What is a Federalwide Assurance (FWA)?

A FWA is an agreement between UC Hastings and DHHS to comply with federal regulations concerning research involving human subjects, including the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46. UC Hastings’ FWA registration number is FWA # 00016952 from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. 

When is FWA Required?

If a study is federally-funded or subject to federal regulatory oversight, the research institution must have an active FWA number prior to initiating the research.  (Note that if UCSF’s Committee for Human Research (CHR) is providing IRB review for your study, the CHR will require FWA submission whether the study is federally-funded or not.  Please see Designating an IRB: UCSF’s CHR or WIRB? to determine which IRB should review your study.)  You do not need to take additional action to meet this requirement.  UC Hastings already has a FWA registration number that applies to all studies conducted by UC Hastings researchers.

Please note the following information regarding UC Hastings’ FWA as you will need this information when you apply for IRB approval at UCSF or WIRB:

• UC Hastings’ FWA registration number is FWA00016952.  UC Hastings’ current FWA was updated on 3/24/11 and will expire on 3/24/2014, upon which date UC Hastings must apply for renewal.  The newest HHS guidelines require renewal every 5 years instead of every 3 years.  Subsequently, UC Hastings’ renewed FWA will remain valid for 5 years.
• The Signing Official for UC Hastings’ FWA is Elise Traynum, JD, General Counsel for UC Hastings (traynume@uchastings.edu). 
• The Human Protections Administrator for UC Hastings’ FWA is Jennifer Dunn, JD (dunnj@uchastings.edu).