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Institutional Review Board

Students Seeking IRB Approval

Forms & Documents

Sample IRB Documents

First Time Submission Assistance

Before submitting your proposal to the UWGB IRB, please do the following:

  • Complete Human Subjects Research Compliance Training.
  • Explore the information on this page
  • If you need any further assistance, please feel free to contact the IRB Chair.
  • Submission Instructions

    Protocols must be submitted by the Principal Investigator (PI) and all correspondence will take place with the PI. Please note, students cannot be the PI. All necessary forms can be located at the top of this page. All submissions must be electronic unless pre-approved by the IRB chair. If you are having difficulties with the electronic form, please contact the IRB chair. Once complete, email the entire proposal as a PDF file to irb@uwgb.edu irb@uwgb.edu. The proposal must be sent as one complete document. Please include all relevant forms as well as the Human Subjects Research CITI certifications and signatures of all investigators involved.

    If you need to access your NIH training certificate, please use this link. Please note, investigators who have existing NIH certification can retain that valid certification for five years from the date of completion—as long as the date of completion is prior to August 1, 2017. Once expired, investigators will need to become certified through CITI.


    Determining if IRB Approval is Required for a Project

    Any project that meets the federal definition of research and uses human subjects must have IRB approval prior to data collection.

    For the purpose of IRB review, research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

    Likewise, human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

    What this means is that if your project uses human subjects and you intend on presenting your data in some sort of public venue (e.g., conference presentations, publication), federal guidelines require that your project be approved by the IRB before data collection.


    Determining if a Project is Exempt, Expedited, or Requiring Full Board Review

    There are three levels of IRB review: Exempt, Expedited, and Full Board Review.

    Research that is classified as Exempt will not require any further review after the initial approval and only needs to be reviewed by the chair of the IRB.

    Research that is classified as Expedited only needs to be reviewed by the chair or by a qualified member of the IRB that has been designated by the chair. It is, however, subject to annual review.

    If your project involves more than minimal risk to participants as defined previously, your project requires a Full Board Review.

    Read more about all three levels of review here.


    Submitting Protocol Modification Forms and/or Annual Progress Reports

    The following information applies to projects approved as expedited or by the full board only (i.e., those projects that are not "exempt"). Exempt research does not require any further review after the initial submission and review.

    Protocol Modification Forms

    If you would like to make any changes to your protocol, you must submit a Protocol Modification Form to the Institutional Review Board. If the modifications are minor (i.e., title change, agency change, addition of data collection sites, etc.) the IRB Chair or designee will review the protocol. If the modifications include more than minimal risk, the protocol will be included on the next IRB agenda for FULL BOARD review.

    Annual Progress Reports

    Projects can only be approved for one year and, if the researcher intends to continue the project past one year, it must receive an annual review from the IRB. The annual review process is as follows:

    1. The researcher will receive a reminder from the IRB one month before their annual review is required.
    2. The researcher submits an Annual Progress Report, outlining any changes or modifications that have been made and/or any adverse events that have occurred.
    3. Unless there have been substantial modifications made to the original protocol, the Annual Progress Report need only be reviewed by the IRB Chairperson.

    *Please note that Annual Progress Reports are needed only if the project continues past 1 year. Annual Progress Reports do not take the place of Final Reports.

    Final Reports

    At the end of one year, unless a protocol modification has been filed and approved, a Final Report form must be submitted. Failure to submit a Final Report may result in future protocols denial. If you have any questions about what information needs to be included in the final report please contact the IRB chair.

    Giving Read-Only Access to Qualtrics Surveys

    To allow the IRB Chair to only view the actual survey(s), do the following:

    1. Log-in to Qualtrics

    2. Select "Collaboration" from the same row as the survey name
    3. In the box on the top left, type the IRB Chair's email address
    4. Click "Add"
    5. Click "Copy"
    6. Click "Save"