Guidance on submitting IND safety reports to the IRB
All IND safety reports must be submitted to the IRB per FDA guidance.
In December 2025, the FDA issued 2 new guidance documents related to safety reporting: Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices and Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.
In the guidance for investigators, it states in section VI: The investigator must submit IND safety reports to the IRB (§ 312.66) because FDA considers safety information that meets the IND safety reporting criteria under § 312.32(c) to be an unanticipated problem involving risk to human participants or others.
We asked the FDA about this as previously we have guided investigators that only IND Safety Reports that meet the definition of an unanticipated problem (UP) for their study or that have new information that might affect the willingness of subjects on the NIH study to enroll or remain in the study need to be reported to the NIH IRB, as many pharma sponsors sent investigators IND safety reports that did not meet the definition of a UP for their protocol/at this site.
The FDA responded to our query, noting their stance that all IND safety reports were also a UP and should be reported to the IRB.
As such, we have updated our guidance now to state that per current FDA guidance, all IND safety reports must be submitted to the IRB. You can find more information about this on our website. Please follow this updated guidance moving forward.
Additionally, we have modified our drug/device interventional protocol template to remove the section (in the template it was section 8.4.7) that stated our previous guidance. If this statement about submitting IND safety reports to the IRB is in your interventional protocol, please delete it with your next planned MOD (to other parts of the study). If your protocol is in data analysis (completed enrollment and no persons remain on study), you do not need to modify your protocol for this.
If you have questions about submitting IND Safety reports to the IRB, please contact our office of compliance and training at: OHSRPCompliance@od.nih.gov