Investigation on Legal Regulation of Commercial Genetic Testing / 中国医学伦理学

The commercial gene test is a kind of detection service different from genetic diagnosis in medical institutions.There is no specific legislation on gene discrimination and genetic information security related to it.This paper adopted the method of comparative study to sort out the related legal issues of commercial gene test,and put forward the regulation ideas and scheme.

Pesquisas genéticas, prognósticos morais e discriminação genética: um estudo de caso sobre traço falciforme / Genetic research, moral prognostic and genetic discrimination: a case study on sickle cell trait

ResumoO estudo analisou os debates, no período de 2000 a 2010, no Conselho Nacional de Saúde (CNS) e na Comissão Intersetorial de Vigilância Sanitária e Farmacoepidemiologia (CIVSF), sobre os temas da vigilância sanitária e articulação com o Conselho Consultivo da Agência Nacional de Vigilância Sanitária (Anvisa). A pesquisa documental, de natureza qualitativa, que analisou 163 atas de reuniões do CNS e da CIVSF, e demais documentos a elas relacionados, buscou reunir informações sobre o contexto político-institucional e as interfaces e conexões entre as três instâncias. Observou-se baixa inserção do tema "vigilância sanitária" na pauta do CNS e uma atuação insuficiente da CIVSF para o fortalecimento desse debate. Conclui-se pela fragilidade de integração entre o Conselho Consultivo da Anvisa e as instâncias de controle social no Sistema Único de Saúde. Esse resultado é fruto de dificuldades de comunicação interinstitucional e da baixa inserção da vigilância sanitária no SUS, historicamente construída.

AbstractThe debate on research ethics can be applied both to the scientific methodology as other disciplines, such as sports. In the field of Brazilian sports health, it has been common research that do genetic testing to identify athletes with sickle cell trait. Despite the persistence of Brazilian sports federations to discriminate athletes with this inherited trait, sickle cell trait is not a disease. This article reports the case of a soccer athlete victim of genetic discrimination: identified with the sickle cell trait, she was deemed unfit to participate in a championship for the Brazilian Football Confederation. The paper analyzes the implications of genetic research to identify the sickle cell trait in the absence of ethical care aimed at preserving the rights of those who submit to testing. It also shows the vulnerability to which are exposed people involved in research that do genetic testing without ethical care or even reasonable justifications and the results are interpreted under the rationality of biological determinism and genetic reductionism. Brazilian sports federations interested in identifying athletes with sickle cell trait should submit this order to study the evaluation of Research Ethics Committees, as this is a potential to cause harm to the procedure of athletes. The genetic test can not be considered an act of health care, since no disease is being treated.

Ethical and Legal Analysis on Genetic Discrimination / 中国医学伦理学

Because the gene right has the attribute of basic human right , as a legal basis for resolving the prob-lem of genetic discrimination , we should confirm its basic legal status .Genetic discrimination has caused the ethi-cal and legal issues in the field of insurance and employment , then put forward the following measures to solve these issues:In the field of insurance , the principle of utmost good faith should be followed to prevent the unscientific use of gene information;In the field of employment , the principle of general prohibition should be combined with the principle of limited exceptions .

Um caso de discriminação genética: o traço falciforme no Brasil / Genetic Discrimination: sickle cell trait in Brazil

Este artigo discute um caso de discriminação genética envolvendo uma atleta brasileira de voleibol identificada como portadora do traço falciforme. O traço falciforme é uma das características genéticas mais prevalentes na população brasileira, mas não é descrito como uma doença genética. O avanço da genética clínica vem provocando uma popularização dos testes genéticos em diferentes contextos de promoção da saúde. Ao criticar o argumento da Confederação Brasileira de Vôlei de que o exame para o traço falciforme seria uma medida de proteção à saúde dos atletas, o objetivo do artigo foi demonstrar como a popularização da informação genética não pode prescindir do aconselhamento genético e de garantias éticas. A análise mostrou que a exclusão da atleta da seleção oficial de vôlei não se justificou por medidas de proteção à saúde, mas por discriminação genética.

This paper analyses a case of genetic discrimination of a Brazilian volleyball athlete. A routine exam identified the sickle cell trait in her blood. The sickle cell trait is one of the most prevalent genetic information in Brazilian population, but it not considered a genetic disease. The advancement of clinical genetic promotes a popularization of genetic tests in different health care initiatives. The aims of this paper are: 1) to criticize the argument supporting the test for sickle cell trait as a health care initiative; 2) to demonstrate how the popularization of genetic information demands genetic counseling and ethical protections. The analysis demonstrates how the athlete exclusion from the official volleyball team is not supported by medicine and is a case of genetic discrimination.

Ethical Analysis of the Technology of Gene Screening / 中国医学伦理学

Since the fundamental breakthrough in human genomics,gene diagnosis and gene therapy have become a hotspot technology in disease diagnosis and treatment.Scientists in UK and USA have applied the technology of gene screening consecutively to give birth to babies knocked out certain virulence genes,which triggered heated and controversial debates on gene screening technology.How should we see this novel technology,a new hope for human life and health,or a misfortune disaster? What attitude should we hold towards gene screening,to ban it all round,or to take scientific advantage of it? This paper brings forward a series of issues related to the novel technology of gene screening.