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Risk–benefit analysis is the comparison of the risk of a situation to its related benefits. Exposure to personal risk is recognized as a normal aspect of everyday life. We accept a certain level of risk in our lives as necessary to achieve certain benefits. In most of these risks we feel as though we have some sort of control over the situation. For example, driving an automobile is a risk most people take daily. "The controlling factor appears to be their perception of their individual ability to manage the risk-creating situation." Analyzing the risk of a situation is, however, very dependent on the individual doing the analysis. When individuals are exposed to involuntary risk (a risk in which they have no control over), they make risk aversion their primary goal. Under these circumstances individuals require the probability of risk to be as much as one thousand times smaller than for the same situation under their perceived control.
Evaluations of future risk:
- Real future risk, as disclosed by the fully matured future circumstances when they develop.
- Statistical risk, as determined by currently available data, as measured actuarially for insurance premiums.
- Projected risk, as analytically based on system models structured from historical studies.
- Perceived risk, as intuitively seen by individuals.
For research that involves more than minimal risk of harm to the subjects, the investigator must assure that the amount of benefit clearly outweighs the amount of risk. Only if there is favorable risk benefit ratio, a study may be considered ethical.
The Declaration of Helsinki, adopted by the World Medical Association, states that biomedical research cannot be done legitimately unless the importance of the objective is in proportion to the risk to the subject. The Helsinki Declaration and the CONSORT Statement stress a favorable risk benefit ratio.