A collection of essays on the human genome, European patent law, cloning, and genetic malpractice suits.

Aim: To analyze the empathizing and systemizing profiles of Brazilian and Portuguese nursing undergraduates. Background: Empathy is a fundamental skill for nursing practice and should be analyzed during the student’s education. Methods: Descriptive study with cross-sectional design. Participants were 968 undergraduate students, including 215 (22.2%) Brazilians from a university in the state of São Paulo and 753 (77.8%) Portuguese students from a higher education institution in central Portugal. The Portuguese and Brazilian versions of the Empathizing/Systemizing Quotient have good internal consistency (...) and reliability. Ethical considerations: In Brazil, approval for the study was obtained from the Research Ethics Committee of the University of São Paulo at Ribeirão Preto College of Nursing (protocol 191/2016) and in Portugal, from the Ethics Committee of the Health Sciences Research Unit: Nursing, Coimbra Higher School of Nursing (protocol P362-09/2016). Results: Most (86%) participants were female and aged between 20 and 24 years. In the general profile analysis between both groups, the domains “Social Skills,” “Contents,” and “Processes” scored higher. Gender differences exist for the feeling of empathy and systemizing, as women scored better on the short version of the Empathy Quotient and men on the Systemizing Quotient. Conclusion: As demonstrated in the domain scores for “Social Skills,” “Contents,” and “Processes,” the undergraduate nursing students analyzed have the ability to deal intuitively and spontaneously with social situations; they are also characterized as methodical people, who like to follow rules, and experience practice better than theory, and the women have a higher empathetic level than men, who in turn are more systemizing. (shrink)

Background: Waiving parent permission can be an option in some epidemiological and social research with adolescents. However, exemptions have not been uniformly considered or applied. Our aim is to critically assess the different factors that could be taken into account when making decisions about waiving active parental permission in observational research with adolescents.DiscussionIn some cases alternatives to parental permission could be applied to protect the rights of both adolescents and parents and also to assure the benefits to adolescents as a (...) group that can come from appropriately conducted studies. However, the criteria of ensuring minimal risk can be difficult to define and apply and a distinction between harm and discomfort is reviewed. Waiving active parental permission could be acceptable when the risk of harm is minimal; when the research questions are related to an activity for which adolescents are not legally considered to be children; when the risk of harm or discomfort may increase if parental permission is required; and when risk of discomfort is low because the questionnaire is not potentially offensive for some adolescents and/or for some parents.SummaryStringent rules concerning parental permission in some studies could be detrimental to adolescents. A framework and a decision tree guide are proposed to help researchers and Research Ethics Committees in their decisions on whether active parental permission must be obtained. (shrink)

La obra incluye legislación de quince países, así como diversos documentos de la ONU, la UNESCO, el Consejo de Europa, la Unión Europea, Comités Nacionales de Ética, dictámenes y resoluciones de Instituciones Internacionales, jurisprudencia española y una selección bibliográfica con unas 1.300 referencias, clasificada por materias. Algunas leyes nacionales y los documentos del Consejo de Europa se publican traducidos al español y en su idioma original, cuando éste se ha considerado fácilmente asequible, con el fin de facilitar el acceso a (...) la fuente directa. (shrink)

A Bioética, que podemos qualificar, sem a menor dúvida, como uma ciência jovem - embora cheia de vigor, dinamismo e em plena expansão - se ocupa, desde as multifacetadas óticas das grandes perguntas que se formula a cada dia, o homem moderno, em torno da vida. Neste livro, os autores tratam de alguns aspectos conceituais que, às vezes, são obliterados no discurso bioético. Por exemplo, quais as relações que se interpõem entre Bioética e Direito, começando por delimitar cada uma destas (...) disciplinas. (shrink)

