Health Sciences IRBs Protocol Exceptions and Deviations Guidance
Version Date: September 20, 2016
Protocol Exceptions and Deviations Guidance
The Health Sciences IRBs recognize that research teams cannot always adhere to protocol requirements. Deviations can occur due to a variety of factors including:
- unanticipated problems
- noncompliance on the part of the research team
- noncompliance on the part of the participant (e.g., fails to take a study drug, takes the study drug at a higher dose than instructed, or misses a study visit due to inclement weather or a personal issue)
Described below are cases when eligibility criteria and protocol deviations generally do not need to be reported to the IRB because they are not expected to adversely affect subject safety or data integrity. Please note: The following exceptions to the noncompliance policy DO NOT apply to any study involving an Investigational Device Exemption (IDE). Any planned deviations for studies involving IDEs must be submitted as a full change of protocol and be approved by the IRB before implementation.
Deviations related to eligibility criteria
A one-time deviation from a single eligibility criterion for a single study participant under UW purview may occur without prior IRB approval in a potentially therapeutic study that meets the ALL of the following requirements:
- The study is fully industry-sponsored or is a federally sponsored, collaborative study with a coordinating center
- The deviation will not affect the safety of the individual participant;
- The deviation does not involve the enrollment of a vulnerable subject population (e.g., children, pregnant women, prisoners, veterans) not previously approved by the IRB for enrollment in the study; and
- The sponsor is informed and approves the deviation before it occurs
If all of the above criteria are met, this one time deviation from the specific protocol eligibility requirement does not need to be reported to the IRB, but should be recorded in the study file. The study participant who does not meet the eligibility criteria should be informed of this deviation. Examples of deviations in eligibility criteria that may fall under this guidance include blood pressure or a laboratory value slightly higher or lower than dictated by the protocol when all other criteria are met.
If additional deviations in the same eligibility criterion occur, they should be reported to the IRB as potential noncompliance within 14 business days and the IRB will evaluate whether any additional action is needed, such as a change of protocol. The IRB strongly encourages investigators to work with sponsors to clarify eligibility criteria if multiple deviations from eligibility criteria are anticipated.
Deviations from IRB-approved eligibility criteria for studies other than those specified above (e.g., non-sponsored or non-therapeutic studies) must be approved by the IRB prior to their implementation unless the deviation is required to eliminate an apparent immediate hazard to the research participant. The study team must submit an unanticipated problem report and generally a change of protocol to the IRB to notify the committee of deviations implemented to eliminate an apparent immediate hazard to the research participant and address the cause of the problem that led to the deviation.
Other protocol deviations that do not require reporting to the IRB:
Protocol deviations under the control of the study team (as opposed to noncompliance due to the subject’s behavior) do not require reporting to the IRB unless they meet ANY of the following criteria:
- The deviation affected or had the potential to affect the subject’s rights, safety or welfare;
- The deviation resulted in a change to the participant’s clinical or emotional condition or status;
- The deviation affected the integrity, accuracy and/or reliability of the research data; and
- The deviation resulted from willful or knowing misconduct on the part of the study team.
If the protocol deviation does NOT meet any of the criteria above, the event does not require reporting to the IRB, but should still be documented in the study records.
If the study team has multiple (i.e., two or more) occurrences of the same kind of deviation that is not otherwise reportable to the IRB (e.g., missed questionnaire, sample collection), please consult with the HS-IRBs Office whether reporting is required.
Subject Deviations from the Study Protocol
Protocol deviations that are the result of subjects’ behavior do not require reporting to the IRB unless they meet ANY of the following criteria:
- The incident(s) suggest that a subject’s safety is being affected, or
- The incident(s) adversely impinge upon the integrity, accuracy and/or reliability of the research data from the subject, or
- A pattern of protocol deviations occurs that indicate a need for changes in the protocol or informed consent document(s).
When an individual subject demonstrates a pattern of repeated noncompliance with the study protocol, the research team should consider withdrawing the participant from the study and/or revising the protocol. If the subject deviation requires reporting to the IRB an unanticipated problem report should be submitted.