Is embryonic stem cell research legal?
Stem cell laws and policy in the United States
In 1973, Roe v. Wade legalized abortion in the United States. Five years later, the first successful human "in vitro" fertilization resulted in the birth of Louise Brown in England. These developments prompted the federal government to create regulations barring the use of federal funds for research that experimented on human embryos. In 1995, the NIH Human Embryo Research Panel advised the administration of President Bill Clinton to permit federal funding for research on embryos left over from "in vitro" fertility treatments and also recommended federal funding of research on embryos specifically created for experimentation. In response to the panel's recommendations, the Clinton administration, citing moral and ethical concerns, declined to fund research on embryos created solely for research purposes, but did agree to fund research on left-over embryos created by "in vitro" fertility treatments. At this point, the Congress intervened and passed the Dickey-Wicker Amendment in 1995 (the final bill, which included the Dickey Amendment, was signed into law by Bill Clinton) which prohibited any federal funding for the Department of Health and Human Services be used for research that resulted in the destruction of an embryo regardless of the source of that embryo. In 1998, privately funded research led to the breakthrough discovery of human Embryonic stem cells (hESC).
Governorship of Mitt Romney
During his 2002 campaign, Romney had expressed broad support for embryonic stem cell research, and said he would lobby President Bush (who the year before had banned most federal funding for such research) to support it. In particular, Romney stated that he supported the use of surplus embryos from fertility clinics for stem-cell research. In early 2005, Romney announced his position on therapeutic cloning for the first time, saying he was against it, but was still in favor of research on unused embryos from fertility treatments. Per this stance, he vetoed a Massachusetts bill to fund stem-cell research because the legislation allowed such cloning of human embryos. "I am not in favor of creating new human embryos through cloning," said Romney, calling the practice "a matter of profound moral and ethical consequence". Romney also opposed the legislation because of its assertion that life does not begin until an embryo is implanted in a uterus. "It is very conceivable that scientific advances will allow an embryo to be grown for a substantial period of time outside the uterus," Romney said in an interview with the "Boston Globe". "To say that it is not life at one month or two months or four months or full term, just because it had never been in a uterus, would be absurd." The state legislature overrode Romney's veto, with many legislators feeling that stem-cell research will be important in the future to the state's biotech industry.
Family Research Council
The Council opposes legalized abortion, stem-cell research which involves the destruction of human embryos and funding thereof (instead advocating research using adult stem cells) and legal recognition of same-sex domestic partnerships in the form of marriage or civil unions. It formerly opposed all forms of gambling. The Council has questioned whether humans are mainly or completely responsible for climate change, and has opposed other evangelicals who have affirmed their belief in global warming.
Human cloning
The Patients First Act of 2017 (HR 2918, 115th Congress) aims to promote stem cell research, using cells that are “ethically obtained”, that could contribute to a better understanding of diseases and therapies, and promote the “derivation of pluripotent stem cell lines without the creation of human embryos…”.
Gordon H. Smith
In 2006, he voted to pass another controversial bill, this time crossing party lines to vote for the Stem Cell Research Enhancement Act. The measure, which would have expanded federal funding of stem cell research to cell lines extracted from embryos discarded during fertility treatment, became the first bill to be vetoed by President George W. Bush. Smith is one of 19 Senate Republicans who voted for the measure.
Stem cell controversy
Researchers at Advanced Cell Technology, led by Robert Lanza and Travis Wahl, reported the successful derivation of a stem cell line using a process similar to preimplantation genetic diagnosis, in which a single blastomere is extracted from a blastocyst. At the 2007 meeting of the International Society for Stem Cell Research (ISSCR), Lanza announced that his team had succeeded in producing three new stem cell lines without destroying the parent embryos. "These are the first human embryonic cell lines in existence that didn't result from the destruction of an embryo." Lanza is currently in discussions with the National Institutes of Health to determine whether the new technique sidesteps U.S. restrictions on federal funding for ES cell research.
Political positions of Mitt Romney
When he ran for governor in 2002, Romney strongly advocated stem-cell research, and he promised to lobby then-President George W. Bush to embrace it. In 2007, Romney supported the use of stem cells obtained from "surplus embryos" for research, but opposed "the creation of new lines of human stem cells for research and vetoed a stem cell research bill as governor." During Romney's 2008 presidential campaign, he renounced his prior position and said that he agreed with Bush's decision to ban federal funding for research on excess embryos. He said that his views had been drastically altered in 2004 after discussing stem cell research with Douglas Melton, a stem cell researcher at Harvard University. The Harvard Stem Cell Institute was planning research that would have involved therapeutic cloning. According to Romney, Melton declared that the research "is not a moral issue because we kill the embryos at 14 days." "I looked over at Beth Myers, my chief of staff, and we both had exactly the same reaction, which is it just hit us hard," recalled Romney. "And as they walked out, I said, 'Beth, we have cheapened the sanctity of life by virtue of the "Roe v. Wade" mentality.'"
Life extension
The use of human stem cells, particularly embryonic stem cells, is controversial. Opponents' objections generally are based on interpretations of religious teachings or ethical considerations. Proponents of stem cell research point out that cells are routinely formed and destroyed in a variety of contexts. Use of stem cells taken from the umbilical cord or parts of the adult body may not provoke controversy.
Stem-cell therapy
Stem-cell therapy has become controversial following developments such as the ability of scientists to isolate and culture embryonic stem cells, to create stem cells using somatic cell nuclear transfer and their use of techniques to create induced pluripotent stem cells. This controversy is often related to abortion politics and to human cloning. Additionally, efforts to market treatments based on transplant of stored umbilical cord blood have been controversial.
Stem cell laws and policy in the United States
When seeking consent from the donor, they must be informed of what will become of their donation. The donor must be informed that the embryonic stem cells would be derived from the embryos from research purposes. The donor must also be informed of the procedures that the embryo would undergo in the derivation process, and that the stem cell lines derived from the embryo may be kept for many years. In addition, the donors must be informed that the donation is not made with direction regarding the intended use of the derived stem cells, and the research is not intended to provide direct medical benefit to the donor. The donor is also to be informed that there may be commercial potential resulting from the research performed, and that the donor is not to benefit from commercial development as a result of the donation. The donor is also to be notified if information that could disclose their identity will be available to the researchers.
