Current External IRBs


National Cancer Institute Central IRB (NCI CIRB) Initiative

The CIRB Initiative is sponsored by the NCI in consultation with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The CIRB provides an innovative approach to the IRB review of adult and pediatric national multi-center cancer treatment trials that significantly speeds up IRB approval and yet maintains a high level of protection for the human research participants. For full details about this initiative, please see the NCI CIRB Initiative website.

The CIRB provides expert IRB review at the national level before the Cooperative Group distributes the protocol to local investigators. UCSF has a formal agreement with the NCI CIRB, so investigators who wish to participate in the Cooperative Group Trials reviewed by the NCI CIRB may take advantage of these reviews.

These reviews include: Adult CIRB, Late Phase Emphasis Adult CIRB and Early Phase Emphasis Pediatric CIRB.

For complete information, visit the How it Works page on the CIRB website.

1. The Adult or Pediatric CIRB receives a completed application, protocol, informed consent form and related materials from the Cooperative Group via the NCI.

2. The full CIRB Board conducts initial review and approves the protocol.

3. After the protocol is activated by the Cooperative Group, all review documents are posted on the CTSU website for access by participating institutions.

4. A local investigator at a participating institution decides to join the clinical trial for a CIRB-approved protocol. The UCSF Cancer Center investigator downloads the application packet and submits to the Cancer Center PRMC.

Once the Cancer Center PRMC approves the protocol, the investigator submits an abbreviated application to the UCSF IRB via iRIS. The UCSF IRB office reviews the submission and confirms CITI human subjects protection training and other applicable ancillary approvals (i.e. Radiation Safety Committee or Biosafety Committee).

5. The UCSF IRB acknowledges the submission and provides notification that UCSF accepts to rely on the CIRB.

6. The CIRB becomes the IRB of Record for this protocol and is responsible for continuing review as well as review of subsequent amendments, potential unanticipated problems, or serious or continuing protocol noncompliance as defined by the CIRB. The UCSF HRPP will receive reports of unanticipated problems and serious and/or continuing noncompliance from the CIRB.

1. PI reviews listing of CIRB approved protocols. These lists are available at the CTSU website. Investigators may choose a new study, or they may transfer a study to CIRB if they have a study active on the list. 

2. PI downloads protocol from CTSU Website. If the PI is interested in participating in one or more of these protocols or transferring an IRB-approved protocol to CIRB, he or she should download the protocol and consent documents.

Important Note: Notify the Cancer Center Protocol Review Committee and obtain its approval for the study to occur at UCSF before submitting the abbreviated application to the UCSF IRB.

3. PI makes the NCI consent form UCSF-specific. Obtain the most recent approved version from the IRB Manager site. The UCSF-specific consent and assents forms should be submitted to the UCSF IRB.  Note that UCSF policy for obtaining assent should be followed. 

Important Note: The NCI allows only local boilerplate additions to the informed consent that have been previously approved by the NCI.

4. PI completes an abbreviated application in iRIS. In section 5, please be sure to indicate "Yes" when asked "This is a CIRB study."

 Please attach UCSF specific consent forms to the submission. 

Important Note: The abbreviated application form requests information about other related committee approvals that are needed. If Radiation Safety and/or Biosafety Approvals are needed, these must be in place before the UCSF IRB can agree to rely on the CIRB for the approval of the study. Also, Key Personnel must complete the online CITI human subjects protection training.

1. The UCSF IRB Notifies PI of Acceptance or Rejection of CIRB Approval. After reviewing the abbreviated application, and confirming Human Subjects Protection Training and other applicable approvals are in place, the UCSF IRB acknowledges the submission and issues an acknowledgement letter confirming that UCSF agrees to rely on the CIRB for this study.

Important Note: The PI may begin enrolling patients as soon as the CIRB registration email notification is received.

2. All continuing review and modification applications are submitted directly to the NCI CIRB. Please only submit a modification to the UCSF IRB for a change of PI. The UCSF IRB will acknowledge the submission in iRIS but will not issue an approval or acknowledgement letter. The UCSF PI will also be able to view the acknowledgement in iRIS. Also submit a Study Closeout Report to the UCSF IRB.

