The LLNL IRB operates under general provisions of the Code of Federal Regulations and holds a DHHS Federalwide Assurance (FWA #00004274, IRB Charter) through the Office for Human Research Protections (OHRP). The LLNL IRB (CTR-2376, LLNL IRB Charter) consists of volunteer scientific and nonscientific experts, including laboratory employees and Livermore Valley community members.
The LLNL IRB Office administers the human subjects review functions through an Institutional Review Board. Members and responsibilities include:
Thomas F. Gioconda,Laboratory Deputy Director,
Authorized Institutional Official for the IRB
Creates a culture that promotes and upholds the highest ethical and scientific principles in the review and conduct of human research. Ensures the independence, authority, and standing of the IRB within the institution to demonstrate a commitment to human subject protections. Provides sufficient resources, space, and staff to maintain the Human Research Protection Program and assesses resources on an annual basis. Supports IRB authority and decisions.
Chairs board meetings, ensures that the board is duly constituted, recruits and selects new board members, as needed, and ensures that adequate funding and resources are available for the IRB to fulfill its mission.
Oversees the day-to-day activities of the office and functions as the primary point of contact. Develops and maintains the IRB website and education plans for IRB members and research staff. Documents the IRB process, philosophy, policies, and procedures.
Part-time administrative support is provided to the Chair and Program Manager.
Both the Chair and Program Manager are the institutional subject matter experts, and represent the Laboratory on the national DOE Human Subjects Working Group Committee. In addition, the Program Manager is a member of the Northern California IRB Consortium and a member of the Society of Research Administrators International, and the SRA Northern California Chapter. Ms. Dake is on the Institutional Review Board at the University of California, Merced.
The Chair and Program Manager ensure compliance with federal and state regulations. The IRB convenes bimonthly board meetings for full-board review of protocols, and on an ad hoc basis, as needed. The board is currently composed of ten (10) individuals, consisting of both Laboratory and non-Laboratory members, with scientific and nonscientific representation. The IRB reviews protocols from directorates throughout the Laboratory.
The protection of human subjects in all the research performed under DOE authorities is of prime importance to the department. All research conducted at DOE institutions—supported with DOE funds, or performed by DOE employees, including research that is classified and proprietary, whether done domestically or in an international environment—must comply with all federal regulations and DOE requirements that address the protection of human subjects.
DOE policy regarding the Protection of Human Subjects is established in the Federal Policy for the Protection of Human Subjects, adopted by DOE June 18, 1991, as Title 10 Code of Federal Regulations (CFR) 745, Protection of Human Subjects and expressed in DOE Order 443.1B, Protection of Human Subjects.
The Secretary of Energy is responsible for the conduct of DOE-related human subjects research. The requirements for implementing this policy are described in DOE Order 443.1B, Protection of Human Subjects to ensure that the research program keeps pace with the changing and complex nature of human subjects research, develops and implements comprehensive educational programs, and performs program compliance reviews.
All DOE employees, contractors, and financial assistance recipients share the responsibility to protect the rights and welfare of human research subjects. Any new proposal for research with human subjects requires that the institution administering the IRB for review and approval of the proposal hold a valid FWA from DHHS’ OHRP.
The management and oversight of the Human Subjects Protection Program within DOE is assigned to the Office of Biological and Environmental Research (OBER) within the Office of Science. OBER oversees the program in collaboration with the National Nuclear Security Administration (NNSA) Human Subjects Research manager(s) who have responsibilities for research involving defense elements within DOE.
Inquiries about the Human Subjects Protection Program and the protection of human subjects should be directed to:
DOE Human Subjects Protection Program Manager
U.S. Department of Energy, GTN
1000 Independence Avenue, SW
Washington, D.C 20585
Cheri Hautala-Bateman, NA-10
NNSA Human Subjects Protection Program Manager
National Nuclear Security Administration (NNSA)
U.S. Department of Energy
1000 Independence Avenue, SW
Washington, DC 20585
In addition, the Laboratory follows the program as prescribed by the U.S. Department of Energy, as indicated in the DOE Human Subjects Web site.