Scientific Review Process at UNC

Beginning September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented.

All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must undergo scientific review. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. 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 IRB at 919-966-3113 or the Office of Clinical Trials at 919-843-2698.

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 whether funded by the NIH or industry must undergo scientific review.

For further guidance on which studies require scientific review click here.

To submit your study for Scientific Review, please complete the SRC Review Request form found here. Send the completed form along with your full protocol (not grant proposal) to SRC@unc.edu.

For further assistance in developing your clinical protocol, please contact NC TraCS here at UNC-Chapel Hill.

NC TraCS provides:

  • Regulatory consultations and guidance on developing and writing a clinical protocol
  • Biostatistical consultations on study design and statistical analysis plans for clinical protocols

For assistance with Regulatory and protocol guidance, please click here:  https://tracs.unc.edu/index.php/services/regulatory/study-implementation

To schedule a Biostatistics consultation, click here:  https://tracs.unc.edu/index.php/services/biostatistics/short-term-consultations

Links and guidance documents to help in developing a research protocol:

The links below provide information that may be useful to you in developing a protocol for submission to OCT for SRS review:

Below are several templates for developing protocols. The most complete is the “Clinical Trials Protocol Template” for which there are two links — an educational one, including examples, and the shell, which is prepared for adding study-specific text as directed by the educational guidance.

Here are alternative templates which are not as complete, but targeted to particular types of study.

SRC Review/Meeting Schedule – December 2019-January 2020

For researchers planning to submit protocols for scientific review in late-December 2019 or January 2020, please note: The University is closed from Dec 24, 2019 through Jan 1, 2020 (inclusive).

Meeting (and deadline) dates are below:

December 2019

Meet: Mon, Dec 16 (deadline Weds, Dec 11)

January 2020

Meet: Mon, Jan 6 (deadline Thurs, Jan 2); Mon, Jan 13 (deadline Weds, Jan 8); Tues, Jan 21 (deadline Weds, Jan 15); and Mon, Jan 27 (deadline Weds, Jan 22).

An SRC Review Request Form and complete Protocol must be received by 2 pm on the deadline date to allow for pre-review and inclusion on the meeting agenda. Submit your materials to: SRC@unc.edu.