Step 2: Preparing and Submitting an Application
Preparing to Submit
Before you submit an application through NC State’s eIRB system for review and approval, the study (or the study portion of the project) must be completely designed. This includes identifying all target participants including third parties, submission of recruitment methods, consent forms, and all instruments and modes of data collection used with participants. This also includes a plan for data access and security. In some cases, it’s necessary for studies to be submitted in phases or stages; please follow the NC State IRB guidance for phased and staged research if needed.
Additionally, training is required prior to IRB approval for anyone on the research team who’s involved in the recruitment process, consent process, implementation of interventions and other data collection processes, or analysis of identifiable or re-identifiable private data — or those supervising a student who will be doing these activities.
All student submissions must be supervised by a faculty point-of-contact who is ultimately responsible for the work and guiding the student through the research process and the IRB process.
To be eligible to submit an IRB application on your own, you must be eligible to serve as Principal Investigator (PI) on a project.
What to Include in Your Application
You must include:
- What the research is about
- Why the research is important
- How the researcher plans to carry out the research project, including:
- Who the participants in the study will be
- The details about all study activities that the researcher would like to implement
- How the research data will be handled, stored, analyzed, and shared
- All participant materials (e.g., recruitment materials, consent materials, procedural protocols and tools, etc.)
- Supplemental materials, as needed (e.g., human subjects research training certificates, cooperative research materials, executed data use agreement or material transfer agreement, scientific merit review, local/participant context review, etc.)
- To apply for an exemption determination, please review the NC State University IRB unit standard on exemptions and directions included in the exemption application form before submitting your materials to the eIRB system.
Submission Tips and Guidance
For detailed information and help regarding the IRB processes and the online IRB application system, please review the eIRB screenshot tutorial for new protocols, amendments, and renewals.
- eIRB screenshot tutorial
- Required human subjects research training
- Required Forms and Suggested Templates
- Understand your Obligations: Laws, University Regulations, and IRB Unit Standards
- Guidance from the IRB on Research Methods, Study Design, and Other Considerations
- Planning Cooperative Research, Reliance Agreements, and Private IRBs