James Sherley
In 2010, Sherley was the named plaintiff in "Sherley v. Sebelius" against Kathleen Sebelius, director of HHS, and Francis Collins, director of the NIH, a case challenging federal (NIH) funding of embryonic stem cell research that resulted in a suspension of much of the NIH funded research on embryonic stem cells. He fought to ban the NIH from funding any research related to embryonic stem cells, and claimed that the decision of the federal government to pay for research on embryonic stem cells was "essentially robbing him of grant money by increasing the competition for funding". After three years of legal effort, the supreme court refused to overturn a lower judge's ruling against Sherley, allowing research to proceed.
Stem cell research policy
The Council of Europe's Convention on Human Rights and Biomedicine seems to ban the creation of embryos solely for research purposes. It has been signed by 31 countries and ratified by 19: Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Georgia, Greece, Hungary, Iceland, Lithuania, Moldova, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain, and Turkey.
Somatic cell nuclear transfer
Proposals to use nucleus transfer techniques in human stem cell research raise a set of concerns beyond the moral status of any created embryo. These have led to some individuals and organizations who are "not" opposed to human embryonic stem cell research to be concerned about, or opposed to, SCNT research.
Human embryonic stem cells clinical trials
As state funding for human embryonic stem cell research grows, there seems to be more support for state sponsored clinical trials. In 2010, California committed fifty million dollars to early-stage clinical trials. Although approved trials must take place in California, scientists are hopeful that this funding will bolster future research in the field.
Stem cell laws and policy in the United States
Research ineligible for NIH funding as dictated within the guidelines include research in which hESCs are introduced into non-human primate blastocysts. Research of the breeding of animals where hESCs may contribute to the germ line are similarly ineligible. NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on the funding of human embryo research. Research using hESCs derived from other sources is also not eligible for funding.
Stem cell research policy
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. 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. It also recommends that, in countries which oppose embryonic stem cell research, scientists should be free to pursue their research elsewhere.
Consumer Watchdog v. Wisconsin Alumni Research Foundation
One possible reason for this apparent lack of concern within the scientific community is that WARF has eased its licensing fees and restrictions to such an extent that most don’t find the overall cost of hESC lines exorbitantly high compared to other cell lines. Also, work on human embryonic stem cell research has been mitigated to a certain extent due to uncertainty about future federal funding and ongoing ethical concerns of such research. Moreover, with the recent discovery of induced pluripotent stem (iPS) cells, many scientists in the field have shifted towards iPS cells for precisely the reasons just stated. Finally, with all of the WARF patents due to expire in 2015, it seems unlikely that the resolution of this case, or any possible future litigation about the ‘913 patent in particular, will have a significant effect on hESC research.
Diana DeGette
DeGette has consistently voted in favor of the use of embryonic stem cell research. DeGette says "we must pass common-sense embryonic stem cell research legislation, placing these regulations into statute and once and for all, ensuring this critical life-saving research can be conducted for years to come, unimpeded by political whims or naysayers." DeGette and Charlie Dent introduced the bipartisan Stem Cell Research Act of 2011, which would provide lasting support for stem cell research.
Stem cell controversy
In 1998, privately funded research led to the breakthrough discovery of human embryonic stem cells (hESC). This prompted the Clinton administration to re-examine guidelines for federal funding of embryonic research. In 1999, the president's National Bioethics Advisory Commission recommended that hESC harvested from embryos discarded after "in vitro" fertility treatments, but not from embryos created expressly for experimentation, be eligible for federal funding. Though embryo destruction had been inevitable in the process of harvesting hESC in the past (this is no longer the case), the Clinton administration had decided that it would be permissible under the Dickey-Wicker Amendment to fund hESC research as long as such research did not itself directly cause the destruction of an embryo. Therefore, HHS issued its proposed regulation concerning hESC funding in 2001. Enactment of the new guidelines was delayed by the incoming George W. Bush administration which decided to reconsider the issue.
Dan Lipinski
In 2007, Lipinski voted against legislation to increase funding for embryonic stem cell research.
Stem cell laws
The primary legislation in South Africa that deals with embryo research is the Human Tissue Act, which is set to be replaced by Chapter 8 of the National Health Act. The NHA Chapter 8 has been enacted by parliament, but not yet signed into force by the president. The process of finalising these regulations is still underway. The NHA Chapter 8 allows the Minister of Health to give permission for research on embryos not older than 14 days. The legislation on embryo research is complemented by the South African Medical Research Council's Ethics Guidelines. These Guidelines advise against the creation of embryos for the sole purpose of research. In the case of "Christian Lawyers Association of South Africa & others v Minister of Health & others" the court ruled that the Bill of Rights is not applicable to the unborn. It has therefore been argued based on constitutional grounds (the right to human dignity, and the right to freedom of scientific research) that the above limitations on embryo research are overly inhibitive of the autonomy of scientists, and hence unconstitutional.
James Langevin
One of Langevin's top priorities as a Member of Congress has been the expansion of federal funding of embryonic stem cell research. His policy position is driven by his paralysis and the possibilities that stem cell research provide in helping this condition; he joined other members of the House in introducing the Stem Cell Research Enhancement Act of 2005, expanding the limited funding put in place in 2001.
Stem cell laws
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 (except South Africa), and most of South America (except Brazil) are restrictive.
Stem cell controversy
The Assemblies of God opposes human embryonic stem cell research, saying, it "perpetuates the evil of abortion and should be prohibited."
Stem Cell Research Enhancement Act
The Stem Cell Research Enhancement Act of 2005 () was the first bill ever vetoed by United States President George W. Bush, more than five years after his inauguration. The bill, which passed both houses of Congress, but by less than the two-thirds majority needed to override the veto, would have allowed federal funding of stem cell research on new lines of stem cells derived from discarded human embryos created for fertility treatments.
