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Ethical responsibility in the German Democratic Republic.

Ethical Responsibility in the German Democratic Republic

There can be no doubt that a close connection exists between the handling of ethical problems in the provision of health services and the social system of a given country. The socialist health care system in the German Democratic Republic (GDR) is part of the sociopolitical program formulated by the government as a fundamental element of social development. This program of equal rights for all, with free-of-charge health care guaranteed by the constitution, avoids many of the problems that may lead to ethical conflicts in public health service. The health service places special emphasis on a preventive strategy that includes a highly developed system of healthcures, the therapeutic use of baths, and an effort to rely, in particular, on medical treatment at home as a basis for an intimate and truly human relationship between doctor and patient.

A significant factor in safeguarding ethics in health service is the absence of any profit-oriented marketing in the medico-technical and pharmaceutical industry, due to drug legislation that is directed purely to medical needs. The absence of any private medical care in general medical practices or hospitals also allows ethical conflicts to be largely avoided. In the GDR, there is close cooperation between religious and state medical facilities. Both collaborate trustfully to the benefit of the patient.

Ethical Issues in Research Nevertheless, ethical problems in medical practice do exist in the GDR. Resolving these problems has largely been the domain of the medical societies; however, the Academy of Postgraduate Education and university courses are also addressing questions of medical ethics.[1]

Currently, questions of ethics in medical research are of central concern. This issue will be discussed here in some detail, for the example of research ethics makes clear fundamental attitudes toward ethical questions in the GDR and also helps to explain some details of this extraordinarily dynamic field.

Today, medical science and medical research in the developed industrialized countries are the crucial alternative not only for improving medical care, but also in preventing diseases. In this context, such fields as biotechnology, genetic engineering, immunology, and even computer science, present various novel, at times incredible, possibilities for medicine and society as a whole. Yet the testing and widespread introduction of these new medical techniques simultaneously give rise to many ethical problems. And unless these problems are overcome, we may encounter a situation similar to that faced at the beginning of the nuclear age. Without high ethical awareness in the world, it will be difficult in the next decades to cope morally with the tremendous progress occurring in the life sciences.

In recent years very clear and unequivocal rules and principles concerning ethics in medical research have been formulated in the GDR. The publication of these ethical principles for experiments on animals as well as for testing new medical procedures and measures has set up standards for medical professionals in this country. As a matter of course, these theses were derived from basic international documents such as the Declarations of Tokyo and Helsinki.

Recommendations on animal experimentation stress that whenever possible experiments on animals should be replaced by alternative procedures, especially in vitro investigations. Any experiment involving animals must adhere strictly to scientific principles based on attitudes of the highest respect to all forms of life in nature. And when animal experiments are scientifically mandated, the organisms used must be of the lowest possible developmental stage consistent with the goals of the research. Research proposals are to be reviewed by the head of the institution in which the research will be carried out, who in fact nominates persons to conduct the research. Proposals must specify in detail the scientific grounds for the experiment and exact protocols for all interventions, noting especially duration, extent, and criteria for breaking off the experiments. Disturbance to the well-being of research animals and particularly the infliction of pain must be minimized.

The application of strict ethical and legal standards in human subjects research is ultimately governed by Article 35 of the Constitution of the GDR and standards set out in the Drug Act and the Medical Technology Decree. Before any novel procedure or drug is tested on man, its risks and benefits, both somatic and psychological, must be carefully assessed. The well-being and personal rights of research subjects must be safeguarded and fully informed written consent obtained prior to testing. Consent for participation by incompetent or not fully competent subjects and minors may be given by their legal guardians. Such research is permitted only when the relevant data cannot be obtained from adult subjects. Research involving pregnant women is permitted only when procedures to be tested serve the interests of the pregnant woman or her child. The content of instructions regarding the trial purpose, protocol, and potential risks must be kept in medical records along with the written consent. The trial plan must be presented before a competent body for evaluation; procedures involving high risk must be evaluated by an expert from the Council for Medical Science. Among other things, the trial plan must contain a clear formulation of research objectives and methods, must specify the tasks and responsibilities of all persons involved in the testing and set out criteria for stopping the test if signs of endangerment or harm to subjects arise, and must provide instructions on recording experimental conditions. observations, and results.

