in Biomedical Research

Fig. 13.1

Hippocrates 460–377 BC

Fig. 13.2

Main steps for attaining permit(s) for scientific investigation. In life sciences approval by ethical committee has a central role

The need for something broader than the traditional Hippocratic medical ethics became apparent after World War II and the special tribunal at Nuremberg, Germany. Many Nazi physicians were tried and convicted because they had violated fundamental human rights in their research during the war. The trials began on December 9, 1946, and the verdict was delivered on August 20, 1947. During the trials ten important points in legitimate medical research, known as the Nuremberg Code, were compiled and were used as the basis of the judgement. The Nuremberg Code has been one of the fundamental documents of modern research ethics, and, for example, the request of voluntary informed consent is in the Code. Many are of the opinion that the Hippocratic tradition continues in the Nuremberg Code, which represents a new and expanded interpretation of the Hippocratic Oath endorsing the experimental approach to medicine but at the same time protecting the patient [6].

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].

Soon after its establishment, the WMA had two important tasks: to define the duties of the physician pointing out also the humanitarian aspects of medicine and to specify the essential principles in medical research. The Declaration of Geneva [7] and the Declaration of Helsinki [8] are the result of these attempts and are the most important declarations of WMA. Both have been revised several times already. In January 2005, WMA launched the Medical Ethics Manual, which is a comprehensive presentation of ethics and its role in medicine dealing also with medical research ethics (Table 13.1). In addition, many research institutes and organizations have formulated ethical guidelines. For oral health researchers, the International Association for Dental Research (IADR) Code of Ethics is essential [9]. However, the principal guidelines in different documents are mainly the same, and most of them refer directly to the Declaration of Helsinki as the basic code of internationally accepted guidelines in biomedical research.

Table 13.1

World Medical Association’s declarations and codes of medical and research ethics

Declaration of Geneva

 • The “Physicians’ Oath”

 • Adopted at the World Medical Association (WMA) 2nd General Assembly in 1948, revised latest in 2017

 • The physician declares his dedication to the humanitarian goals of medicine

International Code Of Medical Ethics

 • Adopted by the WMA 3rd General Assembly in 1949 and amended three times since then

 • Describes the duties of physicians in general, to patients and to colleagues

Declaration of Helsinki

 • A concise summary of research ethics as it is defined by the WMA in 1964

 • Revised many times to meet the requests of the developments in research and in the technologies; latest revision in 2013

 • Regarded as the most important document on research ethics

The WMA Medical Ethics Manual

 • Launched in January 2005, 3rd edition in 2015

 • A comprehensive presentation of ethics and its role in medicine and research

 • Intended also for the use of medical schools throughout the world; translated in many languages

13.6 Biomedical Ethics

13.6.1 Bioethics

As noted before, bioethics is a field of applied ethics . It is interested in ethical questions arising from life sciences, i.e. medicine, biology (including genetics), biochemistry, biotechnology, ecology and many others. Bioethics is inter- and multidisciplinary, and bioethicists have different backgrounds, not only in life sciences but also in disciplines such as sociology, philosophy, theology, history and law. Bioethics began to develop during the second half of the twentieth century with historical background in medical ethics. Modern bioethics is commonly understood to consist of three main subdisciplines, namely, medical ethics, animal ethics and environmental ethics [1]. The need for bioethics arouse because traditional medical ethics was not able to respond to the new questions and challenges caused by technological progress. There were no appropriate tools to treat subjects and issues such as privacy and research involving human subjects in the larger perspective. Bioethics had first the human aspect in forefront. Animal ethics and environmental ethics have then become subdisciplines of bioethics, when the issues such as the responsibility for the nature and environment have emerged. Today, there are established centres dealing with issues of bioethics (Table 13.2).

Table 13.2

Examples of centres for bioethics

The Hastings Center (originally The Institute of Society, Ethics and the Life Sciences), New York

 • Founded by Daniel Callahan and Willard Gaylin in 1969

 • The Hastings Center Report—explores ethical, legal and social issues in medicine, healthcare, public health and the life sciences, both in print and online

 • Visiting Scholar Program in collaboration with Yale University

The Kennedy Institute of Ethics (originally The Joseph and Rose Kennedy Center for the Study of Human Reproduction and Bioethics), Washington, DC

 • Established at Georgetown University in 1971, backed by the Kennedy Foundation

 • The Kennedy Institute of Ethics Journal is an interdisciplinary journal dedicated to philosophical bioethics, online

 • Visiting Researchers Program

Eubios Ethics Institute

 • Founded by Darryl Macer in 1990 in Christchurch, New Zealand and in Tsukuba Science City, Japan—Bangkok, Thailand added to the network in 2005

 • Nonprofit group aiming to stimulate the international discussion of ethical issues and how to use technology in ways consistent with “good life” (eu-bios)

 • Cooperation with many individuals and groups, including, e.g. UNESCO, UNU and Asian Bioethics Association

The European Association of Centres of Medical Ethics (EACME)

 • Founded in 1985

 • Network of academic and nonacademic centres

 • Aim is to promote research, education and consultation in the field of biomedical ethics

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.

Aug 25, 2019 | Posted by in General Dentistry | Comments Off on in Biomedical Research
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