RFU is committed to supporting its key clinical partners and students in conducting evidence-based research and is seeking opportunities to work with our clinical partners to promote scholarship. To this process, RFU brings the resources of a fully accredited research university and JBI. Some examples of these resources include:
Getting started is easy. Simply complete the . This form asks you to provide a project title, brief description, and the interdisciplinary faculty and student(s) you feel might be a good fit for the project.
An RFU faculty liaison will contact you and review the project with you. This review will include a discussion about the a) scope of RFU faculty or student engagement, (b) process for matching faculty and students with the project, and (c) the project timeline. In addition, the faculty liaison will conduct a preliminary review of the project to determine if it is likely human research or a QI/QA project. Based on this discussion, recommendations for next steps will be provided.
Federal regulations only require human research to be reviewed and approved by an IRB while QI/QA projects do not require IRB oversight. However, determining whether a project is Human Research or a QI/QA activity can be challenging. That is why RFU has created a QI/QA faculty mentor group to support its faculty and students in understanding how to correctly apply the university’s checklist and decision trees.
The U.S. Department of Health and Human Services' website is an excellent resource for guidance in distinguishing human research from QI/QA research/projects.
Federal guidelines (45 CFR 46.102(d) that define Research and Human Subject 45 CFR 46.102(f) help to distinguish human from not-human research.
RFU uses a Checklist and Decision Trees to support its faculty and students in making this determination.
No, the intent to publish is not a factor in determining whether an activity requires IRB approval.
RFU’s IRB has created the Guidance and Application Form for Not-Human Research Determination. Faculty and students should submit this completed form to the IRB prior to starting the project if they (a) are uncertain about the QI/QA status of the project; or, (b) need an IRB verification letter as a condition for publication.
IRB approval and oversight should be provided by the principal investigator’s employment organization. In some cases, RFU will recommend the use of an external IRB group to serve in this capacity.