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Risk-benefit Analysis Information

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.[1]

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[2] and the CONSORT Statement[3] stress a favorable risk benefit ratio.

See also

References

  1. ^ Schactman, E. (1994). Risk–benefit analysis. Retrieved from http://capita.wustl.edu/me567_informatics/concepts/riskben.html
  2. ^ http://www.wma.net/e/policy/b3.htm
  3. ^ http://www.consort-statement.org/
Biomedical research: Clinical study design / Design of experiments
Overview

Clinical trial · Clinical trial protocol · Clinical trial management · Academic clinical trials

Controlled study (EBM I to II-1; A to B)

Randomized controlled trial (Blind experiment, Open-label trial)

Observational study (EBM II-2 to II-3; B to C)

Cross-sectional study vs. Longitudinal study, Ecological study Cohort study (Retrospective cohort study, Prospective cohort study) Case-control study (Nested case-control study) Case series · Case study / Case report

Epidemiology/ methods

occurrence: Incidence (Cumulative incidence) · Prevalence (Point prevalence, Period prevalence) association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) · relative (Relative risk, Odds ratio, Hazard ratio) other: Virulence · Infectivity · Mortality rate · Morbidity · Case fatality · Specificity and sensitivity · Likelihood-ratios · Pre/post-test probability

Trial/test types

In vitro / In vivo · Animal testing · Animal testing on non-human primates · First-in-man study · Multicenter trial · Seeding trial · Vaccine trial

Analysis of clinical trials

Risk–benefit analysis

Interpretation of results

Selection bias · Correlation does not imply causation · Null result

Category · Glossary · List of topics
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