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In biomedical research, generally, the success of new therapeutic approaches relies on three conditions: specificity, efficacy, and lack of toxicity. These conditions are often tested in cell cultures, mouse models, and clinical trials before a drug is offered to patients. Hence, if biomedical approaches are to be used therapeutically, one should balance the possible harms and the possible benefits of these methods (perform a risk-benefit analysis). The terms harms and benefits are ethically relevant concepts, since ethical obligations or principles about not inflicting harm (nonmaleficence) and promoting good (beneficence) are generally accepted. The ethical principles of nonmaleficence and beneficence form part of several different ethical theories. For instance, they are the foundation of the utilitarian theory, which says that ethically right actions are those that favor the greatest good for the greatest number. Another example is the Hippocratic Oath, which expresses an obligation of beneficence and an obligation of nonmaleficence: I will use treatment to help the sick according to my ability and judgment, but I will never use it to injure or wrong them.

This entry analyzes the ethical principles of beneficence and nonmaleficence in biomedicine by drawing on the bioethical theory of principles of the American bioethicists Tom L. Beauchamp and James F. Childress. These ethicists have published their theory in several editions of the book, Principles of Biomedical Ethics.

Risk-Benefit Analysis

According to Beauchamp and Childress, the evaluation of risk in relation to possible benefit in bio-medicine is often labeled risk-benefit analysis. They say that the term risk refers to a possible future harm, where harm is defined as a setback to interests, particularly in life, health, and welfare. Statements of risk are both descriptive and evaluative. They are descriptive because they state the probability that harmful events will occur, and they are evaluative because they attach a value to the occurrence or prevention of the events. Commonly in the field of biomedicine, the term benefit refers to something of positive value, such as life or health. Beauchamp and Childress state that the risk-benefit relationship may be conceived in terms of the ratio between the probability and magnitude of an anticipated benefit and the probability and magnitude of an anticipated harm. Use of the terms risk and benefit necessarily involves an evaluation. Values determine both what will count as harms and benefits and how much weight particular harms and benefits will have in the risk-benefit calculation.

Risk and benefit identifications, estimations, and evaluations are all stages in risk-benefit analysis; the next step is risk management, which Beauchamp and Childress define as the set of individual or institutional responses to the analysis and assessment of risk, including decisions to reduce or control risks. These ethicists believe that while risk-benefit analysis may seem like a technical issue, in which risks and benefits are defined, quantified, and compared, the definition of risk and benefits and the evaluation of how much risk is acceptable (risk management) are clearly ethical issues. Beauchamp and Childress offer an example: Risk management in hospitals includes establishing policies aimed at reducing the risk of medical malpractice suits.

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