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JM DOE O 443.1B, Notice of Intent to Develop a Page Change to DOE O 443.1B, Protection of Human Research Subjects

The purpose of the page change is 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. We also propose adding to this section 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. Additionally, we propose making several small corrections and updates to the references, links, and organization titles.

15 JUL 16 - O 443.1B, Protection of Human Research Subjects.pdf -- PDF Document, 417 KB

Writer: Patricia Greeson
  • Management and Operations
ID: JM DOE O 443.1B
Type: Justification Memorandum
OPI: SC - Office of Science
Status: Archive
Approved Date: Jul 16, 2015
Invoking Directive: No

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