Of mice and human embryos: is there an ethically preferred order of preclinical research on new assisted reproductive technologies?

It is widely acknowledged that the responsible introduction of new assisted reproductive technologies (ARTs) requires preclinical safety research, including the use of animal models and human embryos. However, the moral sensitivity of human embryo research has led to regulations and guidance stating that human embryos may only be used for research that cannot also be conducted with animals. We call this the 'use animals first' (UAF) rule. In the field of ART research, this translates into the notion of an ideal chain of consecutive preclinical research steps, where research using human embryos may only be considered as a further step after promising results have been obtained in animals first. This may lead to research ethics committees requiring animal studies that are in fact a waste of time and money, while exposing animals to an infringement of their wellbeing for no good purpose. In this paper, we explore the possible moral arguments behind the UAF-rule and test their validity. We conclude that there are no convincing grounds for upholding this rule and recommend replacing it.

Ethical and legal issues arising in research on inducing human germ cells from pluripotent stem cells.

Derivation of eggs or sperm from pluripotent stem cells or direct reprogramming from somatic cells would have huge effects on assisted reproductive technology. Here we discuss important ethical, legal, and social issues that would be raised by the development of such female or male gametes for clinical use.

¿Un paso adelante hacia la clonación humana con fines terapéuticos? / A step forward in human cloning for therapeutic purposes?

En el presente trabajo se analiza el estado actual de las investigaciones para la obtención de embriones humanos clónicos por transferencia nuclear de células somáticas y de las células troncales embrionarias y su posible utilización con fines terapéuticos. Se analizan algunos aspectos éticos y legales referentes a la obtención y utilización de los embriones humanos clónicos (AU)

Present investigations carried out to produce human embryos by somatic cell nuclear transfer (SCNT embryos) and nuclear transfer human embryo stem cells (NT-ESC) and their use in regenerative medicine are analyzed. Ethical and legal aspects are discussed (AU)

Creating embryos for use in stem cell research.

In this paper I will address whether the restriction on the creation of human embryos solely for the purpose of research in which they will be used and destroyed in the creation of human stem cell lines is ethically justified. Of course, a cynical but perhaps accurate reading of the new Obama policy is that leaving this restriction in place was done for political, not ethical, reasons, in light of the apparent public opposition to creating embryos for use in this research. But the issue of whether the restriction is ethically justified remains important, even if only for another day in the policy arena.

Translating stem cell research: challenges at the research frontier.

This paper will address the translation of basic stem cell research into clinical research. While "stem cell" trials are sometimes used to describe established practices of bone marrow transplantation or transplantation of primary cells derived from bone marrow, for the purposes of this paper, I am primarily focusing on stem cell trials which are far less established, including use of hESC derived stem cells. The central ethical challenges in stem cell clinical trials arise in frontier research, not in standard, well-established areas of research.

[Does 2009 mark a revival of embryonic stem cells?]. / ¿Resucitan al inicio del 2009 las células troncales procedentes de embriones?

The legal possibility of using federal funds to work with embryonic cells and destroy embryos started on March 2009 in the USA. It has nothing to do with regenerative therapies. It is directed to create banks with human cells, banks directed by a few scientists involved in biotechnology enterprises connected with centers of in vitro reproduction. They pursue the use of ad hoc human embryos for biomedical research. The idea of using cell lines derived from embryos is quite spread, and even the idea of obtaining new lines of this type to validate reprogrammed somatic pluripotential cells, the so called iPS cell (induced pluripotent stem), without destroying embryos or using ovules. This type of cells is indeed of great value in medical research and it is opening new possibilities in Cell Therapy. Recent data are analyzed and considerations are advanced encouraging rational alternatives to eliminate embryonic cells in the evaluation of iPS cells.

[The juridical desprotection of the human embryos post the new law of human assisted reproduction and the law of biomedical investigation]. / La desprotección jurídica del embrión humano tras la nueva ley de reproducción humana asistida y la ley de investigación biomédica.

This research try to analyse the juridical statute of the human embryos in accordance with two recent laws which contain ordesr what affects him: the new Law of assisted reproduction technology -Law 14/2006, of 26 may (LRA)-, and the law of biomedical investigation -Law 14/2007, of 3 july (LIB)-, because the embryos in vitro is considered devoid of the quality what give the human dignity, why is allowed not only to research and to test with the remaining preembryos of assisted reproduction, but also to clone embryos with therapeutic purposes and to make a embryonic selection in order to cure other sons of the woman that recourse to fertilization in vitro through the donation of genetic material from the future baby.

Cross-border research on human embryonic stem cells: legal and ethical considerations.

Although stem cell research is a field that stands to benefit a lot from international cooperation, collaboration between scientists of different countries is hampered by the great divergence in national stem cell legislations. More specifically, researchers from countries with restrictive stem cell policies find themselves unable to participate in international research or attend meetings or workshops in more permissive environments as they fear being prosecuted in their home country for activities that are deemed acceptable abroad. Juridical clarity on this subject is long overdue. Legally, extraterritorial jurisdiction based on the nationality principle does not conflict with international law. However, invoking this principle to prosecute stem cell researchers would constitute a breach with the current custom to limit extraterritorial jurisdiction to exceptional crimes or circumstances. On the ethical front, legislators have an obligation towards their constituents to protect them from harm through the criminal justice system, but at the same time they should be wary of legal moralism and of jeopardising freedom of research. Researchers on their part cannot simply ignore the law whenever it deviates from their personal moral opinions, but they are not acting unethically if they perform research that they esteem to be ethically justified where it is also legally accepted. Allowing researchers to work freely abroad-within the jurisdiction of the host country-is a way for legislator and researcher to show respect for each other's different moral values and to balance their rights and obligations towards each other.

