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Risk-benefit analysis is the comparison of the risk of a situation to its related benefits.

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 Assembly, 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 [1] and the CONSORT statement [2] stress a favorable risk benefit ratio.

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