All student research activities involving human subjects must be supervised by a faculty member. Some types of student research activities may not require IRB review beyond faculty supervision because the goal of the research is strictly educational and not intended for generalizable knowledge. In other cases, the faculty member should submit a classroom protocol to the IRB for review.
What Classifies as a Classroom Protocol?
All of the following must be true in order for human subjects research conducted in a classroom setting to be considered outside the purview of the IRB (no IRB approval needed):
- It is a normal part of the student’s coursework
- It is supervised by a faculty member
- Its primary purpose is the development of student skills
- It does not involve more than minimal risk
- It does not include any research subjects under the age of 18
- It does not involve any persons who could be considered as coming from protected or vulnerable’ populations
- It does not involve personal, incriminating, or sensitive topics
- It is not pursued in order to publish the results or share at professional and academic conferences and gatherings.
Research projects involving human subjects for which the primary purpose of the research is to be a learning experience in the methods or procedures of research do not meet the federal definition of ‘research’ and are excluded from IRB review unless the research involves greater than minimal risk, targets vulnerable populations, or involves methods or questions with sensitive, personal, or incriminating topics.
For full definitions of minimal risk, vulnerable populations, and sensitive topics see the Institutional Review Board’s Policy on Classroom Research Prodecures.
How to Submit a Classroom Protocol
To receive approval of a classroom protocol instructors will need to submit the Application for Initial Review to the University of St. Thomas IRB. The approved application will serve as study approval for students in the class where research is to be conducted. When filling out the application, instructors should be sure to indicate that the application is for a classroom protocol (section A.3). Please note that IRB approval for a classroom protocol may not exempt all students from IRB review. Approval of a classroom protocol extends to research projects that involve no more than minimal risk, do not target vulnerable populations, and do not involve methods or questions with sensitive, personal, or incriminating topics. If a student has a project that involves such risks, submission of an Application for Initial Review specific to the student’s research is necessary. The Application for Initial Review can be found on IRBNet. If you have any questions regarding whether or not a research study is excluded from IRB review, please contact Sarah Muenster-Blakley, Director of the Institutional Review Board at firstname.lastname@example.org or call (651)-962-6035.