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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Notice - Changes to the Federalwide Assurance (FWA) and Terms of Assurance

Jun 20, 2011 at 12:00am

OHRP announced the availability of the revised FWA form and Terms of Assurance which have been approved by the Office of Management and Budget.  The key changes in the revised form and terms are the following:

  • Institutions now must designate all internal IRBs on their FWA. If an institution has no internal IRBs, only one external IRB needs to be designated;
  • Institution's Signatory Officials can now sign their FWA submissions electronically on-line. The requirement to submit a hard copy signature page has been eliminated;
  • Institutions now must submit their FWAs (new submissions, updates and renewals) on-line, unless they are unable to do so;
  • The standard approval period for an FWA is now 5 years, instead of 3 years;
  • Now there is a single version of the FWA form and the Terms of Assurance for domestic and international institutions.

Announcement: http://www.hhs.gov/ohrp/index.html

Electronic system: http://ohrp.cit.nih.gov/efile/

Forms: http://www.hhs.gov/ohrp/assurances/forms/index.html