The purpose of this policy is to clarify that UW-Madison students engaged in human participants research are subject to human research protection policies, how to determine when students are engaged in human participants research, who is responsible for making this determination, and the oversight of course assignments.
- Application of Human Research Protection Policies to Student Research
- All UW–Madison undergraduate and graduate students engaged in human participants research (see Section II for a description of human participants research) must obtain UW-Madison IRB approval or exemption before beginning the research. 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.
- Determining When Students Are Engaged In Human Participants 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.
- There are cases where 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.
- Responsibility for Determining When Students Are Engaged in Human Participants Research
- It is the responsibility of the instructor overseeing the course or faculty/staff member who serves as the formal advisor to a student on a project to ensure that the student is aware of the requirement to obtain IRB approval or exemption prior to any engagement in human participants research.
- It is the responsibility of the faculty member/instructor overseeing a course to determine, 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.
- Oversight of Course Assignments
- It is the responsibility of the faculty member/instructor to monitor student projects conducted as part of coursework for the impact on human participants, especially in regard to maintaining participant confidentiality, risks for participants, assuring freedom of participants to withdraw from the project without penalty, and obtaining consent for participation in the project when reasonable.
- Any course assignments that do not meet the definition of human participants research must still be planned and carried out by the student with due consideration of the University's ethical and legal responsibility to protect participants in these activities and/or their data, especially when participants are exposed to more than a minimal risk or participants include those who are considered a vulnerable population. Suitable precautions must be taken to ensure the confidentiality of information obtained from or about participants in the activity.
Adopted By: All Campus IRB
Adoption Date: April 4, 2002
Revised By: Cross Campus Human Research Protection Program (HRPP) Advisory Committee
Revised: March 26, 2015
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