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THE COMMITTEE ON HUMAN RESEARCH

Federalwide Assurance (FWA) - Compliance with DHHS Regulations for Protection of Human Research Subjects

A. UCSF Federalwide Assurance (FWA) 00000068
Approved: March 30, 2009
Expires: March 30, 2012

	UCSF FWA00000068 IRB and IORG0000135 Registration numbers:
	•	IRB 00000229 for the Parnassus Committee
	•	IRB 00000230 for the San Francisco General Hospital Committee
	•	IRB 00003471 for the Laurel Heights Committee
	•	IRB 00005096 for the Mt Zion Committee

Important Note: The UCSF HRPP is in compliance with both DHHS 46 CFR 46 Subpart E and FDA 21 CFR 56 regulations, which require IRB registration with DHHS. Please read the Letter to Sponsors about IRB Membership for more information.

Click here to search for the UCSF FWA in the Office for Human Research Protections (OHRP) Database.

B. FWA Background

The FWA system requires each legally separate entity that engages in Federally-supported human subject research to obtain their own FWA. For example if UCSF has a prime grant from a Federal funder and part of the human subject work is a subcontract to an outside institution (including foreign institutions), the subcontractor must obtain an FWA number before the money can be awarded to that subcontractor.

C. UCSF Affiliates

The following organizations are either formally affiliated with UCSF or have a close collaborative relationship with UCSF. As such they have designated the UCSF IRB(s) as their IRB(s) of record for most or all of their human subjects research:

	Affiliated Institution	FWA #
	Blood Centers of the Pacific (BCP)	00002111
	Blood Systems Research Institute (BSRI)	00006454
	Ernst Gallo Clinical and Research Center (EGCRC)	00000304
	Goldman Institute on Aging	00002525
	J. David Gladstone Institutes	00000087
	Northern California Institute for Research and Education (NCIRE)	00000256
	San Francisco Department of Public Health (SFDPH)	00000162
	San Francisco General Hospital (SFGH)	00000315
	Veterans Affairs Medical Center (VAMC)	00000280

OHRP recognizes that all institutions do not have IRBs. These institutions may designate other IRBs under their FWA that are operated by other entities, if the other entity agrees.

More information on this topic can be found at Working With Other Institutions.

D. UCSF Institutional Components

For a list of the UCSF institutional components that fall under this number, please search for the UCSF FWA here. Examples of institutional components are School of Medicine, Langley Porter Psychiatric Institute, and the Institute for Health Policy Studies.