Continuous approval of all IRB approved human research projects must be maintained by the study team. Any study activities involving a human (dead or alive, prospective, or retrospective), such as, but not limited to: data collection, data analysis, or manuscript preparation/submission, requires a renewal with a Continuing Review Progress Report submitted to the Duke IRB. If a renewal is no longer needed, the study team must close-out the study with a Final Progress Report.
Continuing Renewals and Final Progress Reports must be received at the Duke IRB no later than 30 days prior to the expiration date. The ideal window for these submissions is 45 days prior to the expiration date (http://irb.duhs.duke.edu/modules/irb_home/index.php?id=3).
The IRB is responsible for continuing review of on-going research to ensure that the rights and welfare of human subjects are protected by:
- Conducting continuing review of research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1) and 56.109(f)];
- Determining which studies need verification from sources other than the investigator that no material changes in the research have occurred since the previous IRB review [21 CFR 56.108(a)(2)];
- Ensuring that changes in approved research are promptly reported to, and approved by, the IRB [21 CFR 56.108(a)(3-4)]; and
- Suspending or terminating approval of research that is not being conducted in accordance with the IRB's requirements [21 CFR 56.108(b)(2) and 56.113].
If a study's IRB approval expires:
- No new subjects may be enrolled in the study. Subjects currently enrolled may continue their involvement per protocol requirements if an e-mail is sent to the IRB Chairman and Jody Power, Executive Director of the IRB, petitioning the continuation of treatment for subjects currently enrolled and the request is approved. This e-mail should contain an explanation of the possible risks to subjects should treatment cease and state clearly that treatment needs to continue while awaiting the IRB’s reply.
- All study expenses, including salary fringe costs will be immediately moved to a faculty discretionary fund code.
- The Principal Investigator (PI) may not submit any new studies to the IRB.
- All data collection and/or analyses must immediately be discontinued until IRB approval is obtained. NOTE: Data collected after the IRB expiration date and prior to IRB approval of the renewal is considered “invalid” and cannot be sent to the sponsor.
- Tissue/sample collection and analyses must be discontinued. User Guides are available on the eIRB website (https://eirb.mc.duke.edu) and additional information is available on the Institutional Review Board (IRB) website (http://irb.duhs.duke.edu/).