[An international comparative legal analysis of the regulation of research with human embryonic stem cells]. / Stammzellforschung aus rechtsvergleichender Sicht.

The article is based on the results of a comparative legal study of the status and protection of extracorporeal embryos in a number of European and non-European countries. In this context, the study also deals with the extent to which in vitro embryos can be created and/or used for research purposes (especially for stem cell research). The results show a considerable divergence with regard to existing solutions. This divergence is not due solely to different concepts of protection but is also an indication of the controversial debate on whether such entities are worthy of protection and, if so, to what degree it should be granted. The discussion indeed begins at the level of terminology where the attribute(s) characterizing an "embryo" in the legal sense are - already and seemingly without deeper meaning - anything but uniform. The reasons for this disparity, such as the time factor (which stages of development must have taken place after fertilization of an egg cell by a sperm cell?) or the method of genesis itself (aside from conception, which other methods are used to generate embryos?), could be particularly relevant. The differences mentioned lead, in turn, to the question of which legal consequences researchers must keep in mind - especially regarding the risk of criminal liability - when engaging in international cooperation efforts with peers from more permissive countries.

Cybrid human embryos--warranting opportunities to augment embryonic stem cell research.

The recent vote in the British Parliament allows scientists in principle to create hybrid embryos by transferring human somatic cell nuclei into animal oocytes. This vote opens a fascinating new area of research with the central aim of generating interspecific lines of embryonic stem cells (ESCs) that could potentially be used to understand development, differentiation, gene expression and genomic compatibility. It will also promote human cell therapies, as well as the pharmaceutical industry's search for new drug targets. If this approach is to be successful, many biological questions need to be answered and, in addition, some moral and ethical aspects must be taken into account.

Regulatory issues for personalized pluripotent cells.

The development of personalized pluripotent stem cells for research and for possible therapies holds out great hope for patients. However, such cells will face significant technical and regulatory challenges before they can be used as therapeutic reagents. Here we consider two possible sources of personalized pluripotent stem cells: embryonic stem cells derived from nuclear transfer (NT-ESCs) and induced pluripotent stem cells (iPSCs) derived from direct reprogramming of adult somatic cells. Both sources of personalized pluripotent stem cells face unique regulatory hurdles that are in some ways significantly higher than those facing stem cells derived from embryos produced by fertilization (ESCs). However, the outstanding long-term potential of iPSCs and their relative freedom from the ethical concerns raised by both ESCs and NT-ESCs makes direct reprogramming an exceptionally promising approach to advancing research and providing therapies in the field of regenerative medicine.

Resolving the "egg supply problem" in human embryonic stem cell derivation through technical means--a legal and ethical analysis.

This paper seeks to briefly discuss the legal and ethical problems connected to scientific developments in the field of human embryonic stem cell derivation aimed at solving the "egg supply problem" in stem cell research. The legal situation is discussed in respect of the UK's current regulatory regime, proposed reform and the Oviedo Convention. The scientific developments which are examined are chimeric embryos, in vitro maturation of oocytes, derivation of stem cell lines in connection with pre-implantation genetic diagnosis and the derivation of oocytes from existing stem cell lines.

El estatuto jurídico del embrión en España: de la ley de reproducción de 1988 a la clonación terapéutica de nuestros días / No disponible

Partiendo de la primera norma de reproducción asistida de 1988, el autor pone de manifiesto el estatuto jurídico del embrión en España, haciendo un repaso de las distintas previsiones legales que afectan a dicha realidad biológica generadas a lo largo del tiempo, con especial referencia a la doctrina del Tribunal Constitucional. Se realiza un análisis comparativo de la evolución normativa hasta llegar al momento actual, marcado por la ley de investigación biomédica de 2007 y por la aprobación de la denominada clonación terapéutica (AU)

Starting with the first regulation on assisted reproduction of 1988, the author reviews the different measures in matters of protection of the human embryo that have been generated in these last years, with special attention to the doctrine of the Constitutional Tribunal. The author makes a comparative analysis of its evolution up to the present time, in which there has been an approval of the biomedical research law of 2007 in Spain, and with it, the so called therapeutic cloning (AU)

Ethical, legal and social issues related to cell therapy

El autor analiza las implicaciones de la terapia celular a partir del estudio jurídico que regula la utilización de materia embrionaria: el régimen de la obtención de las células, de la investigación con embriones y de su creación con fines de investigación y de terapia. Se detiene con minuciosidad en las previsiones del Convenio de Derechos Humanos y Biomedicina del Consejo de Europa, y concluye que la “clonación terapéutica” no está prohibida en nuestro ordenamiento jurídico (AU)

The author analyses the implications of cell therapy form a legal study that regulates the use of embryonic material: the regulation of the obtaining of cells, of research with embryonic material; the regulation of the obtaining of cells, of research with embryons and their research and therapeutic use. There is a detailed look at the provisions in the Convention of Human Rights and Biomedicine of the Council of Europe and concludes that “therapeutic cloning” is not prohibited in our legal regulation (AU)