Benioff Children's Hospital Oakland

Transition of Review for Research Conducted at Benioff Children's Hospital Oakland to UCSF's IRB

As a result of the affiliation between Children’s Hospital Oakland and UCSF, the IRB operations have been integrated into the UCSF HRPP Office. Benioff Children’s Hospital Oakland (BCH Oakland) has now been added to the federal-wide assurance (FWA) for UCSF.

Studies that are conducted at both UCSF and Oakland no longer require duplicate site IRB approval.

All new study applications to conduct human subjects research at the Oakland campus must be submitted via iRIS, the UCSF online IRB submission and review system.

Transfer of Existing Studies into iRIS

As of June 30, 2021 the transition process has been completed. All studies previously managed through the BCH Oakland IRB have either been closed or transferred to the UCSF HRPP.

FWA

The Oakland IRB Committee is one of five panels under the UCSF FWA. FWA00000068

A letter to Principal Investigators regarding the composition and function of the six IRB Committees that may be shared with sponsors. 

Oakland IRB Committee

The UCSF Oakland IRB Committee includes representation from the both the East & West Bay campuses, although many of its members previously served on the Children’s Hospital Oakland IRB.
 
Visit our IRB Rosters and Meeting Dates page to view the Oakland IRB Committee meeting schedule and submission deadlines.

IRB Requirement for Conducting Research at BCH Oakland 

Human participant research studies involving BCH Oakland as a site must meet the following requirements:

  • The PI or one of the co-investigators must possess clinical privileges at BCH Oakland.
  • If the study will recruit and/or conduct research activities on a clinical unit, the IRB submission must include a letter of support from the relevant clinical service head (e.g., Chief of the Service, Department Head, Unit Manager) stating that they are aware of the study and support the study’s activities occurring on their unit. 

Submission Instructions

Consent Form Template Requirements

UCSF Health uses a different consent form template than Children’s Hospital Oakland. All ongoing studies should transition to the UCSF consent at next submission or by December 31, 2021 at the latest.

Please review modifcation guidance and Informed Consent templates.

All new studies must submit consent forms that have been formatted to the UCSF templates. 

Consent Addendum for Ongoing Studies

All ongoing research study participants will not need to sign a new consent form but should be provided with an Integration Consent Addendum following transfer and approval in iRIS. The addendum is also available in Spanish. A Certificate of Translation is available for your reference.

Consent Addendum Instructions for iRIS Transfer

The Integration Consent Addendum with the study-specific details should have been uploaded to iRIS along with your previously approved consent forms and study documents. If this has not been done, please perform this task immediately. Forward the IRB stamped version to all study subjects, past and present, to ensure they’ve been informed of the significant new IRB information (email, mail or in-person distribution is acceptable). Sharing of these updates are required for HIPAA and regulatory compliance.

If distributed via email: Email each participant separately. Ensure to save each email correspondence securely and confidentially, including bounce-backs, for your study records.

Note: If your study has a complete HIPAA and consent waiver, this form is not required.

HIPAA Requirements

Use the UCSF Health HIPAA Authorization Form: (PDF) to enroll new research participants. Ongoing participants will not need to sign a new Authorization form (see Consent Addendum Instructions above).

BCH Oakland-Specific Questions on the Initial Review Submission Packet Form

If Benioff Children’s Hospital Oakland (BCH Oakland) is checked as an Institution in the ‘Sites’ section in the Study Application Form, the Initial Review Submission Packet Form will display questions relating to site status (e.g. Active, Data Analysis Only, etc.) and prior IRB review. These questions will be used to route new and continuing Benioff Children’s Hospital Oakland studies to the Pediatrics Committee in iRIS.

For new studies, if BCH Oakland is NOT the primary site, check ‘No’ to 1.9.

