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2.
Rev. bioét. derecho ; (47): 5-15, nov. 2019. ilus
Artigo em Inglês | IBECS | ID: ibc-184862

RESUMO

DNA read and write technologies have accelerated biotechnology at an unprecedented pace. This enhanced capacity to engineer living beings has accelerated not only scientific research, but also the translation into novel therapies. New approved medicinal products include the correction of the diseased genome and synthetic enhancement to fight diseases. These practices are widely supported socially and scientifically. Applications beyond therapy have also be attempted. In 2018, researcher He Jiankui reported on the edition of human germline during the Second International Summit on Human Genome Editing. On the other hand, during the last years, there have also been attempts at somatic genetic enhancement without the provision of detailed outcomes. Reading and writing DNA empowers us to change our world, even ourselves. The social benefits may be enormous. We need to accelerate the debate, including the stakeholders, to foster a responsible use of these technologies and maximize the positive impact on society


Las tecnologías de lectura y escritura de ADN han acelerado la biotecnología a un ritmo sin precedentes. Esta capacidad mejora para diseñar seres vivos no solo ha acelerado la investigación científica, sino también la translación a terapias novedosas. Nuevos medicamentos aprobados incluyen la corrección del genoma enfermo y la mejora sintética para combatir las enfermedades. Estas prácticas son ampliamente apoyadas social y científicamente. También se han intentado aplicaciones más allá de la terapia. En 2018, el investigador He Jiankui informó sobre la edición de la línea germinal humana durante la Segunda Cumbre Internacional sobre la Edición del Genoma Humano. Por otro lado, en los últimos años también se han producido intentos de mejora genética somática. Leer y escribir ADN nos permite cambiar nuestro planeta, incluso cambiarnos a nosotros mismos. Los beneficios sociales


Les tecnologies de lectura i escriptura d'ADN han accelerat la biotecnologia a un ritme sense precedents. Aquesta capacitat millorada per dissenyar éssers vius no només ha accelerat la recerca científica, sinó també la translació a teràpies noves. Nous medicaments aprovats inclouen la correcció del genoma malalt i la millora sintètica per a combatre les malalties. Aquestes pràctiques són àmpliament recolzades social i científicament. També s'han intentat aplicacions més enllà de la teràpia. El 2018, l'investigador He Jiankui va informar sobre l'edició de la línia germinal humana durant la Segona Cimera Internacional sobre l'Edició del Genoma Humà. D'altra banda, en els últims anys també s'han produït intents de millora genètica somàtica. Llegir i escriure ADN ens permet canviar el nostre planeta, fins i tot canviar-nos a nosaltres mateixos. Els beneficis socials poden ser enormes. Necessitem accelerar el debat, incloent-hi les parts interessades a fi de fomentar un ús responsable d'aquestes tecnologies i maximitzar-ne l'impacte positiu en la societat


Assuntos
Humanos , Edição de Genes , Pesquisa Médica Translacional , Biologia Sintética/ética , Biotecnologia/ética , Biotecnologia/instrumentação , Biotecnologia/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
3.
Rev. bioét. derecho ; (47): 77-92, nov. 2019.
Artigo em Espanhol | IBECS | ID: ibc-184867

RESUMO

La reciente aceleración de las investigaciones en ingeniería genética ha situado a Europa en una aporía de difícil solución. Pues bien, no queremos renunciar a determinados valores, aun cuando suponga no poder seguir el ritmo de China o de Estados Unidos; pero si no lo hacemos, corremos el riesgo de ser objeto de una forma de colonialismo muy diferente a la que hemos observado en los siglos precedentes


La recent acceleració de les recerques en enginyeria genètica ha situat a Europa en una aporia de difícil solució. D'una banda, es troba enmig de dos blocs contendents, la Xina i els Estats Units, en una reedició de la Guerra Freda, només que amb la biotecnologia com a mecanisme de dominació; d'un altre, Europa es troba institucionalment fraccionada en tres entitats superposades, el Consell d'Europa, la Unió Europea i l'Oficina Europea de Patents, amb diferències notables quant a legitimitat democràtica i a eficàcia normativa. Doncs bé, no volem renunciar a determinats valors, tot i que suposi no poder seguir el ritme de la Xina o dels Estats Units; però si no ho fem, correm el risc de ser objecte d'una forma de colonialisme molt diferent a la que hem observat en els segles precedents


The recent acceleration of research in genetic engineering has placed Europe in an aporia of difficult solution. On the one hand, it is in the midst of two contending blocs, China and the United States, which in their struggle for world primacy have reissued the Cold War, only with biotechnology as a mechanism of domination. On the other, Europe is institutionally divided into three overlapping entities, the Council of Europe, the European Union and the European Patent Office, with notable differences in terms of democratic legitimacy and normative effectiveness. So, we do not want to give up certain values, even if it means not being able to keep pace with China or the United States; but if we do not, we run the risk of being the object of a form of colonialism very different from that we have observed in previous centuries


