Risks to Research Participants

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The University of Oregon accepts as a basic principle that it has an ethical and moral obligation to safeguard the rights and welfare of all subjects involved in research, training, educational development and other activities where subjects are exposed to a risk that could be detrimental to their health or well-being. In those cases where risk may exist, even with informed consent, approval of a research project will be made only if the potential risks to the individual are outweighed by potential benefits. In evaluating risks and benefits, the CPHS/IRB shall not consider long-range effects of applying knowledge gained in the research as among those risks that fall within the CPHS/IRB's purview of responsibility.

The university shall be responsible for physical or psychological injury to human subjects attributable to university-sponsored research, development, and related activities, to the extent that the university may be found liable under federal and state laws. Therefore, the obligation of researchers to conduct activities in a manner and at such locations as will assure the proximity of adequate medical attention if warranted, and to provide appropriate referrals to subjects for adequate facilities and professional attention should subjects suffer physical, psychological or other injury, is of paramount importance when designing research involving human subjects.

The seriousness of a risk to subjects is a function of the magnitude of the harm and the probability of the harm. A risk may be serious or significant because it has a probability (even a low probability) of great harm (e.g., a low probability of death), or because it has a high probability of slight harm (e.g., a near certainty of physical discomfort or psychological distress).

The risks of participation in research may be part of the research design or may be a consequence of the research procedures, or both (e.g., the risks of an adverse reaction to an investigational drug are part of the research design, while the risk of hematoma from blood drawn in the research is not part of the design but a consequence of the research procedures). Risks may be a consequence of the methods of recording, maintaining, or reporting data, and they may be a consequence of methods of obtaining informed consent.