Human Subject Research



The primary goals of the Western Carolina University Institutional Review Board is to protect the rights and welfare of individuals who participate as subjects while promoting and facilitating the research enterprise, and maintaining an open and cooperative relationship with the research community

Before participants are recruited or data is collected, the IRB must review and approve all research conducted by Western Carolina University faculty, staff, or students, regardless of funding source.

The IRB is registered with the Department of Health and Human Services – Office for Human Research Protections with the Federal-wide Assurance #FWA00010411. This provides assurance that the University will comply with applicable federal laws and regulations related to research with human subjects.

WCU's IRB uses IRBNet for all IRB submissions and the review process. Submissions are no longer accepted through email. Please visit the WCU IRBNet application process for instructions, or contact the IRB by emailing or calling 828-227-7212.

Changes to the Common Rule

The regulations that govern human subjects research (known as The Common Rule, 45 CFR 46) have been updated for the first time since 1991. These updated rules will go into effect January 21, 2019 and can be found here with a brief overview of changes listed below:

  • Annual continuing review will no longer be required for most minimal risk projects
  • New exemption categories have been added and some existing categories have been expanded. 
  • New content requirements for the informed consent document to facilitate participant decision-making
  • Certain activities are specifically designated as not human subjects research

The Office of Research Administration will hold three information sessions for researchers about the updates. Researchers may request other information sessions for their department, lab group, program, or an individualized meeting. 

Information sessions – please RSVP to

October 23, 10:00-11:00 am, UC Catamount

November 14, 9:30-10:30 am, UC Catamount

January 23, 2:00-3:00 pm, UC Catamount

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