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Review of Federally Funded Research
Quorum Review IRB provides review of federally funded studies in the United States, including studies that are regulated by HHS/OHRP. These studies are subject to additional submission and review requirements.
Federally Funded Studies
Submission Requirements
Prior to the Board's review of federally-funded research, the following documentation must be submitted in addition to other required material for review of new protocol submissions:
- A completed Federal Funding Addendum (available on our website or from Customer Relations)
- A complete copy of the applicable grant application or other funding application. (The grant application or other funding applications typically does not need to be reviewed by Quorum Review IRB for a non-awardee institution involved in a multi-site research project. Please contact Customer Relations if you have questions about a multi-site research project.)
- A copy of the federal contract (if available).
- A valid Federal Wide Assurance (FWA) number. A Federal Wide Assurance (FWA) must be filed for each legal entity engaged in the federally funded study as required by 45 CFR § 46.103 and in accordance with the following OHRP guidance: "Engagement of Institutions in Research" (http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm). A copy of the FWA form may be downloaded from the following OHRP website: http://www.hhs.gov/ohrp/assurances/assurances_index.html#domestic. (Please contact the applicable agency if using a different assurance process other than a FWA).
- A completed IRB Authorization Agreement (IAA). (Quorum Review IRB will accept any standard IAA form. You may obtain Quorum’s template IAA from our website or contact Customer Relations.)
Federal Wide Assurance Requirement for IRBs
An independent IRB does not need to obtain a separate FWA. It is generally accepted that the IRB is not actively engaged in the research nor is it a direct recipient of federal funds. Consequently, the IRB can be considered a sub-contractor and as such should be listed on the Sponsor’s FWA form as the IRB of record. More information is available at http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm.
Please contact Quorum Review IRB’s Customer Relations department for clarification or assistance regarding these requirements.
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