Human Subjects Review (HSR)

Understanding Risk

Any person who consents to participate in a research project encounters some risk of harm or discomfort. Risk could range from discomfort about the loss of time that it takes to participate in a brief survey to actual physical harm or death.

As part of the human subjects review process, researchers are asked to identify and address the risks of harm or discomfort to which subjects may be exposed as they participate in the proposed research. The design of the research should minimize all risks as much as possible. Any remaining risks must be clearly identified to participants so that they may make an informed choice about whether or not to participate in the research.

Risk means the possibility of harm or discomfort—including physical, psychological, social, or economic—that a human subject of research may be exposed to as a result of participating in the research. Risk can vary because of a number of factors, including the vulnerability of the subject population, the qualifications of the researcher, and the nature and methods of the research.

Minimal risk, as defined by federal law, “means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i)). For more information about what constitutes minimal risk, refer to the federal Office for Human Research Protections’ guidance about minimal risk research activities.

Risks to human subjects of research generally fall into three categories: physical, psychological, and privacy.

Physical risks

The risk of physical harm is of paramount concern in the protection of human subjects. It is of extreme importance that research participants be protected from participating in research that may lead to their physical harm unless the risk of harm is fully disclosed, mitigated to the degree possible, and justified by the potential benefits of the research. (Read more...)

Psychological risks

Research involving human participants at Evergreen is more likely to be about social science or behavioral than biomedical topics. While the associated risks are usually less for these kinds of projects than in biomedical studies, the potential for harm still exists.  A research activity (e.g. survey, questionnaire, interview, viewing of stimuli) or experimental condition that could potentially result in emotional distress or other forms of psychological disturbance may be considered more than minimal risk. (Read more...)

Risks from loss of privacy

The researcher and the IRB must consider whether any activity could potentially result in negative consequences for the subject due to loss of privacy or breach of confidentiality, and if the research protocols present more than minimal risk for the release of private information. Care must be taken that all aspects of a project (e.g., subject recruitment; research interactions and protocols; data collection, storage, and destruction; reporting) are conducted to adequately protect and secure subjects' private information. (Read more...)