Stem cell laws and policy in the United States
The Republicans largely oppose embryonic stem cell research in favor of adult stem cell research which has already produced cures and treatments for cancer and paralysis for example, but there are some high-profile exceptions who offer qualified support for some embryonic stem cell research. Prominent Republican leaders against embryonic stem cell research include Sarah Palin, Jim Talent, Rick Santorum, and Sam Brownback. In July 2001:
Stem cell controversy
In May 2005, the House of Representatives voted 238–194 to loosen the limitations on federally funded embryonic stem-cell research – by allowing government-funded research on surplus frozen embryos from in vitro fertilization clinics to be used for stem cell research with the permission of donors – despite Bush's promise to veto the bill if passed. On July 29, 2005, Senate Majority Leader William H. Frist (R-TN), announced that he too favored loosening restrictions on federal funding of embryonic stem cell research. On July 18, 2006, the Senate passed three different bills concerning stem cell research. The Senate passed the first bill (the Stem Cell Research Enhancement Act) 63–37, which would have made it legal for the federal government to spend federal money on embryonic stem cell research that uses embryos left over from "in vitro" fertilization procedures. On July 19, 2006 President Bush vetoed this bill. The second bill makes it illegal to create, grow, and abort fetuses for research purposes. The third bill would encourage research that would isolate pluripotent, i.e., embryonic-like, stem cells without the destruction of human embryos.
Political positions of Hillary Clinton
Clinton cosponsored the Stem Cell Research Enhancement Act of 2005, which called for federal funding of stem cell research based on stem cell lines derived from discarded human embryos. The bill was vetoed by President Bush. She also voted for the 2007 bill with the same name that passed in Congress.
Human embryonic stem cells clinical trials
The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients suffering from spinal cord injuries to participate in the trial. The company hoped that GRNOPC1, a product derived from human embryonic stem cells, would stimulate nerve growth in patients with debilitating damage to the spinal cord. The trial began in 2010 after being delayed by the FDA because cysts were found on mice injected with these cells, and safety concerns were raised.
Human embryonic stem cells clinical trials
The FDA approved a phase I clinical trial with ViaCyte beta cells derived from human embryonic stem cell for the treatment of diabetes in August 2014. The cells will be delivered in immunoprotective capsules and pre-clinical results in animal models showed remission of symptoms within a few months. The company reported the successful transplantation of the cells in the first of the 40 patients that will be treated under the trial in late October 2014.
Human cloning
On January 14, 2001 the British government passed The Human Fertilisation and Embryology (Research Purposes) Regulations 2001 to amend the Human Fertilisation and Embryology Act 1990 by extending allowable reasons for embryo research to permit research around stem cells and cell nuclear replacement, thus allowing therapeutic cloning. However, on November 15, 2001, a pro-life group won a High Court legal challenge, which struck down the regulation and effectively left all forms of cloning unregulated in the UK. Their hope was that Parliament would fill this gap by passing prohibitive legislation. Parliament was quick to pass the Human Reproductive Cloning Act 2001 which explicitly prohibited reproductive cloning. The remaining gap with regard to therapeutic cloning was closed when the appeals courts reversed the previous decision of the High Court.
Political positions of John McCain
McCain was a member of The Republican Main Street Partnership and supported embryonic stem cell research. McCain had earlier opposed embryonic stem cell research and credits former First Lady Nancy Reagan, a prominent Republican supporter of such research, with changing his mind in 2001. He states that he believes that stem cell research, and indeed embryonic stem cell research, will continue whether or not the U.S. sanctions it, and so it would be the wisest course of action to support it to the extent that the United States will be able to regulate and monitor the use. In July 2008 he said "At the moment I support stem cell research [because of] the potential it has for curing some of the most terrible diseases that afflict mankind."
Ethics of organ transplantation
Organs from artificial origin like stem cells, is a prospect that researchers hope to use one day. However many of such researches are crictised based on the use of human embryo.
2004 California Proposition 71
The Act makes conducting stem cell research a state constitutional right. It authorizes the sale of general obligation bonds to allocate three billion dollars over a period of ten years to stem cell research and research facilities. Although the funds could be used to finance all kinds of stem cell research, it gives priority to human embryonic stem cell research.
Stem cell controversy
In 2006, researchers at Advanced Cell Technology of Worcester, Massachusetts, succeeded in obtaining stem cells from mouse embryos without destroying the embryos. If this technique and its reliability are improved, it would alleviate some of the ethical concerns related to embryonic stem cell research.
Stem cell laws and policy in the United States
Stem cells are cells found in all multi-cellular organisms. They were isolated in mice in 1981, and in humans in 1998. In humans there are many types of stem cells, each with varying levels of potency. Potency is a measure of a cell's differentiation potential, or the number of other cell types that can be made from that stem cell. Embryonic stem cells are pluripotent stem cells derived from the inner cell mass of the blastocyst. These stem cells can differentiate into all other cells in the human body and are the subject of much scientific research. However, since they must be derived from early human embryos their production and use in research has been a hotly debated topic as the emt introduce new cells into adult bodies for possible treatment of cancer, diabetes, neurological disorders and other medical conditions. Stem cells have been used to repair tissue damaged by disease or age. Cloning also might be done with stem cells. Pluripotent stem cells can also be derived from Somatic cell nuclear transfer which is a laboratory technique where a clone embryo is created from a donor nucleus. Somatic cell nuclear transfer is also tightly regulated amongst various countries.
Stem cell
There are currently no approved treatments using embryonic stem cells. The first human trial was approved by the US Food and Drug Administration in January 2009. However, the human trial was not initiated until October 13, 2010 in Atlanta for spinal cord injury research. On November 14, 2011 the company conducting the trial (Geron Corporation) announced that it will discontinue further development of its stem cell programs. ES cells, being pluripotent cells, require specific signals for correct differentiation—if injected directly into another body, ES cells will differentiate into many different types of cells, causing a teratoma. Differentiating ES cells into usable cells while avoiding transplant rejection are just a few of the hurdles that embryonic stem cell researchers still face. Due to ethical considerations, many nations currently have moratoria or limitations on either human ES cell research or the production of new human ES cell lines. Because of their combined abilities of unlimited expansion and pluripotency, embryonic stem cells remain a theoretically potential source for regenerative medicine and tissue replacement after injury or disease.
