Human Subjects (IRB)

The Institutional Review Board (IRB) protects participant welfare by reviewing research proposals that involve humans to ensure that the planned research activities are ethical in practice and compliant with the federal regulations governing research with human subjects.

The mission of the NC State University IRB office is to advocate for and protect human subjects participating in research by working with investigators to facilitate ethical and compliant research. The IRB values beneficence, justice, and respect for persons. We operationalize these values by practicing transparency, collaboration, education, and communication with researchers and participants.

We review all proposed research through the lenses of ethics and compliance before it is implemented by NC State University researchers. As part of this review process, the IRB asks what the research is about, why the research is important, and how the researcher plans to carry out the project — including who the study participants will be, how the data will be collected and stored, and a number of other important details.

Our office maintains common-sense administrative policies to promote the efficient and effective review of all proposed research involving humans. We educate and train others in practical ethics, legal compliance, and social justice as it relates to research with humans — aiming to minimize risks and maximize benefits. We intervene, when necessary, in research to serve as a participant advocate and an accountability board.

Throughout the research process, the IRB serves as an advocate for all people in research, while also serving as the regulatory body that holds researchers accountable to ethical and compliant standards when completing research with human subjects.

Who serves on the Full Board?

FWA: 00003429
IRB Board Registration: 00000330
I-ORG: 0000200

More about FWA and IRB Registration

IRB Lifecycle

Step 1: Determining if Approval is Required

Definitions of Research and Human Subjects Research
Types of IRB Review/Approval Explained
Interactive Decision Tool: Do I need approval, and if so, what type?
Just-In-Time Approval “JIT” and .118 Determinations
External Researchers, Targeting NC State Populations

Step 2: Preparing and Submitting an Application

How to Submit an Application through the eIRB system
What to Include in Your Application
Submission Tips and Guidance
How to use the eIRB System

Step 3: Application Review Process

How the Initial Review Process Works
Additional Reviews
Review and Approval Turnaround Time

Step 4: Responsibilities After Initial Approval

Requesting an Amendment or Renewal
Additional Requirements for Clinical Trials or DoD Research Activities
Reporting a Complaint, Concern, Problem, Adverse Event or Noncompliance

Step 5: Close a Study

When and How to Close a Study

Request Assistance from the IRB

IRB Office Closure

The NC State University IRB office, like the rest of the University, will close at the end of the business day on Monday, December 23rd, 2024, and re-open on Thursday, January 2nd, 2025. Protocol submissions, emails, and voicemails will be responded to in the order they were filed when the office reopens.

Google Drive Changes

On Monday, September 2, 2024, the Google Service Team will delete all labeled files and folders owned by alumni, former students, and former employee accounts that have been suspended for two or more years (prior to May 2022). This may impact your IRB-approved protocol, so please review the announcement from the IRB Director.

Google Drive & IRB-approved protocols

2023-2024 IRB Newsletter

Recent changes to NC State University IRB office policies, procedures and guidance are highlighted in the newsletter, which is available now to view. We recommend bookmarking this important reference.

NC Parents’ Bill of Rights Law

The North Carolina legislature enacted the “NC Parents’ Bill of Rights” law in August 2023. Aspects of this law affect research with human subjects when the research is completed in NC public K-12 schools.

IRB Workshops

Click to view the Fall 2024 workshop offerings and access the REPORTER link to watch or register for a workshop.

IRB Office Hours

Virtual IRB office hours are first-come, first-served, and open to anyone at NC State who needs help knowing when to apply to the IRB, how to apply to the IRB, or when to change/close/transfer their IRB-approved protocol.