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
|ID:||DOE O 443.1B Chg 1|
|OPI:||SC - Office of Science|
|Approved Date:||Jul 20, 2015|