Stem cell controversy
The discovery of adult stem cells led scientists to develop an interest in the role of embryonic stem cells, and in separate studies in 1981 Gail Martin and Martin Evans derived pluripotent stem cells from the embryos of mice for the first time. This paved the way for Mario Capecchi, Martin Evans, and Oliver Smithies to create the first knockout mouse, ushering in a whole new era of research on human disease. In 1995 adult stem cell research with human use, patented (US PTO with effect from 1995). In fact human use published in World J Surg 1991 & 1999 (B G Matapurkar). Salhan, Sudha (August 2011). Textbook of Gynecology. JP Medical Ltd. pp. 625–. .
Bharadwaj, Aditya; Glasner, Peter E. (2009). Local Cells, Global Science: The Rise of Embryonic Stem Cell Research in India. Taylor & Francis. 
^ "Dr.B.G.Matapurkar gets US patent for surgical procedure for organ regeneration - Patents". www.pharmabiz.com.
^ "Method of organogenesis and tissue regeneration/repair using surgical techniques - US Patent 6227202 Claims". patentstorm.us.
Stem cell laws
Canada's National Embryonic Stem Cell Registry:
Stem cell controversy
The Southern Baptist Convention opposes human embryonic stem cell research on the grounds that "Bible teaches that human beings are made in the image and likeness of God (Gen. 1:27; 9:6) and protectable human life begins at fertilization." However, it supports adult stem cell research as it does "not require the destruction of embryos."
Stem cell
The use of adult stem cells in research and therapy is not as controversial as the use of embryonic stem cells, because the production of adult stem cells does not require the destruction of an embryo. Additionally, in instances where adult stem cells are obtained from the intended recipient (an autograft), the risk of rejection is essentially non-existent. Consequently, more US government funding is being provided for adult stem cell research.
Jim Talent
On February 10, 2006, Talent withdrew his support for the bill, citing the need to balance research and protection against human cloning. This move followed criticism by Talent's opponent in the 2006 election, Claire McCaskill, as well as pressure from Missouri business interests that oppose restrictions on stem cell research. Though this reversal was criticized as being politically motivated, Talent told the Associated Press, "The technology is changing all the time and so I'm always considering whether there is a better way to strike the balance." Talent suggested that moral concerns might be put to rest through a possible future scientific breakthrough – replicating embryonic stem cells without the use of cloned embryos.
David Reardon
Reardon and the Elliot Institute opposed The Missouri Stem Cell Research and Cures Initiative, and proposed a competing initiative which would have prohibited any embryonic stem cell research which resulted in the destruction of a human embryo, as well as some other types of genetic research, in Missouri. The Elliot institute created the website ElliotInstitute.org which mimicked the site of a pro-stem-cell-research group, the Missouri Coalition for Lifesaving Cures. The group sued the Elliot Institute in federal court for alleged copyright and trademark violations. Consequently, the Elliot Institute website was ordered temporarily shut down by a federal judge.
Embryonic Stem Cell Research Oversight Committees
The composition of ESCRO committees was specified to include representatives of the public and people with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in human embryonic stem cell research.
Mike Castle
Castle cosponsored the Stem Cell Research Enhancement Act. The bill proposed expanding the number of embryonic stem cell lines that are eligible for federally funded research, expecting that this funding would generate more research and ultimately greater progress in developing new treatments for a wide range of medical conditions. Presently, the only embryonic stem cell lines eligible for federal funded research were derived before August 9, 2001. This legislation removes that date restriction, along with proposing stronger ethical requirements. After successfully passing both the U.S. Senate and the U.S. House, it received U.S. President George W. Bush's first presidential veto in July 2006.
Embryonic stem cell
BioTime company Asterias Biotherapeutics (NYSE MKT: AST) was granted a $14.3 million Strategic Partnership Award by the California Institute for Regenerative Medicine (CIRM) to re-initiate the world’s first embryonic stem cell-based human clinical trial, for spinal cord injury. Supported by California public funds, CIRM is the largest funder of stem cell-related research and development in the world.
Neuroethics
Most of the issues concerning uses of stem cells in the brain are the same as any of the bioethical or purely ethical questions you will find regarding the use and research of stem cells. The field of stem cell research is a very new field which poses many ethical questions concerning the allocation of stem cells as well as their possible uses. Since most stem cell research is still in its preliminary phase most of the neuroethical issues surrounding stem cells are the same as stem cell ethics in general.
University College Cork
In October 2008, the governing body of the university announced that UCC would be the first institution in Ireland to use embryonic stem cells in research under strict guidelines of the University Research Ethics using imported hESCs from approved jurisdictions. In 2009, Professor of Mathematics at UCC, Des McHale, challenged the University's decision to allow embryonic stem cell research. According to the results of a poll conducted by irishhealth.com, almost two in three people supported the decision made by University College Cork to allow embryonic stem cell research.
Stem cell controversy
Some stem cell researchers are working to develop techniques of isolating stem cells that are as potent as embryonic stem cells, but do not require a human embryo.
Political positions of John McCain
McCain opposed embryonic stem cell research that uses cloned human embryos. In 2006 he supported a trio of U.S. Senate bills designed to increase federal funding for adult stem cell research, ban the creation of embryos for research and offer federal support for research using embryos slated for destruction by fertility clinics. In 2007, in what he described as "a very agonizing and tough decision," he voted to allow research using human embryos left over from fertility treatments.
James Sherley
James Sherley is a biological engineer and the founder of Asymmetrex, an adult stem cell research center. He has also conducted research at the Boston Biomedical Research Institute and Massachusetts Institute of Technology (MIT). Sherley filed a suit against the government in "Sherley v. Sebelius", resulting in a protracted legal battle attempting to ban the government from funding any research relating to embryonic stem cells.
