Scientific Review Requirements

At the College of Medicine, all investigator-written clinical trials or greater than minimal risk human subjects research studies must undergo a scientific review to meet institutional requirements.

• Study teams must provide documentation of scientific review with the IRB submission. 

The scientific review requirement may be fulfilled by one of the following:

EXTERNAL PEER-REVIEW PROCESS

This method includes research studies funded by an NIH grant and studies that have undergone a formal review by the FDA for an IND number. (Note: This process does not include studies that have undergone FDA exemption determinations.)

DEPARTMENT OR INSTITUTE SCIENTIFIC REVIEW COMMITTEES

These departments/institutes have a scientific review process:

• Anesthesiology and Perioperative Medicine
• Cancer Institute (Protocol Review Committee) -- required for all cancer-rleated studies
• Family and Community Medicine
• Neurosurgery
• Neurology
• Obstetrics and Gynecology
• Orthopaedics and Rehabilitation
• Psychiatry and Behavioral Health
• Radiology

SCIENTIFIC REVIEW BY THE CLINICAL RESEARCH CENTER (CRC) ADVISORY COMMITTEE

This method should be used by investigators from departments without a scientific review process.

• This committee meets the first Wednesday of each month.
• Complete applications must be received by the 25th of the month to be included on the next month’s agenda.
• See the Application for Scientific Review for additional information and instructions.
• When making the IRB submission, under Supporting Documents, upload the Preliminary Scientific Review Checklist signed by the Advisory Committee Chair/Acting Chair as documentation of scientific review.

Note: Investigator-written human research studies qualifying for expedited review may also require scientific review at the discretion of the IRB. If scientific review has not already occurred for an expedited study, the investigator will be notified of the requirement during the IRB review process if applicable.