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Office for Human Research Protections (OHRP)

Update and Renewal of Domestic (U.S.) or International (non-U.S.) Federalwide Assurances

Version Date 07/29/2004

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. There are two ways to update your FWA:

  1. a complete update and
  2. limited update, as described below.

Renewal of your institution's FWA is required at the end of the 3-year effective period. Any complete update or renewal that is submitted to and approved by OHRP begins a new 3-year effective period, and must be submitted with the signature of the Signatory Official.

The electronic form may not be used at this time to update or renew an FWA. Institutions that already have an OHRP approved FWA must update or renew their FWA by submitting the hard copy of the completed FWA form.

The current FWA form (click below) should be used when submitting an update or renewal to OHRP.

DOMESTIC FWA FILING INSTRUCTIONS
SAMPLE DOMESTIC FWA FILING DOCUMENT - Rich Text Format(RTF)
SAMPLE DOMESTIC FWA FILING DOCUMENT - HyperText Markup Language Format (HTML)

INTERNATIONAL FWA FILING INSTRUCTIONS
SAMPLE INTERNATIONAL FWA FILING DOCUMENT - Rich Text Format(RTF)
SAMPLE INTERNATIONAL FWA FILING DOCUMENT - HyperText Markup Language Format (HTML)
  1. Complete Update or Renewal of the FWA
    In the upper right-hand corner, indicate by an [x] that this FWA filing is an "Update or Renewal" and provide your institution's FWA number.

    Type or print the full legal name of your institution, city, state, and country (if outside the U.S.) in Item #1 and then proceed to complete all items. With a complete update or renewal, attach a short note indicating which item(s) was updated in your FWA.

    If you choose to submit an update or renewal to your FWA with the form completely filled out with a new signature by the Signatory Official, the expiration date of your institution's FWA will be set for 3 years from OHRP's approval of your submission.
  2. Limited Update
    In the upper right-hand corner, indicate by an [x] that this FWA filing is an "Update or Renewal" and provide your institution's FWA number.

    Type or print the full legal name of your institution, city, state, and country (if outside the U.S.) in Item #1 and then proceed to complete only the items which have been updated. Attach a brief note or cover letter indicating that the item(s) completed are the only changes made since your last FWA filing.

    If you choose to submit an update to your FWA with only the portions of the form completed where changes are being made, the expiration date of your institution's FWA will remain the same.

    Determining Whether the Signatory Official is Required to Sign the Update or Renewal of the FWA

    In an effort to reduce administrative burden, OHRP has idendified the types of updates that require the signature of your Signatory Official and those that do not.

    Substantive updates must be submitted with the signature of the Signatory Official. Substantive updates include changes (additions, revisions, and deletions) to the:

    1. legal name* of the institution (item #1);
    2. components or alternate names of the institution (item #2);
    3. statement of ethical principles (item #3);
    4. applicability and procedural standards (item #4);
    5. IRB/IEC designations (item #5);
    6. Human Protections Administrator (item #6); or
    7. Signatory Official (item #7).
    *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, etc.).
    Minor updates may be submitted without the signature of the Signatory Official. Minor updates include changes to the:

    1. academic degrees or institutional titles (e.g., Vice President for Research),
    2. telephone or fax numbers, or
    3. e-mail or mailing addresses.

    Submitting an Update or Renewal of the FWA to OHRP

    Please submit the FWA application single-sided and with the signature of the Signatory Official by fax (301-402-0438), regular mail, express mail, or hand delivery to OHRP at:

    Division of Policy and Assurances
    Office for Human Research Protections
    The Tower Building
    1101 Wootton Parkway, Suite 200
    Rockville, MD 20852 If you have any questions, please do not hesitate to contact the Division of Policy and Assurances, OHRP, at (301) 496-7005 or within the U.S., 1-866-447-4777.




Last revised: July 29, 2004

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