In their recent article, Brownet alanalyse several ethical aspects around immunity passports and put forward some recommendations for implementing them. Although they offer a comprehensive perspective, they overlook two essential aspects. First, while the authors consider the possibility that immunological passports may appear to discriminate against those who do not possess them, the opposite viewpoint of immune people is underdeveloped. We argue that if a person has been tested positive for and recovered from COVID-19, becoming immune to it, she cannot (...) be considered a hazard to public health and, therefore, the curtailment of her fundamental rights (eg, the right to freedom of movement) is not legitimate. Second, they omit that vaccine distribution will create similar problems related to immunity-based licenses. Vaccine certificates will de facto generate a sort of immunity passport. In the next phases of the pandemic, different immunity statuses will be at stake, because the need to identify who can spread COVID-19 is unavoidable. If a person does not pose a threat to public health because she cannot spread the infection, then her right to freedom of movement should be respected, regardless of how she acquired that immunity. (shrink)

Should we use human germline genome modification (HGGM) only when serious diseases are involved? This belief is the underlying factor in the article written by Kleiderman, Ravitsky and Knoppers to which I now respond. In my opinion, the answer to this question should be negative. In this paper, I attempt to show that there are no good reasons to think that this technology should be limited to serious diseases once it is sufficiently proven to be safe and efficient. In fact, (...) opting otherwise would negatively harm human beings’ right to the highest standard of health that unmodified embryos could promote. Therefore, the issue should not be so much to define adequately what a serious disease is, but rather to elucidate whether this concept should play any role beyond the context of preimplantation genetic testing (PGT). This paper argues that we should not accept the similarity between technologies such as PGT and HGGM because they face different challenges and offer totally different possibilities. Therefore, we are in urgent need to build a completely new ethical architecture that covers the application of germline editing in human embryos. As a part of that process, a much deeper debate on the necessity of distinguishing different disease types is required. (shrink)

The seat belt analogy argument is aimed at furthering the success of coercive vaccination efforts on the basis that the latter is similar to compulsory use of seat belts. However, this article demonstrated that this argument does not work so well in practice due to several reasons. The possibility of saving resources in health care does not usually apply in our societies, and the paternalist mentality that contributed to the implementation of seat belt–wearing obligation was predominant 30 years ago, but (...) it does not apply at this moment. Furthermore, the risk/benefit analysis is totally different in both scenarios. In the case of seat belts, there is no way to discriminate between the users. In the case of vaccines, individuals present with unique circumstances that may differ substantially from those of another and might be foreseen a priori. This means that an analysis must be performed individually before vaccination is imposed. Finally, one must keep in mind that seat belts are often the only way in which we can protect third parties against a tragic hit by the occupant of another vehicle and are very efficient tools for this purpose. Vaccines, in contrast, do not always create sterilising immunity and are definitely not the only way by which we can avoid spreading a virus; immunity certificates, isolation, or even confinement may also serve as viable methods to achieve this purpose. (shrink)

Digital COVID certificates are a novel public health policy to tackle the COVID-19 pandemic. These immunity certificates aim to incentivize vaccination and to deny international travel or access to essential spaces to those who are unable to prove that they are not infectious. In this article, we start by describing immunity certificates and highlighting their differences from vaccination certificates. Then, we focus on the ethical, legal, and social issues involved in their use, namely autonomy and consent, data protection, equity, and (...) international mobility from a global fairness perspective. The main conclusion of our analysis is that digital COVID certificates are only acceptable if they meet certain conditions: that they should not process personal data beyond what is strictly necessary for the aimed goals, that equal access to them should be guaranteed, and that they should not restrict people’s autonomy to access places where contagion is unlikely. We conclude that, if such conditions are guaranteed, digital COVID certificates could contribute to mitigating some of the most severe socioeconomic consequences of the pandemic. (shrink)

Volume 19, Issue 7, July 2019, Page 49-50.

