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Ethical guideposts for allelic variation databases.

Basically, a mutation database (MDB) is a repository where allelic variations are described and assigned within a specific gene locus. The purposes of an MDB may vary greatly and have different content and structure. The curator of an electronic and computer-based MDB will provide expert feedback (clinical and research). This requires ethical guideposts. Going to direct on-line public access for the content of an MDB or to interactive communication also raises other considerations. Currently, HUGO's MDI (Mutation Database Initiative) is the only integrated effort supporting and guiding the coordinated deployment of MDBs devoted to genetic diversity. Thus, HUGO's ethical "Statements" are applicable. Among the ethical principles, the obligation of preserving the confidentiality of information transferred by a collaborator to the curator is particularly important. Thus, anonymization of such data prior to transmission is essential. The 1997 Universal Declaration on the Human Genome and Human Rights of UNESCO addresses the participation of vulnerable persons. Researchers in charge of MDBs should ensure that information received on the testing of children or incompetent adults is subject to ethical review and approval in the country of origin. Caution should be taken against the involuntary consequences of public disclosure of results without complete explanation. Clear and enforceable regulations must be developed to protect the public against misuse of genetic databanks. Interaction with a databank could be seen as creating a "virtual" physician-patient relationship. However, interactive public MDBs should not give medical advice. We have identified new social ethical principles to govern different levels of complexity of genetic information. They are: reciprocity, mutuality, solidarity, and universality. Finally, precaution and prudence at this early stage of the MDI may not only avoid ethically inextricable conundrums but also provide for the respect for the rights and interests of all those involved.

Adult↗

Yet another guideline? The UNESCO draft declaration.

Some people might argue that there are already too many different documents, guidelines, and regulations in bioethics. Some overlap with one another, some are advisory and lack legal force, others are legally binding in countries, and still others are directed at narrow topics within bioethics, such as HIV/AIDS and human genetics. As the latest document to enter the fray, the UNESCO Declaration has the widest scope of any previous document. It embraces not only research involving human beings, but addresses broader concerns in medicine and healthcare. The UNESCO draft declaration has some minor weaknesses, but on the whole, the strengths outweigh the weaknesses. One weakness is that some items in the draft are stated in a way that is too restrictive, thereby appearing to rule out legitimate activities. A strength of the Declaration is that it is relatively brief, yet at the same time contains sufficient detail to make it something more than a rehearsal of mere pieties. As the most recent of the numerous bioethics and human rights documents, the UNESCO draft draws on many of the earlier documents and also includes some of the most recent thinking about ethical norms and obligations. Perhaps its greatest strength lies not in details of the principles or their implementation, but rather in its stature as an international declaration issued by a United Nations organization.

Bioethical Issues↗

[Genes and discrimination].

The Human Genome Project (HGP) is the greatest scientific adventure in modern human biology, and the genetic map that is going to be revealed through this Project is going to be an important basis of the medicine of the future. Human beings do not however depend solely on their genes. In order to comprehend human pathology, it is essential to focus on the genetic factors and on the environmental factors. Genetic diagnoses, being fostered by the HGP, make it possible to know genetic predisposition and the risks of the onset of a given disorder. Predictive medicine offers great hopes, but is giving rise to major concerns and is causing ethics-related dilemmas. Confidentiality, the moral imperative of medicine, is necessary to prevent discriminatory deviations. As is stated in the UNESCO's Universal Declaration on the Human Genome and Human Rights, no one shall be subjected to discrimination based on genetic characteristics.

Discrimination, Psychological↗

[Human dignity as a key notion in the UNESCO declaration on the human genome].

The notion of human dignity plays an increasing role in the bioethical discussion. The UNESCO Universal Declaration on the Human Genome and Human Rights is the best example of this phenomenon. This instrument is the first important step to establish international standards with regard to the ethical and legal problems raised by genetic advances. Nevertheless, the major work is still pending. First, because the concept of dignity requires a better characterization with reference to the new bioethical dilemmas. Second, because the principles enunciated at the international level should be concretized locally through well-crafted national law.

Bioethics↗

[Gen-ethics].

Knowledge is always positive, but its application can not be so. The practice with Knowledges and techniques that can affect essential aspects of the beings must be guided by perfectly established rules. The World Committee on Bioethics elaborate the Universal Declaration on the Human Genome and Human Rights in November of 1997 with the support of all the countries of the world, with no exception, and of all the scientific communities it was established that human cloning can not be used with reproductive purposes. It is very important to make an adequate use of the terminology. Scientists must use a precise language and some groups must be careful before making a pronouncement about specific subjects outside their preparation.

Cloning, Organism↗

[Bioethical principles concerning human genetic data].

UNESCO'S Universal declaration on the human genome and human rights (1997) has been accepted by the international scientific community. To apply these laws, it is necessary to get more specific rules about data regulation, human genetic samples and its derived information in biomedic research. Indeed, genetic material recollection, processing, use and storing, has potential risks over human rights' protection and exercise. The author, member of UNESCO'S intergovernmental Bioethics Committee which approved the final draft in June 2003, has taken part in the writing of the final text of an international declaration about human genetic data, whose abbreviate text is described and commented in this communication.

Biological Specimen Banks↗

The UNESCO Bioethics Declaration 'social responsibility' principle and cost-effectiveness price evaluations for essential medicines.

