Any behavior, action or omission in the conduct or oversight of human research that has been determined to:

1. Affect the rights and welfare of participants and others;
2. Increase risks to participants and others, decrease potential benefits or otherwise unfavorably alter the risk/benefit ratio;
3. Compromise the integrity or validity of the research; or
4. Result from the willful or knowing misconduct on the part of investigators or study staff.

Examples include, but are not limited to the following:

1. Failing to obtain Informed consent before enrolling a participant in a research study;
2. Conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval; 
3. 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
4. Failing to report adverse events, unanticipated problems, or substantive changes to the proposed protocol to the IRB in accordance with IRB policy.