

Transition of IRB Review for Research Conducted at Benioff Children's Hospital Oakland to UCSF's IRB
IRB Requirement for Conducting Research at BCH Oakland
Submission Instructions
Table of Transition East/West IRB Integration
Training
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 are actively integrating. Benioff Children’s Hospital Oakland (BCH Oakland) has now been added to the federal-wide assurance (FWA) for UCSF. During the integration, both institutional FWAs remain in effect and Children’s Hospital Oakland IRB approval letters are valid through the date of expiration.
Studies that are conducted at both UCSF and Oakland no longer require duplicate site IRB approval.
New Studies After April 17, 2020, the current Oakland IRB will stop accepting new study applications in the CYBER IRB system.
As of May 1, 2020, new study applications to conduct human subjects research at the Oakland campus will be submitted via iRIS, the UCSF online IRB submission and review system.
New (initial) study applications will be routed by the appropriate IRB through iRIS. The Researcher will indicate in the study application if study activities, including chart reviews, will take place at more than one study site.
Studies that are primarily conducted at Oakland will be routed to the same panel that currently reviews active BCH Oakland studies.
The IRB has set up a series of Zoom Meetings to provide updates to Oakland researchers. Login details for these Zoom meetings have been emailed to research staff.
Transfer of Existing Studies into iRIS
Investigator Letter to Sponsors
IRB Requirement for Conducting Research at BCH Oakland
Research studies involving BCH Oakland as a site must meet one of the following requirements:
- The PI or one of the co-investigators must be from BCH Oakland. OR
- The IRB submission must include a letter of support from a relevant clinical service head (e.g., Chief of the Service, Department Head) stating they are aware of the study and are in support of study activities taking place on their unit/with their patients/with their patients' data (whichever applicable).
Submission Instructions
If you are submitting a new BCH Oakland study or transferring an existing BCH Oakland study to the UCSF IRB, please review the “BCH Oakland IRB - UCSF IRB Study Transfer Matrix” for details about when to submit your study, what iRIS forms to use, and which documents to upload. View the matrix here:
BCH Oakland IRB - UCSF IRB Study Transfer Matrix
Consent Form Template Requirements
Consent Addendum for Ongoing Studies
Consent Addendum Instructions for iRIS Transfer:
Note: If your study has a complete HIPAA and consent waiver, this form is not required.
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 transferring Benioff Children’s Hospital Oakland studies to the Pediatrics Committee in iRIS.
For transferring studies, check ‘Yes’ to 1.9 and to the follow-up question asking if the study has already been approved by the BCH Oakland IRB and provide the IRB approval number.
For new studies, if BCH Oakland is NOT the primary site, check ‘No’ to 1.9.
1.9 * BCHO 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
CITI Training
iRIS Training
- iRIS 101: Homepage Orientation & Finding your IRB Forms & Documents (interactive)
- Submit a New IRB Study (interactive)
- Make Changes to Approved IRB Studies (interactive)
- Respond to Linked Stipulations from the IRB (interactive)
- Fill out the Personnel Changes form (PDF)
- Fill out the Protocol Enrollment Exception Request form (PDF)
- Submit Post-approval forms (continuing reviews, adverse events, protocol violations, etc.) (PDF)
- Compare different versions of documents and forms (PDF)
- Download and print your IRB Approval Packet (PDF)

On-Boarding Requirements for Volunteer Research Staff
Table of Transition East/West IRB Integration
Topic |
Pre Transitioned (into iRIS) |
Post Transition (into iRIS) |
Emergency Use |
Continue to follow current BCH Oakland Process |
See Emergency Use Guidance for Emergency Use requests May 1st and on. |
Initial Applications |
As of April 20th, Cyber IRB will no longer accept new study applications. If the study is in draft an exception may be made. |
Submit initial applications in iRIS beginning May 1st |
Continuing Reviews |
Submit via Cyber IRB. After continuing review is approved, transfer to iRIS within 4 months of Cyber IRB approval. |
Ongoing Continuing Reviews will be submitted in iRIS after transfer has been submitted and processed. |
Modifications |
Continue submitting in Cyber IRB until the study is transferred to iRIS. Note: The iRIS modification process differs from Cyber IRB |
Once the study has transitioned, all forthcoming modifications must be submitted via iRIS. |
Consent Documents (Actively recruiting Research) |
Continue using Benioff IRB approved consent documents through December 31, 2021. |
Submit transitioned Consent Document via modification form in iRIS. UCSF/BCH Informed Consent template should be used. |
HIPAA Authorization Form |
You may continue using the currently approved HIPAA Authorization form for Active Research only. |
New studies must use the following HIPAA Authorization form. |
Data Use Agreements/Materials Transfer |
BCH Oakland PIs non-affiliated with UCSF should contact Suzanne Haendel through December 2020. |
This process will be updated by December 2020 Contact Office of Sponsored Research |
Subject Complaints/Allegations of Non-Compliance |
Contact IRB phone number in the Informed Consent Click here to report a complaint or allegation of non-compliance |
Email QIU Analyst of the Day Email QIU: [email protected] Guidance is available here. |
Protocol Violations |
Submit via Cyber IRB |
Submit using protocol violation reporting form. |
Adverse Events |
Submit via Cyber IRB |
Submit using Adverse Event reporting form. |
Reportable Information
|
Submit via Cyber IRB Note: DSMB reports may continue to be submitted at Continuing Review until transitioned. |
Submit using reporting form. |
Support |
Contact IRB phone number in 415-476-1814 Email: [email protected] |
|
Additional Resources:
- Clinical Research Resource HUB
- CTSI Resources for Researchers
- CTSI Training for Clinical Research Coordinators
- QIU/ IRB In-Service trainings
- FDA Consults
Frequently Asked Questions:
Q: How will ‘duplicate’ protocols taking place at the Oakland and SF campuses be entered, now that BCHO 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 Cancer Center Review Required?
A: No, Benioff Oakland is not considered a part of the HDFCCC. Cancer Center review will not be required until further notice
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.
Preparing for the integration (Checklist):
Completed |
To Do: |
Confirm that any active studies are not expiring within the next 60 days |
|
If so, submit a Continue review under the pre-integration process to avoid a lapse |
|
Update your CITI profile by affiliating with UCSF |
|
Ensure you have no trouble logging in to iRIS, if so contact IT |
|
Review iRIS training modules to understand system navigation. |
Training
- Take iRIS training tutorials
- Attempt submitting in iRIS using Quick Guides as reference
- Register for iRIS training via Zoom (Schedule to be announced)
- In-person Group Training will be announced once the COVID-19 Public Health Emergency has been cleared.