Northwestern University Feinberg School of Medicine

Department of Radiology

IRB Submission Process

Research Studies

All studies involving human subjects (including use of their medical records) require approval from Northwestern University Institutional Review Board (IRB) in order to ensure compliance with federal and state regulations. Research involving human subjects must comply with the regulations set forth by the U.S. Department of Health and Human Services (HHS) at 45 CFR 46 and the Food and Drug Administration at 21 CFR 50 and 56.

The IRB approval process may take up to four to eight weeks depending on the type of submission.

Expedited Chart Review Studies

If your study involves reviewing medical records (either retrospectively or prospectively), IRB submission requires the following items:

Please note: After the study materials have been submitted to the IRB, approval is generally granted in approximately four weeks. 

Full Board Review Studies

If your study involves more than reviewing medical record, such as MRI studies, etc., IRB submission requires the following items:

Please note: After the study materials have been submitted to the IRB, approval is generally granted in approximately six to eight weeks.

In order to begin the submission process, please prepare a protocol using the current IRB template and email Monica Korell. Once the protocol is received, a coordinator will contact you in order to set up a meeting to discuss your study. At that time, a coordinator will review the protocol with you and discuss the next steps.

Citi Training (Required)

Northwestern University requires all individuals involved in the conduct of human subjects research to complete initial human subjects protection training and to recertify every three years. IRB approval will be withheld if these training requirements have not been met.

These requirements apply to all persons with a significant role in the research, such as those designated as:

Visit the following website for further information and step-by-step instructions
http://irb.northwestern.edu/training/citi

Helpful Links

Consent Form Templates

Templates and Suggested Consent Form Language

HIPAA Regulations

Privacy Rule of the Health Insurance Portability and Accountability Act

NU HIPAA Policy

Office of Research Administration

Contact the Research Administration and Support staff for assistance with many of the administrative requirements related to research.