Transcript Managing Study Expirations

MANAGING STUDY EXPIRATIONS
Michelle Stickler
Virginia Commonwealth University
804-828-0131
[email protected]
WHEN DOES A STUDY EXPIRE?
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Continuing review has not occurred by 11:59pm on the
expiration date
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Study is expired at 12:00am the day after expiration date
Studies that are conditionally approved are not
considered expired even if all conditions have not been
met
WHAT CAN BE DONE TO PREVENT STUDY EXPIRATION?
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Send reminder notice(s) to PI, others
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Set deadline for submitting continuing review
paperwork
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Decide how far in advance to send notice(s)
WHEN A STUDY EXPIRES… THINGS TO CONSIDER
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Who needs to be notified?
Principal investigator
 Research coordinator
 Department chair
 Sponsored programs
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How will notice occur?
Immediate and reliable method needed
 Do you want verification that notice received?
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WHAT DOES EXPIRATION MEAN?
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No study activity may occur including
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Recruitment
Data collection
Interventions/interactions
Data analysis
No sponsored spending related to IRB approved project
Expiration is not a suspension or termination
WHAT IS IN THE BEST INTEREST OF SUBJECTS?
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Option for continuing subject interventions
When in best interest of participants
 PI makes initial assessment
 IRB must confirm via expedited review or convened meeting
 May apply to all subjects or a subset
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WHAT REPERCUSSIONS TO STUDY EXPIRATION MIGHT
BE CONSIDERED?
Limited time frame to obtain continuing review
 Inability to reopen study
 Disallow spending to the funded project supporting the
study
 3 strikes and you’re out
 Multiple instances may be deemed continuing
noncompliance
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QUESTIONS?