Council for International Organizations of Medical Sciences (CIOMS)

Council for International Organizations of Medical Sciences (CIOMS), The Declaration of Inuyama on Human Genome Mapping, Genetic Screening and Gene Therapy (1990), reprinted in Source Book in Bioethics: A Documentary History 322 (Albert R. Jonsen et al. eds., 1998).

The Council for International Organizations of Medical Sciences held its XXIVth Round Table Conference, on the subject of Genetics, Ethics and Human Values: Human Genome Mapping, Genetic Screening and Therapy, in Tokyo and in Inuyama City, Japan, 22 - 27 July 1990. The Conference was held under the auspices of the Science Council of Japan, and cosponsored by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization. It was the fifth in a series entitled Health Policy, Ethics and Human Values: An International Dialogue, begun in Athens in 1984. The participants, numbering 102, came from 24 countries, representing all continents.

In addition to biomedical scientists and physicians, the participants represented a wide range of disciplines including sociology, psychology, epidemiology, law, social policy, philosophy and theology, and brought with them experience in hospital and public health medicine, universities and private industry, and the executive and legislative branches of government. Through presentations and discussions in plenary sessions and working groups, they reached broad agreement on a number of central issues. At its final session the Conference agreed on the following Declaration.

I. Discussion of human genetics is dominated today by the efforts now under way on an international basis to map and sequence the human genome. Such attention is warranted by the scale of the undertaking and its expected contribution to knowledge about human biology and disease. At the same time, the nature of the undertaking, concerned as it is with the basic elements of life, and the potential for abuse of the new knowledge which the project will generate, are giving rise to anxiety. The Conference agrees that efforts to map the human genome present no inherent ethical problems but are eminently worthwhile, especially as the knowledge revealed will be universally applicable to benefit human health. In terms of ethics and human values, what must be assured is that the manner in which gene mapping efforts are implemented adheres to ethical standards of research and that the knowledge gained will be used appropriately, particularly in genetic screening and gene therapy.

II. Public concern about the growth of genetic knowledge stems in part from the misconception that while the knowledge reveals an essential aspect of humanness it also diminishes human beings by reducing them to mere base pairs of deoxyribonucleic acid (DNA). This misconception can be corrected by education of the public and open discussion, which should reassure the public that plans for the medical use of genetic findings and techniques will be made openly and responsibly.

III. Some types of genetic testing or treatment not yet in prospect could raise novel issues, for example, whether limits should be placed on DNA alterations in human germ cells, because such changes would affect future generations, whose consent cannot be obtained and whose best interests would be difficult to calculate. The Conference concludes, however, that for the most part present genetic research and services do not raise unique or even novel issues, although their connection to private matters such as reproduction and personal health and life prospects, and the rapidity of advances in genetic knowledge and technology, accentuate the need for ethical sensitivity in policy-making.

IV. It is primarily in regard to genetic testing that the human genome project gives rise to concern about ethics and human values. The identification, cloning and sequencing of new genes without first needing to know their protein products greatly expand the possible scope for screening and diagnostic tests. The central objective of genetic screening and diagnosis should always be to safeguard the welfare of the person tested: test results must always be protected against unconsented disclosure, confidentiality must be ensured at all costs, and adequate counselling must be provided. Physicians and others who counsel should endeavour to ensure that all those concerned understand the difference between being the carrier of a defective gene and having the corresponding genetic disease. In autosomal recessive conditions the health of carriers (heterozygotes) is usually not affected by their having a single copy of the disease gene; in dominant disorders, what is of concern is the manifestation of the disease, not the mere presence of the defective gene, especially when years may elapse between the results of a genetic test and the manifestation of the disease.

V. The genome project will produce knowledge of relevance to human gene therapy, which will very soon be clinically applicable to a few rare but very burdensome recessive disorders. Alterations in somatic cells, which will affect only the DNA of the treated individual, should be evaluated like other innovative therapies. Particular attention by independent ethical review committees is necessary, especially when gene therapy involves children, as it will for many of the disorders in question. Interventions should be limited to conditions that cause significant disability and not employed merely to enhance or suppress cosmetic, behavioural or cognitive characteristics unrelated to any recognized human disease.

VI. The modification of human germ cells for therapeutic or preventive purposes would be technically much more difficult than that of somatic cells and is not at present in prospect. Such therapy might, however, be the only means of treating certain conditions, so continued discussion of both its technical and its ethical aspects is essential. Before germ-line therapy is undertaken, its safety must be very well established, for changes in germ cells would affect the descendants of patients.

VII. Genetic researchers and therapists have a strong responsibility to ensure that the techniques they develop are used ethically. By insisting on truly voluntary programmes designed to benefit directly those involved, they can ensure that no precedents are set for eugenic programmes or other misuse of the techniques by the State or by private parties. One means of ensuring the setting and observance of ethical standards is continuous multidisciplinary and transcultural dialogue.

VIII. The needs of developing countries should receive special attention to ensure that they obtain their due share of the benefits that ensue from the human genome project. In particular, methods and techniques of testing and therapy that are affordable and easily accessible to the populations of such countries should be developed and disseminated whenever possible.