Protocol Deviation/Violation

Researchers are expected to adhere to the protocol and consent documents that were approved by the Institutional Review Board.

Planned protocol modifications: Modifications to the protocol must be submitted to the IRB on the Protocol Modification Form. They must be approved by the IRB before their implementation.

Unplanned protocol deviations/violations and unanticipated problems:
For unanticipated problems, see Adverse Events.

Unplanned protocol deviations or violations: These include deviations from the approved protocol that have already occurred and breaches of scientific integrity and ethics on the part of the researchers.

Link to Protocol Deviation/Violation Report form in [Word].

Protocol Violations:

Protocol violations are extremely serious situations that require immediate investigation by the IRB Chair and reporting to the Institutional Official (Vice President of Research and Sponsored Programs), and possibly the appropriate external agencies, including the Office for Human Research Protections (OHRP), when warranted. Examples of protocol violations include: events that result from willful or knowing misconduct on the part of the investigator; events that impact ethical principles; events that undermine the scientific integrity of the data; procedures not approved by the IRB that caused or had the potential to cause substantive harm to research participants; failure to use an approved informed consent form; failure to report a known, significant/serious adverse effect.

Protocol violation reports may come from a variety of sources, including research participants, research staff, community members, etc. All reports will be held in confidence. CSUEB’s Human Resources policy and the California Whistleblower Protection Act protect an individual’s identity and shield the individual from reprisal, retaliation, threats or coercion for reporting such information. The IRB adheres to these policies.

Incidents of alleged or known protocol violations will be investigated by the IRB Chair, who may initiate a review to determine the validity of the complaint. Both the IRB and the Institutional Official will be notified of all complaints and the outcome of any investigation. If, after investigation by the Chair, the violation is verified, the situation will be forwarded to the Institutional Official for further action. Reports, including the actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator and/or the research staff, suspend the protocol, suspend the investigator, expulsion of a student etc.) will be sent as required to OHRP, sponsors, and/or the FDA.

Protocol Deviations:

minor deviation does not harm or potentially harm a subject, e.g., changing minor wording on a survey, altering time required for interview, administrative changes to participant documents (phone number). These should be reported to the IRB when discovered during the course of the research and/or no later than 5 working days after their occurrence. These deviations may or may not require a modification (see Modifications).

Major deviations may include such things as neglecting to obtain signatures on a part of a consent form; “interviewing” a survey participant; not following stated inclusion/exclusion criteria; making substantive changes (not administrative) to documents, including materials given to participants; lapse in approval; collecting data after protocol approval expiration. These should be reported to the IRB when discovered during the course of the research and/or no later than 5 working days after their occurrence. These deviations may or may not require a modification (see Modifications), which will need to be reviewed by the IRB. The IRB may give permission to the investigator to use data collected during non-compliance.

Continued occurrence of deviations may trigger a report to the Institutional Official for further action.

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