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DRAFT - DOE O 443.1B Chg 1, Protection of Human Research Subjects

Changes are made to harmonize the definitions in this Order with those in the Federal regulations for the protection of human subjects (10 CFR Part 745), specifically, splitting the definition "human subject research" into "research" and "human subject," and adopting, verbatim, the definitions of "research" and "human subject" from 10 CFR Part 745 and adding the definition of "generalizable," since the determination of whether a project is "research" in 10 CFR Part 745 hinges on whether the work being conducted is generalizable. Small corrections and updates have been made to the references, links, and organization titles.

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The mission of the Department of Energy is to assure America’s security and prosperity by addressing its energy, environmental and nuclear challenges through transformative science and technology solutions.  Available online, the DOE Corporate Overview - 2012