Institutional Review Board
Our team is available to answer your questions about our services and next steps.
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 a quality review to every application that is presented.
It is recommended that you let the IRB decide the category your project fits into, whether it's a research study or a quality improvement project. The IRB is an experienced resource to determine the level of review (if any) that your project requires in order to protect you and the institution.
Administrative Review and Approval: Studies run smoother and with fewer surprises when they are well planned and communicated. For this reason, Lynette McFayden, Research Director, reviews all IRB applications submitted to the IRB, to identify studies that utilize or impact hospital departments, resources, services, facilities, staff, or patients. She can be reached at (910) 667-2641 or email@example.com. Administrative approval and IRB approval must 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 Coordinator and the Research Director for review and comment prior to official submission. Electronic submission is required for this initial review (firstname.lastname@example.org and email@example.com).
Human Subject Protection Training Requirements: In keeping with federal guidelines all investigators and research staff are 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. The CITI course is also accepted in order to fulfill this requirement.
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 Coordinator, at (910) 667-4621, or firstname.lastname@example.org. All final 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 or isn't research?
What is an IRB and it's purpose?
IRB Membership and roster Policy & Procedures
IRB Submission Information
Letter to Principal Investigator, Submission Tips
Submission Guidelines for Full Board Review Studies
Submission Guidelines for Expedited Review StudiesExempt Studies
IRB submission forms.
Informed Consent Information.
Links of Interest
NIH Human Participant Protection training link and other helpful websites.