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          • A Guide to Human Subjects Protection
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          • What is a Federalwide Assurance (FWA)?
          • What is an Institutional Review Board (IRB)?
          • When Is IRB Review Required?
          • What is a Federalwide Assurance (FWA)?
          • UCSF’s CHR or WIRB?
          • Initial Steps for Submitting a Protocol through UCSF’s IRB
          • Initial Steps for Submitting a Protocol through WIRB

          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.  HHS guidelines require FWA renewal every 5 years.  UC Hastings’ FWA was updated in March 2014 and will expire in March 2019, before which UC Hastings must apply for renewal.
          • 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). 
          More information on the OHRP and FWAs can be found at http://www.hhs.gov/ohrp/.  Please do not contact the OHRP for questions related to UC Hastings’ FWA.  Please contact Jennifer Dunn (dunnj@uchastings.edu) if you need any further information.
          University of California - Hastings College of the Law
          University of California Hastings College of the Law in San Francisco is redefining legal education through our experiential, interdisciplinary, and international approach to the law. We integrate rigorous academics with hands-on practice, preparing our graduates to tackle the legal challenges—and leverage the opportunities—of the 21st century.

          UCHastings College of the Law

          200 McAllister Street, San Francisco, CA 94102
          415.565.4600
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