Political positions of the Republican Party
Although Republicans have voted for increases in government funding of scientific research, some members actively oppose the federal funding of embryonic stem cell research beyond the original lines because it involves the destruction of human embryos, while arguing for applying research money into adult stem cell or amniotic stem cell research. The stem cell issue has garnered two vetoes on research funding bills from President Bush, who said the research "crossed a moral boundary".
Stem cell laws
The information presented here covers the legal implications of embryonic stem cells (ES), rather than induced pluripotent stem cells (iPSCs). The laws surrounding the two differ because while both have similar capacities in differentiation, their modes of derivation are not. While embryonic stem cells are taken from embryoblasts, induced pluripotent stem cells are undifferentiated from somatic adult cells.
Stem cell laws and policy in the United States
By executive order on March 9, 2009, President Barack Obama removed certain restrictions on federal funding for research involving new lines of human embryonic stem cells. Prior to President Obama's executive order, federal funding was limited to non-embryonic stem cell research and embryonic stem cell research based upon embryonic stem cell lines in existence prior to August 9, 2001. Federal funding originating from current appropriations to the Department of Health and Human Services (including the National Institutes of Health) under the Omnibus Appropriations Act of 2009, remains prohibited under the Dickey–Wicker Amendment for (1) the creation of a human embryo for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.
Mitochondrial replacement therapy
In the United Kingdom, following animal experiments and the recommendations of a government commissioned expert committee, the Human Fertilisation and Embryology (Research Purposes) Regulations were passed in 2001 regulating and allowing research into human embryos. In 2004, the Newcastle University applied for a licence to develop pronuclear transfer to avoid the transmission of mitochondrial diseases, and was granted the license in 2005. Following further research by Newcastle and the Wellcome Trust, scientific review, public consultations, and debate, the UK government recommended that mitochondrial donation be legalized in 2013. In 2015 parliament passed the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations, which came into force on 29 October 2015, making human mitochondrial donation legal in the UK. The Human Fertilisation and Embryology Authority (HFEA) was authorized to licence and regulate medical centers which wanted to use human mitochondrial donation. In February 2016, the US National Academy of Sciences issued a report describing technologies then current and the surrounding ethical issues.
Stem cell laws
The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Ireland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Greece, Sweden, Spain and the United Kingdom have created the legal basis to support this research. Belgium bans reproductive cloning but allows therapeutic cloning of embryos. France prohibits reproductive cloning and embryo creation for research purposes, but enacted laws (with a sunset provision expiring in 2009) to allow scientists to conduct stem cell research on imported a large amount of embryos from in vitro fertilization treatments. Germany has restrictive policies for stem cell research, but a 2008 law authorizes "the use of imported stem cell lines produced before May 1, 2007." Italy has a 2004 law that forbids all sperm or egg donations and the freezing of embryos, but allows, in effect, using existing stem cell lines that have been imported. Sweden forbids reproductive cloning, but allows therapeutic cloning and authorized a stem cell bank.
2004 California Proposition 71
Human embryonic stem cell research became a public issue in 1998 when two teams of scientists developed "methods for culturing cell lines derived, respectively, from: (1) cells taken from the inner cell mass of early embryos, and (2) the gonadal ridges of aborted fetuses". Since then, this type of research has sparked intense controversy in the United States.
Embryonic Stem Cell Research Oversight Committees
The National Academies' Guidelines make clear that activities related to human embryonic stem cell research should be overseen by an ESCRO committee. Those committees could be internal to a single institution or established jointly with one or more other institutions. Alternatively, an institution may have its proposals reviewed by an ESCRO committee of another institution or by an independent ESCRO committee. Many of these changes are discussed in the "2007 Amendments".
Ira Black
The Stem Cell Institute of New Jersey, formed following the passage of legislation in 2004 making New Jersey the second state in the nation to approve stem cell research, named him as its first director. Affiliated with the University of Medicine and Dentistry of New Jersey, he served there as chairman of the department of neuroscience and cell biology. As director of the Stem Cell Institute, he expressed his frustration with federal opposition to embryonic stem cell research, stating that the therapies that could result from such studies had the potential to "get patients out of bed and out of wheelchairs" and that the researchers in the U.S. were trailing those elsewhere who were able to make further progress in their studies.
Stem Cell Research Enhancement Act
The Stem Cell Research Enhancement Act of 2007 (), was proposed federal legislation that would have amended the Public Health Service Act to provide for human embryonic stem cell research. It was similar in content to the vetoed Stem Cell Research Enhancement Act of 2005.
New York Stem Cell Foundation
In March 2006, NYSCF opened the first privately funded human embryonic stem cell (hESC) laboratory in New York. The lab was free from federal restrictions and allowed scientists to conduct all types of stem cell research, including studies that involve embryonic stem cells, induced pluripotent stem cells, and somatic cell nuclear transfer.
Stem cell laws
China prohibits human reproductive cloning but allows the creation of human embryos for research and therapeutic purposes. India banned in 2004 reproductive cloning, permitted therapeutic cloning. In 2004, Japan’s Council for Science and Technology Policy voted to allow scientists to conduct stem cell research for therapeutic purposes, though formal guidelines have yet to be released. The South Korean government promotes therapeutic cloning, but forbids cloning. The Philippines prohibits human embryonic and aborted human fetal stem cells and their derivatives for human treatment
and research. In 1999, Israel passed legislation banning reproductive, but not therapeutic, cloning. Saudi Arabia religious officials issued a decree that sanctions the use of embryos for therapeutic and research purposes. According to the Royan Institute for Reproductive Biomedicine, Iran has some of the most liberal laws on stem cell research and cloning. Laws and regulations in Jordan allow stem-cell research. A center for stem cell research has acquired a license to begin operating in April 2017 at the University of Jordan.
Stem cell
Use of stem cells from amniotic fluid overcomes the ethical objections to using human embryos as a source of cells. Roman Catholic teaching forbids the use of embryonic stem cells in experimentation; accordingly, the Vatican newspaper "Osservatore Romano" called amniotic stem cells "the future of medicine".
