DOE Human Subjects Research Progam
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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 O 443.1B, Protection of Human Research 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 Institutional Review Board (IRB) for review and approval of the proposal hold a valid Federalwide Assurance (FWA) from the Department of Health and Human Services’ Office for Human Research Protections.
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
Office of Science (SC23.2)
Or the NNSA human subjects protection designee(s), as appropriate.
Content reviewed: May 7, 2012