What is required for Board review of a federally-funded study?
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).
- 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).
- 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/policy/engage08.html. You can submit the FWA form electronically on the OHRP website. For more information visit: http://www.hhs.gov/ohrp/assurances/assurances/file/index.html. (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).
Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.