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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 first step in the review process is to determine if a research project needs IRB review and approval. The Quality Improvement Self-Certification Tool was developed by the UW-Madison Health Sciences IRB Office, and is a very helpful step for the research study team. This short survey tool allows study teams to decide independently whether their project constitutes the definition of “research” or “quality improvement project” under the Common Rule (45 CFR 46, 2018, U.S. Dept. of Health and Human Services) 
 
QI Survey Tool Link: Quality Improvement Self-Certification Tool
 
A Self-Certification survey summary of results will be sent to you upon completion of the survey tool. This tool is designed to provide a pre-certification that the project does not constitute research and further IRB review may not be required. Please note that all Quality Improvement Projects (and research), must be evaluated by the IRB.  Please submit your Self-Certification survey results to the IRB e-mailbox: irb@uwgb.edu. If a follow-up is necessary, we will contact you.  

 

Classroom Research Projects

Please note the IRB suggests that instructors take the short Self-Certification survey and seek IRB approval before conducting any part of a project in the classroom (see QI Projects link above). If your project needs IRB review, it is often expedited or exempt status, and reviewed relatively quickly by the IRB Chair. Research requiring a full board review can be evaluated at the next Board meeting. IRB meetings are held each month during the academic calendar year. If any clarification is needed, please feel free to consult the IRB Office anytime via email: irb@uwgb.edu.
 
If the project and/or experiment that you are doing in the classroom or lab qualify as “research,” then IRB approval is required. Furthermore, If research data or results are intended to be presented to an audience, IRB approval is required.
 
However, in-class presentations often do not constitute the definition of “research” - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. To be certain in this example, the IRB recommends that instructors and students take the short Self-Certification survey tool and/or contact the IRB Office with any questions or concerns. 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.

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 level of 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 research setting, regardless of the level of review according to the federal guidelines in 45 CFR 46.
 
Furthermore, 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. When possible, some strategies for decreasing the potential for coercion can be integrated into your protocol methodology:  

  • having 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.
  • making clear to students that data will not be analyzed until after the semester is completed and course grades have been submitted.
  • offering an alternative assignment for students who do not wish to participate in the study (this procedure is required if students receive either class credit or extra credit for participating in the study).