Health Sciences IRBs Protocol Exceptions and Deviations Guidance
Version Date: December 6, 2017
Protocol Exceptions and Deviations GuidanceThe 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)
Deviations Related to Eligibility CriteriaA 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.
Other Protocol Deviations That Do Not Require Reporting to the IRBProtocol 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.
Subject Deviations from the Study ProtocolProtocol 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).