Human embryonic stem cell research: an Australian perspective.

A conscience vote of individual parliamentarians in the Australian government last month regarding amendments to current legislation regulating human embryonic stem cell research yielded a surprising outcome. Despite opposition by the Australian Prime Minister, the Senate and House of Representatives voted to adopt the recommendations of the Lockhart Review and approve human somatic cell nuclear transfer, thus providing a consistent national policy for all researchers in Australia.

A bioética frente às situações emergentes: a esperança depositada em um cordão umbilical / Bioethics in Emerging Situations - Hope Deposited in an Umbilical Cord

A terapia celular carrega a promessa de se tornar a medicina do futuro, recuperando tecidos danificados ou mesmo eliminando a fila de transplantes. As células-tronco constituem um grupo celular que preserva a capacidade de auto-renovação, podendo diferenciar-se em tipos celulares diversos. A utilização de células-tronco de cordão umbilical, apesar de menos polêmica que as embrionárias, revela muitos aspectos de natureza moral e ética que emergem em relação aos bancos de armazenamento de uso autólogo e alogênico. Hoje, o uso da terapia celular ainda é bastante restrito e depende de um amplo desenvolvimento de pesquisas, contudo, uma grande esperança lhe é depositada. A Bioética é uma ferramenta para o delineamento de parâmetros éticos ao desenvolvimento tecno-científico. O presente estudo revelou que os limites e fronteiras de regulação de seu uso não estão claramente delineados e se mantém em constante transformação, percebendo-se uma clara tendência mundial no incentivo ao modelo alôgenico, a exemplo do Brasil e do Brasilcord. Em decorrência disso, o presente trabalho apresenta uma avaliação da utilização de células-tronco de cordão umbilical frente a visão da autonomia, da vulnerabilidade, da justiça, da equidade, da proteção, da precaução, da responsbilidade, da utilidade e da solidariedade.

Embryonic stem cell research: terminological ambiguity may lead to legal obscurity.

National regulation on embryonic stem cell research in the European Union is ambiguous, due to a lack of consistent scientific terminology as exemplified by the Dutch Embryos Act. To force a breakthrough in this ethically dubious research topic, a more careful use of terminology would be in the interest of both the scientific community and the lawmakers, in order to avoid terminology becoming associated with research or applications for which it is inappropriate. Therefore I will first clarify the technological possibilities in an age of biological control. Secondly, we will critically analyse the statements of the European Convention on Human Rights and Biomedicine concerning embryo research and cloning. The Convention prohibits human reproductive cloning but does not take a clear position on so-called therapeutic cloning. Finally, we will give an overview of the most recent legislative initiatives within the European Union on this matter.

Cloning and stem cells: processes, politics, and policy.

The creation of good science policy requires an understanding of the scientific technologic processes as well as an appreciation of the "politicization process" and contemporary politics. This article encompasses a review of nuclear transfer and stem cell technologies and advances against a backdrop of the politicization of science. The combination of these forces has rendered it almost impossible to develop true consensus on what any national policy regarding nuclear transfer should look like. Careful consideration of the multidimensional nature of these technologies and the myriad of social, economic, and cultural factors they will impact demands, however, that, at the very least, a national dialogue be instituted in an effort to frame good policy pertaining to nuclear transfer and stem cell research.

Ethics of research and the pregnant patient.

In this chapter, we address ethical issues in research involving fetuses and pregnant women, with particular attention to the emerging issue of gene-transfer research. Ethical analyses and arguments are based on the concept of the fetus as a patient. The implications of this concept for the ethics of fetal research are identified. The discussion of gene-transfer research extends those implications to address issues concerning informed consent, assessment of potential fetal and neonatal morbidity in study design, prenatal diagnosis after gene transfer, selection criteria based on abortion preference, science by press conference, germline risks, and public oversight.

[Comments on the Dutch Institute for Health Care Improvement's standard code of practice entitled, "Donation of fetal tissue"]. / Opmerkingen bij het CBO-modelreglement 'Terbeschikkingstelling van foetaal weefsel'.

Under the auspices of the Kwaliteitsinstituut voor de Gezondheidszorg CBO [Dutch Institute for Healthcare Improvement] a standard code of practice was developed as a template for local institutional codes to implement the Law on Foetal Tissue. It is a useful model code, but arguments should have been outlined more explicitly, notably in instances where the code adopts a somewhat stricter position than the Law. The following remarks pertain to the model code: 1. It may be argued that the inclusion or exclusion of 12-15-year-old pregnant girls should be relative to the privacy-related sensitivity of the use of foetal tissue. 2. Transplantation requires additional tests for the safety of the recipient, including testing for HIV/AIDS. A pregnant woman's permission for such testing should not be taken for granted. 3. The abortion technique may be modified in view of the subsequent use of foetal tissue if the woman consents to the modification, with the prerequisites that the modification does not harm the woman and that any potential sensation of pain by the foetus must be minimised.

[Dutch Institute for Health Care Improvement's standard code of practice entitled, "Donation of fetal tissue"]. / CBO-modelreglement 'Terbeschikkingstelling van foetaal weefsel'.

