Beneficence, ethical principle

Bioethics, basing itself on the moral canon of the human being and on the necessity, as a rational being, to morally justify one s own acts, adopts the four ethical principles autonomy and beneficence which pertain to the private sphere of the individual and nonmaleficence and justice which pertain to the public sphere."" ... 

The Belmont report describes the basic ethical principles that underlie research involving human subjects respect for persons, beneficence, and justice. The report discusses application of informed consent, assessment of ri.sks and benefits, and selection of subjects. Its regulations require that IRBs have not fewer than five members who have the capability to judge research proposals in terms of community attitudes. Therefore, IRBs must include people whose primary concerns lie in the areas of legal, professional, and community acceptance rather than in the overall scientific design. 

The Belmont Report (1979) contains the ethical principles on which the federal regulations for protection of human subjects are based. The three basic principles are respect for persons, beneficence, and justice. Respect is reflected by the consent process. As a result the term autonomy is used in the research and healthcare context. A patient is normally regarded as autonomous if he or she can make his or her own judgments and decisions. In the absence of such ability, for example, as in the case of children, prisoners, and those with mental disorders, the person must be protected. In the Belmont Report and Beneficence, beneficence is the process of minimizing harm (risk) and maximizing possible benefits (usually for the community as a whole). Justice is the term used for the criterion that subjects must be fairly drawn from a variety of ethnic, social, and other groups. 

Ethical considerations must be applied from the design to the completion of a clinical trial. Clear scientific hypotheses and objectives are critical. It is difficult to justify a clinical study if it is not clinically important or relevant. There are added ethical considerations for cancer patients, many of whom have been heavily pretreated with other chemotherapy agents and many of whom are terminally ill and may not derive any direct benefit from the agent being studied, particularly in phase 0 and I trials [23]. Clinical trials are conducted under guidelines issued in the Belmont Report of 1978 that protects human subjects and follows principles of respect for persons, beneficence, and justice. Scientific conduct is also guided by ethical principles in that competent and rigorous analysis is required to prevent compromise of the results [24]. 

In the United States it was as a direct result of the revelation of the Tuskegee Syphilis Study that the next U.S. medical ethics initiative emerged. The National Research Act of 1974 was passed (Public Law 93348), which required regulatory protection for human subjects and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979 this commission produced the Belmont Report, named after the Smithsonian Institution s Conference Center, where the discussions were first held in 1976. The report established three ethical principles to allow problems to be solved in the area of ethics in clinical research (1) respect for persons, (2) beneficence, and (3) justice. In general terms, these categories were equivalent to informed consent, risk-benefit assessment, and an appropriate choice of subjects for the research. 

Several fundamental ethical principles guide clinical trials, including clinical equipoise, respect for study participants, beneficence, and justice. These are summarized here in turn. 

The Belmont Report s principle of beneficence refers to the need to ensure that all aspects of a study are designed to obtain the desired knowledge in a way that maximizes benefits and minimizes risks to the participants. The principle of beneficence also means that a risk-benefit analysis must be performed on every proposed study. In determining if fhis ratio is ethical, consideration must be given to the impact on both the participants and society. 

The principles of autonomy, beneficence, nonmaleficence, and justice form a foundation for analysis of ethical quandaries. In addition, a comprehensive ethical analysis will include considerations of cultural and reh-gious diversity of patient-subjects, health care providers and interpersonal relationships an assessment of the profession-based duties and obligations of the health care professionals, including an examination of relevant professional oaths and codes and an analysis of relevantly similar previous bioethical dilemmas. 

All of these can impinge, directly or indirectly, on the autonomy of patients, and deflect hospital care from the best principles of beneficence for each individual case. Furthermore, Bernard Lo,24 a physician and bioethicist at UCSF, discusses possible pitfalls of ethics committees There can be excessive pressure to reach agreement, impairment rather than improvement of decision making and the broader dangers of Group-think , that is attraction toward consensus overcoming the voicing of independent, and possibly discordant, points of view. 

Despite the fact that the new codes of pharmaceutical ethics include the basic principles upon which bioethics is based (i.e., beneficence, autonomy, and justice), they are not complete enough to serve as a framework for making decisions in concrete situations where the basic principles come into conflict. In this case, an ethical foundation and a method are necessary. 

All patients have complex medical conditions so each individual patient is evaluated within these broad criteria (the beneficence principle). The likely benefits of any treatment are balanced against the possible risks before any treatment decision is made. This allows us quite ethically to recommend a course of treatment with significant potential risks if we are satisfied that the potential benefits, and the likelihood that the benefit will occur, more than balance the risk. 

It is sometimes possible that some of the principles in a medical theory come into conflict with each other in some particular settings. For example, in the setting of principlism, ethical difficulties may arise when a competent adult patient s desires conflict with a caregiver s beneficent duty to work for the best clinical interests of the patient. The best known example of this is the Jehovah s Witness patient who refuses a clinically necessary blood transfusion or a patient with peripheral vascular disease who refuses to quit smoking. In Western culture, it is held that as long as the patient is a competent adult and understands the consequences of the decision, then the physician should respect the patient s decision, despite the fact that the decision is unwise and imprudent. However, not everyone is comfortable with such a position. For example, in countries like China, where personal autonomy is often taken to be less important than the needs of the state, one could imagine bioethicists offering a different position. 

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