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:

1. Changing study personnel without notifying the IRB;
2. Shortening the duration between planned study visits;
3. Implementing minor wording changes in study questionnaires without first obtaining IRB approval; or
4. Routine lab missed at scheduled visit and re-drawn later.