University & Medical Center Institutional Review Board
The primary function of the University and Medical Center Institutional Review Board (UMCIRB) is to protect the rights and welfare of human subjects engaged in research at East Carolina University, The Brody School of Medicine, Vidant Medical Center and its affiliates, and in research conducted elsewhere by faculty, students, staff or other representatives of the University in connection with their responsibilities. This mission is accomplished by an institutional commitment to education and establishment of a collaborative relationship with the researchers and key support staff.
Submissions which are found to be incomplete or where the information may be lacking, incorrect, or inconsistent, will not be forwarded for review until such issues have been resolved. This applies to all submissions requiring full, expedited or exempt UMCIRB review.
New Mandatory Process for Clinical Trials-Related Medicare Requirement
***Effective November 15, 2014***
The ORIC has revised the consent document templates in order to comply with the new mandatory ECU and Vidant Health process to meet a Medicare requirement related to clinical trials. Per Section 69.3 of Chapter 32 (“Billing Requirements for Special Services”) of the Medicare Claims Processing Manual, “The billing provider must include in the beneficiary's medical record the following information: trial name, sponsor, and sponsor-assigned protocol number.” The ECU-VMC Research Compliance Committee has worked together to create an easy, efficient, uniform process to bring both institutions into compliance with this Medicare requirement to document a Medicare beneficiary’s trial participation in his/her electronic medical record. For more details about this new process please click here.
You will find these revised consent document templates in the usual locations; the ORIC Website under "Forms and Documents" and the ePIRATE study smart form screen view 7.1.
East Campus Office Hours (2422 Old Cafeteria Building)
Monday - Friday: 8:00 am - 5:00 pm
Appointments may be made by calling: 252-737-2958 or 252-744-2914
electronic Portal for Institutional Research at ECU
ePIRATE is the fully electronic IRB submission, review and tracking system that eliminates the need for paper documents. Your research files are easily accessible through ePIRATE. At any time you may view the status, known in ePIRATE as "study state", of your submission. Features include electronic submissions including initial applications, amendments, and reportable events, continuing review reminders, and easy access for department chairs and other administrators to view up-to-date research submissions.
For details about ePIRATE click on "Electronic IRB Submission Information"
in the navigation menu on the top left side of this page