13.5.2 World Medical Association and the Declaration of Helsinki

In 1947, when the Nuremberg Code was set forth, the World Medical Association (WMA) was also established. A significant reason for establishing WMA was the need to ensure and reinforce the awareness of physicians of their ethical obligations after what had happened in Germany and some other countries during World War II. The WMA is “an international organization that seeks to represent all physicians, regardless of nationality or specialty”. One of its roles is to establish general and globally applicable standards in medical ethics both for medical practice and research [5].

13.6 Biomedical Ethics

13.6.1 Bioethics

The rational approach to the ethical issues is through different ethical theories and approaches. Most important in biomedical ethics including biomedical research are virtue ethics, deontology, consequentialism (especially utilitarianism) and principlism. However, none of these can fully answer even to the most usual ethical questions [5]. Hence, comprehensive ethical discussion should include the best features of each of these approaches, briefly described in the following.

Virtue ethics focuses in particular on the character of decision-makers: “What kind of person should I be?” Moral goodness of an action depends both on the right action and on the right motive. Since antiquity, wisdom, courage, self-control and justice have been the central virtues, that is, types of moral excellence. Virtuous qualities of a physician, for example, are compassion, honesty, prudence and dedication.

Deontology or duty theories consider that the basis of morality lies on specific, foundational principles of obligation. Well-founded rules could then serve as the basis for moral decisions. One well-known foundational principle of duty is the “categorical imperative” of the German philosopher Immanuel Kant (1724–1804): “Treat people as an end, and never as a means to an end”. People should always be treated with dignity. It is noteworthy that deontology is not interested in the consequences of an action but in motives and intentions. Therefore, an act is thought to be morally good, if the motive or intention, which leads to that act, is good.

Consequentialist theories are, according to definition, interested in the consequences or outcomes of the choices and actions. One of the best-known examples of this is utilitarianism where the good is measured by means of utility and may be defined as “the greatest good for the greatest number”. The action which produces the best outcome is then the right one. Outcome measures obviously vary and, for example, in healthcare decision-making cost-effectiveness and quality of life are important. QALYs (quality-adjusted life-years) and DALYs (disability-adjusted life-years) are typical examples. From the physician’s daily practice, an example could be health and well-being or lack of pain and suffering of a patient. It is, however, important to notice that although the principle “the end justifies the means” is a plausible deduction from utilitarianism , it can never be approved in research. Thus, for example, it is morally unacceptable to sacrifice individual human rights to attain a social goal.

Principlism is currently one important trend in approaches of bioethics. Its origin is connected with the Belmont Report (1978/1979), which, according to definition, is “a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects” [10]. The report defines three basic ethical principles in biomedical and behavioural research, namely, respect for persons, beneficence and justice [11]. Beauchamp and Childress have developed principlism further in the context of medical practice by adding to the list of principles also non-maleficence (“not doing wrong”), which in traditional medical ethics is usually expressed as the maxim primum non nocere (“above all do no harm”). Although principles indisputably play a central role in rational decision-making in biomedicine, principlism has been criticized for emphasizing the respect for autonomy over other principles, which is thought to reflect the Western liberal culture and hence not to be necessarily universal [3].

13.6.2 Principles in Applying Biomedical Ethics

Respecting human rights is the cornerstone of ethical assessment. This was proclaimed by the United Nations’ Universal Declaration of Human Rights already in December 1948 and has ever since played an important role both in medical practice and in biomedical research. In the following we briefly describe the basic principles that should be taken into account when pondering biomedical issues of ethics.

Respect for autonomy . The word autonomy derives originally from Greek words autos (“self”) and nomos (“rule”, “governance”). In ancient Greece, it was connected to the independent city-states but now refers to individuals who should be treated as autonomous agents capable of deliberating their personal goals and acting accordingly. In medical context, a person or patient must be able to make his/her own decisions. This is the fundamental principle in biomedical research ethics and also prerequisite for an informed consent. Hence, particular attention is needed in situations where the research subject’s autonomy is diminished, and he/she is unable to give consent (for details, see later).

Non-maleficence, “do no harm”, was emphasized already in the Hippocrates era. Researches thus have an obligation to avoid causing harm to patients and research subjects. Careful risk assessment is thus a prerequisite in research planning.

Beneficence. While non-maleficence is merely refraining from doing, the principle of beneficence demands more, literally “doing good”. Although some authors define the good end in medicine almost exclusively as healing, beneficence is usually thought to have broader sense. It means acting to the best interest of the patient or research subject which may represent different things, for example, development of new treatments, better understanding human physiology, etc.

Justice. The concept of justice is explicated with the terms fairness, entitlement and “what is deserved”. In healthcare, it means that individuals and groups are treated in a fair manner which, in turn, may lead to complex questions when, for example, individual and community interests are taken into account. The importance of social value as a criterion, when deciding if a research project should be approved or not, has become more significant. Consequently, it is thought that justice demands that the results of the research should benefit the population in which the research in question is being carried out. Hence it is not fair that research subjects undergo risks and feel discomfort in one place while the beneficiaries are patients elsewhere [5].

13.7 Practical Principles in Science and in Medical Research Ethics

Clinical research on human subjects is necessary for the progress of medicine. Furthermore, animal studies are often regarded as an essential part of research, especially in translational health research. Many different local, national and international codes, rules and policies on research ethics exist both for research on human subjects and for animal experimentation (Fig. 13.2).

13.7.1 Research Ethics Committees

The researcher has not been left alone with the challenging issues of ethics. The Declaration of Helsinki describes the role and the responsibilities of research ethics committees (Table 13.3). The committee’s approval is necessary already before the study may begin, and its task continues in monitoring ongoing projects. The members of the committee should represent expert knowledge of different professions. The researchers have to demonstrate to the committee why that particular study is worthwhile and that they have enough competence to conduct it. Among other things, the committee reviews the research project’s justifiability on scientific grounds and estimates the assessment of the risks and benefits made by the researcher. The researcher has to prove that the protection of potential research subjects is appropriately secured. Although the researcher may sometimes feel that the committee’s only task is to delay the advances of science, the review and approval of independent research ethics committee actually guarantees the quality of research and is a necessity for the later publication process in any respectable forum.

Table 13.3

The role and responsibilities of an ethical committee

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