The Dutch Law on Foetal Tissue (Wet Foetaal Weefsel) sets out conditions and regulations concerning the donation, storage and permissibility of use of foetal tissue. Each institution where foetal tissue becomes available has to formulate an in-house code of conduct describing how the law will be applied within that institution. A committee, including abortion physicians and gynaecologists, has formulated a number of rules of conduct within the standard code of conduct under the auspices of the Kwaliteitsinstituut voor de Gezondheidszorg CBO [Dutch Institute for Healthcare Improvement]. Complying with this standard code ensures that the law is upheld. In clinical practice, one may deviate from this standard code in case of solid reasons only. Generally, all women can be asked to donate foetal tissue. A basic prerequisite for the inclusion of non-Dutch women is that oral and written communication is possible. The committee considers the age of 16 as a minimum threshold and mental incompetence as an exclusion criterion. Much attention should be paid to providing the women with information and to requesting permission. The basic principle is that the decision to terminate a pregnancy should be strictly separated from the decision to donate foetal tissue. As a general rule, foetal tissue should be stored anonymously. Adjustment of the abortion method in view of the intended scientific research is not permitted.

[Principles and juridical limits to human embryo research]. / Principios y límites jurídicos de la investigación con embriones humanos.

This work intends to provide a wide scope of the legal situation in Brazil referred to Human Embryos and how it has been developed through the 20th century. Across the last century, the human being got the possibility of making genetic experiments with human embryos. Our main goal is to assume the future responsibility of these actions through a juridical and ethical point of view.

Professional self-regulation and guidelines in assisted reproduction.

Australia's scientific expertise in ART has not been matched by similar standards in national regulation. Scientific breakthroughs in the early 1980s were followed by cohorts of State and national inquiries. Early guidelines by the National Health and Medical Research Council were followed by status of children legislation clarifying their parentage where donated gametes were used. The practice and procedure of ART was legislatively regulated in Victoria, Western Australia and South Australia but left to guidelines and accreditation of the Fertility Society of Australia in the remaining States and Territories. The article examines the consequences of an absence of national regulation in dealing with embryo experimentation now that debates have shifted to human cloning and stem cell technology. The article also considers arguments for and against regulation in areas of parental procreative decision-making and embryo experimentation.

When transgressions become transparent: limiting family forms in assisted conception.

This article explores the social processes through which ideas about the family become translated into regulation and practice in assisted conception. Drawing on social problems literature, it is suggested that claims are made (by regulators, practitioners and others) about the desirability of certain family types and that forms of regulation occur when families transgress, in particularly obvious ways, the boundaries of those definitions. The apparently disparate examples of lesbian access to donor insemination and donor anonymity are brought together to illustrate the argument. It is also suggested that much formal regulation and clinical practice is directed towards making such transgressions less transparent, thus protecting the practice of assisted conception from unwelcome scrutiny.

Problems with the regulation of assisted reproductive technology: a clinician's perspective.

The use of the Infertility Treatment Act 1995 (Vic) as a model for regulating reproductive technologies throughout Australia poses many problems. This article argues that the legislation in Victoria is overly restrictive. In particular, banning embryo research is hypocritical. Embryo research was required to develop the clinical procedures and should be used to test innovations. Other problems are restricted access; privacy infringement; an intrusive regulatory body; conflicts with other laws; and confusion because of poor drafting or lack of foresight. Uniform statutes are unnecessary. The interests of individuals and the community are better served by regulation through the Reproductive Technology Accreditation Committee.

The pros and cons of human therapeutic cloning in the public debate.

Few issues linked to genetic research have raised as much controversial debate as the use of somatic cell nuclear transfer technology to create embryos specifically for stem cell research. Whereas European countries unanimously agree that reproductive cloning should be prohibited there is no agreement to be found on whether or not research into therapeutic cloning should be permitted. Since the UK took the lead and voted in favour of regulations allowing therapeutic cloning the public debate has intensified on the Continent. This debate reflects the wide spectrum of diverse religious and secular moralities that are prevalent in modern multicultural European democratic societies. Arguments range from putting forward strictly utilitarian views that weight the moral issues involved against the potential benefits that embryonic stem cell research may harbour to considering the embryo as a human being, endowed with human dignity and human rights from the moment of its creation, concluding that its use for research is unethical and should be strictly prohibited. Given the current state of dissension among the various European states, it is difficult to predict whether 'non-harmonisation' will prevail or whether in the long run 'harmonisation' of legislation that will allow stem cell research will evolve in the EU.

CNS stem cell transplantation: clinical and ethical perspectives.

Central nervous system disorders evoke special fear though their varied and unrelenting threats to memory, cognition, mobility, and every aspect of personal integrity and independence. Understandably, neurologic patients and their families become desperate for help, making fully free, informed consent problematic but not impossible. This desperation mandates our anticipatory attention to ethical questions related to any aggressive new therapy, including central nervous system grafting. In the United States, the right-to-life issue dominates ethical discussions on neural grafting. A variety of alternative tissue sources may permit technically suitable preparations, at least for some uses. If plentiful supplies of grafting cells can be made commercially, this should reduce problems related to allocating scarce resources, although financial and other scarcity barriers may still raise ethical problems. Many contemporary conceptions of selfhood depend on the identity and intactness of the mind and, by implication, the brain as substrate of mind. How much can we reweave the cerebral tapestry without creating a new self, a new identity? These philosophical questions will probably be approached pragmatically and incrementally, in the context of many other developments in human genetics and biomedicine. Our vision of the self will evolve amidst conflicting religious, ethical and pragmatic perspectives.