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The Institutional Review Board (IRB) is responsible for ensuring that studies conducted on humans are safe, fair, ethical and meaningful. Failure to obtain proper approval 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, as a result, do not require IRB oversight, IHQI highly recommends submitting an IRB application before beginning a QI project. Additionally, the IRB cannot have the option of granting 鈥渞etroactive鈥� approval after a project is finished.

Note: the following steps and guidelines are primarily focused on 黑料网-Chapel Hill and 黑料网 Healthcare. Please refer to your respective organization regarding the IRB application process.

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 黑料网 Office of Human Research Ethics (OHRE) by calling 919-966-3113 or emailing irb_questions@unc.edu.

Resources

Read

General IRB Guidance 黑料网 鈥� Chapel Hill Specific Guidelines ): The OHRE website offers various resources to get started with the IRB application process Quality Assurance (QA) and Quality Improvement (QI) checklist 鈥� 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 鈥� 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 鈥� Your data collection plan is pivotal for your IRB application and can help you as your complete your IRB application.
• Project Charter 鈥� The project chart outlines your project purpose and goals which is valuable important that you can include in your IRB application.
• Scholarship 鈥� If you plan to publish your work, it is a good idea to submit an IRB application even if it is not considered research. 聽聽
• Stakeholders Analysis & Engagement 鈥� 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.