Stem cell research policy

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Stem cell research policy varies significantly throughout the world. There are overlapping jurisdictions of international organizations, nations, and states or provinces. Some government policies determine what is allowed versus prohibited, whereas others outline what research can be publicly financed. Of course, all practices not prohibited are implicitly permitted. Some organizations have issued recommended guidelines for how stem cell research is to be conducted.

Contents

International bodies

The United Nations adopted a declaration on human cloning that can be interpreted as calling on member states to prohibit somatic cell nuclear transfer, or therapeutic cloning. In 2005, in a divided vote, "Member States were called on to adopt all measures necessary to prohibit all forms of human cloning in as much as they are incompatible with human dignity and the protection of human life."

The World Health Organization has opposed a ban on cloning techniques in stem cell research.

The Council of Europe's Convention on Human Rights and Biomedicine seems to ban the creation of embryos solely for research purposes. [1] It has been signed by 31 countries and ratified by 19: [2] Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Georgia, Greece, Hungary, Iceland, Lithuania, Moldova, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain, and Turkey. [3]

The Hinxton Group

Researchers, ethicists and assorted spokespersons from 14 different countries have published a set of legal and ethical guidelines relating to stem cell research, in an effort to address conflicting international laws in this area. [4] [5] The ‘Hinxton Group’ met recently for the first time, in Cambridge, and published a consensus statement calling for a ‘flexible’ regulatory framework, which can simultaneously accommodate rapid scientific advance and at the same time accommodate the diversity of international approaches towards stem cell science. [4] It also recommends that, in countries which oppose embryonic stem cell research, scientists should be free to pursue their research elsewhere. [4]

In light of the controversy surrounding Hwang Woo-Suk, the Hinxton Group has additionally recommended a number of measures intended to prevent fraud in stem cell research. The group has requested that all authors of embryonic stem cell papers submit a statement of authenticity of any new cell-lines and that the source of stem cells be clearly specified. [4]

On the ethical issues surrounding embryonic stem cell research, the group has additionally recommended that an international database be created, containing guidelines for ethical practice, research protocols, consent forms, and the information provided to donors. [4]

However, the potential for an international consensus on these matters seems remote given the complexity and diversity of regulatory frameworks in this controversial area of science, both within nations and between nations.

ISSCR

The International Society for Stem Cell Research is developing guidelines for the conduct of stem cell research.

Nations

Embryonic stem cell research has divided the international community. In the European Union, stem cell research using the human embryo is permitted in Ireland, Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however it is illegal in Germany, Austria, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support. [6] Elsewhere, Japan, India, Iran, Israel, South Korea, and China are supportive, Australia is partially supportive (exempting reproductive cloning yet allowing research on embryonic stem cells that are derived from the process of IVF); however New Zealand, most of Africa (excepting South Africa) and most of South America (excepting Brazil) are restrictive.

Related Research Articles

<span class="mw-page-title-main">Human cloning</span> Creation of a genetically identical copy of a human

Human cloning is the creation of a genetically identical copy of a human. The term is generally used to refer to artificial human cloning, which is the reproduction of human cells and tissue. It does not refer to the natural conception and delivery of identical twins. The possibility of human cloning has raised controversies. These ethical concerns have prompted several nations to pass laws regarding human cloning.

<span class="mw-page-title-main">Somatic cell nuclear transfer</span> Method of creating a cloned embryo by replacing the egg nucleus with a body cell nucleus

In genetics and developmental biology, somatic cell nuclear transfer (SCNT) is a laboratory strategy for creating a viable embryo from a body cell and an egg cell. The technique consists of taking an enucleated oocyte and implanting a donor nucleus from a somatic (body) cell. It is used in both therapeutic and reproductive cloning. In 1996, Dolly the sheep became famous for being the first successful case of the reproductive cloning of a mammal. In January 2018, a team of scientists in Shanghai announced the successful cloning of two female crab-eating macaques from foetal nuclei.

Dignity is the right of a person to be valued and respected for their own sake, and to be treated ethically. It is of significance in morality, ethics, law and politics as an extension of the Enlightenment-era concepts of inherent, inalienable rights. The term may also be used to describe personal conduct, as in "behaving with dignity".

S1909/A2840 is a bill that was passed by the New Jersey Legislature in December 2003, and signed into law by Governor James McGreevey on January 4, 2004, that permits human cloning for the purpose of developing and harvesting human stem cells. Specifically, it legalizes the process of cloning a human embryo, and implanting the clone into a womb, provided that the clone is then aborted and used for medical research. The legislation was sponsored by Senators Richard Codey (D-Essex) and Barbara Buono, and Assembly members Neil M. Cohen (D-Union), John F. McKeon, Mims Hackett (D-Essex), and Joan M. Quigley (D-Hudson). The enactment of this law will enable researchers to find cures for debilitating and deadly diseases.

<span class="mw-page-title-main">Leon Kass</span> American physician, scientist, and academic

Leon Richard Kass is an American physician, scientist, educator, and public intellectual. Kass is best known as a proponent of liberal arts education via the "Great Books," as a critic of human cloning, life extension, euthanasia and embryo research, and for his tenure as chairman of the President's Council on Bioethics from 2001 to 2005. Although Kass is often referred to as a bioethicist, he eschews the term and refers to himself as "an old-fashioned humanist. A humanist is concerned broadly with all aspects of human life, not just the ethical."

The Dickey–Wicker Amendment is the name of an appropriation bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton, which prohibits the United States Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. HHS funding includes the funding for the National Institutes of Health (NIH). It is named after Jay Dickey and Roger Wicker, a Republican Representative and Senator, respectively. Technically, the Dickey Amendment is a rider to other legislation, which amends the original legislation. The rider receives its name from the name of the Congressman that originally introduced the amendment, Representative Dickey. The Dickey amendment language has been added to each of the Labor, HHS, and Education appropriations acts for fiscal years 1997 through 2009. The original rider can be found in Section 128 of P.L. 104-99.

