If UCSF is not the IRB of Record, Protocol Violation/ Incidents must not be submitted to UCSF. Submit the Protocol Violation/Incident report to the IRB of Record. Notify the UCSF Privacy Office if the incident is privacy related.

The IRB of Record will notify the UCSF IRB when a determination of Serious, Continuing, and/or Unanticipated Problem is made.

Contact the IRB at (415) 476-1814 or [email protected] and speak with the QIU Analyst of the day with questions.

Note: The SF VA Medical Center (SFVAHCS) has a shorter timeline (5 days) and different definitions than UCSF for reporting certain categories of post-approval events. See the SFVAHCS guidance page and VHA Handbook 1058.01 for specific examples.

Go to My Studies under IRB Study Assistant. Open the active study for which you want to submit the report.  

Click Add New Form to start a blank form. You can copy a previous form by selecting the form you want to copy and clicking Copy Form. The copied form will open automatically.

Anyone listed on the study can sign off and submit it.  

• Open the first study again and click on the Protocol Violation/Incident Report Form link
• Click the "Apply to Multiple" icon next to the correct form
• Check the boxes next to the studies for which you wish to submit this form. Click the "Save a Copy of the Selected Form" button.
• You will then need to open each of the studies you selected, open the copied form and submit the form

HRPP criteria for defining major violations include any of the following:

1. The violation has harmed, or posed a significant or substantive risk of harm, to the research participant
2. The violation resulted in a change to the participant’s clinical or emotional condition or status
3. The violation has damaged the scientific completeness or soundness of the data collected for the study
4. The violation is evidence of willful or knowing misconduct on the part of the investigator(s)
5. The violation involves serious or continuing noncompliance with federal, state or local regulations
6. A member of the UCSF IRB, Privacy Office, IDS, or other UCSF research support unit told you the violation requires reporting

Examples include, but are not limited to:

1. Enrolling participants who did not meet the eligibility requirements.
2. Failing to obtain informed consent prior to any study-specific tests/procedures.
3. Failing to follow protocol procedures that specifically relate to the primary safety or efficacy endpoints of the study.

HRPP criteria for minor violations include all of the following:

1. The violation did not harm or pose a significant risk of substantive harm to the research participant
2. The violation did not result in a change to the participant’s clinical or emotional condition or status
3. The violation did not damage the completeness, accuracy and reliability of the data collected for the study
4. The violation did not result from willful or knowing misconduct on the part of the investigator(s)

Examples of minor protocol violations include, but are not limited to:

1. Routine safety lab work for a participant without new clinical concerns and a history of previously normal lab values is inadvertently omitted at a study visit or performed outside the protocol-defined window. The lab will be performed at the next opportunity and is expected to remain within normal limits.
2. Investigators miss giving a study required self-administered quality of life questionnaire to a participant.

Some examples of study-related incidents include, but are not limited to:

1. Receipt of a significant complaint or concern from a potential or enrolled study participant, such as a complaint/concern that may adversely impact the participant’s safety, rights or welfare. Reminder: Investigators are obligated to make a good faith effort to resolve any study-related concern or complaint they receive.
2. Inappropriate behavior of study participants and/or research personnel.
3. Problems during study recruitment or the informed consent process.
4. Problems with the study design in which a majority of participants have difficulty adhering to the study schedule of procedures.
5. Potential breach of study participant’s privacy or confidentiality (see below).
6. Withdrawal or significant reduction in, resources necessary to adequately and safely conduct study activities.
7. Changes to the protocol to eliminate or reduce an apparent immediate hazard to the safety of research participants or others (see below).

Potential breaches of privacy or confidentiality of study participants’ Protected Health Information (PHI) are “major (reportable) incidents” that must be submitted to the IRB.

The review of these incidents it time sensitive: Submit a Protocol Violation/Incident Report Form in iRIS within 48 hours of the PI’s awareness of the potential breach.

The IRB collaborates with the UCSF Privacy Office to investigate these incidents to meet state and federal regulatory obligations. Investigations must be completed within a short time frame in order to avoid penalties and/or late reporting fines for the institution.

Some examples of major incidents involving privacy or confidentiality:

• Failure to properly execute a HIPAA Research Authorization Form due to
  • Missing a participant’s signature or date
  • Missing initials next to an information type in Section C that has been or will be accessed by the research team
  • Accessing items in Section B that are not approved for access or release by the participant
• Failing to obtain a properly executed consent form due to missing a participant’s signature or date
• Mailing, emailing or otherwise communicating identifiable study participant information to an unauthorized individual (e.g., incorrect participant, incorrect mailing address, incorrect e-mail address, etc.)
• Failing to redact identifiable study participant information sent to a study sponsor (only if the IRB Application and consent form require de-identification)
• Insecure storage or transfer of research data.
• Lost research data

Note: The UCSF Privacy office should be contacted for studies relying on an external IRB if the incident is privacy related. A report to the UCSF IRB is not required if UCSF is not the IRB of record.

Receipt, and subsequent resolution by the study team, of a participant complaint regarding late study payment.

Acknowledge the report — Acknowledgement letter is issued. To view acknowledged documents, select “All” or filter by “Acknowledged,” after no letters are issued unless they are reviewed at a convened meeting. Please review this quick guide (MyAccess login required) for more guidance.

Request additional information about the violation or incident or other related information.

Refer the violation or incident report (or other related information) to the IRB if it appears to meet the HRPP’s institutional definition of an unanticipated problem (UP) involving risk to participants or others and/or an instance of serious or continuing noncompliance. The IRB may query you for additional information and will inform you if one of these determinations is made.

Report event to the Office for Human Research Protections (OHRP), a division of the Department of Health and Human Services (DHHS), appropriate University officials and study sponsors and FDA (for studies under FDA regulatory oversight) if a full IRB panel review determines that the event report is an UP or (after investigation) determines an instance of serious or continuing noncompliance.

Flag the report and monitor the study for additional violation or incident reports.

Require a modification to the study protocol and/or informed consent document.

Temporarily suspend enrollment and/or study treatment.

Permanently suspend or terminate approval of research that has been associated with unexpected serious harm to participants and/or serious or continuing noncompliance.

An unexpected, research-related event where the risk exceeds the nature, severity, or frequency described in the protocol, study consent form, Investigator’s Brochure or other study information previously reviewed and approved by the IRB.

Noncompliance is defined as: failure to follow state or federal regulation, or the University policies, or the requirements of the VHA Handbook 1200.5, or determinations of the IRB for the protections of the rights and welfare of study participants.

Serious Noncompliance is defined as: failure to follow state or federal regulations or University policies or determinations of the IRB for the protection of the rights and welfare of study participants and that, in the judgment of the IRB, results in, or indicates a potential for a) a significant risk to enrolled or potential participants or others, or b) compromises the effectiveness of the UCSF HRPP or the University.

Continuing Noncompliance is defined as: a pattern of noncompliance that continues to occur after a report of noncompliance and a corrective action plan have been reviewed and approved by the IRB.