IRB: Training
The NC State University IRB requires all engaged NC State researchers and all individual investigators to complete human subjects training before receiving IRB approval. Beyond the required training, we also offer synchronous and asynchronous learning opportunities on a variety of human subjects research topics.
Required Training
The NC State University IRB requires all engaged University researchers to complete human subjects research training before receiving IRB approval to work with people. What makes a person engaged in human subjects research? it is when an individual will be involved in recruitment, consent, access or collection of participant data through an interaction, intervention, manipulation of the human’s environment in some way, scraping private personally identifiable data, or analyzing identifiable or re-identifiable private participant data. Engagement extends to individuals such as faculty advisors and dissertation chairs that may not be doing those activities themselves, but are directly supervising someone (e.g., a student) who is recruiting, consenting, accessing or collecting data from a human or analyzing a human’s personally identifiable private data.
Human subjects research training proofs must be provided with the IRB application. Training helps to ensure a participant-centered research design, a research environment that protects participants’ rights and welfare, and researchers who know what to do to ensure ethical research practices. Please refer to the NC State University training requirements for completing research with human subjects guidance for our requirements. Training requirements apply to studies reviewed and approved by the NC State IRB at all levels, including exemptions.
Individuals seeking an individual investigator agreement from NC State University to assist a NC State researcher or team must provide their human subjects research training proofs to the NC State IRB office. Those training proofs must be submitted with the IRB application that the individual investigator is applying to assist an NC State researcher or team with.
External collaborators who are part of a cooperative research project and are overseen by another IRB with an FWA number do not need to provide proof of human subjects research training.
Contractors and consultants to NC State reviewed research typically do not need to provide training proofs either, but it depends on their role on the research team and with participants. Please email the IRB office if there are questions about if training needs to be uploaded for a contractor or consultant and include the eIRB protocol number and the source(s) of funding for the project.
Asynchronous Online Learning
CITI Training
The primary mode NC State researchers use to complete their training requirement is the CITI online training platform. CITI provides entirely asynchronous human subjects research training courses that are available continuously all day and night every week of the year. CITI training is accepted and, in some cases, required for certain types of research and/or research funding. NC State’s CITI license only extends to individuals currently enrolled or employed by NC State University as students, faculty, and staff.
Instructions for how to use CITI at no cost using one’s NC State credentials can be found on the Research Compliance Training webpage.
Individual Investigator Training for Cooperative Research
When NC State University researchers want to collaborate with individuals who are not affiliated with an IRB that has an FWA number on a research project, the University must execute an official agreement for those individuals to be a part of the NC State research team. As part of the agreement, the individual investigator is required to complete NC State’s human subjects research training requirements.
NC State’s CITI license does not extend to individual investigators. The cost of the CITI training needs to be born by the individual or through research funds. The NC State IRB office acknowledges that CITI training is costly and does offer an alternative training option but there are caveats. The alternative training is not acceptable for any studies that are funded from any source (including NC State), clinical trials studying a health related outcome, or are subject to additional oversight from any federal agency (e.g., DoD, DoE, ED, FDA, NASA, NIH, NSF, USDA, etc.).
To learn more about the alternative training, please review the training requirements for unaffiliated investigators, the PowerPoint template for lead researchers to edit appropriately, and the training completion and affirmation. The principal investigator is expected to take an active role in training their individual investigator(s) and provide their revised slide deck with
Synchronous Training Opportunities
Sessions Offered Through the NC State University Libraries
The NC State University IRB office has partnered with the NC State University Libraries to offer multiple sessions for researchers working with human subjects. These sessions are live and specialized targeting areas that researchers ask most about. These sessions are offered in the fall and spring semesters and include sessions such as IRB Basics: Part 1; IRB Basics: Part 2; IRB Basics: Part 3 – eIRB application (exempt and non-exempt); Medical Devices; Mobile Technology; Qualitative Research; Secondary Data; Survey Research, and more. A comprehensive list of offerings can be found by reviewing the list of available IRB workshops. Researchers sign up for these sessions through REPORTER.
Targeted Training for Your Classes or Research Team
We provide training for your team’s specific needs should you request targeted training from our office, including guest lectures for classes where research ethics and compliance are addressed. Use the Group Education Event Form to submit a request. All requests are honored when possible and advance notice is appreciated.
Drop-in Virtual Office Hours
Drop-in office hours are for anyone at NC State University that has IRB-related questions, such as if you even need to file an IRB application, what level of IRB review or type of IRB application you need to submit, or how to propose changes to an already approved protocol. While IRB staff won’t write your IRB application for you during office hours, we can be a sounding board and provide guidance to empower you to be able to successfully write or revise your IRB application.
Drop in office hours are offered twice a month during the Fall and Spring semesters. Each meeting has its own Zoom link and password. You can find more imore information in the News section of the IRB website’s homepage.
One-on-One Consultations
If you’d like to meet with us individually, please email the appropriate IRB office representative:
- Email irb-coordinator-pre@ncsu.edu about applying to the IRB, eIRB system issues, “just-in-time” requests, and .118 determinations
- Email irb-coordinator-post@ncsu.edu about protocol amendments, renewals, closures, post-approval monitoring, DoD/HRPO-affiliated research, ClinicalTrials.gov, and ResearchMatch
- Email irb-coordinator-admin@ncsu.edu about cooperative research matters (reliance agreements, letters of acceptance of an exemption determination, and individual investigator agreements) and projects supported by the NSF, FDA, and/or NIH
- Email irb-coordinator-ed@ncsu.edu about IRB class chats, drop-in office hours, specialized research topic workshops and events, educational resources and guidance, and questions
- Email irb-director@ncsu.edu for complex or nuanced questions