U.S. Department of Health & Human Services
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What are the key features of the Federalwide Assurance (FWA)?
The key features of the Federalwide Assurance (FWA) are the following:
a) The identifying information for the institution filing the FWA, the Human Protections Administrator (or a reliable point of contact) at the institution, and the institutional official signing the FWA;
b) A list of the institution’s legal components that operate under different names that will be covered by the FWA and the city and state or country where the component is located. (legal components are generally defined as parts of your institution that may be viewed as separate organizations, but remain part of the legal entity or institution, for example, ABC University can list its XYZ University Hospital, KLM School of Public Health, and EFG Institute for International Studies as components);
c) A statement of ethical principles to be followed in protecting human subjects of research;
d) An applicability statement indicating that the FWA applies whenever the institution becomes engaged in human subjects research conducted or supported by any United States (U.S.) federal department or agency that has adopted the U.S. Federal Policy for Protectionof Human Subjects (known as the Common Rule), unless the research is exempt from Common Rule requirements or a Common Rule agency or department determines the research will be conducted under a separate assurance of compliance. U.S. institutions may voluntarily extend the Common Rule or 45 CFR part 46 to all research conducted by the institution regardless of the source of support;
e) An assurance of compliance indicating that the institution will comply with the Terms of the FWA. An institution outside of the U.S. also must assure that it will comply with one or more procedural standards whenever it engages in research covered by the FWA. A list of 6 such standards is included or an institution can submit another standard for the protection of human subjects that is recognized by the Common Rule departments and agencies. (See Terms of Assurance, section 3(b));
f) The designation of all internal IRBs that will review the research covered by the FWA. If the institution has no internal IRB, it must designate the external IRB that reviews all research covered by the FWA. If the institution relies upon multiple external IRBs, the institution should designate the external IRB that reviews the largest percentage of the research covered by the FWA. All IRBs designated on an institution’s FWA must be registered [http://www.hhs.gov/ohrp/assurances/irb/index.html] with OHRP before the FWA can be approved). Please note that all IRBs reviewing research covered by an instituion’s FWA must be registered whether or not they are designated on the institution’s FWA;
g) Whenever the Institution relies upon an IRB operated by another institution or organization for review of research covered by the FWA, the institution must ensure that this arrangement is documented by a written agreement between the institution and the other organization or institution operating the IRB. The agreement must outline their relationship and include a commitment that the IRB will adhere to the requirements of the Institution’s FWA. OHRP’s sample IRB Authorization Agreement may be used for this purpose, or the parties involved may develop their own agreement. This agreement must be kept on file at both institutions/organizations and made available to OHRP or any U.S. federal department or agency conducting or supporting research covered by the FWA upon request;
The signature of an official authorized to represent the institution, identified on the FWA as Signatory Official. The Signatory Official must assure that human subjects research to which the FWA applies is conducted in accordance with the Terms of Assurance. The Signatory Official must electronically sign the FWA using the electronic submission system available through the OHRP website at: http://ohrp.cit.nih.gov/efile/, unless the institution lacks the ability to submit its FWA electronically.The Signatory Offical typically is someone at the level of President, Chief Executive Officer, Chief Operating Officer, Director General, or Chancellor.
Last Reviewed: 08/30/2011
Related Questions:
- Do international institutions have a separate FWA form or Terms of Assurance?
- Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?
- Are there options other than the Federalwide Assurance (FWA) for obtaining an assurance of compliance to conduct HHS-supported or -conducted research?
- Who is covered by a Federalwide Assurance (FWA)?
- What are the procedures for submitting a Federalwide Assurance (FWA)?