1.9 * BCH Oakland STUDY: You checked UCSF Benioff Children's Hospital Oakland (BCH Oakland) as a site. Is BCH Oakland the PRIMARY study site: (REQUIRED)

  • Yes
  • No

* Has this study already been approved by the BCH Oakland IRB: (REQUIRED)

  • Yes
  • No

* What is the original BCH Oakland IRB number: (REQUIRED)

Single (Central) IRB and Reliance Agreements

Research Committee

The Oakland Research Committee (RC) will continue to review new study applications that have not been adequately peer reviewed. Generally, this refers to industry and investigator-initiated studies. The Research Committee Chair makes the final determination as to whether a protocol requires review by this committee.

Updates to FDA 1572 Form

FDA’s Frequently Asked Questions – Statement of Investigator (Form FDA 1572), states the following:

There are two instances when it is necessary for an investigator to complete and sign a new 1572: when an investigator is participating in a new protocol that has been added to the IND and when a new investigator is added to the study (21 CFR 312.53(c)).

If there are other changes to information contained on a signed and dated 1572 (e.g., an IRB address change, the addition of new co-investigators, the addition of a clinical research lab), the investigator should document the changes in the clinical study records and inform the sponsor of these changes, so that the sponsor can appropriately update the IND. The 1572 itself does not need to be revised and a new 1572 need not be completed and signed by the investigator. The sponsor can accumulate certain changes and submit this information to the FDA in, for example, an information amendment or a protocol amendment.

We advise that your 1572 be updated to reflect the new FWA number. The IRB does not need a copy of the updated form 1572. However, sponsors and/or the FDA may need the document.

The following may be used to complete section 5 of an updated FDA form 1572:

Name of IRB: UCSF IRB

Address: University of California, San Francisco

490 Illinois Street, Floor 6

San Francisco, CA 94143

Learn more regarding these updates from the HRPP Letter to Sponsors.

iRIS Training

Table of Transition East/West IRB Integration

Topic

Post Transition 

Emergency Use

See Emergency Use Guidance for Emergency Use requests.

Initial Applications

Submit initial applications in iRIS.

Continuing Reviews

Ongoing Continuing Reviews will be submitted in iRIS.

Modifications

All modifications must be submitted via iRIS.

Modification Guidance

Consent Documents (Actively recruiting Research)

UCSF Benioff Children’s Hospitals Informed Consent template should be used.

HIPAA Authorization Form

New studies must use the UCSF HIPAA Authorization form.

Data Use Agreements/Materials Transfer

Contact Office of Sponsored Research

Subject Complaints/Allegations of Non-Compliance

Email QIU Analyst of the Day: [email protected]

Guidance is available here.

Protocol Violations

Submit using protocol violation reporting form.

Adverse Events

Submit using Adverse Event reporting form.

Reportable Information

  • DSMB reports
  • Audit/Monitoring reports w/significant findings
  • Hold on Study Activity due to unexpected risks or required by an oversight entity.
  • Other safety information or publication
  • Pharmacy Packet Inserts

Submit using reporting form.

Reportable Information

  • Updated Investigators Brochure (IB updates important to subject safety = prioritize the submission. Otherwise, submit in a timely manner.)
 Submit reporting or modification Form

Support
 

Additional Resources

 

Frequently Asked Questions:

Q: How will ‘duplicate’ protocols taking place at the Oakland and SF campuses be entered, now that BCH Oakland studies will be in iRIS as well?

A: In some cases there will be two active protocols (IRB #s). Generally, we would like one iRIS application if the protocol is active at both sites. Exceptions can be made. Contact the front desk for exception inquiries.

Q: Is Review by the UCSF Cancer Center Protocol Review and Monitoring Committee (PRMC) Required?

A: BCH Oakland is not considered a part of the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC). If the study is only being opened at BCH Oakland, then PRMC review will not be required until further notice. However, if the study will be opened at BCH Oakland and UCSF Benioff Children's Hospital San Francisco, then PRMC review is required. Email [email protected] with any questions.

Q: Is Radiation Safety Review Required?

A: Yes, for new studies only. Radiation review will not be required for studies that already have IRB approval.

Q: Is Biosafety Review Required?

A: Yes, for new studies only.

 

 

Last updated: November 12, 2024