The notion of the human embryo is not immutable. Various scientific and technological breakthroughs in reproductive biology have compelled us to revisit the definition of the human embryo during the past 2 decades. Somatic cell nuclear transfer, oocyte haploidisation and, more recently, human stem cell-derived embryo models have challenged this scientific term, which has both ethical and legal repercussions. Here, we offer a legal perspective to identify a universally accepted definition of ‘embryo’ which could help to ease and unify the (...) regulation of such entities in different countries. (shrink)

Should we be allowed to refuse any involvement of artificial intelligence technology in diagnosis and treatment planning? This is the relevant question posed by Ploug and Holm in a recent article in Medicine, Health Care and Philosophy. In this article, I adhere to their conclusions, but not necessarily to the rationale that supports them. First, I argue that the idea that we should recognize this right on the basis of a rational interest defence is not plausible, unless we are willing (...) to judge each patient’s ideology or religion. Instead, I consider that the right must be recognized by virtue of values such as social pluralism or individual autonomy. Second, I point out that the scope of such a right should be limited at least under three circumstances: if it is against a physician’s obligation to not cause unnecessary harm to a patient or to not provide futile treatment, in cases where the costs of implementing this right are too high, or if recognizing the right would deprive other patients of their own rights to adequate health care. (shrink)

BackgroundSome persons conceived with donor gametes react negatively when they found their birth via donor conception. They request access to information about and seek to communicate with the donor. However, some countries mandate donor anonymity. Other countries allow donor-conceived persons to access donor information, but they can only use this access if their parents have disclosed donor conception to them. We investigated a thorny issue of donor conception: whether donor conception should be shifted from an anonymous basis to a non-anonymous (...) basis.MethodsWe review the issues and concerns regarding donor conception. We then consider the impact of direct-to-consumer genetic testing on donor conception, as well as the influence of donor conception on offspring’s identity and the potential of different types of donors. To discuss the future policy of donor conception, the policies on the anonymity of gamete donors were investigated using publicly-available documents in 15 countries.ResultsThe aim of mandating donor anonymity is to protect the privacy of the donor and intended parents. However, the diffusion of direct-to-consumer genetic testing may make it impossible to maintain anonymity. Birth via donor conception shapes the offspring’s identity, and the donor may further influence the development of offspring’s identity through communications. It remains important to disclose donor conception to donor-conceived offspring and to provide them with donor information. However, that information might be insufficient for some donor-conceived persons. Here are benefits to having open-identity donors and known donors. Such donors can make an agreement with the parents regarding future communication with the offspring, although both sides should respect privacy. Subsequent counseling for all parties involved can result in better tripartite communication agreements.ConclusionsIn sum, ethical and practical issues that complicate donor anonymity are driving a shift to non-anonymous donor conception, in which all parties come to a communication agreement. To pave the way for such a donor conception system, transitional measures can be put into place. For countries that already adopted non-anonymous donor conception, ensuring the communication agreements is important to protect the rights of parents, donor, and offspring. (shrink)

This book provides a current analysis of the legal and ethical challenges in preparing for and responding to chemical, biological, radiological, nuclear and explosive crises. From past events like the Chernobyl nuclear incident in Russia or the Bhopal chemical calamity in India, to the more recent tsunami and nuclear accident in Japan or the Ebola crisis in Africa, and with the on-going threat of bioterrorism, the need to be ready to respond to CBRNE crises is uncontroversial. What is controversial is (...) whether we are on a path that adequately prepares us for the next event. The ethical and legal scholars in this volume hold that much work remains to be done and offer this book to stimulate further reflection and dialogue around CBRNE crises. This is an indispensable book for both students and scholars of bioethics, international law, public health, as well as for regulators and administrators developing policy and legislation related to public health planning and emergency responses. (shrink)

Casgevy, the world’s first approved CRISPR-based cell therapy, has been priced at $2.2 million per patient. Although this hefty price tag was widely anticipated, the extremely high cost of this and other cell and gene therapies poses a major ethical issue in terms of equitable access and global health. In this Perspective, we argue that lowering the prices of future CRISPR therapies is an urgent ethical imperative. Although we focus on Casgevy as a case study, much of our analysis can (...) be extrapolated to the controversies over affordable access to other gene and cell therapies. First, we explain why this first-of-its-kind CRISPR therapy might be so expensive. We then analyze the ethical issues of equity and global health of early CRISPR treatments. Next, we discuss potential solutions to lower the prices of CRISPR gene therapies. We conclude that the approval of CRISPR transforms our obligations of justice and compels us to bring future gene therapies to the maximum possible number of patients with serious genetic diseases at affordable prices. (shrink)

