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Scientific review of some forms of clinical research at the University of North Carolina at Chapel Hill (UNC-CH) is required prior to IRB submission. The criteria for SRC review are investigator-initiated clinical research (whether funded or unfunded):

  • That meets the regulatory and/or institutional greater than minimal risk criteria (Generally, a study that requires Full Board review at a convened IRB Committee Meeting meets the threshold for greater than minimal risk; refer to the UNC OHRE website for more information regarding risk determination and types of IRB review)

    — AND —

  • That has not previously undergone rigorous scientific review by a panel of experts assembled specifically to evaluate the project using criteria similar to the SRC. FDA or NIH Study Section review is not synonymous with SRC review and cannot be substituted as such…

    — AND —

  • That does not have a focus on cancer research nor recruits research subjects from UNC Oncology clinics. Such studies are to be submitted for review by the UNC Protocol Review Committee

    — AND —

  • In which UNC’s role is NOT solely that of a participating study site in a multi-center, industry-sponsored study.

Scientific review at UNC-CH requires submission of a comprehensive protocol written to accepted industry standards and incorporating all the elements that the SRC considers when reviewing proposed research for scientific merit (the value to be gained, e.g., how the new information will advance understanding in a particular line of scientific inquiry) and scientific integrity (the yielding of useful information, e.g., alignment between study design, sample size calculation, aim(s), recruitment method(s), outcome measures, study procedures, data collection/quality assurance, safety monitoring, and statistical analysis plan(s)). Please refer to “What is a Protocol” to better understand the differences between a protocol and a grant proposal.

If a protocol meeting SRC standards as described above was developed as part of a grant or funding application, it may be possible to submit it for scientific review. Consult the templates library to confirm that all required elements are present If the existing protocol does not present each of the elements in sufficient detail, it must either be amended to include/expand upon them – or a new protocol using the appropriate template must be created and submitted.

New investigators may obtain guidance and education regarding protocol development, regulatory compliance, and biostatistics input – at no cost or nominal cost – through the UNC North Carolina Translational and Clinical Sciences Institute (NC TraCS); additionally, the SRC Coordinator provides feedback on SRC submissions prior to distributing protocols to reviewers.

Note: Beyond satisfying the UNC requirement for scientific review, other agencies/entities are increasingly mandating submission of a standardized, comprehensive protocol as part of their application/registration/review processes:

  • FDA IND or IDE submission
  • NIH clinical trial grant submission
  • External (single) IRB review
  • registration
  • Scientific journals (per ICMJE: “As part of peer review, editors are encouraged to review research protocols, plans for statistical analysis if separate from the protocol…”)

Acquiring the education and training required to provide a well-conceived, well-planned, and well-written protocol not only positions investigators to meet these demands, but provides a “roadmap” that will prepare them for the rigors and responsibilities of clinical research.