Ethics Committees The implementation of these theses and other ethical regulations is overseen by the Working Group on Ethics in Medical Research of the Council of Medical Sciences, which functions as a national ethics committee. At present, the committee consists of fifteen members representing different medical disciplines, as well as a lawyer and a social scientist. Subordinate to the central ethics commission are the ethics consultants of the individual scientific councils affiliated with the main research projects of the overall state-supported program of medical research. The scientific councils of the individual medical disciplines and projects have been authorized to assess ethical questions in research, thus avoiding the establishment of a variety of separate ethics committees. The function of ethics committees is also assumed by the faculties of the medical universities.

In this way, a system of ethical guidance, assistance, and control has been created, which functions not as a separate entity but is integrated into the system of decisionmaking and control in medical research. Regular training of the ethics consultants of the scientific councils ensures the necessary competence. In addition, the central national ethics committee is publishing a series on "Ethics in Medical Research."[2]

All fundamental ethical problems in medical research are referred to the central national ethics committee, which is presently discussing questions of research with embryonic cells and tissues as well as gene therapy. The national committee has previously concluded discussions on problems of heart transplantation and of artificial organ replacement. The central national ethics committee functions as an advisory body to the Minister of Health, and all its recommendations and decisions become part of the strategy adopted by the Ministry of Health.

Special attention is paid to the ethical responsibility of the rising generation of medical professionals. To this end, annual seminars on ethical problems in medical education and post-graduate training for top research staff are held. Furthermore, the university faculties carefully monitor the observance of ethical rules in medical graduation work. Finally, medical journals are requested by the Minister of Health to observe carefully ethical principles in all their publications.[3]

Thus, a whole network of guidance and control in questions of medical ethics has arisen. The policy of the GDR is to develop a consciousness of ethical responsibility among all those involved in medical research rather than imposing regimentation and administration. The response of the medical community to this strategy has been uniquely positive. Thus the national ethics committee is receiving requests from research groups, to an increasing extent, for advice and support in addressing ethical problems. This is an expression of the high awareness of responsibility on the part of the individual research groups. A further advantage is that, while the individual research groups are working very hard, they are not subject to a particular, materially induced pressure to succeed.

Ethics in medical research is by no means understood only as a conformity to certain legal and moral standards; it is also considered indispensable for selecting research topics. Today, no country has unlimited resources, and hence the selection of topics for research necessitates giving priority to the ethically most important problems or, conversely, omitting important items if an erroneous strategy is adopted. The program of medical research being set up and carefully discussed by expert groups is understood as a state research program in which individual interests are subordinate to the statewide intention. This approach guarantees that the ethically most important tasks will be among the priorities of the national research program. In this way, particular attention is given to cancer, cardiovascular, and AIDS research.

Ethical considerations likewise play a central role in decisions to be made on individual health technologies.[4] Not everything that is new in health technology is good; not all that is good is needed. It is by no means unethical to demand adequate assessment of new technology before it is diffused. On the contrary, it is unethical to squander resources on hazardous and ineffective care.

To summarize the state of medical research ethics in the GDR, we can formulate the following principles and objectives:

Any work done in the field of medical research ethics should proceed from the requirement that scientific progress must be spurred rather than hampered by bureaucracy and inappropriate administration.

The central national ethics committee and its subordinate groups and councils are not understood to be an organ of adjudication but rather one of collective consultation and discussion.

The ultimate goal is to meet the high moral concepts of the socialist society in questions of ethics in medical research. These include fulfillment of all obligations toward science, and the safeguarding of human rights. References [1]E. Luther, "Beitrage zur Ethik in der Medizin," Medizin und Gesellschaft 19 (1983); E. Luther, G. Baust, U. Korner, Ethik in der Medizin (Halle: Beitrage Martin-Luther-Universitat, 1986); E. Luther, Ethik in der Medizin (Berlin: Verlag Volk und Gesundheit, 1986). [2]Stephan Tanneberger, Ethik in der Medizinischen Forschung 6 (1989). [3]R. Kieser and Stephan Tanneberger, "Der Einflu[Beta] von Fachzeitschriften auf die Forschungsethik in der Medizin," Zeitschrift fur klinische Medizin 40 (1985), 1803-1805. [4]Stephan Tanneberger, "When Must a New Approach to Treatment Be Introduced? The Ethics of Technology Assessment," International Journal of Technology Assessment in Health Care 4 (1988), 113-20. Stephan Tanneberger is the chairman of the Committee on Medical Ethics, Council of Medical Science, Berlin, German Democratic Republic.
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Title Annotation:medical ethics
Author:Tanneberger, Stephan
Publication:The Hastings Center Report
Date:Jul 1, 1989
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