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Home > WIRB Services > IRB Review > Federally Funded Research

Special considerations for Federally Funded Research

Grants
For federally funded research, WIRB must review a complete copy of the grant application. There is an exception to this requirement for multi-site research; the requirement for IRB review of the grant applies only to the awardee institution. The grant generally need not be reviewed by the IRBs (including WIRB) at non-awardee institutions participating in the multi-site research; however, there may be situations or certain types of research in which the Board may require the complete grant as part of its review for an investigator at a non-awardee institution.

FWAs
When an institution (a legal entity) receives federal funding for research, the institution usually must obtain an assurance as required under section 45 CFR § 46.103 of the Common Rule. Each separate legal entity that is engaged in the research must obtain an assurance. For research funded by agencies that are part of the Department of Health and Human Services (DHHS), this will usually be a FederalWide Assurance (FWA), obtained from the Office for Human Research Protections (OHRP). Those agencies outside of DHHS that have adopted the Common Rule may accept a FederalWide assurance, or may use a different assurance mechanism. OHRP provides guidance on when an institution is engaged in research at http://www.hhs.gov/ohrp/policy/index.html#engagement.

Prior to the Board's review of federally-funded research, the following requirements must be met:

As described in the OHRP guidance entitled "Engagement of Institutions in Research," a Federalwide Assurance (FWA) must be filed for all sites engaged in federally-funded research. The guidance is available at http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm. The FWA form is posted on the OHRP website. You can access this form at http://www.hhs.gov/ohrp/assurances/assurances_index.html#domestic. Please provide WIRB with a copy of the DHHS-approved FWA application.
An IRB Authorization Agreement must be completed. Click here for a sample pre-filled authorization agreement in which WIRB is listed as Institution A. Please complete the Institution B sections of the form.
Third, WIRB requires that Investigator Training Certificates must be on file with WIRB prior to WIRB review of the research. The Investigator and key personnel must complete the NIH training ("Human Participant Protections Education for Research Teams" ) at http://cme.cancer.gov/, or an equivalent course. "Key personnel" are all individuals responsible for the design and conduct of the study. Modules 1, 2 and 3 of the OHRP training modules must be completed by the Signatory Official (on the FWA) and the Human Protections Administrator (primary contact). The OHRP training can be found at http://137.187.172.153/CBTs/Assurance/login.asp.

At the time of initial review of the protocol, the Board also participates in a teleconference with a member of the research staff at the site. The attendee in this teleconference is typically the study coordinator or another full-time employee who can answer basic questions about the research facilities, subject recruitment, consent processes, and community attitudes toward research.
Additional information about FWAs and IRB review of federally-funded research can be found on the OHRP website at http://www.hhs.gov/ohrp/.

Contact WIRB's Client Services for clarification or assistance regarding these requirements

WIRB reviews research funded by the Department of Defense, the Department of Education and other federal agencies, as well as research that will be submitted to the Environmental Protection Agency.

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