Office for Human Research Protections (OHRP)

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

Version Date 07/10/2009

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 should be submitted to OHRP. � Your institution's FWA must be renewed at least every 3 years.

LIST OF APPROVED ASSURANCES AND REGISTERED IRBs
(http://ohrp.cit.nih.gov/search/)

Tracking the Status of an FWA Submission

Once 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/.

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:

� 1) electronic submission, or 2) hard copy submission.

*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

1. 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.

2. Follow the instructions for completing and submitting the FWA form found at http://www.hhs.gov/ohrp/humansubjects/assurance/filasuri.htm for domestic (U.S.) institutions or at http://www.hhs.gov/ohrp/humansubjects/assurance/ifilasuri.htm for international institutions.� Links to the FWA forms are provided below.

3. You must submit the update (renewal) to the FWA with the signature of the Signatory Official.�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
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

B.� Instructions for Hard Copy Submission of a Limited Update of an FWA

1. 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.

2. Complete paragraph 1.� Then complete those sections of the FWA where changes are to be made.� Follow the instructions for completing and submitting the FWA form found at http://www.hhs.gov/ohrp/humansubjects/assurance/filasuri.htm for domestic (U.S.) institutions or at http://www.hhs.gov/ohrp/humansubjects/assurance/ifilasuri.htm for international institutions.� Links to the FWA form are provided below.

3. Substantive limited updates must be submitted with the signature of the Signatory Official. � Substantive updates include changes (additions, revisions, and deletions) to the critical information provided in paragraphs 1-7 the FWA; e.g., change in the Human Protections Administrator or Signatory Official, addition of an IRB or component, etc.� Minor updates may be submitted without the signature of the Signatory Official.� Minor updates include changes to non-critical information; e.g., academic degrees or institutional titles (e.g., Vice President for Research), telephone or fax numbers, or e-mail or mailing addresses, etc.

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
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

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

DOMESTIC FWA FILING INSTRUCTIONS
FWA FORM FOR DOMESTIC (U.S.) INSTITUTIONS (RTF)
FWA FORM FOR DOMESTIC (U.S.) INSTITUTIONS (HTML)
INTERNATIONAL FWA FILING INSTRUCTIONS
FWA FORM FOR INTERNATIONAL (NON-U.S.) INSTITUTIONS (RTF)
FWA FORM FOR INTERNATIONAL (NON-U.S.) INSTITUTIONS (HTML)

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