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.

DOE IRB Managers/Administrators are responsible for managing the review of protocols that come to their respective IRBs and ensuring that researchers at their institutions are aware of the types of research that need such review and the Federal and DOE-specific requirements. They are also responsible for ensuring that appropriate information is provided to the DOE Human Subjects Research Database (per DOE Order 443.1C) 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.

DOE provides an electronic submission system for all IRB Managers/Administrators to use.  The IRB Electronic Submission System (hereafter, IRB system) is the Huron Click Commerce-based software used by DOE’s Central IRBs and a number of the DOE site IRBs for processing of IRB applications.  The IRB Managers/Administrators are able to manage and oversee the workflow for their site projects and grant access to PIs and researchers via this IRB system.  Both site and DOE document libraries are also available on this system.

DOE holds monthly calls for the Human Subjects Working Group (HSWG), a group of DOE IRB chairs and administrators, and other DOE and field office representatives.  Contact the DOE and NNSA Human Subjects Protection Program Managers at DOE HQ if you have questions or want to participate in the HSWG.

DOE understands the need for IRB Managers/Administrators to remain up-to-date on changes and new topics related to HSR.  In order to ensure the ongoing commitment to this, the program covers the registration and hotel costs annually for a representative group of IRB Managers/Administrators throughout the DOE complex to participate in the Public Responsibility for Medicine and Research (PRIM&R) Advancing Ethical Research (AER) meeting.  A 1-day meeting to discuss DOE policy issues and provide DOE -specific updates/training is typically held just prior to or following the PRIM&R AER meeting.