Submitted by kkg4003 on August 15, 2023 - 4:45pm
Definition:
Procedures and policies that apply to research taking place outside the U.S. often differ from those set forth in the U.S. federal policies. U.S. federally funded research activities in a foreign country may be approved only if the ethical protections are equivalent to those in the U.S. This is also true for FDA approval of drugs/devices/biologics tested outside the United States.