Samuel H. Wood
In 2008, Wood created embryo copies of himself by placing his skin cells in a woman's egg, marking the first time anyone had done so with adult skin cells. The five cloned embryos were later destroyed, In January 2008, Wood and Andrew French, Stemagen's chief scientific officer in California, announced that they had successfully created the first five mature human embryos using DNA from adult skin cells, aiming to provide a less-controversial source of viable embryonic stem cells. Dr. Wood and a colleague donated skin cells and the DNA from those cells was transferred into human eggs. It is not clear if the embryos produced would have been capable of further development, but Dr. Wood stated that if that were possible, using the technology for reproductive cloning would be both unethical and illegal. The five cloned embryos, created in Stemagen Corporation lab in La Jolla, were later destroyed. Ethics concerns were subsequently raised.
Stem cell controversy
Many of the debates surrounding human embryonic stem cells concern issues such as what restrictions should be made on studies using these types of cells. At what point does one consider life to begin? Is it just to destroy an embryo cell if it has the potential to cure countless numbers of patients? Political leaders are debating how to regulate and fund research studies that involve the techniques used to remove the embryo cells. No clear consensus has emerged. Other recent discoveries may extinguish the need for embryonic stem cells.
Albrecht Kossel Institute for Neuroregeneration
The Institute is one of only a few medical facilities in Germany that is authorized by the government to conduct human embryonic stem cell research.
Somatic cell nuclear transfer
SCNT involving human cells is currently legal for research purposes in the United Kingdom, having been incorporated into the Human Fertilisation and Embryology Act 1990. Permission must be obtained from the Human Fertilisation and Embryology Authority in order to perform or attempt SCNT.
Human Fertilisation and Embryology Authority
This allows researchers to carry out embryonic stem cell research and therapeutic cloning providing that an HFEA Licence Committee considers the use of embryos necessary or desirable for one of these purposes of research.
Stem cell laws and policy in the United States
2008 "GOP" Presidential Candidate John McCain was a member of The Republican Main Street Partnership, and supported embryonic stem cell research, despite his earlier opposition. In July 2008 he said, "At the moment I support stem cell research [because of] the potential it has for curing some of the most terrible diseases that afflict mankind." In 2007, in what he described as "a very agonizing and tough decision," he voted to allow research using human embryos left over from fertility treatments. Former First Lady Nancy Reagan and Senator Orrin Hatch also support stem cell research, after first opposing the issue. Former Senator Frist also supports stem cell research, despite having initially supported past restrictions on embryonic stem cell research. 2008 V.P. candidate Palin opposed embryonic stem cell research, which she said causes the destruction of life, thus this research is inconsistent with her pro-life position and she does not support it. She said, in an interview with Charlie Gibson, that she supports adult stem cell research approaches.
Embryoid body
ESCs are the subject of much public debate due to the ethical questions arising from the derivation from blastocyst-stage of development, necessitating the destruction of the embryo. Although much early EB research was conducted using ESCs derived from mouse sources, cell lines derived from human sources are necessary to fulfill the clinical promise of ESCs. While current U.S. regulations, initiated by the executive order of President Barack Obama in 2009 allow federal funding for hESC lines that are approved by the National Institutes of Health (NIH), the derivation of new hESC lines using federal funding is prohibited by the Dickey-Wicker Amendment. However, due to the association of EB research with ESCs, the long term outcomes of EB research may be subject to regulation by local or federal policy changes. EBs however, are amenable to the use of alternative pluripotent cell sources, such as iPS cells, which holds promise for future applications in three-dimensional stem cell differentiation.
Stem cell laws and policy in the United States
In 2011, a United States District Court "threw out a lawsuit that challenged the use of federal funds for embryonic stem cell research." The decision was a case on remand from the United States Court of Appeals for the District of Columbia Circuit.
Stem cell laws and policy in the United States
The NIH guidelines define which hESC research is eligible to receive NIH funding through a series of regulations which applicants for funding must adhere to. Applicants proposing research, may use stem cell lines that are posted on the NIH registry, or may submit an assurance of compliance with section II of the guidelines. Section II is applicable to stem cells derived from human embryos.
Consumer Watchdog v. Wisconsin Alumni Research Foundation
Consumer Watchdog vs. Wisconsin Alumni Research Foundation is a case focusing on an appeal filed by Consumer Watchdog (CW) to invalidate a patent held by the Wisconsin Alumni Research Foundation (WARF) regarding the in vitro cell culture of human embryonic stem cells (hESCs). This case is still currently ongoing in the U.S. Court of Appeals for the Federal Circuit and is the latest in a series of attempts by CW to revoke one of the three patents held by WARF on hESCs.
Stem cell controversy
In the past, it has been a necessity to research embryonic stem cells and in doing so destroy them for research to progress. As a result of the research done with both embryonic and adult stem cells, new techniques may make the necessity for embryonic cell research obsolete. Because many of the restrictions placed on stem cell research have been based on moral dilemmas surrounding the use of embryonic cells, there will likely be rapid advancement in the field as the techniques that created those issues are becoming less of a necessity. Many funding and research restrictions on embryonic cell research will not impact research on IPSCs (induced pluripotent stem cells) allowing for a promising portion of the field of research to continue relatively unhindered by the ethical issues of embryonic research.
Embryonic stem cell
Embryonic stem cells (ES cells or ESCs) are pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo. Human embryos reach the blastocyst stage 4–5 days post fertilization, at which time they consist of 50–150 cells. Isolating the embryoblast, or inner cell mass (ICM) results in destruction of the blastocyst, a process which raises ethical issues, including whether or not embryos at the pre-implantation stage should have the same moral considerations as embryos in the post-implantation stage of development. Researchers are currently focusing heavily on the therapeutic potential of embryonic stem cells, with clinical use being the goal for many labs. Potential uses include the treatment of diabetes and heart disease. The cells are being studied to be used as clinical therapies, models of genetic disorders, and cellular/DNA repair. However, adverse effects in the research and clinical processes such as tumours and unwanted immune responses have also been reported.
