University of California, Irvine Human Research Protections Standard Operating Policies and Procedures Policy Number: 55 Title: Protocol Deviation and Violation Reporting Date of Last Revision: 01/21/2007 Policy: It is the policy of the UC Irvine (UCI) Institutional Review Board (IRB) to be notified of any protocol violations that result in an increase in risk or a decrease in benefit to participants, affect the subject's rights, safety, and welfare or affect the integrity of the data. I. Deviations A. It is the responsibility of the Investigator not to deviate from the protocol approved by the IRB, except to avoid an immediate hazard to the participant. B. A change in the protocol to eliminate an apparent immediate hazard to a research subject constitutes a reportable event to the IRB via the “Adverse Event/Unanticipated Problems Involving Risk to Participants or Others” in accordance with IRB Policy 19. C. Prior to implementation of any change to the protocol an Investigator must submit a modification request to the IRB and receive written approval (See IRB Policy 17) D. Deviations (accidental or intentional changes) are not reportable to the IRB when they: 1. Do not increase risk or decrease benefit. 2. Do not affect the participant’s rights, safety, welfare, or 3. Do not affect the integrity of the data. E. Investigators may choose to notify the IRB of deviations by submitting the “Tracking Log for Non-Reportable Events.” If so, the HRP staff will perform an administrative review of the form. F. Repetitive deviations will be brought to the attention of the IRB Chair or his/her designee. The IRB Chair or his/her designee, or the IRB Committee could rule that multiple deviations constitute a violation. II. Violations A. Violations as defined by the UCI IRB are reportable events to the IRB because such violations increase risk or decrease benefit, affect the participant’s rights, safety, welfare, and/or the integrity of the resultant data, they are reported as an adverse event and/or an unanticipated problem to the participant or others (See IRB Policy 19) B. Protocol violations must be reported to the IRB via the “Adverse Event/Unanticipated Problems Involving Risk to Participants or Others” in accordance with IRB Policy 19. C. Protocol violations should also be reported to the Data and Safety Monitoring Board. References: 21 CFR 56.108 1 Procedure Number: 55.A Title: Procedure for Protocol Deviation and Violation Reporting Procedure: This procedure provides guidance in the reporting requirements and responsibilities of the Investigator and the UC Irvine (UCI) Institutional Review Board (IRB) regarding protocol deviations and/or violations. I. Lead Researcher (LR) Responsibilities A. The LR submits any changes in the protocol prior to implementation to the IRB for review and approval as required by the Federal regulations using the “Modification Request.” B. The LR monitors research activities for adherence to the protocol and to determine if protocol deviations or violations have occurred. C. Violations must be reported to the IRB via the “Adverse Event/Unanticipated Problems Involving Risk to Participants or Others” in accordance with IRB Policy 19. D. An LR may choose to report deviations to the IRB that do not affect the risk/benefit ratio or the participant’s or other’s rights, safety or welfare and/or on the integrity of the data, the LR uses the “Tracking Log for Non-Reportable Events.” E. All protocol violations and other reportable events per IRB Policy 19 should be reported to the Data and Safety Monitoring Board. II. IRB Committee Responsibilities The IRB will review violations reported under this policy according to IRB Policy 19. III. IRB Analyst or Higher Responsibilities A. The Analyst will verify if deviations submitted by the LR qualify as a deviation per IRB definition and did not affect the risk/benefit ratio, the participant’s or other’s rights, safety or welfare and/or on the integrity of the resultant data. 1. The Analyst will stamp the original document as received as an administrative acknowledgement of receipt. 2. A copy of the document will be placed in the IRB file and the original returned to the LR. B. If the Analyst determines the deviation constitutes a violation that may have affected the risk/benefit ratio, the participant’s or other’s rights, safety or welfare, and/or on the integrity of the data, the Analyst will request the event be reported to the IRB utilizing the “Adverse Event/Unanticipated Problem Involving Risks to Participants or Others” reporting process. C. At any time, the Analyst may consult with the IRB Chairperson or his/her designee for guidance. 2