OFFICE FOR PROTECTION OF HUMAN SUBJECTS

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ABOUT RESEARCH COMPLIANCE AT THE UO

In accordance with the Federal Policy on the Protection of Human Subjects (DHHS Policy 45 CFR Part 46, effective August 19, 1991), University of Oregon assumes the responsibility for the protection of the rights and welfare of human subjects who participate in research and other activity projects conducted by, or under the supervision of, faculty, staff, or students. To conduct this responsibility effectively, the University maintains a Committee for the Protection of Human Subjects/Institutional Review Board (CPHS/IRB) competent to review research, training, and other activity protocols involving human subjects and to evaluate both risk and protection against risk for those subjects. It is the function of the CPHS/IRB to (1) determine and certify that all projects reviewed by the CPHS/IRB conform to the regulation and policies set forth by DHHS regarding the health, welfare, safety, rights, and privileges of human subjects; and (2) assist the investigator in complying with DHHS regulations in a way that permits accomplishment of the research activity.

The CPHS/IRB aims to provide a service to the University and the public by facilitating ethical treatment of research subjects while at the same time supporting the investigator's endeavor to advance knowledge.

Research Involving Human Subjects

All research projects in which human subjects participate, whether funded or unfunded are subject to the federal regulations governing such research. When an investigator plans to conduct research involving human subjects, s/he would be advised to contact the Office for Protection of Human Subjects (OPHS) as early as possible. Aspects of a project which may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way which will facilitate approval.

Determining Human Subjects Involvement

The initial determination as to whether a research project should be considered human subjects research should be made by the investigator. Investigators should consult the Office for Protection of Human Subjects for advice on this question. Final authority for making this determination rests with the Committee for the Protection of Human Subjects/Institutional Review Board (CPHS/IRB) or its designee. For additional guidance on determining human subjects involvement and level of review, see the regulations decision charts at the following link to the Office of Human Research Protections.

In general, research which involves data gathered solely for internal, on-campus use would not need to be reviewed (e.g., classroom initiated research or training grants). If, however, the results of this research will be disseminated in any way, then the research must receive prior approval from the CPHS/IRB. If no dissemination is planned at the time the data are gathered, but the possibility of future dissemination exists, the faculty member/student would be advised to submit the project for approval prior to initiating the research. The Committee is unable to give post facto approval.