VCU IRB Study Closure vs Study Expiration
VCU IRB Study Closure vs Study Expiration …
What is the appropriate way to end VCU IRB oversight of a research study?
Appropriate
- Study Closure: When a study has been completed or terminated and meets the criteria for closure, a formal study closure request which provides a final status report should be promptly submitted to the IRB for review.
Not Appropriate
- Study Expiration: Letting a study expire does not satisfy the investigator’s responsibility to close the study. Expiration occurs if a continuing review is not approved before the expiration date specified by the IRB. Upon expiration, all research activities must cease (including recruitment, enrollment, data collection, interactions/interventions with participants, and data analysis) until a continuing review is submitted and approved by the IRB. The only exception is the continuation of current participants for their safety, which requires prompt submission of a justification for continuation. If a study is complete, see Study Closure above.
Please Keep in Mind
- Once a study is complete and meets the criteria for closure, please submit a study closure request through RAMS-IRB.
- Allowing a study to expire in lieu of submitting a study closure request does not satisfy the investigator’s responsibility to close the study.
- Principal investigators with a study in an Expired state will NOT be permitted to submit a new study for initial IRB review until the expired study has been addressed by submitting a continuing review or study closure request, as appropriate.