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

Functional areas: Human Subjects, 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.

o4431bPgCh-Redline_7-17-15.pdf -- PDF Document, 223 KB

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Writer: Elizabeth White
  • Health
  • Safety
ID: DOE O 443.1B Chg 1
Type: Order
OPI: SC - Office of Science
Status: Archive
Approved Date: Jul 20, 2015
CRD: Yes
Invoking Directive: No

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