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 


  Stem Cells

 What are the key international policy positions addressing stem cell research?      

  • The International Society for Stem Cell Research (ISSCR) supports stem cell research within a specific ethical framework. The organisation published Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006) which applies to the derivation and use of pluripotent stem cell lines and does not encompass somatic (adult) stem cell research, research involving the derivation of human embryonic stem cells, or foetal tissue research. It includes provisions on research evaluation by independent committees (both regional and international), conditions related to participant consent and addresses intellectual property issues.
  • In 2004, the Human Genome Organisation (HUGO) Ethics Committee released its Statement on Stem Cells. The Statement encourages respect for differing personal and religious beliefs on the status of the human embryo. It promotes stem cell research, but recommends the adoption of regulations to ensure responsible and transparent practices. To achieve this, it states that independence and freedom of research are essential.
  • The European Group on Ethics in Science and New Technologies of the European Commission created Opinion No. 15 Ethical Aspects of Human Stem Cell Research and Use in 2000, which clarifies the powers of European institutions with respect to ethical considerations and research funding. According to the Opinion, basic ethical principles such as human dignity, autonomy, justice, safety and respect for pluralism within the European Community should guide this activity. The Group points out that the creation of embryos for research purposes is premature and favours the use of alternative sources of stem cells (i.e. embryos left over from assisted reproduction procedures, foetal tissues, etc.). It also states that the same conditions that apply in relation to tissue donation should apply to retrieval of adult stem cells. Finally, it clearly indicates that each member state is free to legislate on derivation of stem cells, but that if states permit it, a centralized authority to control access and research must be created.


  Human Genetic Research

 What is the regulatory framework governing human genetic research in Canada?      

  • At the federal level, there are no laws that specifically explore questions related to human genetic research. Nonetheless, certain articles in the Food and Drugs Act and its various regulations govern the use and sale of medications resulting from research involving humans. This Act could apply in the context of research with the goal of evaluating a genetic test before allowing its use in the clinic.
  • Also, certain articles in the Assisted Human Reproduction Act deal with genetic research in humans.
  • The Tri-Council Policy Statement (CIHR, SSHRC, NSERC, 1998, 2000, 2005) devotes an entire chapter (chapter 8) to genetic research involving humans.


  Stem Cells

 What is the regulatory framework governing stem cell research in Canada?      

Much of the Canadian regulatory framework concerns research involving human embryos. For a complete overview of the framework governing stem cell research in Canada, one must take into account several different statutes and guidelines.

  • The Assisted Human Reproduction Act (2004) authorizes research on stem cells within a specified framework. The Act applies to the derivation of stem cells from human embryos, but does not apply to research using human embryonic stem cell lines that have already been created. It prohibits the creation of embryos for research purposes (art. 5(b)), so researchers may only use embryos created as part of assisted reproduction procedures that are no longer needed to that end. In this case, donors must consent to the use of their unused embryos in research. An agency known as the Assisted Human Reproduction Agency of Canada is created and mandated by the Act to regulate activities involving the use of embryos in reproduction and research.
  • The Canadian Institutes of Health Research (CIHR) created the Updated Guidelines for Human Pluripotent Stem Cell Research (2007) to ensure the ethical and scientific oversight of stem cell research. The guidelines set explicit ethical standards for eligible funding and are based on principles found in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (e.g. informed consent, respect for privacy and confidentiality, ethics review, etc.). Furthermore, the guidelines establish explicit criteria for research, including restricting the use of embryos for research to embryos created originally for reproductive purposes, with the free and informed consent of the parties to the reproductive project, and without any commercial transaction. Additionally, they mandate that all human pluripotent stem cell research proposals must be approved by the Stem Cell Oversight Committee (SCOC). Finally, they propose the creation of an electronically accessible national registry of human embryonic stem cell lines generated in Canada.
  • Similarly, the TCPS proposes an ethical framework for research involving humans.  The policy statement includes a section applicable to research involving human gametes, embryos or fetuses. The only embryos that may be used for stem cell research are those that have been created as part of medically assisted reproduction, but are no longer needed for that purpose (chapter 9).


  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.


 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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