  • Perform initial reviews of new research studies, discuss issues with the lead organization and Study Chair, and make final decision of approval or disapproval of the study.
  • Maintain and make accessible to designated IRBs the CIRB review materials.
  • Carry out continuing reviews, and reviews of submitted serious adverse events, protocol amendments, DSMB reports and any other documents submitted by the lead organization or Study Chair.
  • Notify each local institution PI of any new materials and any changes in the study approval status.
  • Assume ultimate responsibility for all aspects of the study. Please refer to the Responsibilities of PIs and CRCs page for full details of these responsibilities.
  • Maintain a copy of the UCSF IRB acknowledgement letter in the study file in case the UCSF HRPP, the UCSF Audit Services, the federal government or the funding agency audits the study.
  • Review CIRB website regularly to keep current with all information including amendments to CIRB-approved studies.
  • Submit internal (on-site) adverse event, protocol violations and incident reports to the CIRB.
  • Submit continuing review and modification materials to the CIRB in a timely manner.

Notify CIRB and/or UCSF IRB if any parts of this process are unclear. In this way, improvements and revisions can be made to ensure that process will be both efficient and effective. For NCI CIRB questions, email [email protected]. For UCSF IRB questions, email [email protected].

Fresno Community Hospital and Medical Center (Community Health System)

There is a Memorandum of Understanding (MOU) between the Fresno Community Hospital and Medical Center and the University of California that applies to all categories of human research (that is, full committee and expedited research). When applicable, the MOU allows research to be reviewed by the Fresno Community Hospital and Medical Center rathar than having to also be reviewed by the UCSF IRB. Note that under all circumstances applications are required at both locations. 

As of July 2020, the UCSF IRB can review for Fresno Community Hospital and Medical Center when UCSF is also engaged in the research. CHS IRB leadership will determine whether the UCSF IRB can be relied upon on a case-by-case basis.  Please contact [email protected] for more information.

As of August 2022, Community Medical Center is now Fresno Community Hospital and Medical Center, doing business as Community Health System (CHS). 

To be eligible for this MOU, the following conditions must be met:

  • The research will be conducted at any of the Fresno Community Hospital and Medical Center facilities, or involves identifiable data or specimens from any CHS facilities.
  • There must be a UCSF PI on the study.
  • Submit and application in iRIS. Make sure you're in "IRB Assistant." You will receive further instructions after you submit. You can submit at UCSF at the same time you are submitting to the CHS IRB. Note that both funded and unfunded studies should be submitted in iRIS. 
  • Submits an application to the Fresno Community Hospital and Medical Centers’ IRB according to that IRB’s guidelines. The PI should indicate to the Fresno Community Hospital and Medical Centers’ IRB that the study is funded through UCSF.
  • Follow the standards and guidelines of the Fresno Community Hospital and Medical Centera’ IRB for the reporting of any post approval events. These include adverse events, other safety information, and/or protocol violations or incidents.
  • Follow the standards and guidelines of theFresno Community Hospital and Medical Centers’ IRB for submitting amendments and renewal applications.
Community Medical Centers’ IRB
  • Is the IRB of Record for studies reviewed under this MOU and is responsible for continuing review as well as review of subsequent amendments and serious adverse events.
UCSF Fresno Grants and Research Office
  • Is responsible for comparing grant applications with corresponding CHS IRB applications.
  • Is responsible for collecting and forwarding financial disclosure documents to the UCSF COIAC.

UCSF Fresno Faculty eligibility is based on the UCSF requirements.

Note that UCSF Fresno is a department of the UCSF School of Medicine. If you have any questions please contact [email protected]

Private IRBs

UCSF has reliance agreements with several private IRBs. If a study is eligible for private IRB review and the PI chooses this option, the PI will be responsible for submitting the study to the UCSF IRB and the private IRB. These submissions can occur in parallel, but the private IRB will not review the study until UCSF has confirmed that the study is eligible.

Studies that meet the following criteria are eligible for private IRB review:

Exceptions: Research involving the following must be reviewed by the UCSF IRB

  • Neonates
  • Transplant research
  • Surgical techniques or procedures
  • Studies that require full committee GESCR review, or GESCR chair review
  • Gene transfer, gene therapy
  • Investigational radiologic procedures
  • Studies that use artificial intelligence applications or generative AI tools

The HRPP reserves the right to make additional exceptions and has final say on whether research must be reviewed by IRB.

The following steps should be followed for all studies that intend to rely on a private IRB for review.

