Safeguarding Rights of Research Subjects
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 Committee for the Protection of Human Subjects (CPHS)/Institutional Review Board (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.
Responsibilities
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.
Level of Risk
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.
Examples of Potential Risks to Subjects
Potential risks fall into five broadly-defined categories. Research Compliance Services and the CPHS/IRB will weigh the potential risks of research against the potential benefits as part of the review process.
Researchers are expected to take steps to minimize potential risks.
Physical risks include physical discomfort, pain, injury, illness, or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric magnetic or gravitational fields, etc. Engaging a subject in a social situation which could involve violence may also create a physical risk.
Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Sensory deprivation, sleep deprivation, use of hypnosis, deception, or mental stresses are examples of psychological risks.
Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include payment by subjects for procedures not otherwise required, loss of wages or other income, and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.
Legal risks exist when the research methods are such that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable.
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the right to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data. In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity. If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized staff may access it. Identities of individual subjects must never be released without the express consent of the subject. In addition, if an investigator wishes to use data for a purpose other than the one for which it was originally collected and the data are still identifiable (e.g., a code list for the data still exists), the investigator may need to obtain consent from the subjects for the new use of the data.
