Noncompliance, Protocol Exceptions and Deviations
IRB Member Fact Sheet--Version Date: January 2013
Federal regulations require the reporting of serious and continuing noncompliance to the IRB, institutional officials and certain federal agencies and department heads. Because the federal regulations do not define noncompliance, institutional policy must be applied. This document describes the campus policy regarding noncompliance, how the term is defined, and requirements for IRB review.
Definition of Noncompliance
The University of Wisconsin-Madison defines noncompliance as “any failure to follow (1) federal regulations, state laws or institutional policies relevant to human subjects research, or (2) the requirements and determinations of the reviewing IRB.” When noncompliance has occurred, federal regulations require IRBs to determine whether the incident is serious, continuing, or both. The UW-Madison defines serious noncompliance as non-compliance that affects the rights and welfare of participants or that may put participants at risk of harm. Continuing noncompliance is defined by the UW-Madison as multiple or repeated instances of noncompliance, particularly after written notice from the IRB that the investigator must take action to correct noncompliance. The multiple or repeated instances of noncompliance may occur on one protocol or on more than one protocol and may occur simultaneously or over a period of time.
Examples of noncompliance with federal regulations may include:
Examples of serious noncompliance include:
Minor Administrative Noncompliance
Minor administrative noncompliance is an occasional instance of noncompliance that does not affect the rights and welfare of participants or put participants at risk of harm. An example is a single instance of failure to submit a continuing review progress report to the IRB in time to prevent the lapse of approval.
Protocol Exceptions and Deviations vs. Noncompliance
The Health Sciences IRBs have recognized that investigators frequently enroll subjects, usually with permission from the study sponsor, who may deviate from a single eligibility criterion in a minor way or who may have a study visit outside the timeframe required by the study. Consequently, the Health Sciences IRBs determined that if the investigator and sponsor agree that a single instance of an "exception" or "deviation" from the protocol does not present a safety risk to the subject or potential subject it does not require reporting to the Health Sciences IRBs. These deviations and exceptions are not considered noncompliance, but rather an expected aspect of industry-sponsored clinical research. Repeated instances of the same exception or deviation, however, are considered noncompliance.
IRB Determinations about Noncompliance
If the IRB makes an initial assessment of the noncompliance report as representing potentially serious or continuing noncompliance as defined above, the committee renders a preliminary determination. The investigator is then provided with an opportunity to respond to this preliminary finding and provide additional relevant information or detail any potential mitigating circumstances that might not have previously been considered. The IRB will review this response and make a final determination regarding the noncompliance. If the IRB makes a final determination that a report constitutes serious and/or continuing noncompliance, it must also make recommendations regarding whether the Institutional Official will report the noncompliance to the OHRP, the VA, the FDA and any other federal department or agency that funds or supports the research in which the noncompliance occurred.
In addition to making a determination of serious and/or continuing noncompliance, the committee also must decide what further action is required.
Actions related to the protocol can include:
The IRB may require additional action, such as protocol or consent form revisions, even without a finding of serious or continuing noncompliance.
NOTE: Although the IRB can suspend the research study, only the Institutional Official has the authority to suspend an individual’s privileges to conduct research.
IRB Review of Corrective Action Plans:
As part of the noncompliance report to the IRB, investigators are required to outline a corrective action plan to prevent similar errors from occurring in the future. The IRB reviews this for adequacy and may require revision if not found to be sufficiently robust. Corrective action plans may include:
For further information about noncompliance, please contact the Health Sciences IRBs Office at (608) 263-2362 or consult HS IRB website at Events Requiring Reporting to the IRB