Oversight of the Human Subjects Protection Program (HSPP) within DOE is assigned to the Associate Director of Science for Biological and Environmental Research (BER), who is the DOE Institutional Official for Human Subjects Research. The program is managed in collaboration with the Department’s semi-autonomous National Nuclear Security Administration (NNSA). DOE and NNSA each have an HSPP Manager, who reports functionally to the DOE Institutional Official. The HSPP managers work closely with DOE’s Headquarters and field organizations that fund and conduct human subjects research. DOE has two central institutional review boards (IRBs) and multiple site IRBs. Each DOE site that conducts research involving human subjects is responsible for establishing and maintaining its own HSPP, in compliance with local, state, federal and DOE-specific requirements. While most sites have their own internal IRBs, some use one or both of DOE’s central IRBs or, alternatively, an external IRB. Research that is conducted by multiple DOE sites is reviewed by one of the two Central DOE IRBs.
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