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Benioff Children's Hospital Oakland

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

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 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 five IRB Committees that may be shared with sponsors may be accessed here.

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.

The Oakland IRB Committee meeting schedule/submission deadlines can be found here. 

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.
 
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.

Click here for modification instructions 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 (right click to download document) 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 new UCSF Health BCH Oakland HIPAA Authorization Form: PDF Template 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

Please contact the Reliance Coordinator for inquiries regarding reliances.

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

A letter regarding these updates from the HRPP Letter to Sponsors can be found here.

iRIS Training

The UCSF IRB’s iRIS Help Site offers interactive tutorials and downloadable PDF guides on the following topics:

You will need to sign into MyAccess to access the iRIS Help site:

Resources

Table of Transition East/West IRB Integration

Topic

Post Transition (into iRIS)[KE1]

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

See reporting requirements

Submit using protocol violation reporting form.

Adverse Events

See reporting requirements

Submit using Adverse Event reporting form.

Reportable Information

  • Updated Investigators Brochure
  • 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

See reporting requirements

Submit using reporting 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.

 
 
 
 
 
 
 
 
 
 
 
 
 
 

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

UCSF Health uses a different consent form template than Children’s Hospital Oakland. Active studies may continue to use the BCH Oakland consent template until December 31st, 2021. After that date, all ongoing studies must transition to the UCSF consent form format.
 
The following statement about Treatment and Compensation for Injury must be added to the consent by December 31, 2021. UCSF handles research-related injury compensation differently than BCH Oakland which is why this is a requirement. A modification to update the consent form should be submitted to update the Informed Consent document after the study has been transferred into iRIS.
 
Click here for modification instructions 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 (right click to download document) 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:

Complete the Integration Consent Addendum with the study-specific details and upload to IRIS along with your previously-approved consent forms and study documents. The IRB will stamp the Addendum when the transferred study is processed. Forward the 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: Individually email each participant separately. Ensure to securely and confidentially save each email correspondence 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 new UCSF Health BCH Oakland HIPAA Authorization Form: PDF Template 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 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 * 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

Single IRB and Reliance processes are currently under development.
 
A letter for sponsors regarding the integration of the IRBs is in development.
 
A guide for COG studies is in development.
 
Please contact the Reliance Coordinator for inquiries regarding reliances.
 

Amendments

If an investigator needs to make an amendment to a study (modification), the application can be processed via CYBER.  Investigators are not required to transfer a protocol into iRIS before processing an amendment.Once a protocol is transferred to iRIS, then all subsequent amendments (modifications) are processed via iRIS.

 

Research Committee

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

 

CITI Training

The CITI license for Children’s Hospital Oakland will be expiring in September 2020. The IT group is investigating the feasibility of exporting BCH Oakland CITI training records into iRIS, but this may not be possible.
 
All researchers and study personnel should add ‘University of California, San Francisco’ as an Institution and download any active training course certificates for their records. Click here for guidance.
 
Researchers and study staff with CITI training completed prior to that date will be required to complete the UCSF Human Subjects Protection Training Course.
 
For updated CITI information please review this memo dated 8/25/20.

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 IND in, for example, an information amendment or a protocol amendment.
 
After your study has been transferred into the iRIS system. We advise that your 1572 is 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
 
A letter regarding these updates from the HRPP Letter to Sponsors can be found here.
 

iRIS Training

Resources

On-Boarding Requirements for Volunteer Research Staff
At this time volunteers must be processed at both UCSF and BCH Oakland.
UCSF Volunteer Information: click here
BCH Volunteer Contact: Darlene Wilson [email protected]
 

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.

Modification Guidance

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

See reporting requirements

Submit using protocol violation reporting form.

Adverse Events

Submit via Cyber IRB

See reporting requirements

Submit using Adverse Event reporting form.

Reportable Information

  • Updated Investigators Brochure
  • 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 via Cyber IRB

Note: DSMB reports may continue to be submitted at Continuing Review until transitioned.

See reporting requirements

Submit using reporting form.

Support

Contact IRB phone number in 415-476-1814

Email: [email protected]

 

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 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

  1. Take iRIS training tutorials
  2. Attempt submitting in iRIS using Quick Guides as reference
  3. Register for iRIS training via Zoom (Schedule to be announced)
  4. In-person Group Training will be announced once the COVID-19 Public Health Emergency has been cleared.