The United Nations Scientific, Education and Cultural Organisation (UNESCO) has commenced drafting a Universal Bioethics Declaration. Some in the relevant UNESCO drafting committee have previously desired to restrict its content to general principles concerning the application (but not necessarily the goals) of science and technology. As potentially a crucial agenda-setting statement of global bioethics, however, it is arguable important the Universal Bioethics Declaration transparently address major bioethical dilemmas in the field of public health, such as universal access to affordable, essential medicines. Article 13 (Social Responsibility) of the Preliminary Draft Universal Bioethics Declaration states: 'Any decision or practice shall ensure that progress in science and technology contributes, wherever possible, to the common good, including the achievement of goals such as: (i) access to quality health care and essential medicines, including for reproductive health and health of children.' Cost effectiveness pricing systems, such as that most notably used in Australia's Pharmaceutical Benefits Scheme (PBS), arguably represent one of the most scientifically effective mechanisms whereby public monies may be utilised to assist in the provision of medicines for the common good. They contain two essential elements: first, a process of scientific evaluation of objectively demonstrated therapeutic significance, and then, a fiscal lever (the government reimbursement price) attached to that evaluation. It is now well established that the US Pharmaceutical Research and Manufacturers Association (Pharma), through the assistance of the US Trade Representative (USTR), saw the Australia United States Free Trade Agreement (AUSFTA) as an opportunity to fulfill a legislative mandate to 'eliminate' the cost-effectiveness pricing system in Australia's PBS. One of the most remarkable features of the arguments raised against the PBS in this context was the fact that they made almost no reference to the normative discourse of bioethics or international human rights. Provisions such as Article 13 in UNESCO's Universal Bioethics Declaration, although they will create no immediate obligations under international law, may play an extremely valuable role in legitimising the use of bioethical and human rights concepts in access to medicines debates surrounding multilateral and bilateral international trade deals such as the AUSFTA.

Australia↗

Human rights in the world of the genetic revolution.

The Biotechnological Revolution provides enormous possibilities to human development (nutrition, medicine, industry), while at the same time, creates social-ethical apprehensions due to the dangers to Human Rights that an improper use could generate. In this respect, Human Rights are presented as the "religion" of our time: accepted by all, although not equally practised. These rights, classified in the Universal Declaration of the United Nations, are the terms which society uses to ponder the ethical peformance of individuals and organizations. Harmonisation between Biotechnology and Human Rights should be based on a continuous social debate in which the principles that contribute to the respect of the human's essential nature should arise. As a starting point, considerations concerning the repercussions which the different genetic techniques have on each of the individually considered Human Rights, i.e. on dignity, equality, freedom, the right to health, to intimacy or to a worthy environment should be developed. Moreover, an international vision of the problem should be imposed since it should be remembered that initiatives that avoid attacks on Human Rights are either taken internationally or are condemned to failure. The following work was not written to give practical solutions to ethical conflicts but simply to consider some of the aspects which can create controversy in the search for a coherent future for human nature.

Biotechnology↗

Property rights, genes, and common good.

This paper applies aspects of Hugo Grotius's theologically informed theory of property to contemporary issues concerning access to the human DNA sequence and patenting practices. It argues that Christians who contribute to public debate in these areas might beneficially employ some of the concepts with which he worked--notably "common right," the "right of necessity," and "use right." In the seventeenth century, wars were fought over trading rights and access to the sea. In the twenty-first century, information and intellectual property are the issues of the day. Grotius's writings serve to correct the overemphasis in modern liberalism on individual rights, and have practical application to the debate concerning the reduction of the human genome to the status of private property.

Access to Information↗

[Human values and respect of human rights in oppressive conditions].

Human rights, an issue of political debates in the last decades, listed in the United Nations Declaration of 1946 are rooted in the humanistic tradition of philosophy and religion. The UN declared their universal character and made state organizations responsible for their observation. Among all human rights that for freedom is usually perceived as crucial. Psychiatry developed in Europe primarily a caring function. The medical model developed in psychiatry through the 19th c. supplied the criteria for medical diagnosis of mental disturbance, and elaborated a system of treatment which included long term hospitalization. Medicalization of psychiatry (recently coming back) is a force which gives courage to those who suffer, to their families, and to professionals as well. This power however, can be easily abused, when a psychiatrist adopts a position of someone who knows better that which is good for his/her patient. Legal regulations of the circumstances of psychiatric treatment, especially treatment against the patient's will should prevent the abuse of the mentally disturbed person's right for freedom. The goal is usually achieved by clear description of clinical and other conditions under which a person can be committed, and by establishing the committed person's right to claim the decision to be unjust. Poland is a country without legal regulation in the area of mental health (there are only administrative acts). For more than sixty years several projects on mental health law have been worked on. The last one which came to the Sejm (parliament) in 1980 was withdrawn by the "Solidarity" Trade Union. At present, the membership of Poland in international organizations makes an introduction of mental health law an obligation. Having no legal regulation, Polish psychiatry has been a self-regulating system. It is worth to note that even in the hard Stalinist period (1947-1956) there was no abuse of psychiatry for political reasons. The main reason for Polish psychiatry staying free from political abuse is seen in the role of internalized norm of human dignity. But others should also be taken into account. It was a specificity of the political situation that the ruling powers did not insist that psychiatrists cooperate. On the other hand the integration of the Polish psychiatric community was helpful in observing the rule of non-collaboration. One of the most important factors is seen as the experience and memory of NAZI crimes in the field of psychiatry in Poland. Extermination of psychiatric patients had to leave the feeling of the importance of psychiatrist's own responsibility.(ABSTRACT TRUNCATED AT 400 WORDS)

Civil Rights↗