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Cloning Techniques Applied to Human Beings. An Assessment of the Ethical and Legal Criteria with Respect to New Developments in Cloning Techniques and Stem Cell Research - [German]


Duration:

Jan 1999 - Jan 2003

Funding body:

DFG Förderinitiative Bioethik

Contact:

Institut für Wissenschaft und Ethik (IWE)

Bonner Talweg 57

53113 Bonn

Germany

Phone: +49-(0)228-3364-19 20 Fax: +49-(0)228-3364-19 50

E-Mail: iwe@iwe.uni-bonn.de
URL: http://www.iwe.uni-bonn.de

Head:

Denker, Hans-Werner (Prof. Dr. Dr.)

Günther, Hans-Ludwig (Prof. Dr.)

Honnefelder, Ludger (Prof. Dr. Dr.)

Siep, Ludwig (Prof. Dr.)

Member:

Beckmann, Jan P. (Prof. Dr.)

Beier, Henning (Prof. Dr. Dr.)

Bülow, Detlev von (MinDgt. a.D.)

Fuchs, Michael (Dr.)

Honecker, Martin (Prof. Dr.)

Lanzerath, Dirk (Dr.)

Advena-Regnery, Barbara (M.A.)

Heinemann, Thomas (Dr.)

Schütze, Hinner (Rechtsassessor)

Short Description:

The term «cloning» refers to techniques that aim at the identical genetic reproduction of cells or whole organisms. Cloning techniques such as embryo splitting or the generation of embryonic stem cells (ES cells) have already been used in research and animal breeding for many years. These techniques become highly critical in their ethical dimension when applied to human beings, as happened in late 1998 when, for the first time, the sourcing and culturing of human ES cells was realised in vitro. Moreover, the increasing possibility of being able to reproduce any number of genetically identical human embryos in laboratories has given rise to a broad spectrum of reactions. These reactions range from enthusiastic approval to deep concerns, depending on the assessment and weighing of the aims these techniques can achieve and the means taken in order to achieve them. The ethical controversy turns especially on the question whether the aims and goals for which these techniques are being deployed are to be considered legitimate, and whether the means taken in order to achieve these goals are justifiable in terms of their direct and indirect consequences. In this context the question of the ethical and legal status of cells and organisms that have been or are to be cloned arises, as well as the question whether any protective rights based on their status ensue.

Concerning possible objectives of applying cloning technology to humans, the current discussion distinguishes between reproductive and therapeutic cloning. Reproductive cloning aims at creating a human being that is born to the world. Therapeutic cloning on the other hand is aimed at developing therapeutic approaches for human diseases with the help of cloning technology. It can include basic research into and artificial influencing of the mechanisms of cell differentiation, the development of cell transplantation procedures and of procedures to artificially produce complex organs for transplantation purposes. Furthermore, it can also include selective therapeutic intervention in the abnormal development of a human embryo as well as the testing of pharmaceutical and toxic influences on embryonic development.

Currently, the methods being used for therapeutic objectives mainly consist in the generating and using human ES cell lines, which are mainly obtained using one of the following two methods: The first process consists of cultivating totipotent embryonic cells obtained by in vitro fertilisation, from human blastozysts, the second consists of cultivating primordial germ cells of miscarried or aborted human fetuses. A third technique, which could be applied to human beings as well, consists of producing embryonic stem cells by transferring a somatic cell nucleus into an enucleated egg cell. The latter procedure has already successfully been applied to various animal species (such as Dolly the sheep).

A consensus currently exists at an international level to view the objectives pursued by reproductive cloning as illegitimate and to observe a ban or at least a moratorium on reproductive cloning. On the other hand, in view of the nature of the therapeutic goals being pursued, the objective of therapeutic cloning can be generally viewed as legitimate - albeit on condition that this research is geared exclusively to this goal. In this case, the general disagreement and ethical problems revolve less around the issue of the legitimacy of the objectives being pursued than around the justifiability of the means being used. The question of the methods being used for the various cloning techniques also raises the issue of what merits protection and, consequently, of the ethical and legal status of the human cells which are used for cloning purposes and are being cultured.

Important arguments in the debate as to which status these cells should be assigned point to their respective potential for biological differentiation and development which at present can often be determined only on an approximate basis and expressed only by means of probability assessments due to a lack of reliable biological differentiation markers. These circumstances shed light on the difficulties involved in determining «status». At the same time, it is evident that «status» plays a central role in the current discussion and in the decision-making process in ethical issues. For example, based on the status of the particular cells to be used in cloning it is possible to make ethical differentiations in assessing the various techniques which can be used to clone human embryo cells. For instance, in vitro cloning of embryonic gametes from dead fetuses does not involve destroying an embryo or the use of totipotent embryonic cells - in contrast to the use of embryoblasts from «surplus» embryos.

The objective of this project is to examine the connections outlined above between possible goals of cloning activities in the human domain and the methods that are needed or could possibly be used to achieve these goals; the relationship between the arguments revolving around «purpose» and the arguments revolving around «status»; and the role that biological differentiation potential plays with regard to the status discussion. Within this context, the authors identify and analyse the decision-making criteria used in various countries for the ethical and legal assessment of cloning that involves humans; they also develop approaches for forming a comprehensive ethical judgement.

Keywords

cloning – embryo research – embryonic stem cells – medical ethics – reproduction medicine

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