IRB Office Holidays & Compliance Reminders

Please note that the Human Research Protection Program (IRB, QIU, and GESCR) will be closed on:

• December 24^th, 25^th, and 31^st, 2025
• January 1^st, 2026 

IRB Guidance

The IRB website and iRIS Help Site have extensive guidance on all things IRB.

• Information and resources for the appropriate conduct of Human Subjects Research: https://irb.ucsf.edu/.  
• iRIS help guides and tutorials: https://iris-help.ucsf.edu/irb-iris (requires MyAccess login).
• Ensure that all study personnel are properly trained for their roles in the study.
• Ensure that the list of personnel in the IRB application is current and those listed as Key Study Personnel maintain current CITI Human Subjects Protection Training.  
• Promptly report any protocol violations, adverse events and other reportable events/items that meet the UCSF reporting requirements to the IRB. Please review and follow the Post-Approval Reporting Requirements Summary Sheet.
• Ensure that any collaborating sites have current IRB approval prior to engaging in any research activities, including sharing UCSF data or samples. 
• Ensure that the consent method follows current UCSF guidelines for enrolling participants who speak a language other than English.

Principal Investigator Responsibilities

• Ensure that all study personnel are properly trained for their roles in the study.
• Ensure that the list of personnel in the IRB application is current and those listed as Key Study Personnel maintain current CITI Human Subjects Protection Training. 
• Promptly report any protocol violations, adverse events and other reportable events/items that meet the UCSF reporting requirements to the IRB. Please review and follow the Post-Approval Reporting Requirements Summary Sheet.
• Ensure that any collaborating sites have current IRB approval prior to engaging in any research activities, including sharing UCSF data or samples. 
• Ensure that the consent method follows current UCSF guidelines for enrolling participants who speak a language other than English.

Ongoing IRB Review

There are several institutional requirements you must adhere to while conducting your IRB-approved study. You are required to submit the following forms to the IRB office when applicable:

• Modifications: You must submit a modification request and receive IRB approval prior to implementing any changes to your study.
• Key Study Personnel (KSP) Changes: Submit a Personnel Changes form when the only change you are making is to add or remove KSP. 
• Adverse Events, Protocol Violations or Incidents, and other types of Events or Safety Information: See the Post-Approval Reporting Requirements Summary Sheet to determine if/when you need to report to the IRB.
• Continuing Review: If your study has an IRB expiration date, submit a Continuing Review with sufficient time before the expiration date. See our October bulletin for instructions on finding your expiration date.
• Study Closeout Report: You must close your study once the research has been completed or is permanently inactive.

Translation Resources

The UCSF IRB strongly encourages enrollment of a heterogeneous participant population. UCSF's Clinical & Translational Science Institute (CTSI) Participant Recruitment Program and the CTSI Research Action Group for Equity (RAGE) Program offer tools, services, and consultations to support recruitment of underrepresented populations. Click the program links for more information and to request a consultation.

Research Data Security

A  security risk assessment by UCSF IT Security AND a Data Transfer Agreement by the Office of Sponsored Research (OSR -- Industry Contracts Division) must be completed if your study involves the collection, transmission, or storage of information when that data will be shared with or be accessible to any non-UCSF entity (e.g., pharmaceutical companies, UCSF Affiliated Institutions) or individual.

• For industry or federally sponsored clinical studies, the contract with the sponsor covers data access/sharing and hence a Data Transfer Agreement is not required for such studies. If data will be shared with or hosted by a vendor (e.g., cloud software services), a security risk assessment and UCSF procurement contract must be completed. 
• Third-party or vendor-hosted applications include cloud-hosted applications and applications hosted by collaborating institutions
• UCSF or department-hosted applications include any application managed by UCSF or developed by the department 

These requirements apply for both identifiable and de-identified data for funded and unfunded research. Questions about these policies must be directed to UCSF IT and OSR, not to the IRB. 

• To determine if a Data Security Risk Assessment is required, contact the intake team at [email protected]. More information about the assessment process is available at https://it.ucsf.edu/service/it-security-risk-assessment.
   
• For information about Data Sharing Reviews: Visit https://data.ucsf.edu/data-sharing or email [email protected].
   

For information about establishing contracts for data sharing engagements: Visit https://icd.ucsf.edu/material-transfer-and-data-agreements or email [email protected]. 

Research at San Francisco Veterans Affairs Health Care System (SFVAHCS)

If the SFVAHCS is engaged in this research, you must secure approval of the VA Research & Development Committee in addition to UCSF IRB approval and follow all applicable VA and other federal requirements. The IRB website has more information.  

Wishing you a peaceful New Year,

Your colleagues at the UCSF HRPP