Skip Navigation

United States Department of Health & Human Services

 

spacer

line

Print Print    Download Reader PDF

OHRP Home | About OHRP | Search OHRP | Contact OHRP | OHRP News


 

Office for Human Research Protections (OHRP)

Assurances

Version Date 7/09/2009

Obtaining an approved assurance from OHRP is a two-step process. First, you must ensure that the IRB(s) you designate under the Assurance are registered with OHRP. If not, submit the registration. Second, you must complete the Assurance application, below.

Please note: the fact that the Office for Human Research Protections (OHRP) has approved an institution's assurance does not mean that OHRP has determined that the institution is complying with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46. It means that an institution has submitted all of the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects research conducted or supported by HHS or other research covered by the assurance. The Federalwide Assurance is the only type of assurance accepted and approved by OHRP.

FAQs on Assurances

LIST OF APPROVED ASSURANCES AND REGISTERED IRBs

Basic Assurance Requirement

If your institution is engaged in human subjects research (not otherwise exempt) that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), then your institution must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects.

Tracking the Status of an FWA Submission

Once you have submitted an FWA, you may track the progress of your document until the FWA is approved. Once your institution's FWA is approved, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/.

Assurance Submission

OHRP Recommended FWA Training Modules

Other Forms

Who to Contact re: Assurances

Steps to File a Domestic (U.S.) Federalwide Assurance (FWA)

Domestic (U.S.) Paper-Based Assurance

  1. Download or Print the Instructions, the Terms of Assurance, and the FWA form.
    • FWA form [HTML]
    • FWA form [RTF - 339KB]
  2. Read the Instructions and the Terms of Assurance.
  3. Review and fill out the FWA form.
  4. (Signatory Official) Sign and date the FWA form.
  5. Fax the completed FWA form to OHRP at:

    (240) 453-8202
    or mail the FWA form to:

    Office for Human Research Protections
    U.S. Department of Health and Human Services
    1101 Wootton Parkway, Suite 200
    Rockville, MD 20852
  6. Forms to download:

Domestic (U.S.) Electronic Assurance (for NEW submission only)

  1. Download or print the Instructions and the Terms of Assurance.
  2. Read the Instructions and the Terms of Assurance.
  3. Go to the website to create electronic FWA submission.
    1. Click "Enter New FWA."
    2. Request electronic submission number, which will be e-mailed to you.
    3. Return to website and enter data to complete the FWA form. All areas marked with an "*" must be completed. You may work on the FWA, exit, and return as many times as you would like.
    4. Review your entries carefully before clicking the "SUBMIT" button.
    5. Print a copy of the FWA form for your file and for signature.
  4. (Signatory Official) Sign and date the FWA form.
  5. In order to process the electronic submission, you must FAX a copy of the signed FWA form to OHRP at:

    (240) 453-8202
    or mail the FWA form to:

    Office for Human Research Protections
    U.S. Department of Health and Human Services
    1101 Wootton Parkway, Suite 200
    Rockville, MD 20852
  6. Forms to download:

Tracking the Status of an FWA Submission

Once you have submitted an FWA, you may track the progress of your document until the FWA is approved. Once your institution's FWA is approved, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/.

Steps to File an International (non-U.S.) Federalwide Assurance (FWA)

(Note that covered research conducted or supported by HHS is expected to comply with the requirements of 45 CFR part 46. See the July 7, 2006 Notice on Interpretation of Assurance Requirements [PDF - 57.2KB])

International Paper-Based Assurance

  1. Download or Print the Instructions, the Terms of Assurance and the FWA form.
    • FWA form [HTML]
    • FWA form [RTF - 339KB]
  2. Read the Instructions and the Terms of Assurance.
  3. Review and fill out the FWA form.
  4. (Signatory Official) Sign and date the FWA form.
  5. Fax the completed FWA form to OHRP at:

    (240) 453-8202
    or mail the FWA form to:

    Office for Human Research Protections
    U.S. Department of Health and Human Services
    1101 Wootton Parkway, Suite 200
    Rockville, MD 20852
  6. Forms to download:

International Electronic Assurance (for NEW submission only)

  1. Download or Print the Instructions and the Terms of Assurance.
  2. Read the Instructions and the Terms of Assurance.
  3. Go to the website to create electronic FWA submission.
    1. Click "Enter New FWA."
    2. Request electronic submission number, which will be e-mailed to you.
    3. Return to the website and enter data to complete the FWA form. All areas marked with an "*" must be completed. You may work on the FWA, exit, and return as many times as you would like.
    4. Review your entries carefully before clicking the "SUBMIT" button.
    5. Print a copy of the FWA form for your file and for signature.
  4. (Signatory Official) Sign the Assurance form.
  5. In order to process the electronic submission, you must FAX a copy of the signed FWA form to OHRP at:

    (240) 453-8202
    or mail the FWA form to:

    Office for Human Research Protections
    U.S. Department of Health and Human Services
    1101 Wootton Parkway, Suite 200
    Rockville, MD 20852
  6. Forms to download:

Tracking the Status of an FWA Submission

Once you have submitted an FWA, you may track the progress of your document until the FWA is approved. Once your institution's FWA is approved, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/.
spacer

HHS Home | Questions? | Contact HHS | Accessibility | Privacy Policy | FOIA | Disclaimers

The White House | USA.gov | HHS Archive | No FEAR Act

U.S. Department of Health & Human Services · 200 Independence Avenue, S.W. · Washington, D.C. 20201