GUIDELINES FOR HUMAN SUBJECTS RESEARCH AT UW–STEVENS POINT
Statement of Principles, Summary of General
Institutional Policies and Applicability
The University of Wisconsin–Stevens Point is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as "The Belmont Report."
The University is committed to compliance with federal rules for the protection of human research subjects. In general, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR Part 46), known as the "Common Rule," are followed by UW–Stevens Point regardless of the source of project funding. This commitment is in compliance with the Office for Human Research Protections (OHRP, formerly OPRR) now under the direction of the Office of the Secretary, Department of Health and Human Services. This commitment requires UW–Stevens Point to comply with the comprehensive regulations published in the Common Rule which require that all research projects involving human subjects be approved by an Institutional Review Board (IRB). The Food and Drug Administration (FDA) also protects human research subjects through its investigational drug and device regulations.
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
The regulatory requirements are applicable to all University authorized activities which in whole or in part involve research with human subjects if one or more of the following apply:
In accordance with federal regulations, all research involving human subjects must be reviewed by the Institutional Review Board for the Protection of Human Subjects (IRB).
The IRB has the authority to review, approve, disapprove, or require changes for approval in research activities involving human subjects. IRB members come from a variety of disciplines, including at least one member who is not affiliated with the university.
The IRB requires completion of a research protocol form. The form contains explanatory information about the specific requirements. IRB approval is required for all research involving human subjects. In addition, the IRB requires that everyone dealing with subjects must receive training in research ethics. This requirement can be met by completing the Human Subjects Protection Training.
If the protocol is for a sponsored project, IRB approval must be provided to the office of Grant Support Services before an account can be established by the university. Protocols may be submitted as part of an application for external funding, which may require IRB approval at the time of submission of the grant proposal. Approval must be indicated on the UW Transmittal Form.
If a project does not initially include human subjects, but human subject participation is needed at later time, the PI must submit a protocol and obtain IRB approval prior to initiating the research activities involving human subjects. For such projects that have extramural support, the office of Grant Support Services must be notified of IRB approval. The office of Grant Support Services will notify the sponsor of the IRB’s approval and human subject participation will not be permitted until this certification of IRB review and approval is received by the sponsor.
Usually, IRB approval is granted for a period of one year. For projects of longer duration, the PI must submit a renewal application. Each IRB conducts continuing review of all research involving human subjects at intervals appropriate to the degree of risk, but not less than once per year, depending on the nature of the research and the risks to human subjects. Research can only be renewed twice using the form for Renewal of Continuing Research. After that, a new form for Original Research must be submitted for review and approval. In accordance with federal regulations, the IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's decisions, conditions, and requirements, or that has been associated with unexpected serious harm to subjects.
Changes in research protocols, which may alter the risks to the research subjects and occur during the period for which IRB approval has already been given, must not be initiated by the PI until the proposed changes are approved by the IRB. An exception is made for changes necessary to eliminate apparent immediate hazards to the subjects.
Human research involves risks that may be social, psychological, financial, or physical. Others, in addition to the research subject, also may be at risk, including persons discussed in the study, the investigator, society at large, and UW–Stevens Point. The IRB does not expect research to be free from risk, but does expect the investigator to be aware of the risks, to minimize risk when possible, and to take appropriate precautions whenever necessary.
For more information contact one of the following persons:
Dr. Jason Davis, Chair
OR
Dr. Michael (Mick) Veum, Associate Vice Chancellor
IRB - Human Subjects
Academic Affairs/202A
Main
346-4598 346-3710
jdavis@uwsp.edu
mveum@uwsp.edu
Protocols should be addressed to IRB/Grants Office and sent to 204 Old Main Building.