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 research participants including third parties, designing all research procedures, and uploading all required supplemental documentation (e.g., human subjects research training, consent materials, procedures for each data collection mode, and other materials that are required for review, e.g., exemption request form, OIT drafted data and access security plan (DASP) et al).

DASPs are required for all protocols that involve highly sensitive “red” data or ultra-sensitive “purple” data, NIH funding, a data use agreement (DUA) such as NCDPI and NCERDC data, material transfer agreement (MTA) such as biospecimen transfer from a HIPAA covered entity, and select other cases. To request a DASP, the principal investigator must request a data and access security plan request through the “Service Now Portal”. If a DASP is not required, researchers will detail their data management plan either in the exemption request form for studies that are eligible for an exemption determination or on the data security tab of the eIRB application.

Human subjects research training is required before 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. At minimum, this is the principal investigator and the faculty point-of-contact supervising a student who will be doing these activities. Proofs of training completion should be uploaded to the IRB application for all NC State University research team members and all individual investigators. If the research protocol is cooperative in nature and another IRB with an FWA number will oversee those collaborators, those individuals’ human subjects research training does not need to be uploaded because that IRB will ensure that the collaborator(s) have their training done.

To be eligible to submit an IRB application to the IRB office, you must be eligible to serve as principal investigator (PI) on a project. All student submissions must be supervised and submitted by the NC State faculty member guiding the student’s IRB application process, will be supervising the student through the human subjects research process once the protocol is approved, and who is ultimately responsible for the human subjects research work.

Infrequently, 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.

What to Include in Your Application

Before submitting a research proposal to the IRB office to pre-review, make sure you have included the following information:

• Research Purpose: A brief and clear explanation of what your study is about.
• Study Importance: A brief and clear explanation of why this research matters and needs to be done (aka “critical purchase” – what is your research adding to the scholarly discourse that is currently missing or contributing that isn’t yet available to people)
• Participant Details: A clear description of who will take part in your study and how they will be selected to participant. Participants include primary and third party participants who will be included in research interventions, interactions, manipulations of the human environment, and/or personally identifiable private data (information and/or biospecimens) that are collected from participants or scraped from secondary data. If any vulnerable populations are targeted (e.g., students – especially your own students, employees/subordinates) or excluded (e.g., elderly, pregnant) from the research, there needs to be a scientific justification for doing so as convenience is not an acceptable justification.
• Study Activities: A step-by-step breakdown of everything you will ask participants to do.
• Data Management Plan: Specific details on how you will collect, store, analyze, and share the research data – including future use such as inputting the research data into an AI tool or model.
  • For exempt-level studies that do not require a DASP, this information should be provided in the exemption request form
  • For non-exempt studies, researchers provide this information on the Data Security tab of the IRB application even if the research team also has a DASP for the protocol. BME department, please follow the instructions provided to your unit.
• Supplemental Documents: The below list is not exhaustive. What is required varies from study to study depending on the research design and can change as research contexts and laws do but at a minimum:
  • All studies must upload:
    • Human subjects research training certificates for all engaged members of the research team at NC State University and any individual investigators
    • Consent/permission/assent materials unless the study qualifies for and is granted a waiver of consent/permission or, for research involving minors, the children are under the age of 7 years old
    • All data collection procedures, eg. survey questions, semi-structured interview protocol, focus group protocol, food taste test ballot, benign behavioral intervention like a VR session or research lab visit with multiple processes and activities, etc.
    • All formal agreement paperwork associated with the study, e.g., executed data use/sharing agreement, executed material transfer agreement, institutional authorization agreement form for cooperative research studies
    • All completed ancillary reviews required by the IRB, e.g., scientific merit for non-exempt DoD affiliated research studies, code review for software/applications/AI tools that are modified or purpose-built, Institutional Biosafety Committee (IBC) review, Institutional Animal Care and Use Committee (IACUC), local/participant context reviews for all non-exempt international research and some exempt-level research as determined by the IRB office
    • Broad Consent form and specific research participant facing content if AI (including generative AI) will be used in the study:
      • To collect or analyze participant data
      • Interact, intervene, or manipulate a participant
      • To use participant data to build or test an AI model
  • Exempt studies also need to include:
    • Exemption request form
  • Non-exempt studies also need to include:
    • All participant recruitment materials
    • All participant communications, e.g., research participation confirmation/reminder emails, compensation communications, etc.
    • BME department: Please refer to IRB guidance specific to your unit on the Procedures and Guidance page

Submission Resources

For detailed information and help regarding the IRB processes and the online IRB application system, please review the following links. 

• Training Webpage
  • Asynchronous Training (CITI)
  • Synchronous and Asynchronous Training (NC State University Libraries IRB Workshops)
  • Group Education Events
  • Drop-in IRB Office Hours
  • Individual Consultations
• Cooperative Research Webpage
  • Reliance agreements for non-exempt research
  • Letter of acceptance of an exemption determination made for a cooperative research study determined to be exempt by another IRB with an FWA number
  • Individual investigator agreement for individuals not affiliated with an IRB with an FWA number that want to assist an NC State research team with the team’s research
• Exempt Protocols (Including FLEX Exemptions)
  • IRB Policies, Rules, and Regulations webpage – especially the unit standard on exemptions and (if applicable to the research proposed) FERPA
  • Exemption request form
  • Consent/permission/assent/Broad Consent forms
  • IRB Procedures and Guidance webpage for educational research exemption decision tree, specific unit-level guidance (e.g., DELTA, CVM, BME etc.), and guidance on various research methods and procedures
• Non-Exempt Protocols
  • eIRB screenshot tutorial for new non-exempt protocols and all (exempt and non-exempt) renewals and amendments – BME individuals, supplement this tutorial with guidance given to your specific unit
  • IRB Forms and Templates webpage
  • IRB Procedures and Guidance webpage
  • IRB Policies, Rules, and Regulations webpage