Deviations (i.e., unapproved changes, even if unintentional) from IRB-approved protocols and noncompliance with established regulations, policies and procedures may occur during the course of a research study. This policy is established to ensure that all instances of potential or known noncompliance (including deviations) are addressed carefully, consistently and with consideration for regulations, laws and University policy.
It should be noted that changes to protocols or otherwise failing to comply with University IRB policies may also necessitate review and investigation by other appropriate University officials, which may result in disciplinary actions or sanctions.
Sources of Reports of Noncompliance
Information regarding noncompliance may come to the attention of the IRB from a variety of sources, including but not limited to:
· New applications
· Research summaries and progress reports from investigators
· Internal audits
· FDA audit reports
· Monitoring activities by sponsors
· Adverse event, problem, or safety reports
· Members of the research team
· Participants or their family members
· Community members
Each complaint or concern is taken seriously and reviewed by the University's Research Integrity Office (RIO) Quality Improvement Officer (QI Officer), RIO Director, or IRB Chair or designee in a consistent, prompt, and professional manner.