735. Protocol Deviations

Updated July 14, 2021

A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not implement or follow some aspect of a research study as approved by the IRB.

All deviations reflect a failure to comply with the approved study and as such, are instances of potential noncompliance and must be reported to the IRB. Protocol deviations have the potential to place participants at risk and can also undermine the scientific integrity of the study, thus jeopardizing the justification for the research.

Examples of Protocol Deviations

The following list is provided for illustration purposes only and is not meant to be exhaustive:

• enrolling a participant who did not meet all the inclusion/exclusion criteria;
• failing to obtain or document informed consent as approved by the IRB prior to initiation of study procedures;
• performing a study procedure not approved by the IRB;
• failing to perform a required lab test;
• dispensing or dosing error for study medication/drug;
• conducting a study visit outside of the required timeframe;
• failing to report unanticipated problems involving risks to participants or others to the IRB and sponsor (if applicable);
• failing to follow safety monitoring plan;
• implementing unapproved recruitment procedures;
• allowing an unauthorized person to obtain informed consent;
• failing to provide participant with a copy of the consent form;
• exceeding approved enrollment numbers.

Reporting Timeframe

Non-Exempt Research

For non-exempt research, protocol deviations must be reported to the IRB within five business days of their occurrence or identification.

If a protocol deviation meets the criteria of unexpectedness, relatedness to research, and increased risk, it should be reported to the IRB as an Unanticipated Problem.

Exempt Research

For exempt research, investigators are advised to contact Research Integrity to discuss any protocol deviations that may have occurred in their studies.

Reporting Protocol Deviations to the IRB

For non-exempt research, investigators must report protocol deviations to the IRB by completing and electronically submitting the appropriate Reportable Event Form available in IRBNet. The information in the report should allow the IRB to evaluate the nature and potential consequences of the deviation. For example:

• Does the situation involve unapproved changes to or divergence from an approved research plan?
• Does the event suggest participants or others may be at greater risk of harm than was previously known or recognized?

Upon becoming aware of a protocol deviation, investigators must determine if immediate corrective actions are necessary to protect the safety and welfare of research participants. Investigators must also consider what types of corrective measures should be taken to prevent future occurrences. The deviation report must include a description and justification for all corrective actions taken without prior IRB approval.

IRB Review of protocol Deviation Reports

A Research Integrity staff member performs a thorough review and evaluation of the deviation report. Requests for clarifications, corrections or revisions to the report from the Principal Investigator (PI) are made if further information is needed to assess the deviation.

Each protocol deviation reported to the IRB is evaluated to determine if it had a significant effect on the participants’ rights, safety, or welfare, or corrupted the integrity or the resultant scientific data. The IRB Chair may be consulted at any time during this process for assistance.

After the review and evaluation of the incident, the following actions may be taken:

• The deviation is completed with the determination indicated as either acknowledgment of an administrative error or minor noncompliance. IRBNet correspondence is sent to the PI.
• The deviation is returned to the PI to be submitted as an Unanticipated Problem via the appropriate Reportable Event Form in the IRBNet library.
• If the review determines that the deviation possibly meets the definition of serious or continuing noncompliance, the deviation is handled according to the UNR policy for noncompliance.