Institutional Review Board
New Hanover Regional Medical Center Institutional Review Board (IRB) is devoted to subject safety as it relates to the rights and welfare of people participating in research. This board operates in accordance with all applicable laws, regulations, and guidelines for clinical trials. Compliance is maintained with the FDA Code of Federal Regulations, Office for Human Research Protections (OHRP), and Good Clinical Practice (GCP) guidelines (see the links on this website). The IRB strives to provide the highest quality review to each and every protocol that is presented. To maintain this level of review, the IRB is committed to a monthly training program.
Administrative Review and Approval: Studies run smoother and with fewer surprises when they are well planned and communicated. For this reason, Anne Patterson, the Clinical Research Officer, reviews all IRB applications prior to submission to the IRB, to identify studies that utilize or impact hospital departments, resources, services, facilities, staff, or patients. She can be reached at (910) 343-2641 or anne.patterson@nhrmc.org . Once administrative approval has been obtained, submission may be made to the IRB. IRB approval must also be obtained prior to the start of any research activities.
IRB Submission: Researchers are required to submit their IRB application and supporting documents to the IRB Compliance Coordinator and the Clinical Research Officer for review and comment prior to official submission. Electronic submission is preferred for this initial review (amy.southerland@nhrmc.org and anne.patterson@nhrmc.org ).
Human Subject Protection Training Requirements: In keeping with federal guidelines all principal investigators and research staff will be required to obtain Human Participants Protection Education. A link to the NIH online training program is located under the "Links of Interest" tab or the URL is listed on the IRB application. You will be required to provide a certificate of completion with your submission.
IRB Website and Resources: To learn more about the IRB and how to submit a study for review, please use the links below. All of the forms needed for submission and maintenance of a study protocol can be downloaded from the Submission Forms tab. If you have questions regarding the information on this site, you may contact Amy Southerland, IRB Compliance Coordinator, at (910) 343-4621, or amy.southerland@nhrmc.org. All submissions should be submitted to Amy at New Hanover Regional Medical Center, Institutional Review Board, P.O. Box 9000, Wilmington, NC 28402-9000.
About the IRB
What is an IRB IRB Membership Purpose Policy & Procedures (New)
IRB Submission Information
Letter to Principal Investigator IRB Member Roster 2010 Meeting Schedule Fee Schedule Submission Guidelines for Full Board Review Studies Submission Guidelines for Expedited Review Studies Submission Tips Q&A
Submission Forms
Click here to download IRB submission forms.
Links of Interest
Click here for a list of websites that might be of interest to you.
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