Political positions of Mike Huckabee
Huckabee has said that embryonic stem cell research creates life only to end a life. He applauded George W. Bush's veto of legislation meant to loosen federal funding for embryonic stem cell research in June 2007, saying that the bill was wrong on moral grounds and based on inconclusive science. He also said that scientists have developed other types of stem cell research that would not require the use of a human embryo. He said that "vital scientific research can and is being conducted without the destruction of life."
Stem cell laws and policy in China
As a result of the increased interest in this field of research, in 2003, the People's Republic of China Ministry of Science and Technology and Ministry of Health issued official ethical guidelines for human embryonic stem cell research in its territories. The guidelines strictly forbid any research aimed at human reproductive cloning and require that the embryos used for stem cell research come only from:
Shelley Moore Capito
Capito supports embryonic stem cell research. In May 2005, as a representative, Capito broke with her party, voting with a majority of Democrats, to repeal restrictions on embryonic stem-cell research funding. Capito also voted in 2006 to attempt to override President Bush's veto of the 2005 bill. In June 2007, Capito voted against banning the cloning of human embryos. Previously, Capito had voted for a bill to ban the cloning of human embryos. Also in 2007, Capito again voted in favor of funding stem-cell research. She also voted in favor of research using stem cells derived from donated embryos. In 2009, Capito voted for a budget bill that prohibited the creation of human embryos for research.
Stem cell controversy
A portion of stem cell researchers use embryos that were created but not used in "in vitro" fertility treatments to derive new stem cell lines. Most of these embryos are to be destroyed, or stored for long periods of time, long past their viable storage life. In the United States alone, an estimated at least 400,000 such embryos exist. This has led some opponents of abortion, such as Senator Orrin Hatch, to support human embryonic stem cell research. See also embryo donation.
Stem cell laws
Brazil has passed legislation to permit stem cell research using excess in vitro fertilized embryos that have been frozen for at least three years.
Neurotechnology
The ethical debate about use of embryonic stem cells has stirred controversy both in the United States and abroad; although more recently these debates have lessened due to modern advances in creating induced pluripotent stem cells from adult cells. The greatest advantage for use of embryonic stem cells is the fact that they can differentiate (become) nearly any type of cell provided the right conditions and signals. However, recent advances by Shinya Yamanaka et al. have found ways to create pluripotent cells without the use of such controversial cell cultures. Using the patient's own cells and re-differentiating them into the desired cell type bypasses both possible patient rejection of the embryonic stem cells and any ethical concerns associated with using them, while also providing researchers a larger supply of available cells. However, induced pluripotent cells have the potential to form benign (though potentially malignant) tumors, and tend to have poor survivability "in vivo" (in the living body) on damaged tissue. Much of the ethics concerning use of stem cells has subsided from the embryonic/adult stem cell debate due to its rendered moot, but now societies find themselves debating whether or not this technology can be ethically used. Enhancements of traits, use of animals for tissue scaffolding, and even arguments for moral degeneration have been made with the fears that if this technology reaches its full potential a new paradigm shift will occur in human behavior.
Stem cell laws and policy in the United States
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. Missouri Constitutional Amendment 2 (2006) (Missouri Amendment Two) was a 2006 law that legalized certain forms of embryonic stem cell research in the state.
Stem cell laws and policy in the United States
There must also be a clear distinction between the donor's decision to create embryos for reproductive purposes, and the decision to donate embryos for research. This is ensured through a number of regulations which follow. First, the decision to create embryos for reproductive purposes must have been made without the influence of researchers proposing usage for the embryos to derive hESCs for research purposes. Consent for the donation of embryos should have been given at the time of donation. Finally, donors should have been informed that they have the right to withdraw consent at any time until derivation of stem cells from the embryo, or until the identity of the donor can no longer be linked to the embryo.
Stem cell controversy
China has one of the most permissive human embryonic stem cell policies in the world. In the absence of a public controversy, human embryo stem cell research is supported by policies that allow the use of human embryos and therapeutic cloning.
Bernard Siegel (attorney)
In both 2003 and 2004, Siegel played a pivotal role in protecting a form of stem cell research in the United Nations, which was under the threat of being banned by world treaty. In 2003, he brought some of the world’s most prominent stem cell research scientists together at a meeting at the U.N. to educate delegates about the need to ban human reproductive cloning (the cloning of a whole person) while keeping nuclear transfer research (for the cloning of stem cells) legal throughout the world. That very year, the U.N. avoided the passage of a treaty that would have banned nuclear transfer research worldwide by a single vote. In 2004, the treaty was downgraded to a nonbinding resolution that left the matter of whether or not to allow nuclear transfer up to the various nations.
Stem cell controversy
In 1998, James Thomson and Jeffrey Jones derived the first human embryonic stem cells, with even greater potential for drug discovery and therapeutic transplantation. However, the use of the technique on human embryos led to more widespread controversy as criticism of the technique now began from the wider non-scientific public who debated the moral ethics of questions concerning research involving human embryonic cells.7
Stem cell controversy
Generally speaking, no group advocates for unrestricted stem cell research, especially in the context of embryonic stem cell research.
Kevin Eggan
In August 2004, Eggan moved to Harvard University in Cambridge, Massachusetts, as a junior fellow, becoming an assistant professor of Molecular & Cellular Biology at their Stem Cell Institute ("HSCI") in 2005. At the time, stem cell research in the United States was threatened by political pressure due to concerns over the ethics of human embryo research, and research such as this was at risk of potentially being made illegal. Federal funding for stem cell research had recently been removed, and part of his role was to obtain private funding to replace it. Eggan took on a second role as the assistant investigator for Stowers Institute for Medical Research, a philanthropical medical research group in Kansas City, Missouri.
Irish Stem Cell Foundation
The Foundation agrees with the Irish Council Of Bioethics and the Irish Committee for Assisted Human Reproduction that Irish stem cell research needs a strong, transparent ethical and legislative structure. In 2010, the Foundation issued a public policy document on embryonic stem cell research.
