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Library > Fact Sheets > IRB Assurance of Compliance
IRB ASSURANCE OF COMPLIANCE
Posted 6/5/2009
Printable Fact Sheet
Assurance of Compliance
What is an Assurance?
An Assurance of Compliance is a formal written, binding agreement that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved. The AF assurance is a signed agreement between the institutional official of an institution engaged in Air Force sponsored research and HQ AF/SGRC which assures that all research will be performed according to the requirements of AFI 40-402, 32 CFR 219 and 10 United States Code 980.
What is research and when does an institution become engaged in research?
"An institution becomes 'engaged' in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes." See 32 CFR 219.102(d), (f). Also, see OHRP definition of Engagement in Research: http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm
Who has to have an assurance? Do contractors and their subcontractors have to have an assurance?
32 CFR 219.103 Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. Each institution engaged in research which is covered by this policy and which is conducted or supported by a federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in this policy.
How does my institution get an Air Force Assurance of Compliance?
The following templates may be used to apply for an Assurance of Compliance:
For Institutions that already have a Federal Wide Assurance with OHRP, an Addendum to the Federal Wide Assurance will be required.
For Non-DoD Institutions that do NOT have a Federal Wide Assurance, you must attain one by visiting the following site: http://www.hhs.gov/ohrp/assurances/assurances_index.html.
In addition you will also need to complete a DoD addendum for the above FWA which can be found in the forms and templates section of our site.
In either case, an Air Force IRB is required to review and approve any Human Subjects Research that is sponsored by the Air Force. A Research Review Agreement designates the AFRL Wright-Site IRB as an IRB authorized to review research for your institution. This document is required with the submission of both the FWA Addendum and the Non-DoD Assurance applications.
These agreements are scoped, meaning an institution may select to apply the Assurance and/or the Research Review Agreement to one research protocol, a selected group of protocols or all research occurring at an institution. However, selecting any option other than a single research protocol will require prior coordination through HQ USAF/SGRC.
If you are a DoD institution, please contact the IRB directly, as these forms will not apply.
How long does it take to get a Federal Wide Assurance?
After the signed paperwork is submitted to OHRP, it takes about 1 week to process.
Will any Assurance do and who gets to determine what an acceptable Assurance is?
AFI 40-402 3.1. Assurances. All human research conducted or supported by the Air Force shall be conducted under an Assurance of compliance acceptable to the Air Force, unless the research is exempt from these regulations under 32 CFR 219.101(b). A DoD Assurance is required for research performed at DoD facilities and funded by the DoD. A DoD Assurance issued by the Air Force is required for research conducted by the Air Force at an Air Force facility. Any changes to an Assurance covering research conducted or supported by the Air Force must be prospectively approved by HQ AF/SGRC.
Who approves DoD/Air Force Assurances?
AFI 40-402 3.1.1. Applications for DoD Assurances issued by the Air Force must be reviewed and approved by HQ AF/SGRC prior to initiation of any human research.
What about non Air Force Assurances issued by other Federal Departments?
AFI 40-402 3.1.4. Non-Air Force Assurances. In most cases, a DoD Assurance will be required. However, in some cases, HQ AF/SGRC may accept an Assurance issued by DHHS. Whenever the Air Force accepts an Assurance not issued by the Air Force, the institution must provide a separate written assurance that it will comply with requirements unique to the Air Force, including this instruction and all attachments, and that it will report to the Air Force continuing compliance and safety issues, such as continuing reviews, adverse events, and protocol deviations, in accordance with this instruction.
Are there contractor-specific regulations?
AFI 40-402 4.1. Contractor Studies. This section sets out procedures for contracted research involving the use of human subjects. An organization may not award a contract for research involving the use of human subjects until the requirements of this instruction have been fully met.
AFI 40-402 4.1.4. The Air Force will not award a contract involving a human subject to an individual unless he or she is affiliated with or sponsored by an organization that can, and does, assume responsibility for that subject.
AFI 40-402 4.1.5. Any organization applying for a contract to conduct research involving a human subject must provide a written assurance that it will abide by the policy for protection of human subjects as stated in this instruction.
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