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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 Human Subjects Committee (HSC) 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. March 8, 1983), define "research" as "a systematic investigation designed to develop or contribute to generalizable knowledge." The same guidelines define "human subject" as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the person, or (2) identifiable private information." 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 HSC and to its adopted procedures.

Procedure

For each human subject research project, a "Request for Approval of Human Research" form is to be completed and submitted to the Office of the Provost/Vice Chancellor for transmittal to HSC. Formal approval of that request must be obtained before the human subject research portion of that project may begin. There are three different approval processes, dependent upon the type of human subject research involved. In some instances only the completed "Request" form and minimal time will be needed to obtain approval; other instances will necessitate both additional documentation and additional time.

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. The sponsoring faculty member should submit the request forms on behalf of the student and is responsible for assuring adherence to the guidelines.

Detailed information regarding procedures is provided in the HSC document, "Procedures for Requesting Approval of Human Subjects Research." Copies of this document, application forms, or the background document, "Assurance of

Compliance with HHS Regulations for Protection of Human Research Subjects," are available from department chairpersons or the Office of the Provost/Vice Chancellor. Direct requests for additional information to HSC members or the Office of the Provost/Vice Chancellor.

900 Wood Road · P.O. Box 2000 · Kenosha, WI 53141-2000 P 262-595-2345