Non-compliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention. Examples of continuing non-compliance may include but are not limited to: repeated failures to provide or review progress reports resulting in lapses of IRB approval, inadequate oversight of ongoing research, or failure to respond to or resolve previous allegations or findings of noncompliance.
