We have updated Data and Safety Monitoring guidance for Investigator-Initiated studies that are more than minimal risk. It is posted here under “DSMP, Site Monitoring, and DSMB Guidance,” under “Related Guidance.”

Please note that some high-complexity studies do require external/independent monitoring, so please consult with the IRB, and/or Margaret Huber in the Office of Research Integrity and Compliance, early on in your planning and budgeting.

Important Reminder: You must consult with the Emory IRB before submitting a “Single IRB” plan for a multisite NIH grant proposal. It is very challenging to shift gears (and budget) at JIT stage, which may be necessary if we find there are issues with the plan.

See our Collaborative Research page for more information.