IRB & Regulations
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 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:
- Protocol
- Data collection sheet
- Coded identifier list
- Completed IRB application
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, IRB submission requires the following items:
- Protocol
- Subject consents
- Completed IRB application
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 Emily Powell. 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:
- Principal investigators and co-investigators
- Individuals named on a study grant or contract proposal
- Individuals listed on an FDA form 1572 for the conduct of the research at Northwestern University or at an affiliate institution
- Individuals named as a contact person in the informed consent document(s) or recruitment materials for research
- Individuals who obtain informed consent from prospective participants in research
- Individuals who obtain individually identifiable health information under a Northwestern University Business Associate Agreement.
Visit the IRB website for further information and step-by-step instructions.