Assuntos
Humanos , Biotecnologia/ética , Patentes como Assunto/ética , Edição de Genes , Sistemas CRISPR-Cas , Bioética , Europa (Continente) , Patentes como Assunto/legislação & jurisprudência
4.
Rev. bioét. derecho ; (47): 141-157, nov. 2019.
Artigo em Espanhol | IBECS | ID: ibc-184871

RESUMO

La clonación y transgénesis animal son prácticas biotecnológicas en auge, para nada exentas de problemáticas éticas en lo que respecta al uso que hacen de los animales no humanos. En este artículo se examinan los diversos ámbitos de aplicación de la clonación animal (médico-farmacéutico, industria alimentaria, recreación de especies extintas, clonación de animales de compañía e industria artística y deportiva) y se revisan los principales argumentos éticos que cuestionan la clonación y la transgénesis animal desde una perspectiva antiespecista. Esta perspectiva sostiene que los animales no humanos son merecedores de consideración moral como sujetos de vidas significativas, y no únicamente como medios para la realización de fines humanos


La clonació i transgènesi animal són pràctiques biotecnològiques creixents i no exemptes de problemàtiques ètiques pel que fa a l'ús que fan dels animals no humans. En aquest article s'examinen els diversos àmbits d'aplicació de la clonació animal (metge-farmacèutic, indústria alimentària, recreació d'espècies extintes, clonació d'animals de companyia i indústria artística i esportiva) i es revisen els principals arguments ètics que qüestionen la clonació i la transgènesi animal des d'una perspectiva antiespecista. Aquesta perspectiva sosté que els animals no humans són mereixedors de consideració moral com a subjectes de vides significatives, i no únicament com a mitjans per a la realització de finalitats humanes


Animal cloning and animal transgenesis are growing biotechnological practices, not at all exempt from ethical problems regarding the use they make of non-human animals. This article examines the different areas of application of animal cloning (medical-pharmaceutical, food industry, recreating of extinct species, cloning of companion animals and the art and sport industries) and reviews the main ethical arguments that question cloning and animal transgenesis from an antispeciesist perspective. This perspective argues that non-human animals deserve moral consideration as subjects of meaningful lives, and not only as means for the achievement of human ends


Assuntos
Animais , Clonagem de Organismos/ética , Clonagem de Organismos/veterinária , Biotecnologia/ética , Direitos dos Animais/legislação & jurisprudência , Sistemas CRISPR-Cas , Proteína 9 Associada à CRISPR , Pesquisa Biomédica/ética , Animais de Laboratório
5.
Kennedy Inst Ethics J ; 29(1): 51-66, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31080177

RESUMO

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.


Assuntos
Temas Bioéticos , Bioética , Biotecnologia/ética , Genética/ética , Academias e Institutos/ética , Comitês Consultivos/ética , Comitês Consultivos/história , Comitês Consultivos/legislação & jurisprudência , Biotecnologia/história , Biotecnologia/tendências , DNA Recombinante/história , Governo Federal , Terapia Genética/ética , Terapia Genética/história , Terapia Genética/legislação & jurisprudência , Genética/legislação & jurisprudência , Guias como Assunto , História do Século XX , História do Século XXI , Projeto Genoma Humano/ética , Projeto Genoma Humano/história , Projeto Genoma Humano/legislação & jurisprudência , Humanos , Legislação como Assunto , Masculino , Política Pública/história , Política Pública/legislação & jurisprudência , Estados Unidos
8.
Fordham Law Rev ; 87(1): 437-83, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30296034

RESUMO

Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.


Assuntos
Biotecnologia/ética , Biotecnologia/normas , Sistemas CRISPR-Cas , Pesquisas com Embriões/ética , Edição de Genes/ética , Edição de Genes/normas , Regulamentação Governamental , Biotecnologia/legislação & jurisprudência , Pesquisas com Embriões/história , Pesquisas com Embriões/legislação & jurisprudência , Edição de Genes/legislação & jurisprudência , Regulamentação Governamental/história , História do Século XX , Humanos , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/história , Pesquisa com Células-Tronco/legislação & jurisprudência , Estados Unidos
10.
Biochem J ; 475(4): 803-811, 2018 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-29490910

RESUMO

It is generally accepted that transgenesis can improve our knowledge of natural processes, but also leads to agricultural, industrial or socio-economical changes which could affect human society at large and which may, consequently, require regulation. It is often stated that developing countries are most likely to benefit from plant biotechnology and are at the same time most likely to be affected by the deployment of such new technologies. Therefore, ethical questions related to such biotechnology probably also need to be addressed. We first illustrate how consequentialist and nonconsequentialist theories of ethics can be applied to the genetically modified organism debate, namely consequentialism, autonomy/consent ethics (i.e. self-determination of people regarding matters that may have an effect on these people) and virtue ethics (i.e. whether an action is in adequacy with ideal traits). We show that these approaches lead to highly conflicting views. We have then refocused on moral 'imperatives', such as freedom, justice and truth. Doing so does not resolve all conflicting views, but allows a gain in clarity in the sense that the ethical concerns are shifted from a technology (and its use) to the morality or amorality of various stakeholders of this debate.


