UMCIRB: Human Subject Research and the New Year

The University and Medical Center IRB offers the following reminders for researchers either currently conducting human research or planning to conduct human research in the new academic year.

• The federal guidelines (The Common Rule) governing human research require that non-exempt human research be reviewed and approved by the Institutional Review Board (UMCIRB) before the research commences.
• The Common Rule includes categories of human research that are exempt from the federal regulations. At ECU, this determination must be made before the study commences and only by the UMCIRB.
• If a human research study has an UMCIRB expiration date, it is the responsibility of the principal investigator (PI) to submit a continuing review to the UMCIRB approximately 30 days prior to the expiration date if the study is to continue. A non-exempt human research study should not be allowed to expire under any circumstances.
• The UMCIRB has a new SOP titled “Expiration of IRB Approval” effective May 5, 2019. Take a moment to review this new SOP which formalizes the expectations of the UMCIRB and the process for addressing human research at ECU that is allowed, by the PI, to expire.
• When all research activity for non-exempt human research has been completed the PI is responsible for submitting a final report to the UMCIRB. Take a moment to review the UMCIRB SOP titled “Study Completion and Closure.”
• If, for whatever reason, a PI is separating from the university, they must either transfer their non-exempt study to another ECU investigator if the study is to continue after their separation, or submit a final report if the study is completed and being closed. If a student investigator fails to take one of these steps before leaving the university, the faculty supervisor will be responsible for this task.