Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with the research plan as approved by a designated IRB, or federal regulations or institutional policies governing such research. Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times.
Noncompliance includes deviations to the protocol made in the interest of a single participant such as to coordinate study visits. Noncompliance may result from the action of a participant, investigator or staff and may or may not impact the rights and welfare of research participants or others, or the integrity of the study. Complaints or reports of noncompliance from someone other than the research investigator are handled as allegations of noncompliance until such time that the allegation is validated or found to be invalid and dismissed.
Any behavior, action or omission in the conduct or oversight of research involving human subjects that deviates from the approved research plan, federal regulations or institutional policies but because of its nature, the research project or the subject population,
- Does not place, or have the potential to place, participants and others at greater risk than previously anticipated;
- Does not have a substantive effect on the value of the data collected; and
- Does not result from willful or knowing misconduct on the part of investigators or study staff.
Examples of minor noncompliance may include, when such noncompliance does not create additional risks to subjects:
- Changing study personnel without notifying the IRB;
- Shortening the duration between planned study visits;
- Implementing minor wording changes in study questionnaires without first obtaining IRB approval; or
- Routine lab missed at scheduled visit and re-drawn later.
Any behavior, action or omission in the conduct or oversight of human research that has been determined to:
- Affect the rights and welfare of participants and others;
- Increase risks to participants and others, decrease potential benefits or otherwise unfavorably alter the risk/benefit ratio;
- Compromise the integrity or validity of the research; or
- Result from the willful or knowing misconduct on the part of investigators or study staff.
Examples include, but are not limited to the following:
- Failing to obtain Informed consent before enrolling a participant in a research study;
- Conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval;
- Enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion of the IRB Chair, designee, or convened Committee, places the participant(s) at greater risk; or
- Failing to report adverse events, unanticipated problems, or substantive changes to the proposed protocol to the IRB in accordance with IRB policy.
A pattern of noncompliance that, in the judgment of the IRB Chair, designee or convened Board,
- Indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others,
- Compromises the scientific integrity of a study such that important conclusions can no longer be reached,
- Suggests a likelihood that noncompliance will continue without intervention, or
- Involves repeated or frequent instances of minor noncompliance.
Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance