(a) If an institution does not currently hold an FWA, it should submit one. An FWA listed in OHRP's current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) and Approved Assurances” is acceptable for the purposes of this policy.
(b) The OHRP Web site includes links to instructions and the forms for submitting both a domestic and international FWA at: http://www.hhs.gov/ohrp/assurances/assurances_index.html. To expedite approval of a FWA, as well as any update/renewal, the institution shall use the OHRP Electronic Submission System. Once the institution “submits” an electronic file to OHRP, the institution must fax or mail (but not both) a copy of the signature page to initiate the review process. The institution shall mail the FWA to the OHRP, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852, or fax it to OHRP at 240-453-8202 (but not both).
