Date new process begins: Monday, September 19, 2016
All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must be submitted for review to the UNC Scientific Review Committee. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol.
Beginning Monday, September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented prior to the review. Investigators should anticipate at least 7 business days for this review.
For non-oncology studies, scientific review can be conducted externally by an independent organization that has no conflict of interest with the submitted research activity or internally by the UNC Scientific Review Committee. For example, a multicenter study funded by the NIH or a multicenter industry-sponsored study with an external IRB is considered to have undergone scientific review. A UNC-faculty investigator-initiated study (with greater than minimal risk) whether funded by the NIH or industry must undergo scientific review.
To submit your study for Scientific Review, please complete the SRC Review Request form found on the Office of Clinical Trials website. Send the completed form along with your complete protocol document or master protocol document (not grant proposal) to OCT@unc.edu.
Grant proposals will be accepted until September 19th. After this date, investigators will be required to submit the complete protocol document or master protocol document for review. For information on how to develop a complete protocol document please refer to the OCT website. Initially, statistical review will continue to be a one-page report given to the Scientific Review Committee.
For resources and templates for writing study protocols please refer to the OCT website. For further assistance in developing your protocol or any questions about this process, including information about biostatistics, please contact NC TraCS and request a consult.
If your project has greater than minimal risk, it requires scientific review. The review must be completed and approved by the Scientific Review Committee (SRC) or Oncology Protocol Review Committee prior to IRB submission. If you are unsure if your project requires SRC review, please contact the Office of Clinical Trials at 919.843.2698.