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).
Monday, 15 July 2013
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