Prevention and management of fraud--in theory.
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The bill to restore federal funding for human fetal tissue research has been passed by the House and awaits Senate approval. But it requires women who are willing to donate fetal tissue to certify that they did not have an abortion with the intent to donate. It further requires researchers to keep the certifications on file and available for government audit. Both requirements spell trouble.
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In accordance with the German Animal Welfare Act, animal experiments in fundamental biomedical research may only be performed after licensing by the responsible authority. This license may only be granted if the experiments are considered indispensable and if the distress of the animals seems ethically acceptable in relation to the purpose of the study. Since 1987 advisory committees have been established to support the authorities in the evaluation of these provisions. Animal welfare organisations had expected case-by-case evaluations of the in-dispensability of research proposals and of the distress of the animals and the scientific benefit of the experiments to take place in these committees, so that such projects that would not meet the criteria of ethical acceptability could be prevented. However, already the lack of parity in the advisory committees alone, in which as a rule four scientists counterpart two representatives from animal welfare organisations, often-times prevents a balanced discussion of these provisions from taking place. Additionally, due to the freedom of science granted in the German Constitution without reservations, until 2002 also the licensing authorities were merely permitted to perform a formal examination of the applications. In the mean time, by including animal welfare as a national objective in the Constitution, the preconditions were made to enable an examination of the contents. From the point of view of animal welfare it therefore is to be requested that now also the advisory committees are ascribed more importance in the course of the licensing procedure and to establish the legal framework for this, if necessary by a revision of the Animal Welfare Act.
While many European countries are entering unknown legal terrain where the embryo in vitro is concerned, France can already look back on a long tradition of public discussion and legal codification of ways of dealing with in vitro embryos. In its comprehensive law of 1994, France had still rejected embryo research; however, due to the promising perspectives of stem cell research, the new law now pending implies a clear liberalization of the 1994 provisions. Both the French lawmakers and the National Ethics Commission have repeatedly argued that possible utilization of embryos for research purposes may seem legitimate from the moment that there is no more "parental project." De facto, this concept implies that an embryo can be transformed into an object from the moment that the parents cease to desire it and that the value of protection is solely dependent on the will of third persons. At the same time, France is still speaking of guaranteeing respect for the "dignity of the embryo," which would mean that an embryo must not be reduced to a thing and treated for purposes which are not his own. Therefore, the French solution is not a consistent and honest solution, and in its new legal provisions, France has involved herself in manifold contradictions. France has rejected the conception of pre-embryo, but is de facto following Britain's model without making it explicit.
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A critical analysis is undertaken of the ethical debate on two general classes of research activities that bear on the future of human gene therapy: (i) the human fetus and (ii) the preimplantation human embryo after in vitro fertilization (IVF). The conclusion is that the hope of human gene therapy and of other clinical applications of the human genome initiative is in danger because of the obstacles to research in reproductive biology and human genetics in the federal sector.
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