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Do I need IRB approval?

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.

Quality Improvement Projects

The Quality Improvement Self-Certification Tool was developed by the UW-Madison Health Sciences IRBs Office.

This tool allows study teams to make the decision about whether their project constitutes the definition of research under the Common Rule (45 CFR 46) independent of the IRB. The tool is designed to provide certification that the project does not constitute research and further IRB review is not required.

Program Evaluation Self-Certification Tool

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).