Examples: law, child, reproduction, ...
 Genetic Testing and Screening 

 Human Genetic Research 

 Cloning 

 Stem Cells 

 Genomics and Population Health 

 Pharmacogenomics 

 Children and Genetic Research 

 Research Ethics Boards 

 Consent 

 Confidentiality 

 Genetic Discrimination 

 Insurance and Genetic Information 

 Employment and Genetic Information 

 Intellectual Property 

 Secondary Use of Genetic Data 


  Cloning

 What is cloning?   

Cloning is a process in which genetically identical copies of an organism (human, animal or plant) are created.

A clone can be created using one of two techniques:

1.  By transferring the nucleus of a somatic cell (a non reproductive adult cell, such as a skin or muscle cell) into an ova that has had its nucleus removed. This procedure is known as somatic cell nuclear transfer (SCNT). Dolly the sheep (the first mammal cloned using an adult cell) was conceived using this method.

2.  By separating cells during early developmental stages. This type of cloning can also occur naturally (for example, identical twins).




 What is therapeutic or research cloning?   
Therapeutic cloning uses cloning technology to develop stem cells for research and future clinical applications. It involves the creation of an embryo for the purpose of research and not to produce a human clone.



 What is reproductive cloning?   
The aim of reproductive cloning is to generate another organism with identical genetic characteristics. This is achieved by transferring a nucleus from an adult cell into an egg from which the nucleus has been removed (SCNT). Stimulation of this cell then allows the beginning of the cell division process. Ultimately, an embryo is created and is transferred into the uterus of a female host.



 What is the goal of cloning?   

Therapeutic cloning may be of great interest in the creation of embryonic stem cells for research and therapy. It could lead to the production of tissues for potential transplantation or replacement of defective or dead cells. The cells composing a cloned embryo are immunologically compatible with the adult cell donor. It is thus possible to extract stem cells from a cloned embryo and graft them on the donor without the risk of graft rejection. This procedure is currently used to treat burn victims.

Another use for therapeutic cloning is to test new drugs and treatment strategies. Indeed, cloned cells or animals present the advantage of uniformity of drug response.

Finally, reproductive cloning could be a solution available for sterile or homosexual couples wanting to have genetically related children.




 What are the key international policy positions addressing human therapeutic and reproductive cloning?   



 What is the regulatory framework governing therapeutic cloning in Canada?   
  • The Assisted Human Reproduction Act (2004) prohibits the creation of embryos for research purposes. The Act defines a human clone as: “a result of the manipulation of human reproductive material or an in vitro embryo, contains a diploid set of chromosomes obtained from a single — living or deceased — human being, foetus or embryo” (Article 3) and specifies that human cloning for any purposes, including therapeutic cloning, is prohibited.
  • The Updated Guidelines for Human Pluripotent Stem Cell Research (2007) of the Canadian Institutes of Health research states that “research involving somatic cell nuclear transfer into human oocytes (cloning) or involving stimulation of an unfertilized egg to produce a human embryo (parthenogenesis) for the purposes of developing human embryonic stem cell lines or other cell lines of a pluripotent nature” would not conform to the guidelines (Art. 8.2.2).



 What is the regulatory framework governing reproductive cloning in Canada?   
  • The Assisted Human Reproduction Act (2004) includes a definition of human clone. It clearly prohibits human cloning (Art. 5 (1)(a)) for any purposes. Severe criminal penalties are provided in case of violation of these provisions.
  • The Canadian Institutes of Health Research released Updated Guidelines for Human Pluripotent Stem Cell Research (2007) which states that “research involving somatic cell nuclear transfer into human oocytes (cloning) or involving stimulation of an unfertilized egg to produce a human embryo (parthenogenesis) for the purposes of developing human embryonic stem cell lines or other cell lines of a pluripotent nature” (Art. 8.2.2) would not conform to the guidelines.



 What is the regulatory framework governing cloning in Québec?   
There is no specific regulatory framework governing cloning in Québec. The federal framework applies.



What are the ethical and social issues surrounding cloning?

  •  Human dignity   
  • The import of human dignity in this context depends on one’s perspective on cloning, the status of human embryos, and of the value of human life. In a pluralistic society like Canada, opposing views on what dignity means with regard to embryos coexist. For some, cloning negatively impacts the principle of human dignity, and for others, it does not. Arguments such as human diversity, sanctity, individuality and uniqueness are often cited by opponents of reproductive cloning.



  •  Instrumentation of human life   
  • Some argue that the main problem with cloning is the creation of human beings for specific purposes (for example, to have spare organs, etc.). As the WHO points out in A dozen questions (and answers) on human cloning, there is a risk “that people exist to serve purposes set by other people” or to turn humans into manufactured objects.

    Others fear the consequences of the possibility of “bringing the dead back to life” and replacing deceased children or loved ones using cloning. This does not take into account the fact that people are not self programmed by genes. Environmental factors also influence development.

    Finally, cloning techniques require a large number of eggs to create a single viable clone. Some see this as posing a risk in terms of the potential exploitation of women and the commercialization or industrialization of human procreation.




  •  Freedom of research   
  • A response to opponents of cloning often comes from researchers claiming freedom of research. The argument is rooted on the idea that scientific research is a mode of expression. Up to now, the Supreme Court of Canada has not made any statement in this issue.

    Some international normative documents recognize freedom of research as a fundamental right (for example, the Universal Declaration on the Human Genome and Human Rights, Art. 12(b); the Universal Declaration on Bioethics and Human Rights, preamble and  Art. 2(d); and the Convention on Human Rights and Biomedicine, Art. 15).




  •  Eugenics   
  • The Canadian Oxford Dictionary defines the term “eugenics” as “the science of improving (esp. human) populations by controlled breeding for desirable inherited characteristics.”

    The use of cloning for eugenic purposes is the most common concern about this technology. The majority of laws, guidelines, and formal agreements forbid the use of cloning for eugenic purposes.




  •  Other issues   
  • General issues linked with experimental techniques such as medical safety and child protection are often raised. In the particular context of reproductive cloning, there is also an aspect of social experimentation.

    Many uncertainties remain, such as the status of human clones, the risk of discrimination, ambiguous relationships, confused personal identity and harmed psychological development. In fact, cloning seriously challenges the very notions of reproduction and family. Some are already proposing the adoption of a charter of rights for clones to prevent these potential problems.






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