Approval of a research project by the IRB does not end a researcher’s responsibilities with respect to reporting to the IRB!
IRB review and approval must be obtained before any change to a human subjects research protocol is implemented, unless the project is Exempt. See Modifications below.
For projects that involve more than minimal risk (and in some study-specific special circumstances), the IRB must re‐review the project and its progress prior to the expiration of its approval period, which is determined by the IRB and usually lasts one year. See Continuing Review/Continuations below.
Finally, researchers have an obligation to report adverse events, unanticipated problems, or protocol deviations to the IRB as soon as they are aware of the problem. See Reportable New Information (RNI) below.
IRB Tip! Appoint a Study Team Member as "PI Proxy"
Once you have approval, you may appoint a PI Proxy (or Proxies) who may submit Modifications and Continuing Reviews on your behalf. The ESTR Study Submission Guide can provide more information on managing PI Proxies.