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Institutional Review Board

Faculty & Academic Staff Seeking IRB Approval

Forms & Documents

Sample IRB Documents

First Time Submission Assistance

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

  1. Complete Human Subjects Research Compliance Training Step-by-step registration instructions can be found here
  2. Familiarize yourself with the IRB Policy and Procedures Manual
  3. Explore the information on this page
  4. If you need any further assistance, please feel free to contact the IRB Chair.

Submission Instructions

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 and the IRB Chair. The PI must submit this protocol and all correspondence will take place with the PI. The proposal must be sent as one complete document. Please include all relevant forms as well as the IRB certifications and signatures of all investigators involved.

If you need to access your existing 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.

Classroom Research Projects

If the projects and/or experiments that you are doing in the classroom or lab qualify as research, then IRB approval is required. However, in-class presentations do not constitute a contribution to generalizable knowledge. Thus, unless the intention is to present to an audience outside the institution, IRB approval is not required.

All course assignments involving human participants that do not fall under the category of research must still be planned and carried out with due consideration of the University's ethical and legal responsibility to protect individuals involved in these activities.

Keep in mind that unless the research requires full board review, it can be evaluated relatively quickly, as is often needed for the classroom setting.


Scholarship of Teaching and Learning (SoTL) Projects

SoTL Projects require the same IRB approval process that any other project would require.

Most, but not all, SoTL Projects qualify for either exempt or expedited review. However, because many SoTL projects utilize the instructors' own students as participants and given the inherent power differential present in the teacher-student relationship, the potential for coercion is great in this type of research, regardless of the level of review. Students may feel pressured to participate in such projects because they are worried about the impact of not participating on their grade, wish to help out an instructor who they like, etc.

Some strategies for decreasing the potential for coercion are to (when possible):

  • Have someone, unaffiliated with the class or the data analyses, collect the data so that whether or not a student participated will be unknown to the instructor.
  • Make it clear to students that data will not be analyzed until after the semester is completed and grades have been submitted.
  • Offer and alternative assignment for those students who do not wish to participate in the study (this is required if students receive either class credit or extra credit for their participation).

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"