IRB: Procedures and Guidance
The NC State IRB maintains a wealth of documentation and other resources to assist researchers throughout the IRB Lifecycle. Here, you’ll find all of the NC State IRB’s 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 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.
Use of Secondary Information as Data for Research
Using existing or future secondary data for research means that you want to use information or biospecimens — originally collected for non-research purposes — as data for your research project or you want to use information or biospecimens — originally collected for research purposes other than the project currently proposed — as data for the research project that you are now proposing. Data and materials do not have to exist at the time of your IRB application submission; they just need to be or have been collected or generated for purposes other than the research you are proposing.
Sometimes, using secondary data/specimens subjects the study to additional requirements. These may be related to HIPAA, FERPA, GDPR, or require a Data Use Agreement or Material Transfer Agreement.
- Secondary Data and the IRB
- Use of Social Media for Research with Human Subjects
- Data Management and Security
- Assessment/Eval/QA/QI and Research
Forms and Templates
- FERPA Gatekeeper Access to Site Letter (Template)
- FERPA Supervisor Records Access Letter (Template)
- HIPAA Participant Authorization and Revocation (Form)
- NC State University Internal PI Access Request for NC State Held HIPAA Record (Form)
- Researcher Request to IRB for Waiving Participant HIPAA Authorization (Form)
- Application for Small Scale Repository (Form)
- Waiver of Consent Request (Form)
- Data Access and Security Plan (Form)
Qualitative Research Methods and Modes
Qualitative research methods are used to understand the lived experiences of participants. Examples of qualitative research methods include but are not limited to interviews, focus groups, observations, action research, textual analysis (e.g., document review — including review of social media), or visual analysis (e.g., review of video or use of the method photo-voice).
- Qualitative Research Methods and the IRB
- Creating Interview Protocols
- Creating Focus Group Protocols
- Implementing Photovoice in a Protocol
- Survey Research and the IRB
- Secondary Data and the IRB
- Use of Social Media for Research with Human Subjects
- Images and Recordings in Research with Humans
- Identifiable Data Sets
Forms and Templates
- Optional Interview/Focus Group/Lab Visit Scheduling (Template)
- Optional Interview/Focus Group/Lab Visit Confirmation and Reminder Emails (Template)
- Optional Member Checking Email (Template)
- Confirmation and Reminder emails (Template)
- Scheduling Activities Through Qualtrics (Template)
Survey Research
Surveys involve asking questions of people. A survey can range in format from short and simple to in-depth and intensive — and there are multiple ways that surveys can be implemented, requiring different ethical and regulatory issues to be addressed throughout the study. Should the survey be implemented online, the suggested software for NC State researchers to use is Qualtrics.
Benign Behavioral Interventions
A benign behavioral intervention is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and should give the researcher no reason to think the subjects will find the interventions offensive or embarrassing. Examples of benign behavioral interventions could include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. This method/mode of data collection can also include Augmented Reality (AR) or Virtual Reality (VR) as long as no data are collected from the participants’ bodies (e.g., eye tracking).
- Benign Behavioral Interventions
- Use of Augmented Reality (AR) and Virtual Reality (VR) (coming soon)
- Research Involving Deception
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.
Methods and Modes of Data Collection
- Survey Research and the IRB
- Qualitative Research Methods and the IRB
- Secondary Data and the IRB
- Use of Social Media for Research with Human Subjects
- Images and Recordings in Human Subjects Research
- Use of Applications and Software for Research with Human Subjects
- Identifiable Data Sets
- Blood Draws
- Creating Interview Protocols
- Creating Focus Group Protocols
- Implementing Photovoice in a Protocol
- Optional Qualtrics Set-Up
- Assessment/Eval/QA/QI and Research
- The General Data Protection Regulation
Study Design
- Is it Research?
- Is it Human Subjects Research?
- Roles and Expectations Faculty Advisors
- Phased and Staged Research
- Data Management and Security
- Incentives and Compensation for Research Participants
- Researchers Enrolling in Their Own Research
- Multisite Study Checklist
- BME Study Submission or Update
- Implementing Food Quality Studies
- Targeting NC State University Students as Research Participants
- Genomics For NC State Researchers
- Mandated Reporting and Research with Human Subjects
- Class Projects that are Not regulated Research
- Deception in Human Subjects Research
- Benign Behavioral Interventions
- Citizen Science
- When Oral History Becomes Research with Human Subjects
- Water, Soil and Farmed Food Sampling
- College of Veterinary Medicine Research activities (coming soon)