In accordance with federal regulations and UW–Madison polices, all research involving human participants must be reviewed and approved by an Institutional Review Board prior to any research intervention with a participant. See, UW-Madison IRBs on the UW-Madison Human Research Protection Program website (http://info.gradsch.wisc.edu/research/hrpp/index.html).
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(d); 21 CFR 50.3(c)).
A human subject (or human participant) is a living individual about whom an investigator (professional or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information. (45 CFR 46.102(f); 21 CFR 50.3(g)).
All UW–Madison undergraduate and graduate students engaged in any kind of research project (including independent study, research credits, senior thesis projects, Hilldale Awards, etc.) involving human participants must obtain approval of a campus IRB before beginning the research. Approval may be granted as part of a previously approved project by obtaining the agreement of the principal investigator, who must submit a change of protocol request to add the student's name as key personnel on the project application form. A student who submits an application for new protocol review by an IRB must list a faculty member or instructor as the principal investigator.
All graduate student research involving human participants for inclusion in a Master's thesis or doctoral dissertation must also be approved by an IRB before beginning the research. A graduate student who submits an application for new protocol review by an IRB must list their advisor or other faculty mentor as the principal investigator.
Note for social and behavioral research:
An additional policy applies if your project involves only the use of publicly available social science data sets. See, Existing Datasets Policy on the UW-Madison Human Research Protection Program website (http://info.gradsch.wisc.edu/research/hrpp/index.html).
Student projects conducted within an academic course may be categorized as either a course assignment or disseminated research. Disseminated research includes data that are formally presented to any audience beyond the course (e.g. poster, oral or written paper, seminar). Disseminated research must be reviewed by an IRB.
If the data collection and interpretation are for pedagogical purposes only and are contained wholly within the course environment, the student project should be categorized as a course assignment. Such data are gathered without the intention of dissemination beyond the instructor and students of the course.
All course assignments that do not fall under the category of disseminated research must still be planned and carried out with due consideration of the University's ethical and legal responsibility to protect individuals who participate in these activities, especially when participants are exposed to more than a minimal risk. "Minimal risk" is defined as risks anticipated in the proposed activity that are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
All projects involving special populations as participants (e.g., prisoners; individuals with physical or mental disabilities; economically or educationally disadvantaged; institutionalized individuals; pregnant women; fetuses) require additional safeguards. Suitable precautions must be taken to ensure the confidentiality of the results of any procedure pertaining to a particular person who is a participant in the activity. See, Vulnerable Populations on the UW-Madison Human Research Protection Program website (http://info.gradsch.wisc.edu/research/hrpp/index.html). UW–Madison's policies for human research protection are posted on the Human Research Protection Program website (http://info.gradsch.wisc.edu/research/hrpp/HRPPpolicy.html).