1. The PI submits an abbreviated IRB application through iRIS.

IRB Application Form:

  • In the "Sites, Programs, Resources, and External IRB Review" section, answer Yes to this question: "This application includes a request to rely on another IRB (other than NCI CIRB)."
  • In the "Relying on Another IRB" section, select the applicable private IRB or select "Other" and specify the IRB in the text box.

Attachments: Attach the sponsor’s protocol as an Other Study Document. Submit all other attachments – including the consent form(s) – directly to the private IRB. Note: Use the UCSF consent form templates (see Important Notes below).

2. The HRPP staff reviews the study to confirm eligibility and generates an acknowledgement letter allowing the UCSF PI to rely. The PI should provide this letter to the private IRB.

3. Submit a Study Closeout Report to the UCSF IRB when the study is closed with the private IRB.

Important Notes:

  • Only one submission to the UCSF IRB is necessary. Once eligibility has been confirmed, all future submissions and reporting are between the PI and the private IRB.

  • The private IRB will not review until HRPP confirms eligibility.

  • The consent forms submitted to the private IRB must follow the UCSF consent templates. You can also use the following checklist as a guide: Consent Form Checklist for Using a Non-UCSF Consent Form. The private IRB is responsible for ensuring consistency with that template.
  • The study team will not receive continuing review reminders from the HRPP; however, the private IRB will email reminders.

Conflicts of Interest: HRPP will forward COIAC findings and management plans, if any, to the private IRB. The private IRB has final say on management plan for research they oversee. The management plan may require a modification to the study.

Radiation Safety Committee: Radiation Safety may require specific consent form wording. This may require a modification to the study.

Other committees, departments and personnel: They will continue to have their own review requirements.

Submission and Review Process by Each Private IRB

  1. The PI submits an application to WIRB through WIRB's online electronic system. Register for an account on the WIRB site. WIRB will train PIs and their staff on how to use this system.
  2. WIRB reviews the study.
  3. WIRB notifies PI and HRPP of approval.

1. The PI submits an application to Advarra IRB through Advarra IRB's online electronic system, CIRBI. The steps for login and starting a new submission are summarized below.  Advarra IRB can train PIs and their staff on how to use this system.

  • Go to the CIRBI web site, click "sign up" and create a user profile. Then you will be issued credentials to access the system.
  • After you register, you will be directed to your home page whenever you log into CIRBI, and will be able to create and access your studies. NOTE: Any colleagues who want access to the study submission in CIRBI will need to register before you begin to create it, so that they are in your company directory and you can select them as contacts while creating your submission. The PI also needs register in advance.
  • Click “Create new submission” to start a new protocol submission.
    • Select the entry “Investigator/Site Application” to provide information about your PI, as well as your site.
    • The applications are based on smart forms, so you will not be able to advance to the next page of questions unless you answer all required questions (with a red asterisk) on each page. However, there is a solution as you create your submission: above the white box of questions on each page, you will see a gray bar that says “Save, Exit, etc.” The last choice is “Jump To.” If you click on that, a drop down list of all pages of the application will appear, and you can move from page to page without having to complete each one until you are ready to submit the application.

2. Advarra IRB reviews the study.

3. Advarra IRB notifies PI and HRPP of approval.

Relying on other Academic Medical Centers and Hospitals

Please submit directly into iRIS. Mark in section 6 that you are using an external IRB. Attach the protocol, any applicable ancillary committee reviews, localized consent form(s) (if UCSF is enrolling), and the reliance agreement if it’s in a file format.

This slide deck explains the entire process in greater detail. You can find an itemized list of all the steps of the process on slides 16 and 17. The list references the slides that explains the related step in more detail. If you have additional questions about the process, please ask via the Ask Andy form

This information pertains to IRBs who are acting as the single IRB/central IRB/IRB of record.  All reliance agreements including IRB Authorization Agreements, SMART IRB Addenda, and Letters of Indemnification must comply with UCOP guidance on reliance agreements. Agreements with Indemnification, Insurance, or Governing Law terms may require review by UCSF or UCOP Legal Counsel, which can lead to significant delays.  The Trial Innovation Network Letter of Indemnification has already undergone Legal Counsel review and does not require additional review. Cooperating sites are encouraged to use the Trial Innovation Network wording to avoid delays. 

The UCSF Privacy Board makes HIPAA determinations for studies reviewed by external IRBs. 

Instructions for using IREx when relying on another IRB

IREx instructions can be found here. Please note that these instructions only apply when you are using another IRB.

Last updated: April 4, 2024