Audit

Audits may occur during the course of the research or after a project is completed. They may involve external sponsor requirements, UW requirements or state or local governmental requirements. Non-financial compliance areas include, but are not limited to, research involving animals or human participants, financial conflicts of interest, chemical or biological hazardous material, export controlled activities, intellectual property, and data management. For sponsored research led by UW and subcontracted to other institutions, UW has responsibilities for assuring and monitoring subrecipient compliance in auditable areas.

 Roles

• The Principal Investigator (PI) is responsible for overall compliance with respect to the research project.
• All research team members are responsible for individual understanding and fulfilling compliance requirements.
• Departmental research administrators may identify information, tools, and other compliance resources.
• Central administrative units are responsible for managing compliance in specific areas by providing information, tools and oversight, University-wide.

Plan/Act

• Identify the auditable areas for the research project, including subrecipients, where applicable.
• Establish, practice, and document procedures in all auditable areas to minimize or mitigate negative audit findings.

Human Subjects Research Considerations

Researchers are required to promptly report to the IRB the preliminary and final results of any audit by federal regulatory agencies, such as the Food and Drug Administration, using Zipline (the IRB application software).