Policy 25
University of Wisconsin-Parkside
Human Subject Research Policy
Policy #25
Background
Because it is morally and ethically imperative that the rights and freedoms of the individual be honored and protected throughout research activities, UW-Parkside has filed formal assurances with the Department of Health and Human Services (HHS) that the university will furnish those protections, to the best of its ability. This assurance involves any activity conducted by the university or its agents, including faculty, staff, or students. The procedures adopted by the UW-Parkside Institutional Review Board (IRB) are designed to achieve that goal and to implement those assurances. At the same time, it is imperative to avoid unnecessary impediments to the conduct of legitimate research, and the procedures also seek to serve that goal.
The assurances and procedures pertain solely to research involving human subjects. The relevant federal guidelines, 45 CFR 46 (Rev. July 19, 2018), define "research" as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." The same guidelines define "human subject" as "a living individual about whom an investigator (whether professional or student) conducting research: (I) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (II obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." Any activity which might reasonably be construed as satisfying these definitions and which is performed in any sense under the aegis of UW-Parkside is subject to the jurisdiction of the IRB and to its adopted procedures.
Procedure
All individuals involved with conducting research on human subjects must go through CITI Human Subject Research training. This includes faculty and staff as well as students. Students acting as researchers or research assistants in conducting human subjects research should complete CITI training. The IRB suggests that students in classes where research on humans is taught complete CITI training.
For each human subject research project, a study proposal must be submitted through the online Cayuse for IRB submission system for review by the IRB. To complete submission of the study, the proposal must be certified by the principal investigator and an organizational approver (department or program chair or dean) before the IRB can review it. The study proposal will be reviewed by an IRB analyst who will determine if the study should be processed as exempt or go through an expedited or full board review. Formal approval of the study proposal must be obtained before the human subject research portion of that project may begin.
Research conducted by students must be carried out under faculty supervision and sponsorship--whether or not it is to be conducted as part of a classroom project. Research conducted by students in a classroom setting with the primary instructional purpose of learning how to conduct research is not required to be submitted for IRB review, but this research must be closely supervised by the instructor to ensure that the research complies with ethical guidelines. Because the primary purpose of this form of research is instructional, students do not need to submit their projects for IRB review. These projects would be considered exempt from IRB review as they would not qualify as ‘research’ under federal guidelines given that the intention of the projects is not to contribute to generalizable knowledge per se, but for student learning. However, the following conditions and stipulations apply. It is the instructor’s responsibility to supervise student research projects to ensure that they comply with guidelines for the ethical conduct of research involving people as research subjects. Instructors should submit their assignment descriptions to the IRB for review for official exemption at the start of, if not prior to, the semester of the class research project. If there are plans or the possibility for presentation or publication of student research projects, those projects should be submitted for IRB review prior to the collection of data.
Human subjects research carried out by students to complete graduate degree thesis requirements or for the purpose of public dissemination must be submitted for IRB review. The sponsoring faculty member will be the officially designated principal investigator for the study. The study may be submitted by either the faculty sponsor or by the student.
Additional detail information regarding IRB review processes may be obtained through the IRB website (https://www.uwp.edu/explore/offices/researchadmin/irb.cfm).
*Revised Fall 2022