Bioethics And Its Limitations

The most influential approach to bioethics over the last 25 years has been "principlism," the idea that most issues in clinical and research ethics can be resolved by reference to a set of four basic principles: beneficence, respect for persons, justice, and nonmaleficence.

The first three principles were set out by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In many respects, however, they reassert the guidelines articulated in the Nuremberg Code, which forms part of the judgment on German doctors accused of crimes against humanity in their experiments on concentration camp inmates during World War II (1). The Allied Powers were slow to acknowledge that similar concerns could be raised about some of their research and clinical practices (2). In the United States and the United Kingdom, growing concern was expressed during the 1950s and 1960s about the way in which some patients were being treated (3-6). Some of this was reflected in the drafting of the Declaration of Helsinki in 1964 (1; current text can be found at (7), but a further set of U.S. scandals (8,9) provoked Congress to intervene by establishing the National Commission in 1974.

The Belmont Report's principles will be considered together with the additional principle of nonmaleficence introduced by Beauchamp and Childress (10) in the first edition of their classic textbook.

Beneficence. An action should achieve some positive good rather than simply being carried out for its own sake. Research should not be carried out on human subjects merely to increase scientific knowledge. There must be a clear and identifiable potential benefit either to those taking part or to others similarly situated in the future. Similarly, patients should not be given a treatment that the clinician knows to be ineffective or futile. There is, of course, room to debate as to what constitutes a benefit, whether the benefit is proportional to the risks, how the future benefits can be weighed against present hazards, and so on.

Nonmaleficence. Beauchamp and Childress noted that it was often difficult in medicine to be certain of the benefits of a treatment or the outcomes of a trial. Indeed the element of uncertainty is part of the moral justification for research and experiment. If beneficence could not be demonstrated, they argued that the intervention at least should do no harm. Different bioethicists differ in how widely they define harm. Some concentrate on physical harms, whereas others include possible social harms. These might include being embarrassed or stigmatized by the public disclosure of private medical information.

Autonomy. Human beings in full possession of their faculties should be allowed to determine their own fate. Other people should not take decisions for them or restrict their decision-making. This principle is often used to criticize medical paternalism, where doctors limit the information and choices offered to patients in the belief that they, as experts, know better than the patients as to what actions are in their best interests. It also underlies the notion of informed consent, that people have a right to be aware of all the risks and benefits attached to a course of action and to decide for themselves whether to accept them. Bioethics often struggles to deal with the definition of "full possession of their faculties." Does autonomy apply to people with mental health problems? Does autonomy apply to people with Alzheimer's? Does autonomy apply to children? Who counts as a child for this purpose? A related issue is the position of people whose rights to self-determination may be compromised, such as prisoners. Can a convicted prisoner freely decide whether to take part in a risky medical experiment?

Justice. People who are equal in relevant respects should be treated equally. The difficulty here is often one of defining "relevant respects" and "equal treatment." The principle is intended to be one of nondiscrimination on medically relevant criteria. However, this leaves open the possibility of discrimination on social criteria, which comes to the same thing. For example, in the United States, it may not be acceptable to discriminate between people in need of health care on the grounds of race. However, it is entirely acceptable to discriminate on the grounds of income, which can have a similar effect. There is a comparable difficulty in deciding what is a medically relevant criterion. In the United Kingdom, some cardiac surgeons have refused to give coronary artery grafts on smokers the same priority as given for nonsmokers. Is this discrimination against an autonomous patient choice or on the basis of the different risk/benefit ratio of the intervention and a desire to focus resources on those most likely to benefit for longest? Similarly, should age be disregarded as a criterion in allocating organs for transplant, focusing purely on the prospective recipient's current health status, or should preference be given to the youngest recipient at a given health status on the basis that they are likely to survive longest post-transplant?

These principles have had a wide international influence and are often used almost as if they were a checklist for ethical decision-making. In recent years, however, they have come under increasing criticism: even Beauchamp and Childress (11) have conceded their limitations in the most recent (fifth) edition of their textbook. Much of the criticism is targeted on the way that they prioritize individual rights over collective welfare: when justice and autonomy conflict, autonomy almost always wins (12). Although this is understandable in the historical context, the results have been to ally bioethics to U.S. individualism in ways that are damaging to more collectively oriented health systems (13,14). There is now greater interest in developing ways of thinking about ethical issues that strike a different balance between autonomy and community, recognizing that there is sometimes a collective interest in limitations on individual choices of treatment or in actively encouraging participation in research.

A number of issues covered by these four principles are raised by the development of pharmacogenetics. However, the analysis presented here will also discuss several broader topics relating to the potential social impact of the technology on individuals, their families and particular social groups, and also legal issues about professional responsibility and corporate liability.

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