Assuntos
Biotecnologia/ética , Teoria Ética , Técnicas de Transferência de Genes/ética , Plantas Geneticamente Modificadas , Produtos Agrícolas , Humanos
11.
Philos Ethics Humanit Med ; 13(1): 1, 2018 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-29343272

RESUMO

Today, thanks to biomedical technologies advances, some persons with fertility issues can conceive. Transgender persons benefit also from these advances and can not only actualize their self-identified sexual identities but also experience parenthood. Based on clinical multidisciplinary seminars that gathered child psychiatrists and psychoanalysts interested in the fields of assisted reproduction technology (ART) and gender dysphoria, philosophers interested in bioethics, biologists interested in ART, and endocrinologists interested in pubertal suppression, we explore how new biotechnical advances, whether in gender transition or procreation, could create new ways to conceive a child possible. After reviewing the various medical/surgical techniques for physical gender transition and the current ART options, we discuss how these new ways for persons to self-actualize and to experience parenthood can not only improve the condition of transgender persons (and the human condition as a whole through greater equity) but also introduce some elements of change in the habitual patterns of thinking especially in France. Finally, we discuss the ethical issues that accompany the arrival of these children and provide creative solutions to help society handle, accept, and support the advances made in this area.


Assuntos
Biotecnologia/ética , Fertilização , Técnicas de Reprodução Assistida/ética , Pessoas Transgênero , Disforia de Gênero , Humanos , Pessoas Transgênero/psicologia
12.
Sci Eng Ethics ; 24(6): 1673-1696, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-28952071

RESUMO

The Safe-by-Design approach in synthetic biology holds the promise of designing the building blocks of life in an organism guided by the value of safety. This paves a new way for using biotechnologies safely. However, the Safe-by-Design approach moves the bulk of the responsibility for safety to the actors in the research and development phase. Also, it assumes that safety can be defined and understood by all stakeholders in the same way. These assumptions are problematic and might actually undermine safety. This research explores these assumptions through the use of a Group Decision Room. In this set up, anonymous and non-anonymous deliberation methods are used for different stakeholders to exchange views. During the session, a potential synthetic biology application is used as a case for investigation: the Food Warden, a biosensor contained in meat packaging for indicating the freshness of meat. Participants discuss what potential issues might arise, how responsibilities should be distributed in a forward-looking way, who is to blame if something would go wrong. They are also asked what safety and responsibility mean at different phases, and for different stakeholders. The results of the session are not generalizable, but provide valuable insights. Issues of safety cannot all be taken care of in the R&D phase. Also, when things go wrong, there are proximal and distal causes to consider. In addition, capacities of actors play an important role in defining their responsibilities. Last but not least, this research provides a new perspective on the role of instruction manuals in achieving safety.


Assuntos
Atitude , Biotecnologia/ética , Inocuidade dos Alimentos , Indústria de Embalagem de Carne , Pesquisadores/ética , Responsabilidade Social , Biologia Sintética/ética , Técnicas Biossensoriais , Tomada de Decisões , Ética em Pesquisa , Humanos , Participação dos Interessados
13.
Sci Eng Ethics ; 24(2): 335-348, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-28660387

RESUMO

The scientific development of 3D bioprinting is rapidly advancing. This innovative technology involves many ethical and regulatory issues, including theoretical, source, transplantation and enhancement, animal welfare, economic, safety and information arguments. 3D bioprinting technology requires an adequate bioethical debate in order to develop regulations in the interest both of public health and the development of research. This paper aims to initiate and promote ethical debate. The authors examine scientific aspects of 3D bioprinting technology and explore related ethical issues, with special regard to the protection of individual rights and transparency of research. In common with all new biotechnologies, 3D bioprinting technology involves both opportunities and risks. Consequently, several scientific and ethical issues need to be addressed. A bioethical debate should be carefully increased through a multidisciplinary approach among experts and also among the public.


Assuntos
Temas Bioéticos , Bioimpressão/ética , Biotecnologia/ética , Impressão Tridimensional , Transplante de Tecidos/ética , Bem-Estar do Animal/ética , Animais , Ética em Pesquisa , Direitos Humanos , Humanos
15.
Am J Bioeth ; 18(12): 36-48, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-31159699

RESUMO

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' "foundational" nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.