Biolaw is an autonomous interdisciplinary legal discipline, with great theoretical and practical relevance because of its possible social effects. This contribution deal with the most relevant different approaches to bioethical problems according to the main juridical systems, as they are civil law and common law. A main topic is also the relation between Biolaw, Bioethics and Biopolitics.

Anna Smajdor’s proposal of whole body gestational donation (WBGD) states that female patients diagnosed as brain-dead should be considered for use as gestational donors. In this response, Smajdor’s proposal is rejected on four different accounts: (a) the debated acceptability of surrogacy despite women's autonomy, (b) the harm to dead women ́s interests, (c) the interests of the descendants, and (d) the symbolic value of the body and interests of relatives. The first part argues that WBGD rests on a particular conception (...) of the instrumentalization of bodies that cannot be circumvented simply by the patient’s consent and relinquished autonomy. The second part argues the importance of avoiding any harm to dead women’s interests. The third part identifies the importance of the interest of the foetus in the light of Procreative-Beneficence principle that Smajdor overlooks. And finally, the fourth part considers the symbolic value of the human body and the interest of relatives. The main goal of this commentary is not to show that WBGD cannot be implemented; rather, it is to show that there are not any good arguments in favour of doing so. (shrink)

The possibility of obtaining stem cells from human embryos has given rise to an intensive legal and ethical debate. In this paper, attention is paid to the normative disparity and ambiguity in Europe. An argument for the need for a minimal legal harmonization is made; and a prudent and flexible way to reach this successfully is suggested. Establishing a common legal framework seems to be the only way to guarantee true competitiveness for the European scientific community.

The risks of uncontrolled dissemination of GMOs has made it clear that biosafety is a very relevant matter that goes beyond the State boundaries. This approach has had its corresponding reflection at the policy level, which reveals that the public powers and the legislators have been sensitive to this existing preoccupation in ever-growing sectors of society. From the European regulations, one can deduce a set of principles, which must guide the decisions of the public powers in matters related to biosafety: (...) precaution, authorisation and inspection, “step by step”, “case by case”, traceability and transparency, among other. (shrink)

Despite the availability of safe vaccines against SARS-CoV-2, some people will remain vulnerable because they will not be vaccinated. Who are these non-vaccinated people? We can distinguish two groups: (i) persons who cannot be vaccinated for clinical reasons and who, despite having been vaccinated, have not achieved immunity; (ii) persons who voluntarily refuse to get vaccinated. These groups have in common an immune system that will make them vulnerable to COVID-19. The reasons for their vulnerability and the ethical judgment they (...) deserve are different; the solutions offered to them are also different. In the case of those who voluntarily avoid vaccination, States are not compromised to introduce new protective policies. In the case of people who remain involuntarily vulnerable, instead, the response should be articulated on the same rules and principles that inform the social model of disability because they will live with an organic disability. (shrink)

This article explores medical responsibility and negligence from an ethical and legal perspective within the Colombian context. It highlights causes of negligence such as deficiencies in professional training and organizational problems. The article emphasizes "objective imputation as key to determining the criminal responsibility of the physician" (Alvarado D. 2019). The objectives include analyzing the current legal framework in Colombia and assessing the link between medical ethics and legal responsibility. The methodology builds upon a thorough examination of specialized literature, including peer-reviewed (...) scientific articles in medicine and law, as well as legal documents and ethical regulations. A targeted search was conducted across various bibliographic databases including Google Scholar, Redalyc, Scielo, Dialnet, Biomed Central, Miguel De Cervantes Virtual Library, and BVS virtual health library. (shrink)

