IRB: Procedures and Guidance
The NC State University IRB maintains a wealth of documentation and other resources to assist researchers throughout the IRB lifecycle. Here, you'll find all of our guidance documents on study design, data collection methods and modes, and other considerations.
This webpage organizes the NC State University IRB guidance into five thematic sections. Each section provides documents that summarize or link to relevant laws, regulations, policies, and contexts alongside suggestions for researchers in how to comply with those requirements within the research protocol submitted for NCSU IRB review and approval.
We begin with “IRB Operations and Expectations” which includes guidance on what is and is not regulated (and thus reviewed) by the NC State IRB office and general expectations of all University affiliated researchers engaged in human subjects in terms of training, conflicts of interest management, mandatory reporting processes, faculty point-of-contact oversight of student research, and specific guidance for individual units at the University.
The second section, “IRB Application,” links to eIRB application screenshot tutorials, exemption-eligible research decision tree for educational research, and selected forms for exemption requests, protocol renewal, protocol closure, and IRB review by external IRBs.
“Research Populations” follows the “IRB Application” section and here you will find NC State University specific guidance on vulnerable research participant populations commonly targeted by our researchers, such as students, minors, those who are incarcerated, pregnant, or affiliated with the Department of Defense, and those who will enroll in their own research.
One of the largest portions on this page is our “Research Methods and Procedures” section that contains guidance on qualitative methods, primary and secondary data collection procedures, and use of specific data tools and types including artificial intelligence, software applications, medical devices, augmented and virtual reality, biosampling, and more.
The concluding section of this webpage, “Research Data Management, Use, and Sharing,” provides crucial information on data identifiability, sensitivity, and sharing that honor participant consent, participant privacy, data confidentiality, and applicable laws and regulations.
IRB Operations and Expectations
- Is it Research? Guidance
- Is it Human Subjects Research? Guidance
- Class Projects That Are Not Regulated Research Guidance
- Comparisons between Assessment/Eval/QA/QI Projects and Research Regulated by the IRB
- When Oral History Becomes Research with Human Subjects Regulated by the IRB
- When Pilot Studies and Feasibility Work is Regulated by the IRB
- Phased and Staged Research Guidance
- Human Subjects Research Training Requirements for All NCSU IRB Reviewed Studies
- Faculty Points-of-Contact Unit Standard
- Managing Conflicts of Interest Unit Standard
- Mandated Reporting and Research with Human Subjects
- Researchers Enrolling in Their Own Research Guidance
- Guidance for Specific NCSU Units
- Biomedical Engineering Joint Department with UNC-Chapel Hill
- College of Education
- College of Veterinary Medicine Guidance
- Community Counseling, Education, and Research Center (CCERC) Guidance
- DELTA Guidance
- Food, Bioprocessing, and Nutrition Sciences Consumer Food Preference, Taste, and Quality in Human Subjects Research Guidance
IRB Application
- Exemption Request Form – updated 9/12/2025
- Exemption Unit Standard
- Educational Research Exemption Eligibility Decision Tree
- eIRB Screenshot Tutorial for Non-Exempt Protocol Applications and Protocol Amendments and Renewals (Exempt and Non-Exempt) – updated 9/22/2025
- eIRB Application Screenshot Tutorial for Cooperative Research
- Renewal Request Form for NIH Funded Studies
- Risks and Benefits in Human Subjects Research Guidance
- Study Closure Request Form
- Use of a Private IRB for Select More Than Minimal Risk Research Studies
Research Populations
- Targeting NC State University Students as Research Participants Guidance
- Inclusion of Minors Attending Post-Secondary Institutions in Research Unit Standard
- Research Involving Minors Unit Standard
- Department of Defense (DoD) Affiliated Research Unit Standard
- Local Context and Participant Context Reviews Unit Standard
- Research with Immigrants, Migrants, and Displaced Populations Guidance
- Research with Pregnant People and Neonates Unit Standard
- Research with Those Who Are Incarcerated Unit Standard
- Researchers Enrolling in Their Own Research Guidance
- Research Match Procedures and Guidance
Research Methods and Procedures
- Artificial Intelligence Participant Information Sheet Elements
- Artificial Intelligence Supplemental Form
- Applications and Software Information Sheet (Appendix D)
- Benign Behavioral Interventions Guidance
- Blood Draws Guidance
- Clinical Trials Unit Standard
- Citizen Science Guidance
- Consumer Food Preference, Taste, and Quality in Human Subjects Research Guidance
- Department of Defense (DoD) Affiliated Research Unit Standard
- Exercise Science Research Guidance – In Development
- FERPA Records Access for Research Purposes Guidance
- FERPA Secondary Data IRB Applications and Supporting Documentation Guidance
- Genetics and Genomics Research
- Health Insurance Portability and Accountability Act (HIPAA) Unit Standard
- Modified or Purpose-Built Applications and Tools Used with Human Research Subjects
- Applications and Software Information Sheet (Appendix D)
- Applications and Software Consent Addendum (Appendix C)
- Artificial Intelligence Supplemental Information Form
- Artificial Intelligence Participant Information Sheet Elements
- Code Review Form
- Use of Applications and Software for Research with Human Subjects Guidance
- Use of Artificial Intelligence in Human Subjects Research Guidance
- When Mobile Software Applications and Wearables Become Medical Devices Guidance
- Images and Recordings in Research with Human Subjects Guidance
- Incentives and Compensation for Research Participants Guidance
- Medical Devices
- Phased and Staged Research Guidance
- Photovoice Ethics Agreement Form
- Qualitative Research Methods and the IRB Guidance
- Qualtrics (an NCSU licensed online survey tool) Informational Weblinks
- Research Involving Deception Guidance
- Research Match Procedures and Guidance
- Researchers Enrolling in Their Own Research Guidance
- Secondary Data and the IRB Guidance
- Survey Research and the IRB Guidance
- Translation Verification Guidance
- Universal Design in Human Subjects Research Guidance – In Development
- Use of Applications and Software for Research with Human Subjects Guidance
- Use of Artificial Intelligence in Human Subjects Research Guidance
- Use of Augmented Reality (AR) and Virtual Reality (VR) Guidance
- Use of Social Media for Research with Human Subjects Guidance
- Water, Soil, and Farmed Food Sampling Guidance
- When Mobile Software Applications and Wearables Become Medical Devices Guidance
Research Data Management, Sharing, and Use
- Collection and Reporting of Demographic Information Guidance
- Data Security and the IRB Guidance
- “Data Use Agreements” Research Administration and Compliance Webpage
- FERPA Records Access for Research Purposes Guidance
- General Data Protection Regulation (GDPR) Guidance
- Identifiable Data Sets Guidance
- Incentives and Compensation for Research Participants Guidance
- Mandated Reporting in Human Subjects Research Guidance
- NCSU OIT Data Management Framework Webpage
- NCSU OIT Data Sensitivity Framework Google Sheet
- Use of Applications and Software for Research with Human Subjects Guidance
- Use of Artificial Intelligence in Human Subjects Research Guidance
- Use of Social Media for Human Subjects Research Guidance