Depending on the nature and purpose of the project, student research may require IRB review as described below.
All UW–Madison undergraduate and graduate students engaged in human participants research must obtain UW-Madison IRB approval or exemption before beginning the research (except for some class-related projects; see below). The research of a graduate student involving human participants for inclusion in a master’s thesis or doctoral dissertation must be approved or determined to be exempt by a UW-Madison IRB before beginning the research.
Student projects conducted within an academic course involving data, samples, or images collected from or about people may meet the federal definition of human participants research if the project is systematic and develops or contributes to generalizable knowledge.
If the data, sample, or image collection and interpretation are for pedagogical purposes only and gathered without the intention of dissemination beyond the scope of the course, the student project should be categorized as a course assignment rather than human participants research and thus IRB review is not required. For example, IRB review is not required when course work may be presented to a group beyond the course as part of the pedagogical process, such as an event showcasing the work of students in the class. In these situations, this limited dissemination is not considered to constitute developing or contributing to generalizable knowledge and thus the requirement for IRB review is not triggered.
Course Instructor and Advisor Responsibilities
Course instructors and faculty/staff members who serve as the formal advisor to a student on a project are responsible for the following:
- Ensuring that the student is aware of the requirement to obtain IRB approval or exemption prior to any engagement in human participants research.
- Determining prior to assigning a project, whether the project is a course assignment or constitutes human participants research and ensure that any students engaged in human participants research obtain IRB approval or exemption prior to commencing that project.
- If a student research project is originally conducted as a course assignment, but develops into human participants research, the faculty member or instructor overseeing the course or project must ensure IRB approval or exemption is obtained before the project can continue.
- Monitoring student projects conducted as part of coursework for the impact on human participants, especially maintaining participant confidentiality, assuring freedom of participants to withdraw from the project without penalty, and obtaining consent for participation in the project when reasonable.
- Ensuring student researchers give due consideration of the University’s ethical and legal responsibility to protect participants and their data, especially when participants are exposed to more than a minimal risk or participants include those who are considered a vulnerable population.
- Ensuring any changes in the research project, adverse events, or incidents which may affect the conduct of research will be reported to the IRB.
- Reviewing the proposed research study, including assessing whether the topic and design are appropriate for student research.
- Ensuring the student researcher has the necessary experience and training to conduct the research.
- Meeting with the student researcher on a regular basis to monitor study progress.
- If the study procedures are carried out in a location away from the University or regular channels of communication are not feasible, you will make alternate arrangements to continue communication with the student-investigator;
- If you will be unavailable, you will arrange for an alternate faculty advisor to assume the above responsibilities and will advise the IRB of this change.