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Monday, 15 July 2013

Legislation and guidelines stem cell

During recent decades, stem cell research has posed a challenge for politicians and national and international regulatory agencies. Despite challenges across different societies, stem cell research continues to be conducted by researchers. The need for oversight and regulation to prevent unethical conduct and negative outcomes is  recognized by many scientists. As a result, international and national bodies have tried to guide stem cell activities ethically. General ethical guidelines such as the  Belmont report (Department of Health, Education, and Welfare, 1979), Helsinki declaration (The World Medical Association [WMA], 2008), and International   Ethical  Guidelines  for  Biomedical  Research  Involving  Human  Subjects (Council  for  International  Organizations  of  Medical  Sciences  [CIOMS],  2002)  should  be observed by stem cell researchers. There are also specific stem cell guidelines and standards internationally and in various countries.
Establishment of international ethical guidelines and legal frameworks for human cloning
was  considered  at  the  end  of  the  20th  century.  The  issue  of  reproductive  cloning  was discussed several times in United Nations agencies after the birth of Dolly in 1997. In 1998, the  United  Nations  General  Assembly  endorsed  a  Declaration  in  which  reproductive cloning of human beings was banned (United Nations Educational, Scientific and Cultural Organization, 2004).

The Universal Declaration on the Human Genome and Human Rights (The United Nations Educational, Scientific and Cultural Organization [UNESCO], 1997)  (Section C-Article 11), and  the  report  of  UNESCO’s  International  Bioethics  Committee  (IBC)  on  “The  Use  of Embryonic Stem Cells in Therapeutic Research” (UNESCO, 2001) were compiled to address these complex issues in  different societies. Other international organizations such as the World Health Organization (WHO) compiled relevant resolutions too.
The International Society for Stem Cell Research (ISSCR) has also tried to address relevant
scientific,  cultural,  religious,  ethical,  and  legal  differences  across  national   borders  by preparation of the "Guidelines for the Conduct of Human Embryonic Stem Cell Research" (ISSCR, 2006). The mission of the taskforce for compiling the guidelines was stated as: "…to emphasize the responsibility of scientists to ensure  that  human stem cell research is carried out according to rigorous standards of research ethics, and to encourage uniform research practices that should  be  followed  by  all  human  stem  cell  scientists  globally."  Due  to  the  ever-increasing therapeutic uses of stem cells in clinical practice, the "Guidelines for the Clinical Translation of Stem Cells", were compiled in 2008  (ISSCR, 2008). The Guidelines address three major areas of translational stem cell research: (a) cell processing and manufacture; (b) preclinical studies; and (c) clinical research.
As to the disputes on the time when personhood starts, the guidelines and Acts determine this.  The  United  Kingdom's  Human  Fertilization  and  Embryology   Act,  for  instance, determines the point of primitive streak development as the point when human life begins and research must be stopped (Balint, 2001, citation of Human Fertilization and Embryology Act, 1990).
As Childress (2004) emphasizes, the connection between ethics and public policy  remains important. Two types of public policies have special relevance to human stem cell research, public policies on use of governmental funds, and public policies on whether, apart from the use of governmental funds, to permit, regulate, or prohibit activities such as human cloning (Childress, 2004).
Many societies have attempted to characterize the legal status of the human  embryo and regulate  stem  cell  research.  Considerable  differences  exist   between  countries  in  the regulation  of  stem  cell  research.  In  the  United  states,  the  National  Bioethics  Advisory Committee (NBAC) decided that creation of embryos purely for research purposes was not acceptable,  while  in  the   United   Kingdom,  the  Human  Fertilization  and  embryology Authority  permits the creation of embryos for research but the embryos must never be implanted (Balint, 2001). In addition, in the United Kingdom and some other  countries where  stem  cell  research  under  national  regulations  is  permitted,  there  are  standard guidelines  and  recommendations  for  public  and  private   sectors;  there  are  no  such regulations and supervision in the US (Balint, 2001). The National Institutes of Health (NIH) provided guidelines on Human stem cell  research with the aim of "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells" (NIH, 2009).
In  Canada,  Human  Pluripotent  Stem  Cell  Research  Guidelines  released  by  the  Canadian Institutes  of  Health  Research  (Canadian  Institutes  of  Health  Research,  2010),  and  the Assisted  Human  Reproductive  Act  (Health   Canada,  2004),  are  the  most  important regulations concerning the use of stem cells in research and reproductive technologies.
In Costa Rica and Germany, eradication of embryos for research purposes is  prohibited.
Some countries, such as Belgium and the United Kingdom, allow research on  surplus
embryos and created embryos within 14 days after fertilization. In Denmark  and  Japan,
while  research  on  surplus  embryos  is  permissible,  the  creation  of  embryos  solely  for
research  purposes  is  prohibited  (United  Nations  Educational,  Scientific  and   Cultural
Organization, 2004). Many European countries have prohibited reproductive  cloning, but there is a wide spectrum of diverse religious and secular beliefs about that (Nippert, 2002). In the Middle East, Iran, as a pioneer country in stem cell research (Ilkilic and Ertin, 2010; Saniei and De Vries, 2008) that reported the establishment of a new stem cell line in 2003 (Baharvand et al, 2004), has recently established ethical guidelines for stem cell research and
treatments in the country (Nejad-Sarvari et al, 2011).
Banning public funding for stem cell research in some countries like the US  caused some
worry about potential "brain drain", but funding the research costs by non-profit and private sectors  has  offered  many  opportunities  for  scientists  to  follow  such  research  in  these countries (Dresser, 2010).

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