Assuntos
Biotecnologia/legislação & jurisprudência , Sistemas CRISPR-Cas , Genética Médica/legislação & jurisprudência , Patentes como Assunto/legislação & jurisprudência , Biotecnologia/economia , Biotecnologia/ética , Edição de Genes , Pesquisa em Genética/legislação & jurisprudência , Genética Médica/economia , Genética Médica/ética , Política de Saúde/legislação & jurisprudência , Humanos , Licenciamento/legislação & jurisprudência , Patentes como Assunto/ética , Justiça Social
17.
FEMS Microbiol Lett ; 364(20)2017 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-29029027

RESUMO

Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies-both scientifically and commercially-depend, in part, on the patent regime available for each, and researchers' willingness to enforce those patents against others.


Assuntos
Biotecnologia/ética , Biotecnologia/legislação & jurisprudência , Patentes como Assunto/ética , Patentes como Assunto/legislação & jurisprudência , Anti-Infecciosos , Repetições Palindrômicas Curtas Agrupadas e Regularmente Espaçadas , Vetores Genéticos , Humanos , Vírus
18.
AJOB Empir Bioeth ; 8(1): 58-67, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28949871

RESUMO

BACKGROUND: The availability of assisted reproductive technologies (ARTs) in the medical marketplace complicates our understanding of reproductive public policy in the United States. Political debates over ARTs often are based on fundamental moral principles of life, reproduction, and kinship, similar to other reproductive policies in the United States. However, ARTs are an important moneymaking private enterprise for the U.S. biotechnology industry. This project investigates how the U.S. states regulate these unique and challenging technologies as either moral policies or economic policies. METHODS: This study employs ordinary least squares (OLS) regression to estimate the significance of morality and economic policy variables on ART policies at the state level, noting associations between state-level political, economic, and gender variables on restrictive and permissive state-level ART policies. RESULTS: Economic variables (reflecting the biotechnology industry) and advocacy for access to ART on behalf of infertility patients increase the chances of states passing policies that enable consumer use of ARTs. Additionally, individual ART policies are distinct from one another in the ways that morality variables increase the chances of ART regulations. Surprisingly, the role of religious adherence among state residents varied in positive and negative relationships with individual policy passage. CONCLUSIONS: In general, these results support the hypothesis that ART laws are associated with economic as well as moral concerns of the states-ARTs lie at the intersection of issues of life and reproduction and of scientific innovation and health. What is most striking about these results is that they do not follow patterns seen in the legislation of abortion, contraception, and sexuality in general-those reproductive policies that are considered "morality policy." Similarly, economic variables are not consistently significant in the expected direction.


Assuntos
Biotecnologia/legislação & jurisprudência , Regulamentação Governamental , Setor de Assistência à Saúde/legislação & jurisprudência , Marketing , Princípios Morais , Política Pública , Técnicas de Reprodução Assistida/legislação & jurisprudência , Aborto Induzido/ética , Biotecnologia/economia , Biotecnologia/ética , Anticoncepção/ética , Feminino , Setor de Assistência à Saúde/economia , Setor de Assistência à Saúde/ética , Humanos , Infertilidade , Análise dos Mínimos Quadrados , Legislação Médica , Masculino , Defesa do Paciente , Gravidez , Religião , Técnicas de Reprodução Assistida/economia , Técnicas de Reprodução Assistida/ética , Comportamento Sexual , Sexualidade/ética , Estados Unidos
20.
Mar Drugs ; 15(7)2017 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-28672802

RESUMO

Normative ethical considerations of growth of the marine biotechnology and aquaculture disciplines in biopharming, food production, and marine products commercialization from a bioethical perspective have been limited. This paucity of information begs the question of what constitutes a bioethical approach (i.e., respect for individuals or autonomy; beneficence, nonmaleficence, and justice) to marine biotechnology and aquaculture, and whether it is one that is appropriate for consideration. Currently, thoughtful discussion on the bioethical implications of use, development, and commercialization of marine organisms or their products, as well as potential environmental effects, defaults to human biomedicine as a model. One must question the validity of using human bioethical principlism moral norms for appropriating a responsible marine biotechnology and aquaculture ethic. When considering potential impacts within these disciplines, deference must be given to differing value systems in order to find common ground to advance knowledge and avoid emotive impasses that can hinder the science and its application. The import of bioethical considerations when conducting research and/or production is discussed. This discussion is directed toward applying bioethical principles toward technology used for food, biomedical development (e.g., biopharming), or as model species for advancement of knowledge for human diseases.


Assuntos
Aquicultura/ética , Organismos Aquáticos , Temas Bioéticos , Biotecnologia/ética , Animais , Humanos
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