Human Subject Research
The University of Wisconsin-Green Bay's administration and research community endorses the importance of protecting the welfare and rights of all individuals who take part in any study initiated by UWGB faculty, staff or students. While many studies involve little or no risk to the individual, certain studies may involve short or long-term risks which will require the informed consent* of those involved and a collegial determination that the risks are minimal and justified in terms of the expected benefits.
All studies, either funded or unfunded, which involve other than trivial risk to the individual or groups of individuals as determined by the Principal Investigator or the Coordinator of the Office of Grants and Research Research, and/or the Vice-Chancellor's Office, will require formal review by the Human Subjects Review Committee which serves as the Institutional Review Board (IRB) as defined in the Federal Government Regulations 45 CFR Part 46 (Federal Register 1/26/81, PP8366-8392). It should be noted that the UWGB policy goes beyond the federal regulations and seeks to provide advice on all projects, whether federally funded or not, which involve non-trivial risks to human subjects.
The definition of low or trivial risks follows the federal guidelines which, for example, generally exclude school based testing in subject areas, and questionnaires which provide anonymity and require generally public information.
Student research projects normally will not be reviewed by the IRB but should be reviewed at the faculty/department/unit level. The faculty member or members supervising student research requiring review will inform their unit chair, who will appoint a Unit Review Committee (URC). Any case which, in the judgment of the Unit Review Committee, involves significant risk or minimum benefit must be submitted to the IRB for review.
Faculty and staff must declare the level of risk on the "Internal Review Form" (the green sheet) which accompanies the review of each formal proposal for extramural funding. PI's will be asked to rate their proposal involving human subjects as:
- No human subjects
- Little or no risk to human subjects
- IRB approval requested
In cases where there is uncertainty on the level of risk, the IRB review will be mandatory.
Approval by the IRS will be based on the federal guidelines referred to above, but the essential components are:
- Minimum risk to the individual in terms of physical or psychological factors as well as guaranteeing rights to privacy
- Desirable benefit to the individual, to society or to social groups
- Signed forms from the research subjects indicating full compliance with informed consent
- The PI will be required to file a report requesting approval using the attached format for funded or unfunded projects deemed to need IRB review. Detailed information on compliance with the federal regulations and request for review forms are available in the Office of Grants and Research. The request must reach the IRB two weeks before the submission deadline. Approval is for a period of 12 months.