Federalwide Assurance (FWA) Information
The Federal Policy (Common Rule) for the protection of human subjects requires that each institution "engaged" in Federally-supported human subject research file an Assurance with the DHHS Office of Human Research Protections (OHRP). The Assurance formalizes the institution's commitment to protect human subjects. UCLA's Federalwide Assurance (FWA00004642) was approved in January 2003 and remains active unless otherwise notified. The FWA expiration date is revised each time UCLA's FWA is modified.
To verify the current expiration date of UCLA's FWA, go to the OHRP website and use these criteria to search the database:
- Document Type: Assurances (FWAs)
- FWA Number: 00004642
Below is a sample search result. The "Type" column verifies that U of California Los Angeles has an FWA and the "Status" column verifies it is active. By clicking on the institution name listed in the "Institution" column, the current expiration date of the FWA can be verified. Note: the link below is inactive.
IRB Registration Information
The UCLA general campus IRBs are registered with OHRP and the medical IRBs are registered with OHRP and FDA. To verify that UCLA's IRBs are registered (i.e., active) with OHRP and FDA, go to the OHRP website and use these criteria to search the database:
- Document Type: Institutional Review Boards (IRBs)
- IRB Number: Use the one of the following UCLA IRB numbers
- Medical IRB 1 (MIRB1): 00000172
- Medical IRB 2 (MIRB2): 00000173
- Medical IRB 3 (MIRB3): 00004473
- North General Campus IRB (NGIRB): 00000174
- South General Campus IRB (SGIRB): 00004474
Below is a sample search result. The "IRB Type" column verifies the IRB is registered with both OHRP and FDA and the "Status" column indicates the registration is active. Note: the link below is inactive.
Oversight of IRB Registration:
- UCLA OHRPP is responsible for ensuring that each UCLA Institutional Review Board (IRB) is registered with the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP). The OHRPP Senior Director, or designee, is responsible for oversight of IRB registration, renewal, and required updates.
- A newly established UCLA IRB will be registered, when required, before the IRB begins reviewing research for which registration is required. OHRPP maintains documentation of each UCLA IRB's registration number, effective date, and expiration date.
- OHRPP monitors IRB registration expiration dates through a centralized administrative tracking process. Registrations are reviewed sufficiently in advance of expiration to permit timely submission and are renewed at least every three years, or sooner when an update is required. When an IRB registration is renewed or updated, OHRPP verifies that the information submitted to OHRP is current and accurate.
IRB Membership Rosters and Composition Review:
- OHRPP maintains the official membership roster for each UCLA IRB. The roster identifies regular and alternate members and contains the information necessary to document compliance with applicable federal requirements regarding IRB composition and membership. OHRPP staff update the official roster when a member is appointed, removed, changes status or role, or when other information relevant to the member's IRB service changes.
- OHRPP reviews IRB membership and composition on an ongoing basis and updates the applicable federal IRB registration within required regulatory timeframes. Registration information is updated within 90 days following a change in the IRB chairperson or registration contact.
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- For IRBs registered with FDA, changes in the types of FDA-regulated products reviewed by an IRB are reported within the applicable regulatory timeframe.
- OHRPP also updates registration information when otherwise required by OHRP or FDA and maintains documentation of registration submissions and confirmations.