noncompliance

An action or omission on the part of the researcher or IRB that is inconsistent with any of the following:

• The ethical principles of human subjects research as described in the Belmont Report;
• Federal, state, and/or local regulations applicable to human subjects research under the jurisdiction of the 91̽»¨IRB;
• 91̽»¨policies and procedures governing human subjects research;
• The research activities as approved by the 91̽»¨IRB, including any IRB requirements or determinations.