<span class="mw-page-title-main">Designer baby</span> Genetically modified human embryo

A designer baby is a baby whose genetic makeup has been selected or altered, often to not include a particular gene or to remove genes associated with disease. This process usually involves analysing a wide range of human embryos to identify genes associated with particular diseases and characteristics, and selecting embryos that have the desired genetic makeup; a process known as preimplantation genetic diagnosis. Screening for single genes is commonly practiced, and polygenic screening is offered by a few companies. Other potential methods by which a baby's genetic information can be altered involve directly editing the genome before birth, which is not routinely performed and only one instance of this is known to have occurred as of 2019, where Chinese twins Lulu and Nana were edited as embryos, causing widespread criticism.

Christians take multiple positions in the debate on the morality of human cloning. Since Dolly the sheep was successfully cloned on 5 July 1996, and the possibility of cloning humans became a reality, Christian leaders have been pressed to take an ethical stance on its morality. While many Christians tend to disagree with the practice, such as Roman Catholics and a majority of fundamentalist pastors, including Southern Baptists, the views taken by various other Christian denominations are diverse and often conflicting. It is hard to pinpoint any one, definite stance of the Christian religion, since there are so many Christian denominations and so few official statements from each of them concerning the morality of human cloning.

The stem cell controversy is the consideration of the ethics of research involving the development and use of human embryos. Most commonly, this controversy focuses on embryonic stem cells. Not all stem cell research involves human embryos. For example, adult stem cells, amniotic stem cells, and induced pluripotent stem cells do not involve creating, using, or destroying human embryos, and thus are minimally, if at all, controversial. Many less controversial sources of acquiring stem cells include using cells from the umbilical cord, breast milk, and bone marrow, which are not pluripotent.

In bioethics, the ethics of cloning refers to a variety of ethical positions regarding the practice and possibilities of cloning, especially human cloning. While many of these views are religious in origin, some of the questions raised by cloning are faced by secular perspectives as well. Perspectives on human cloning are theoretical, as human therapeutic and reproductive cloning are not commercially used; animals are currently cloned in laboratories and in livestock production.

Bernard Siegel is the Executive Director of the nonprofit Regenerative Medicine Foundation based in Wellington, Florida.

Royan Institute is an Iranian clinical, research and educational institute dedicated to biomedical, translational and clinical researches, stem cell research and infertility treatment. It is a public non-profitable organization affiliated to Academic Center for Education, Culture and Research. It was established in 1991 by the late Dr. Saeid Kazemi Ashtiani as a research institute for Reproductive Biomedicine and infertility treatments. In 1998 this institute was approved by Ministry of Health as Cell Based Research Center with over 46 scientific members and 186 lab technicians.

The National Academies called for the establishment of Embryonic Stem Cell Research Oversight (ESCRO) Committees in its 2005 Guidelines for Human Embryonic Stem Cell Research to manage the ethical and legal concerns in human embryonic stem cell research. Because of the complexity and novelty of many of the issues involved in that research, the Guidelines committee believes that all research institutions engaged in human embryonic stem cell research should create and maintain these committees at the local level.

The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, otherwise known as the European Convention on Bioethics or the European Bioethics Convention, is an international instrument aiming to prohibit the misuse of innovations in biomedicine and to protect human dignity. The Convention was opened for signature on 4 April 1997 in Oviedo, Spain and is thus otherwise known as the Oviedo Convention. The International treaty is a manifestation of the effort on the part of the Council of Europe to keep pace with developments in the field of biomedicine; it is notably the first multilateral binding instrument entirely devoted to biolaw. The Convention entered into force on 1 December 1999.

Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country. In the European Union, stem cell research using the human embryo is permitted in Sweden, Spain, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving support. Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa, and most of South America are restrictive.

Stem cell laws and policy in the United States have had a complicated legal and political history.

The laws and policies regarding stem cell research in the People's Republic of China are relatively relaxed in comparison to that of other nations. The reason for this is due to different traditional and cultural views in relation to that of the West.

The multilateral foreign policy of the Holy See is particularly active on some issues, such as human rights, disarmament, and economic and social development, which are dealt with in international fora.

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<span class="mw-page-title-main">S. Matthew Liao</span> Taiwanese-born American philosopher

S. Matthew Liao is an American philosopher specializing in bioethics and normative ethics. He is internationally known for his work on topics including children’s rights and human rights, novel reproductive technologies, neuroethics, and the ethics of artificial intelligence. Liao currently holds the Arthur Zitrin Chair of Bioethics, and is the Director of the Center for Bioethics and Affiliated Professor in the Department of Philosophy at New York University. He has previously held appointments at Oxford, Johns Hopkins, Georgetown, and Princeton.

References

  1. Chapter V, Article 18 of the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm
  2. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings
  3. Andorno, Roberto (July 2005). "The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law" (PDF). Journal of International Biotechnology Law. 2 (4): 134. doi:10.1515/jibl.2005.2.4.133 . Retrieved 18 March 2014.
  4. 1 2 3 4 5 "Consensus Statement". The Hinxton Group. 24 February 2006. Archived from the original on 22 December 2008.
  5. Rick Weiss (2 March 2006). "Universal stem cell principles proposed". The Washington Post .
  6. Mlsna, Lucas J. (2010). "Stem Cell Based Treatments and Novel Considerations for Conscience Clause Legislation". Indiana Health Law Review . United States: Indiana University Robert H. McKinney School of Law. 8 (2): 471–496. ISSN:1549-3199. LCCN:2004212209. OCLC   54703225.