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BENEFITS, ETHICS, AND RISKS

Morality requires that people not only treat each other autonomously and refrain from harming one another, but also that people contribute to each other's welfare. These beneficial actions fall under the principle of "beneficence." It is appropriate to distinguish two further principles under the general principle of beneficence—the "provision" of benefits, and the "balancing" of benefits and harms.

Questions commonly arise in biomedicine about the comparison of, and relative weights of, costs, risks, and benefits. Questions about medical treatment are routinely decided by reference to the probable benefits and harms, and questions about the justification of research involving human subjects are resolved in part by determining whether or not the risks to subjects outweigh the benefits. Risk-benefit relations are best conceived in terms of a ratio between the probability and magnitude of an anticipated benefit and the probability of an anticipated harm.

Questions of risks and benefits can be faced in two contrasting situations. In one, the research to be done offers benefits for the patient as well as for the society; testing the effectiveness of a new medicine is an example. In the other, the research offers promise of benefits for society but negligible benefits, and even some risks, for research subjects; this might involve evaluating the safety (but not the effectiveness) of a new medication.

For example, in submitting a research protocol (e.g., for testing the effectiveness of a new medication) involving human subjects to an institutional review board (IRB) for approval, an investigator is expected to array the risks to subjects and the benefits to both subjects and society, and then to explain why the probable benefits outweigh the risks. The IRB then offers its own assessment. If the research is approved, the investigator is expected to describe the risks and benefits to potential subjects so they can make an informed decision about their participation in the research. This application of the principle of beneficence to research can, with only slight reformulation, be extended to the treatment of patients and the delivery of health services.

JOHN H. BRYANT

(SEE ALSO: Autonomy; Beneficence; Benefit-Cost Analysis; Ethics of Public Health)

BIBLIOGRAPHY

Beauchamp, T. L., and Childress, J. R. (1989). Principles of Biomedical Ethics. New York: Oxford University Press.

Council for International Organizations of Medical Sciences (2000). International Ethical Guidelines for Research Involving Human Subjects, revised edition. Geneva: Author.