Please note that the Human Research Protection Program (IRB, QIU, and GESCR) will be closed on:
- December 24th, 25th, and 31st, 2025
- January 1st, 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.
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.
- New cybersecurity risk assessment requests: Submit a request at tiny.ucsf.edu/SRA.
- Follow up on an existing risk assessment request: Email [email protected]. Please include your ServiceNow request (RITM) number when available.
- General Cyber Risk questions: Email [email protected].
- General Security Awareness questions: [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