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, methods and modes of data collection, and other considerations.
IRB Guidance
This section provides guidance on study design, methods and modes of data collection, and IRB considerations.
The NC State University IRB provides guidance for the most commonly asked questions, employed methods, and how to navigate the varying laws, regulations, and policies. Many of these guidance documents include or link to required forms, policies, and templates.
Does My Project Need IRB Review?
- Is it Research?
- Is it Human Subjects Research?
- Assessment/Eval/QA/QI and Research
- Class Projects That Are Not Regulated Research
- Pilot Studies and Feasibility Work IRB Unit Standard
- Citizen Science
- Multisite Study Checklist
- When Oral History Becomes Research with Human Subjects
- Water, Soil, and Farmed Food Sampling
- College of Veterinary Medicine Research Activities
Expectations for Researchers
- Roles and Expectations Faculty Advisors
- Mandated Reporting and Research with Human Subjects
- Human Subjects Research Training Requirements
- Change in Lead PI: Passing Down, Inheriting, and Transferring IRB Protocols
Guidance for Specific NC State University Units
- Biomedical Engineering – Joint Department with UNC-Chapel Hill
- Study Submission or Update
- BME IRB Procedures Template
- Biomedical Engineering Department Unit Standard
- IDE Full Board Determination Sheet
- Implementing Food Quality Studies
- Data from the Community Counseling, Education, and Research Center
- The Friday Institute and the IRB
- College of Veterinary Medicine
Participants
- Researchers Enrolling in Their Own Research
- Targeting NC State University Students as Research Participants
- Citizen Science
- Research Match Procedures and Guidance
- Research with Indigenous and First Nations People, American Indians, or Involving Sovereign Tribes
- Researching People Who Are Migrants, Immigrants, and/or Refugees
Primary Data Collection
- Qualitative Research Methods and the IRB
- Creating Interview Protocols
- Creating Focus Group Protocols
- Implementing Photovoice in a Protocol
- Survey Research and the IRB
- Use of Social Media for Research with Human Subjects
- Images and Recordings in Research with Human Subjects
- Qualtrics
- Benign Behavioral Interventions
- Research Involving Deception
- Use of Applications and Software for Research with Human Subjects
- Blood Draws
- Medical Devices Used in Research
- Phased and Staged Research
- When IBC and the IRB Overlap
- Research Involving Alcohol Testing
Data Agreements, Data Sharing, Data Access and Security, and Participant Confidentiality
- Data Management and Security
- Data Access and Security Plan
- Research Administration and Compliance “Data Use Agreements” Guidance
- Identifiable Data Sets
- Optional Member Checking Template Email
- The General Data Protection Regulation
- Mandated Reporting and Research with Human Subjects
- Collection and Reporting of Demographic Information
Genetics and Genomics
Genomics research usually generates identifiable information about an individual and those biologically related to them, within the same group in a region as them, or both. Genomics research can uncover information about a participant that has a direct bearing on their future or their family’s future. This information might be unsuspected and, therefore, has both potentially wonderful and potentially harmful consequences to the individual or their relatives. Please note that the NIH genomic data sharing policy only applies to NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.