US-EPA , protections HSR (2005)

“EPA has promulgated the Common Rule, making it applicable to human
research that the Agency conducts or supports. The requirements of
EPA’s codification of the Common Rule currently do not, however, apply
to third-party human research intended for submission to or considered
by EPA, except when the research is conducted under an applicable
assurance of Common Rule compliance approved by OHRP and that has been
voluntarily extended to cover third-party research.
Currently no federal agency has taken administrative action to
extend the requirements of the Common Rule to third-party human

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