Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?
OHRP is sometimes asked if, when an international institution selects a procedural standard under section 4.b of the FWA for International (non-U.S.) Institutions that has less stringent requirements than 45 CFR part 46, can the institution disregard the more stringent requirements of 45 CFR part 46? It is current OHRP policy that in the absence of a determination of equivalent protections provided by a procedural standard other than 45 CFR part 46, the requirements of 45 CFR part 46 must be applied to research conducted or supported by HHS. Section 3 of the Terms of the FWA for International (Non-U.S.) Institutions (see section B of the document) state that all U.S. federally conducted or supported human subjects research to which the FWA applies will also comply with any additional human subjects regulations and policies of the U.S. federal department or agency conducting or supporting the research and any other applicable U.S. federal, international, state, local, or institutional l
Related Questions
- Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?
- What are the key features of the Federalwide Assurance (FWA) for international (non-U.S.) institutions?
- When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?
