Institutional Review Board Application

The Institutional Review Board (IRB) is responsible for helping ensure that studies conducted on humans are safe, fair, ethical and meaningful. Failure to obtain the appropriate approval determination in advance could not only cause potential harm to human subjects but also jeopardize your ability to access data, prevent you from publishing the results, and place you and your organization in violation of federal regulations.

Although most QI projects are considered Non-Human Subjects Research (NHSR) projects and therefore do not require IRB oversight, IHQI strongly recommends submitting an IRB application before beginning a QI project. Additionally, the IRB cannot provide retroactive approval after a project has already been completed.

Note: The following steps and guidelines are primarily focused on studies at UNC Chapel Hill and UNC Health. Please refer to your respective organization for institution specific IRB application policies.

Key Steps

• Complete a project charter to identify what type of work you are conducting. 
• Using the information from your project charter, complete the Quality Assurance (QA) and Quality Improvement (QI) Screening Checklist to determine if you need IRB approval.
• If you need approval based on the checklist, submit your work through IRB prior to beginning your project. If you do not need approval, complete the IRB application as Non-Human Subject’s Research. Note: You must submit your project for IRB review if you are participating in an improvement collaborative.
• If you have any questions, contact the UNC Office of Human Research Ethics (OHRE) by calling 919-966-3113 or submitting a OHRE service request ticket.

Resources

Read

General IRB Guidance Quality Improvement Activities Frequently Asked Questions  UNC – Chapel Hill Specific Guidelines IRB and Office of Human Research Ethics (OHRE): The OHRE website offers various resources to get started with the IRB application process Quality Assurance (QA) and Quality Improvement (QI) checklist – This document which is also referenced above provides a checklist to help researchers distinguish QA/QI activities from human subject research that requires IRB review IRB Decision Tree – This document provides oversight on how to appropriately complete the IRB application process when conducting research on human subjects.

Related QI Concepts

• Data Collection Planning – Your data collection plan is pivotal for your IRB application and can help you as your complete your IRB application.
• Project Charter – The project charter outlines your project purpose and goals which are valuable information to include in your IRB application. 
• Scholarship – If you plan to publish your work, it is a good idea to submit an IRB application even if it is not considered research.   
• Stakeholders Analysis & Engagement – Having an understanding of your stakeholders can help you determine how to best complete the IRB application and whether your project is considered research on human subjects. It is important to consider the involvement of patients and families in particular.