Chapter 21

Special Considerations for Federally Funded Research

FWAs

The submission form will prompt you to provide the appropriate, required documentation for review of research involving an FWA. 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 (HHS), this will usually be a Federal-wide Assurance (FWA) obtained from the Office for Human Research Protections (OHRP). Those agencies outside of HHS that have adopted the Common Rule may accept a Federal-wide 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/engage08.html.

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 Federal-wide Assurance (FWA) must be filed for all sites engaged in federally-funded research. The guidance is available at:http://www.hhs.gov/ohrp/policy/engage08.html. OHRP requires all FWA applications be submitted electronically using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically.  If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email (see http://www.hhs.gov/ohrp/assurances/contact/index.html) and explain why it was unable to submit its FWA electronically. The registration number for WCG IRB is IRB00000533 (Canadian sites use IRB00002354). WCG IRB will request a copy of the DHHS-approved FWA application, but if it is not available, it is not required for review.
  • An IRB Authorization Agreement must be completed. The form (Reliance Agreement) is available on the Forms page of https://www.wcgclinical.com/irb-resources/.  

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 WCG IRB’s Client Care for clarification or assistance regarding these requirements.