U.S. Department of Health & Human Services
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Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?
OHRP is sometimes asked whether, if an international institution selects a procedural standard under the FWA that has less stringent requirements than 45 CFR part 46, the institution may disregard the more stringent requirements of 45 CFR part 46.
It is current OHRP policy that in the absence of an OHRP determination that a procedural standard affords protections equivalent to the protections provided by 45 CFR part 46, the requirements of 45 CFR part 46 must be applied to all research conducted or supported by HHS.
As described in a July 7, 2006 Federal Register notice (71 FR 38645) it is OHRP’s position that if an international institution selects a procedural standard under its FWA other than 45 CFR part 46, any requirements of 45 CFR part 46 still must be satisfied for non-exempt human subject research that is conducted or supported by HHS.
For example, the International Conference on Harmonization E-6 Guidelines for Good Clinical Practice (ICH-GCP-E6) do not specifically limit use of expedited review for research undergoing continuing review by the IRB. For research conducted or supported by HHS, if an international institution selected ICH-GCP-E6 as its primary procedural standard on its FWA, the IRB may only use an expedited review procedure to conduct continuing review of HHS-conducted or supported research if the research qualifies for expedited review as provided for under HHS regulations at 45 CFR 46.110.
Please note that the statements above pertain to compliance with the requirements of 45 CFR part 46 for non-exempt human subjects research that is conducted or supported by HHS. If the institution needs guidance regarding implementation of the Common Rule and/or other applicable U.S. federal regulations for research that is not conducted or supported by HHS, the institution should contact appropriate officials at the U.S. federal department or agency conducting or supporting the research.
Last Reviewed: 06/17/2011
Related Questions:
- Are there options other than the Federalwide Assurance (FWA) for obtaining an assurance of compliance to conduct HHS-supported or -conducted research?
- What are the procedures for submitting a Federalwide Assurance (FWA)?
- Who may sign as the Signatory Official on a Federalwide Assurance (FWA)?
- Where can I find the instructions and forms for submitting a Federalwide Assurance (FWA)?
