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 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 stem cells?   

Stem cells are the foundation cells of every organ, tissue and cell in the human body. They are undifferentiated; in other words, they do not have a specified function or specialized physiological properties. During their development, they become specialized (for example, forming different tissues such as intestines, heart, nervous system, etc.). One of the most interesteing characteristics of stem cells is their capacity for self-renewal by division, meaning that they can divide to form more stem cells that will eventually become specialized cells.

Because stem cells can specialize during the course of their development and perform different functions, they have the potential to replace damaged, aged, or dead cells.




 What are the types and sources of stem cells found in humans?   
During the embryonic stage of human development, embryonic stem cells (ES cells) can be obtained by extracting cells from very early embryos (4 to 7 days after fertilization). At this stage, they are totipotent, meaning that they have the ability to develop into any type of cell in the human body. Starting on the 6th day after fertilization, the cells begin to specialize. They then become pluripotent, which means that their ability to specialize is more limited. Pluripotent stem cells can be found in umbilical cord blood (collected from the umbilical cord immediately after) or more generally in the cells of the foetus. Finally, adult stem cells can be found in adult tissue and organs. When an organism is fully developed, stem cells are referred to as multipotent, meaning that they can differentiate into only one type of specialized tissue cell (for example, epidermal stem cells can form any type of skin cells and hematopoietic stem cells present in bone marrow produce different types of blood cells). In fact, these tissue-specific stem cells can be found in any part of the body.



 What is the goal of stem cell research?   

One basic aim of stem cell research is to improve understanding of the process of human development (i.e. how age affects different cells, natural replacement of damaged cells, spreading of cancer and other diseases, etc.).

Another important reason that stem cell research is insteresting is because many diseases such as Parkinson’s disease or Alzheimer’s disease are the result of cell loss or cell damage. Embryonic stem cells may be used to create and replace damaged, dead or aged tissues. This is known as cell-based regenerative therapy.

Although the majority of cellular therapies are still in the experimental stage, certain techniques are already practiced, such as bone marrow replacements or skin grafts, or used to treat leukemia, lymphoma and burns.

Another potential use of stem cells arises in the context of drug testing. This consists of developing stem cells into specialized cells to test the effect of medications on these cells. This entails certain benefits, including: improvement in the efficiency and accuracy of drug testing, reduction of costs, and reduction in the use of animals in drug testing. Similarly, stem cells could be used to measure the effects of toxic substances in drugs, food and in the environment generally. 

Finally, stem cell research could have an effect in boosting the development of research in Pharmacogenomics, which is based on the development of drugs for specific cell types.




 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.



 How is stem cell research regulated indifferent countries?   
Countries around the world have adopted different approaches to the regulation of stem cell research. These approaches reflect their legal traditions and cultural and religious beliefs. A list of laws, policies, regulations or guidelines by country or region in relation to stem cells is available on the HumGen module StemGen at the following address: http://www.stemgen.org/mapworld.cfm



 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).



 What is the regulatory framework governing stem cell research in Quebec?   
There is no specific regulatory framework for stem cell research in Quebec. The federal framework applies.



What are the ethical and social issues surrounding stem cells?

  •  Respect for human life   
  • Respect for human life requires that we show respect for human embryos. Some people believe that embryonic stem cell research violates this principle, as an embryo is destroyed during the process of stem cell line derivation. Others argue that the potential benefits of stem cell research (e.g. alleviating human suffering) represents a way of showing respect for human life.

    Additional concerns rest on the belief that the creation of embryos for research purposes and the derivation of stem cell lines might lead to the de-sensitisation of human life and to potentially uncontrolled commercialisation or instrumentalization of the human body.

    One must keep in mind that these issues are directly linked with another key issue: the moral and legal status of the human embryo.




  •  Human dignity   
  • The concept of human dignity is a difficult one because it is unclear what it means exactly; and this is exacerbated by the fact that it has been employed to justify fundamentally opposing views. Most authors understand the notion of human dignity as our essential humanity, what makes us human. Consequently this concept is closely related to beliefs regarding the moral status of the human embryo.



  •  Status of the human embryo   
  • This is a delicate question with various answers according to each individual’s conception of the embryo. On the one hand, some consider embryos to be cell masses having no more value than any other biological cell or tissue. On the other hand, some confer the human embryo full personhood status; that is, they consider the human embryo to have the same moral status as a human being that has been born.

    Finally, many people hold a gradualist view; they consider moral status to be a continuous process; as the embryo proceeds through stages of development, it gradually gains moral value. This position emphasizes the embryo’s potential to become a human being and, hence, affords the embryo “special respect”. Canadian policy, like many other countries, has adopted this middle ground position.






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