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Office for Human Research Protections (OHRP)Update and Renewal of Domestic (U.S.) or International (non-U.S.) Federalwide AssurancesVersion Date 06/06/2005 Whenever there is a change in information on file with the Office for Human Research Protections (OHRP) regarding your institution's Federalwide Assurance (FWA), an update to the FWA must be submitted to OHRP. � Your institution's FWA must be renewed at least every 3 years. LIST OF APPROVED ASSURANCES AND REGISTERED IRBs/IECs Tracking the Status of an FWA SubmissionOnce you have submitted an update or renewal to an FWA, you may track the progress of your document until the update or renewal is approved. All approved FWAs, with their expiration date, are listed on the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR. Methods for Submitting an Update or Renewal to an FWA There are two methods for submitting an update or renewal of an FWA to OHRP: *Note: Changes in the legal name of the institution must be accompanied with a letter from the Signatory Official explaining the details leading to the change (e.g., acquisition, change in legal organization, merger, etc.). I.� Electronic Submission When you use the OHRP Electronic Submission System (ESS) to “update” your institution’s FWA, you are really renewing the FWA.� That is, before submitting the electronic record to OHRP for review and approval, you are responsible for ensuring that the entire FWA record is complete and accurate.� You must have an e-mail address in order to use the OHRP ESS.� Submission of documents using the ESS will expedite processing the update/renewal of your institution’s FWA.� You will be guided through the electronic submission process at http://ohrp.cit.nih.gov/efile. II.� Hard Copy Submission There are two types of updates that may be submitted in hard copy:� 1) a complete update, or 2) a limited update, as described below.� Any complete update submitted to OHRP will be considered a renewal of the FWA, and when approved, will begin a new 3-year effective period.� Limited updates will retain the expiration date assigned.� The signature of the Signatory Official will be required in most cases for both types of updates. A.� Instructions for Hard Copy Submission of a Complete Update (Renewal) of an FWA
FAX:�240-453-8202 Division of Policy and Assurances B.� Instructions for Hard Copy Submission of a Limited Update of an FWA
Please submit the FWA form single-sided.� You may fax OR mail the FWA to OHRP; however, please do not do both. FAX:� 240-453-8202
Division of Policy and Assurances The current FWA form (click below) should be used when submitting an update or renewal to OHRP. DOMESTIC
FWA FILING INSTRUCTIONS |
Last revised: March 3, 2006