IRB Information Guide

This is information on how to submit an IRB in the Orthopaedic CRU

Every Department in the Duke University School of Medicine has a CRU – Clinical Research Unit. All IRB submissions must first go through a CRU review. The CRU must approve each application before it is submitted to the IRB.

When an investigator has a research idea that will enroll human subjects or use data from human subjects, review by the DUHS IRB is needed. As a first step toward the IRB submission, investigators are required to complete the Orthopaedic Research Study Intake Form. This is a REDCap form that will inform the Ortho CRU team of the research idea. This form is accessible from this webpage or directly from this URL.

The purpose of the REDCap form is twofold:

  1. *Allows the CRU team to determine the feasibility of the project (Can this be done at all or in part?)
  2. Asks the Investigator to provide the information that will be needed for the IRB submission

*While the CRU does assess the feasibility of a given study – much of the assessment of Scientific Importance for a particular project is done in the Clinical Divisions. When necessary, as part of the feasibility review, the CRU team will reach out to the Clinical Division/Section to plan any CRC effort necessary and provide the potential financial and resource impact of the project within the Division’s (or section’s) portfolio. The Division/Section Chief then has an opportunity/obligation to give input on the priority of research projects based on importance to the specialty area.

When the REDCap form is submitted, the CRU team reviews the submission. There are 3 possible outcomes:

  1. CRU Team contacts the investigator and requests them to work with Clinical Research Resources (contacts listed below) to improve or complete the study design – and will make feasibility assessment after design is completed
  2. CRU Team contacts the investigator and discusses why the study is not feasible in its current form and suggests ways to make a variation of the project possible
  3. CRU Team contacts the investigator and approves study feasibility and encourages IRB submission.

If the investigators need help with developing the Study Design, there are several Departmental Resources to assist. The expectation is every project will have a designated clinical faculty member who is the PI – primary investigator.

The Clinical Research Resources provided through our Department’s CRU include working with:

  • Chad Cook, DPT – who can assist with study design, sample size determination, and statistical analyses
  • Carrie Killelea, PhD – who can assist with determining if CRC effort is needed, and if so-how much CRC time should be planned for, regulatory elements, and streamlining the study (work-flow design, agreements, study type, consent type, etc)
  • Adam Goode, DPT – who can assist clinical faculty seeking Federal (NIH/DOD) Clinical Research funding
  • Cindy Green, PhD – who can assist with statistical design and data analysis of greater complexity