1. Managing Study Expirations
Michelle Stickler
Virginia Commonwealth University

2. When does a study expire?
Continuing review has not occurred by 11:59pm on the expiration date
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

3. What can be done to prevent study expiration?
Send reminder notice(s) to PI, others
Set deadline for submitting continuing review paperwork
Decide how far in advance to send notice(s)

4. When a study expires… things to consider
Who needs to be notified?
Principal investigator
Research coordinator
Department chair
Sponsored programs
How will notice occur?
Immediate and reliable method needed
Do you want verification that notice received?

5. What does expiration mean?
No study activity may occur including
Recruitment
Data collection
Interventions/interactions
Data analysis
No sponsored spending related to IRB approved project
Expiration is not a suspension or termination

6. What is in the best interest of subjects?
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

7. 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

8. QUESTIONS?