Institutional Review Board

Learn More

Our team is available to answer your questions about our services and next steps.

Research Staff Directory

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:  Administrative review and approval allows for the assessment of operational feasibility.  Studies may require both administrative and IRB approval before research activities may be initiated. 

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 (amy.southerland@seahec.net and lynette.mcfayden@seahec.net).

Human Subject Protection Training Requirements:   In keeping with federal guidelines, Investigators and study staff are required to complete CITI training including Good Clinical Practice (GCP) and Human Subject Protection Education.  For assistance, please contact Monique Harris (Monique.harris@seahec.net).

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 amy.southerland@seahec.net.  All final submissions should be submitted to Amy at New Hanover Regional Medical Center/SEAHEC, Institutional Review Board, 2511 Delaney Ave., Wilmington, NC 28403.

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 
Fee Schedule
Submission Guidelines for Full Board Review Studies
Submission Guidelines for Expedited Review StudiesExempt Studies

Submission Forms

IRB submission forms.

Informed Consent Information.

Links of Interest

Click here for other helpful websites.