Policy Updates

Policy 3014-105 IRB Reliance was revised effective 02/13/2025 to specify that all external IRB approval letters and approved documentation must be submitted to IRBO no later 2 weeks from study team receipt.

Policy 402 Research Involving Children was revised 3/20/2025 with the addition of a footnote letting study teams know that they can direct questions about the legal decision maker for a child to the NIH Office of Legal Counsel.

Policy 404 Research Involving NIH Staff as Study Subjects was revised effective 3/12/2025 to: 1) Expand the title of this policy to Research Involving NIH Staff or Immediate Family Members of Study Team Members as Subjects. 2) Clarify at Section C.2. that only NIH federal employees must review NIH Manual Chapter: 2300-630-3 - Leave Policy for NIH Employees Participating in NIH Intramural Research Program (IRP) Biomedical Research Studies when considering participation in NIH research, and 3) Section C.9. was revised to specify when enrolling an immediate family member of a study team member, informed consent may not be obtained by the study team member who is related to the potential participant.

Policy 405 Research Involving American Indian/Alaska Native Persons, Their Data and Biological Materials was published and is effective as of 7/9/2025. Review the information page on this website for how this policy is being implemented.

Policy 500 Research Involving Drugs, Biological, and Nutritional Products was revised effective 8/5/2025 to remind investigators to notify the IRB when the Sponsor has withdrawn the IND, consistent with Policy 801 Reporting Research Events.

Policy 502 Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles) was revised effective 3/19/2025 to direct investigators to Policy 801 for more details about event reporting for expanded access protocols.

Policy 801 Reporting Research Events was revised effective 4/3/2025 to clarify expectations for event reporting for expanded access protocols to the IRB. Events related to Intermediate-size Patient Population INDs and Treatment INDs must be reported consistent with Section E.1.b of Policy 801. Events related to Single Patient INDs do not need to be reported to the IRB. Regardless of the type of expanded access IND, PIs are still expected to comply with FDA reporting requirements to the Sponsor and to the FDA.

The policy was revised effective 5/5/2025 to clarify reporting requirements for minimal risk protocols that do not require continuing review. For these studies, the PI is expected to track minor deviations and only report them to the IRB if they rise to the level of a reportable event, such as a major deviation, non-compliance, or unanticipated problem. These events are to be reported consistent with Policy 801.

The policy was revised effective 8/6/2025 to specify that investigators must report to the IRB within 7 days of Sponsor notification that the IND has been withdrawn.