Human Subjects Activities

Before Starting Research

Before beginning any aspect of research that involves human subjects (e.g., pilot studies, recruiting subjects, beginning trials), the Principal Investigator must complete CITI Training and receive written approval from the IRB. To receive written approval, you must submit either a Request for Exemption, a Classroom-based Research Protocol Form, or a Research Protocol Form on IRBNet (all forms are available on IRBNet).

The IRB Review Process

Requests for Exemptions, Classroom-Based Protocols, and Protocols qualifying for Expedited Review will receive an initial review within 14 business days of submission. The IRB Chair (a fellow faculty member) will email the PI with a determination such as approved, approved with changes, modifications requested, more information needed, Full Review required, or rejected.

Making Changes to Approved Research

If the research protocol requires any changes during the study, submit a Modification Form to IRBNet at least 30 days before these changes are set to begin. Modifications cannot take place until approved by the IRB. 

Continuing Approved Research Beyond the Expiration Date

If the Principal Investigator wishes to continue the research beyond the termination date, an IRB Continuation Form must be submitted to IRBNet 30 days before expiration. Research may not continue beyond the termination date unless approved by the IRB. 

Closing Approved Research

All researchers must also complete a Closeout Form to officially terminate any study that was approved or certified exempt by the UNC Asheville IRB. This form should be submitted within 30 days of completion or termination of all research activities for a study, even if the current approval period has expired. Do not close out a study under any of the following conditions (instead, apply for Continuation):

  • enrollment at the UNC Asheville-approved site is ongoing,
  • research-related interventions and/or follow-up at the UNC Asheville-approved site is ongoing,
  • participant follow-up at the UNC Asheville-approved site is ongoing,
  • data analysis or manuscript preparation that involves the use or access to personally identifiable information is ongoing, or
  • if there is an external study sponsor and the sponsor has not provided permission to close the study with the IRB.