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Preparing an IRB Submission

Once you have determined that your project needs IRB review, complete the steps below to prepare your IRB submission documents.

  1. Begin your submission in Cayuse.
  2. Required Forms. All applications will need at least the following forms
    1.   Informed Consent Document (unless waiver requested)
      1. Create Consent Document as a Word document and upload.
      2. Use “Informed Consent Checklist” in IRBNet “Forms and Templates” to be sure all required parts are included
      3. See “Informed Consent Sample” in IRBNet “Forms and Templates” for an example
    2. Measurement tools (e.g., surveys, interview questions, physical measurement, demographics)
      1. Create measurement tools as a Word document and upload.
    3. Recruitment materials (e.g., script, talking points, email, letter)
      1. Upload own version of recruitment materials
    4. CITI training certificates
      1. Upload the CITI certificates for all faculty, staff, and students on the project
    5. Institutional Alliance Agreement (IAA)
      1. Submit this document if (1) UNF’s IRB is the IRB of record, (2) the PI of the study is UNF faculty, staff or student (with faculty advisor) and (3) desires to share anonymous/de-identified data with an external, collaborating Co-PI at another university.
      2. Submit this document when (1) UNF faculty, staff or student (with faculty advisor) is a Co-PI on an external study with (2) and external PI and (3) where the external institution’s IRB will be the IRB of record.
    6. Dual Use Agreement
      1. Submit this form if an Institutional Alliance Agreement (IAA) will not be used.
      2. Submit this form when the UNF PI has secondary, anonymous/de-identified data to be shared with an external Co-PI who is not on the protocol.
  2. Optional Forms. The nature of the project will determine the optional forms that need to be uploaded. IRB will need to see copies of all documents you will be using in your interactions with human subjects. Download templates of forms from IRBNet “Templates and Forms” or create versions when templates aren’t available, complete them, and upload them into your IRBNet package. Common forms include:
    1. Debriefing document (applicable if using deception or more than minimal risk)
    2. Informed Assent (applicable if including those without capacity to consent such as minors)
    3. Parental/Guardian Permission (applicable if including those without capacity to consent such as minors)
    4. IRB approvals from collaborating institutions (if collaborating institution has IRB)
    5. Letters of support from controlled facilities (e.g., principal letter of support)
    6. Funding applications and award letters (if applicable)
  3. Sign Package (PI and Faculty Advisor if Student is PI)
  4. Submit Package


Federal Guidelines: 45 CFR 46: HHS Federal Policy for Protection of Human Subjects

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