFR §50.25(b)(5)
21 CFR §56.108(b)(2)
38 CFR §16.103(b)(5)(i)
38 CFR §16.116(b)(5)
45 CFR §46.103(b)(5)(i)
45 CFR §46.116(b)(5)
http://www.hhs.gov/ohrp/policy/continuingreview2010.html#section-h
Protocol number:
Date of expiration:
1. All research activities have stopped
Correct_____
False_____ explain below
2. All recruitment has stopped
Correct_____
False_____ explain below
3. No research interventions/interactions
Correct_____
False_____ explain below
4. All data collection has stopped
Correct_____
False_____ explain below
5. No new subjects enrolled
Correct_____
False_____ explain below
6. No analysis of identifiable data
Correct_____
False_____ explain below
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For IRB purposes
ID:
Date received:
Chair signature:
Explanation(s)
1. All research activities have stopped
2. All recruitment has stopped
3. No research interventions/interactions
4. All data collection has stopped
5. No new subjects enrolled
6. No analysis of identifiable data
In space below (or an attached sheet), provide an explanation as to why there was a lapse in
approval and the measures that have been put in place to avoid this in the future.
PI name
Signature
Date
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