The progress of modern medicine is essentially based on systematic experimental research into disease mechanisms, diagnostics and therapy. However, the interrelationship between medical practice and research inevitably gives rise to a potential ethical conflict. Whereas medical action is committed to the well-being of the individual patient, scientific action primarily aims at gaining generalizable knowledge. The uncertainty of risks and benefits of medical research with human subjects conflicts with the medical ethical principles of beneficence and non-harm in dealing with the subject. On the other hand, the use of a therapy or diagnostic whose benefits and safety have not been scientifically confirmed must also be considered unethical. This basic conflict cannot be resolved with a sweeping blow, but must be moderated again and again and pacified as far as possible.
In the course of the increasing establishment of scientific methods in medicine, the first conflicts between research interests and the interests of the test subject occurred in Germany towards the end of the 19th century. Criticism related primarily to the performance of experiments on unenlightened patients. In 1900, prompted by the debate about Albert Neisser’s experiments on a syphilis vaccine, in which Neisser had injected eight young women with the serum of syphilis patients without their knowledge, the Prussian Ministry of Culture published an instruction to hospital directors explicitly demanding the informed consent of the subjects and prohibiting research on persons incapable of giving consent[1]. This initial regulation of medical research was followed in 1931 by the more expansive guidelines issued by the Reich Ministry of the Interior[2]. These guidelines are remarkable in several respects. For the first time, the need for research on humans was explicitly linked here with the equally existing, special duty of the physician towards the individual welfare of the test subject. The rules formulated at that time, such as the duty to justify and assess the risks and benefits of experiments, the requirement of preclinical investigations, the principle of informed consent, and the special protection of the dying, persons in distress, and minors, anticipated what would not find its way into international guidelines until much later, such as the Declaration of Helsinki from 1964. And yet the guidelines of the Reich Directive did not prevent a massive breach of civilization after the National Socialists came to power in 1933. Disregarding human dignity and medical ethics, German physicians instrumentalized inmates of concentration camps for a wide variety of human experiments, some of which were fatal; but abusive experiments on patients were also carried out in sanatoriums and nursing homes.
Some of these crimes under National Socialism were dealt with in the Nuremberg Medical Trials of 1946 – 1947 [3]. The resulting Nuremberg Code represented a first international attempt to commit medical research to ethical principles. However, it was not until the Declaration of Helsinki [4], published by the World Medical Association in 1964, that it achieved a broader international impact. In the following decades, the ethical principles formulated there were further developed into the research ethics valid today. In addition to the Declaration of Helsinki [5], which has been revised several times, they can be found, for example, in the Good Clinical Practice Guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which were developed jointly by the EU, the USA and Japan [6], or in the Oviedo Convention on Human Rights and Biomedicine of the Council of Europe [7], but also implemented in part in the German Medical Products Act (AMG) and Medical Devices Act (MPG).
In principle, the various ethical conventions reinforce the individual welfare of the test subject as having priority over the interests of research. Derived from the concept of human dignity, general welfare and research interests alone must not take precedence over the rights of the individual, but rather a careful balancing of the expected benefits with the possible risks must first take place. In this balancing process, the principles for biomedical ethics formulated in the Belmont Report[8] and by Beauchamp & Childress [9] such as: Respect for the Autonomy of the Person, Beneficence, Non-Harm, and Justice, provide basic ethical guidance. From these abstract ethical principles, the following concrete rules and conditions can be derived to legitimize research involving human subjects and to ensure a balance between the protection of the subject and the freedom of research enshrined in the Basic Law: Risk-benefit balance with respect to the individual subject, significance of the research project for medical science, scientific validity, fair subject selection, and free informed consent[10]. Good Clinical Practice guidelines also create requirements for implementing these principles.
The history of abusive experiments in Germany as well as in other parts of the world, e.g. in the Tuskegee Syphilis Study (1932 – 1972) or disclosed by Henry Beecher’s publication in 1966[11], prove: The ethical principles of human research alone are not sufficient to prevent abuse. Additional procedural mechanisms are needed to ensure that the principles of research ethics are implemented in practice. To this end, the highly effective model of consultation by an independent ethics committee was introduced starting in the 1970s. In Germany, ethics committees assess biomedical research involving human subjects as well as body materials and data attributable to an individual. By comprehensively evaluating study and test plans on the basis of the criteria of scientific quality, legal admissibility, and ethical and medical defensibility, ethics committees make a decisive contribution to moderating the areas of ethical conflict in medical research[12]. In doing so, attention must also be paid to the freedom of research, which is protected by the Basic Law. Ethics committees therefore strive to proactively safeguard the well-being of the research subject as well as medical progress on the basis of ethically legitimized, high-quality research practice.
The first German ethics committees were established in 1973 at the universities of Ulm and Göttingen. In 1975, the demand for independent ethics committees was laid down in the revised Declaration of Helsinki in Tokyo [13]. Subsequently, a large number of ethics committees were established in the Federal Republic of Germany. Since 1983, the ‘Association of Medical Ethics Committees in the Federal Republic of Germany’ has formed a platform for cooperation among ethics committees under public law.
With the model professional code of conduct for physicians of 1985, which obliges researching physicians to seek advice from an ethics committee [14], the current federal system of ethics committees in Germany was established. Independent medical ethics committees were established according to state law. The activities of the ethics committees are based on various legal regulations, some of which are significantly influenced by European law. Accordingly, a consenting evaluation by the responsible ethics committee is mandatory by law for clinical studies. In the GDR, there was a central review committee that had to approve clinical trials, but there was no comparable development of independent and regional ethics committees.
The ethical principles for medical research involving human subjects provide orientation for research practice, and their consideration enables medical research to comply with ethical standards. Ethics committees make an important and indispensable contribution in this regard. Also, against the background of today’s demands on medical research, which is increasingly shaped by economic interests, accelerated research practice also due to global health challenges, and the opportunities and challenges of digitalization, it is clear that research ethics requires continuous further development in a dialog between practice and theory.
Das Logo des Arbeitskreises zeigt den Kentauren Chiron, den Sohn der Nymphe Philyra und des Kronos. Chiron war der Lehrer des Asklepios (Aesculapius) und galt in der Antike als mythischer Schutzpatron der Medizin.
