The faculty, medical staff, employee, and students of Rush University Medical Center are committed to following all applicable laws and regulations governing research activity:

• To protect human subjects participating in research from risk or harm insofar as humanly possible
• To exercise scientific integrity
• To be good stewards of research grants and contracts
• To minimize conflicts of interests that might unduly influence professional judgment

The Office of Research Compliance serves as an institutional resource by providing information, training and guidance on research-related regulations, policies and guidelines. A partial listing of federal and state agencies that govern research at Rush, in one form or another, includes:

• Office of Human Research Protections, DHHS
• Office of Research Integrity, DHHS
• Office of Laboratory Animal Welfare, DHHS
• Food and Drug Administration
• National Institutes of Health
• U.S. Public Health Service
• U.S. Department of Agriculture
• Centers for Disease Control and Prevention
• Department of Defense
• Department of Education
• Department of Transportation
• Department of Veterans Affairs
• National Science Foundation
• Illinois Nuclear Regulatory Commission
• Medicare coverage decision rules

The Office of Research Compliance conducts two kinds of audits on a not-for-cause basis. Each year, the research compliance staff conducts random audits of approximately 10 percent of all Rush investigators. This kind of audit, while internal to Rush, mimics the FDA investigator audit in form. Investigator research files are checked for internal consistency, for adherence to the protocol and Rush policies and for consistency with the central Institutional Review Board (IRB) files. Discrepancies or problems are brought to the attention of the investigator (for discussion and remedy) and to the IRB.

Each year, research compliance staff also audit a subset of research administration systems within the Medical Center — for example, by sampling IRB minutes or files, by sampling the record-keeping of designated repository managers, by sampling the comprehensiveness of Unexpected and Serious Adverse Event reporting, by sampling the Institutional Biosafety Committee minutes and so forth. Discrepancies or problems are brought to the attention of the associate dean for research and the director of corporate compliance.

Finally, the Office of Research Compliance works closely with the chief compliance officer of the Medical Center and the Corporate Compliance Committee to examine, audit and develop corrective action plans for all institutional compliance problems of a research nature.

For more information, contact: