For IRB Managers / Administrators

This section is meant to be a resource for IRB Managers/Administrators.
It is critical that all DOE/NNSA (henceforth referred to as DOE) IRB Managers/Administrators understand their responsibilities related to human subjects research (HSR) that is funded by DOE, conducted at DOE facilities/national laboratories, or conducted by or with DOE or DOE laboratory employees.

  • Ensure that you, your staff, the Principal Investigator (PI), and all members of the research team who will interact with human subjects or their identifiable data, complete required training.
    • DOE requires that IRB Managers/Administrators have initial CITI training (or comparable training) and refresher training at least every 3 years thereafter.
    • DOE strongly recommends that IRB Managers/Administrators complete the Certified IRB Professional (CIP) process.

They are also responsible for ensuring that appropriate information is provided to the DOE Human Subjects Research Database (per DOE Order 443.1C Chg. 1) in a timely manner, and that researchers conducting human subjects research take training in the protection of human subjects.

  • Make sure the PIs and researchers know they are not allowed to start any HSR activities until they have received the final IRB approval memo and any other additional local approvals.
  • Review training certificates of the research team to ensure it is current.