The new generation of psychopharmacological products have proved their efficacy. Some neuro-degenerative diseases, such as Parkinson's and Alzheimer's diseases, could be treated by means of the gene therapy. Although the aetiology of such diseases is still not completely known, it has been proven that the patients lack some substances that could be produced by means of the transfer of in vivo or ex vivo genes that codify them in the proper places of the brain. Furthermore, it is announced that the (...) implantation in laboratory grown stem cells of diverse origins is very hopeful. Cerebral (micro)electronic implants could be effective to fight some motor diseases as well as sensory functions. All of these kinds of new treatments need to be tested through clinical research. Most national legislation includes provisions on the clinical trials of drugs and a series of guarantees, procedures and conditions which are designed to ensure protection for individuals used in experiments and to assure that the trial is indeed of scientific relevance. However, few lay down similar regulations or provide for specific controls for the research of other treatments. Finally, enhancement of psychic capacities pose new problems for society as well as do the need for new legal decisions. (shrink)

Organ shortage constitutes an unsolved problem for every country that offers transplantation as a therapeutic option. Besides the largely implemented donation model and the eventually implemented market model, a theorized automatic organ procurement model has raised a rich debate in the legal, medical and bioethical community, since it could show a higher potential to solve organ shortage. In this paper, we study the main arguments for and against this model. We show how, in the light of empirical data extracted from (...) countries with a universal health care system, its implementation could lead to a positive impact on organ procurement rates. Three factors are envisioned as fundamental in the comprehension and a possible regulation of the automatic organ procurement model: the lack of recognition of the conscientious objection, the preservation of the right to choose end of life conditions, and the need to avoid incentives for families or healthcare professionals. (shrink)

The application of genetic editing techniques for the prevention or cure of disease is a highly promising tool for the future of humanity. However, its implementation contains a number of ethical and legal challenges that should not be underestimated. On this basis, some sectors have already asked for a veto on any intervention that modifies the human germ line, while supporting somatic line editing. In this paper, I will support that this suggestion makes no sense at all, because the somatic/germ (...) line disjunctive has no moral relevance and, therefore, it should not play any role in legal terms. I will provide a number of reasons to hold this assumption, such as the non‐sacred nature of the germ line, the difference between germ line and human genome modification, or the moral importance of the presence of a will to create modified descendants. While doing so, I will provide some examples of the different approaches to germ line editing adopted by different regulations so as to demonstrate that, contrary to what is sometimes stated, a general ban on this practice is not the rule, but the exception. Additionally, I will show how alternative options which currently exist, such as a selective ban based on criteria different to the germ line/somatic line distinction, match better with the need to conciliate research needs and legitimate ethical concerns. Finally, I will introduce some further suggestions to this same purpose. (shrink)

The aim of the present paper is to reinforce some of the affirmations made by Vera Lucia Raposo in a recent paper published by the Journal of Bioethical Inquiry. According to her, germline gene editing does not violate human dignity at all. This article offers some complementary ideas supporting her statement. In particular, four main arguments are stressed. Firstly, not only is the idea of human dignity unclear, but the idea of the human genome suffers from a general lack of (...) concreteness, which has dramatic consequences for the debate. Secondly, it is highlighted that if we believe that the immutability of the human genome underpins human dignity, then it should be our duty to use the tools of genetic modification to reverse any accidental changes that occur in nature. Thirdly, it is showed that if the alteration of germline constitutes an attack on human dignity, then we should also refrain from performing medical practices such as chemotherapy, which cause precisely this effect. Finally, we argue that modification of germline is not contrary to human dignity but an excellent expression of our autonomy. (shrink)

