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Assurances
Version Date 10/25/2006
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.
FAQs on Assurances
LIST OF APPROVED ASSURANCES AND REGISTERED IRBs/IECs
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/asearch.asp#ASUR.
Domestic (U.S.) Paper-Based Assurance
- Download or Print the Instructions, the Terms of Assurance, and the FWA form.
- FWA form [HTML]
- FWA form [RTF - 339KB]
- Read the Instructions and the Terms of Assurance.
- Review and fill out the FWA form.
- (Signatory Official) Sign and date the FWA form.
- 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
- Forms to download:
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Domestic (U.S.) Electronic Assurance (for NEW submission only)
- Download or print the Instructions and the Terms of Assurance.
- Read the Instructions and the Terms of Assurance.
- Go to the website to create electronic FWA submission.
- Click "Enter New FWA."
- Request electronic submission number, which will be e-mailed to you.
- 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.
- Review your entries carefully before clicking the "SUBMIT" button.
- Print a copy of the FWA form for your file and for signature.
- (Signatory Official) Sign and date the FWA form.
- 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
- Forms to download:
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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/asearch.asp#ASUR.
(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
- Download or Print the Instructions, the Terms of Assurance and the FWA form.
- FWA form [HTML]
- FWA form [RTF - 339KB]
- Read the Instructions and the Terms of Assurance.
- Review and fill out the FWA form.
- (Signatory Official) Sign and date the FWA form.
- 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
- Forms to download:
|
International Electronic Assurance (for NEW submission only)
- Download or Print the Instructions and the Terms of Assurance.
- Read the Instructions and the Terms of Assurance.
- Go to the website to create electronic FWA submission.
- Click "Enter New FWA."
- Request electronic submission number, which will be e-mailed to you.
- 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.
- Review your entries carefully before clicking the "SUBMIT" button.
- Print a copy of the FWA form for your file and for signature.
- (Signatory Official) Sign the Assurance form.
- 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
- 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/asearch.asp#ASUR.
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