A pattern of noncompliance that, in the judgment of the IRB Chair, designee or convened Board,

1. Indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others,
2. Compromises the scientific integrity of a study such that important conclusions can no longer be reached,
3. Suggests a likelihood that noncompliance will continue without intervention, or
4. 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