En un mundo globalizado, el consumidor posee un poder superior al que nunca ha tenido. La amplitud de los mercados hace que le sea muy sencillo sustituir unos bienes por otros a la hora de satisfacer una necesidad. Sus decisiones de compra son, a su vez, las que deciden qué empresas triunfarán y cuáles no. De ahí que sea cada vez más cabal hablar de soberanía del consumidor. La conciencia de este poder es esencial, ya que permite pensar en formas (...) de poner límites al libre mercado basadas en la idea de justicia. Ahora bien, esto sólo será posible a través de acciones concertadas, que utilicen herramientas eficaces, como el boicot de compra. Este texto analiza las posibilidades con las que cuenta el consumidor para ejercer su poder adecuadamente. (shrink)

El edificio Rana Plaza, en Bangladesh, se vino abajo en Abril 2013. Como consecuencia, más de mil personas perdieron la vida. Este suceso despertó inmediatamente una fuerte crítica a la actuación de las grandes corporaciones trasnacionales. Se les acusó de no haber hecho todo lo que podían para mejorar las condiciones laborales en ese país, a pesar de que su poder de compra les permitía dictar las reglas. Este artículo pretende explorar la legitimidad de esa acusación. Con tal fin, se (...) explorará la responsabilidad moral de la situación existente en muchos países en vías de desarrollo. Ese análisis desvelará que, más allá de las citadas corporaciones, es posible hablar de responsabilidades en el caso de muchos de nosotros. Nuestra doble vertiente de ciudadanos y consumidores/inversores nos dota de un poder que implica también una responsabilidad. (shrink)

El objetivo de este texto consiste en analizar las consecuencias que la creación de quimeras e híbridos puede llegar a tener sobre los paradigmas éticos con los que contamos ahora mismo, especialmente el antropocentrismo. Intentaremos demostrar que este paradigma no es capaz de afrontar adecuadamente la existencia de esta clase de seres, que desafían las premisas sobre las que se construye. Esto debería llevarnos a reemplazarlo por otros modelos éticos.

Human germline gene editing constitutes an extremely promising technology; at the same time, however, it raises remarkable ethical, legal, and social issues. Although many of these issues have been largely explored by the academic literature, there are gender issues embedded in the process that have not received the attention they deserve. This paper examines ways in which this new tool necessarily affects males and females differently—both in rewards and perils. The authors conclude that there is an urgent need to include (...) these gender issues in the current debate, before giving a green light to this new technology. (shrink)

La aparición de las modernas técnicas de modificación genética (CRISPRCas9) ha abierto maravillosas expectativas en el campo de la biomedicina. Sin embargo, su aplicación sobre la línea germinal humana despierta todavía una fuerte oposición por parte de amplios colectivos. A menudo se aduce que factores como el riesgo que implica esta técnica, su propia futilidad, la amenaza implícita a la integridad del genoma humano, o la posibilidad de que acaben dando naturaleza a una nueva eugenesia justifican la necesidad de trazar (...) una prohibición o, al menos, una moratoria sobre ellas. En este texto debatiremos la solvencia de cada uno de estos argumentos, concluyendo que, en realidad, no hay buenos motivos para oponerse a la técnica que nos ocupa. (shrink)

Hasta mediado s del siglo pasado, el tema que nos ocupa, la presencia de Cristo en los sacramentos, se resumía y concentraba, po r no deci r que se agotaba, en la presencia real eucanstica. O sea el concept o 'presencia' de Cristo se reservaba en la practica únicamente para su realización máxima en la Eucaristía; era la presencia real somática la que absorbía cualquier otra forma de presencia sacramental, que en todo caso quedaba en la sombra. Subrayo lo de (...) presencia sacramental, porque obviamente la presencia divina llenándolo todo, abarcando el cosmo s y la historia, no era desconocida Po r lo que a mi se m e alcanza, la primera vez que en un documento eclesiástico se hace explícita referencia a la presencia de Cristo en los sacramentos es precisamente en la única encíclica enteramente consagrada a la liturgia que hasta hoy conocemos : la Mediator Dei promulgada por Pío XII el 20 de noviembre de 1947. La doctrina aquí propuesta ha tenido tal aceptación o recepción que pertenece ya, podríamos decir, al tesoro de la Tradición. (shrink)