Teaching Projects that Involve Collecting Data from Human Subjects
Students in courses often carry out projects that involve collecting information from people. Students in a course in research methods may, for example, learn how to conduct interviews by developing a set of questions about some topic, interviewing several other students about that topic, and then reporting their findings back to the classroom. In most cases, such course-based projects do not meet the federal standard of "research." However, that determination should be made by the IRB, so educationally focused projects require "limited review" by the IRB.
To initiate that review instructors assigning educational projects involving collecting data from human subjects are asked to contact the IRB and provide relevant details so that the IRB can make a determination regarding the projects’ status as “teaching activity” or "scientific research." The email should include a brief description of the project and address the following questions:
- What is the purpose of the project? (Note: Many projects involve collecting data from other people, but some of these projects are designed to achieve non-scientific outcomes. For example, teaching projects are designed to achieve educational outcomes (e.g., teaching students about research methods or to further their understanding of course material).
- Is the project a systematic investigation that will support conclusions that hold (generalize) across contexts and populations? (Note: The Code of Federal Regulations (45 CFR 46) pertaining to human participant protections defines research to be “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Activities such as journalistic interviewing, oral histories, program evaluations, consumer opinion sampling, and data-based strategic planning are not designed to yield information that generalizes to other contexts and populations.)
- Will the findings be made available to other researchers? (Note: Findings that are never communicated to the scientific community are not generalizable knowledge; communication can traditional publications, but also presentation at scientific meetings or colloquia, a paper stored in the university library, in a research data-base accessible from the Internet)?
- Do you plan to use the data generated in a subsequent research project that is designed to yield generalizable knowledge? (Note: Retroactive approval of data collected for non-research purposes is rarely granted by the IRB).
The IRB will review the educational activity to determine if the project is one that falls under the regulatory standards of the 45 CFR 46. If that review indicates the project does not require approval by the IRB, then the instructor will be asked inform their students that the project is a course-based learning activity and is not designed to yield generalizable findings. As a class-based learning activity, it is not a formally-approved IRB study, and should not be described as "approved" by the University's IRB. Additionally, it may not be included in any future research nor communicated to the scientific community (e.g., disseminated in a research forum).
Please note:
- Determinations are for the current academic year only. Because regulations and policies pertaining to the ethics of humans in research change over time, you are asked to renew the approval of this teaching project each academic year.
- The IRB recommends that all students who conduct projects involving human participants, and their supervising instructors, complete training in the ethics of research. You and your students can meet this requirement by completing the training online.
- The IRB recommends that your students document those who take part have been informed about the project and consent to participate. If a consent form is used, should not indicate that the project has been approved by the University of Richmond IRB as the IRB does not have the authority to make that determination.
- If the project is determined to be research, then a complete IRB submission will be required.