Juergen Hescheler
Hescheler has been working with embryonic stem cells ever since the late 1980s. Beginning with studies on cellular signal transduction, and starting with works on signalling pathways in different cells (g-protein phosphorylation, electrophysiology of channels) he focussed on embryonic stem cells and has since defined many important basic aspects of both fundamental research and clinical applications. He was the first scientist worldwide to perform electrophysiological and functional experiments on stem cells and differentiated phenotypes thereof. He achieved a first functional characterization of cardiomyocytes developed from embryonic stem cells which is an important prerequisite for their subsequent use in regenerative medicine. He thus pioneered the establishment of stem cell research for application in transplantation medicine. In 2002, he was among the first scientists in Germany to obtain permission to work with human embryonic stem cells. In his current position, as Chairman and Director to the Institute for Neurophysiology at the University of Cologne, his research areas include work on embryonic and adult stem cells, induced pluripotent stem cells, mesenchymal stem cells and germline pluripotent stem cells. Among progressing the use of stem cells for translational purposes, aiming at tapping the potential of stem cell biology towards clinical application, Hescheler actively promotes the vision of EPAA through innovative alternative testing strategies, applying stem cells towards toxicity testing. Apart from the rationale of promoting 3R principles it is his goal that coordinating a multidisciplinary research effort undertaken by various projects and consortia led by Hescheler will generate pathway- and evidence-based understanding of long-term toxic effects, thus moving toxicology from a rather descriptive science towards a more mechanistic-driven predictive one. 
Hescheler has been appointed coordinator of various European Consortia such as FunGenES, CRYSTAL, and more recently ESNATS and DETECTIVE. He is also coordinator of the BMBF consortium “iPS and adult bone marrow cells for cardiac repair”. In 2004 he founded and since chaired the German Society of Stem Cell Research (GSZ). He is an active member of the Scientific Panel of the AXLR8 Consortium and a member of steering committee of Stem Cell Network North Rhine Westphalia.
Consumer Watchdog v. Wisconsin Alumni Research Foundation
On January 20, 1995, James Thomson filed an initial application for patent rights based on his pioneering work in isolating and maintaining long-lived culture of primate and human embryonic stem cells. As a result of this filing, the United States Patent and Trademark Office (USPTO) eventually issued three patents to Thomson, which were all later assigned to WARF: U.S. Patents Nos. 5,843,780 (December 1, 1998), 6,200,806 (March 13, 2001), and 7,029,913 (April 18, 2006). These patents are commonly referred to as the ‘780, ‘806, and ‘913 patents, respectively, and are all entitled “Primate Embryonic Stem Cells.”
Embryonic stem cell
In November 2011 Geron announced it was halting the trial and dropping out of stem cell research for financial reasons, but would continue to monitor existing patients, and was attempting to find a partner that could continue their research. In 2013 BioTime, led by CEO Dr. Michael D. West, acquired all of Geron's stem cell assets, with the stated intention of restarting Geron's embryonic stem cell-based clinical trial for spinal cord injury research.
Kevin Eggan
Eggan's team reported that they had created cells similar to human embryonic stem cells without destroying embryos, a major step toward someday possibly defusing the central objection to stem cell research. These discoveries sparked extensive debate in the United States Congress, with opponents of the use of embryonic stem cells from fetuses arguing that these or similar methods of creating stem cells from skin might be eventually used instead to satisfy the conflicting demands of medical research and morals.
Hwang Woo-suk
On May 12, 2006, Hwang was charged with embezzlement and bioethics law violations after it emerged much of his stem cell research had been faked. The "Korea Times" reported on June 10, 2007, that Seoul National University fired him, and the South Korean government canceled his financial support and barred him from engaging in stem cell research. While being charged with fraud and embezzlement, he has kept a relatively low profile at the Sooam Bioengineering Research Institute in Yongin, Gyeonggi Province, where he currently leads research efforts on creating cloned pig embryos and using them to make embryonic stem-cell lines.
Stem cell controversy
Similarly, the sole Jewish majority state, Israel, permits research on embryonic stem cells.
2006 United States Senate elections
Perhaps most importantly, 62% favored a ballot proposal that would allow all types of embryonic stem cell research allowed under federal law - a measure Talent had recently announced that he was against.
Stem cell laws
In 2001, the British Parliament amended the Human Fertilisation and Embryology Act 1990 (since amended by the Human Fertilisation and Embryology Act 2008) to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:The United Kingdom is one of the leaders in stem cell research, in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK. A new £10 million stem cell research centre has been announced at the University of Cambridge.
North East of England Process Industry Cluster
Fundamental medical research is done in this region at several of its universities. For example, Newcastle University was the first to receive a licence in the UK to perform research on stem cells and this is a leading centre for such research today. Indeed Karim Nayernia was the first to isolate spermatagonial stem cells at this University. Many new healthcare developments have arisen from this research work.
Human Fertilisation and Embryology Act 1990
Research on human embryos can only be performed for specifically defined purposes that must be considered 'necessary and desirable' by the Human Fertilisation and Embryology Authority. Research can only be performed on an embryo for a maximum of fourteen days or until the primitive streak appears. The genetic composition of any cell within the embryo cannot be altered during the embryo's formation for research.
Fetus Farming Prohibition Act
Some writers, including Robert P. George and Wesley J. Smith, have argued that embryonic-stem-cell research will inevitably lead to such procedures. Some supporters of embryonic stem cell have rejected this comparison. Other bioethicists and medical experts, including Jacob M. Appel and Sir Richard Gardner, have welcomed the possibility of using fetuses as a way to increase the supply of organs available for transplantation.
Dignity
In 1997, the National Consultative Committee for Ethics in the Life and Health Sciences, as well as other observers, noted that France's dignity-based laws on bio-medical research were paradoxical. The law prohibited the willful destruction of human embryos but directed that human embryos could be destroyed if they were more than five years old. The law prohibited research on human embryos created in France but permitted research on human embryos brought to France. The law prohibited researchers from creating embryos for research but allowed researchers to experiment with embryos that were superfluous after "in vitro" fertilization.