Stem cell laws and policy in the United States
   HOME

TheInfoList



OR:

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


Science background

Stem cell In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type o ...
s are cells found in all multi-cellular organisms. They were isolated in mice in 1981, and in humans in 1998.John Ydstie and Joe Palca, "Embryonic Stem Cells Made Without Embryos," ''NPR'', November 21, 2007, found a
NPR website story of 11-21-09
Retrieved April 8, 2009.
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 The inner cell mass (ICM) or embryoblast (known as the pluriblast in marsupials) is a structure in the early development of an embryo. It is the mass of cells inside the blastocyst that will eventually give rise to the definitive structures of ...
of the
blastocyst The blastocyst is a structure formed in the early embryonic development of mammals. It possesses an inner cell mass (ICM) also known as the ''embryoblast'' which subsequently forms the embryo, and an outer layer of trophoblast cells called the t ...
. 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.
Stem cell treatments Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. , the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone-marrow transplantation, but ...
are a type of cell therapy that introduce new cells into adult bodies for possible treatment of
cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...
,
diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ap ...
, 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 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 (egg cell) and implanting a ...
which is a laboratory technique where a clone embryo is created from a donor nucleus.
Somatic cell nuclear transfer 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 (egg cell) and implanting a ...
is also tightly regulated amongst various countries. Until recently, the principal source of human embryonic stem cells has been donated embryos from
fertility clinic Fertility clinics are medical clinics that assist couples, and sometimes individuals, who want to become parents but for medical reasons have been unable to achieve this goal via the natural course. Clinics apply a number of diagnosis tests and s ...
s. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from
amniotic fluid The amniotic fluid is the protective liquid contained by the amniotic sac of a gravid amniote. This fluid serves as a cushion for the growing fetus, but also serves to facilitate the exchange of nutrients, water, and biochemical products betwee ...
donated by pregnant women hold much of the same promise as embryonic stem cells." In 2000, the NIH, under the administration of President
Bill Clinton William Jefferson Clinton ( né Blythe III; born August 19, 1946) is an American politician who served as the 42nd president of the United States from 1993 to 2001. He previously served as governor of Arkansas from 1979 to 1981 and agai ...
, issued "guidelines that allow federal funding of embryonic stem-cell research."


Political beginnings

In 1973, ''
Roe v. Wade ''Roe v. Wade'', 410 U.S. 113 (1973),. was a landmark decision of the U.S. Supreme Court in which the Court ruled that the Constitution of the United States conferred the right to have an abortion. The decision struck down many federal and st ...
'' 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.
ISSN An International Standard Serial Number (ISSN) is an eight-digit serial number used to uniquely identify a serial publication, such as a magazine. The ISSN is especially helpful in distinguishing between serials with the same title. ISSNs ...
br>1549-3199
LCCN The Library of Congress Control Number (LCCN) is a serially based system of numbering cataloged records in the Library of Congress, in the United States. It is not related to the contents of any book, and should not be confused with Library of ...
br>2004212209
OCLC OCLC, Inc., doing business as OCLC, See also: is an American nonprofit cooperative organization "that provides shared technology services, original research, and community programs for its membership and the library community at large". It was ...
:.
In 1995, the NIH Human Embryo Research Panel advised the administration of President
Bill Clinton William Jefferson Clinton ( né Blythe III; born August 19, 1946) is an American politician who served as the 42nd president of the United States from 1993 to 2001. He previously served as governor of Arkansas from 1979 to 1981 and agai ...
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 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 Se ...
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).


Federal law

No federal law ever did ban stem cell research in the United States, but only placed restrictions on funding and use, under Congress's power to spend. In February 2001,
George W. Bush George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd president of the United States from 2001 to 2009. A member of the Republican Party, Bush family, and son of the 41st president George H. W. Bush, he ...
requested a review of the NIH's guidelines, and after a policy discussion within his circle of supporters, implemented a policy in August of that year to limit the number of embryonic stem cell lines that could be used for research. (While he claimed that 78 lines would qualify for federal funding, only 19 lines were actually available.) In April 2004, 206 members of
Congress A congress is a formal meeting of the representatives of different countries, constituent states, organizations, trade unions, political parties, or other groups. The term originated in Late Middle English to denote an encounter (meeting of a ...
, including many moderate Republicans, signed a letter urging President Bush to expand federal funding of embryonic stem cell research beyond what Bush had already supported. 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 In vitro fertilisation (IVF) is a process of fertilisation where an egg is combined with sperm in vitro ("in glass"). The process involves monitoring and stimulating an individual's ovulatory process, removing an ovum or ova (egg or eggs) ...
clinics to be used for stem cell research with the permission of donors — despite Bush's promise to veto 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, 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. The National Institutes of Health has hundreds of funding opportunities for researchers interested in hESC. In 2005 the NIH funded $607 million worth of stem cell research, of which $39 million was specifically used for hESC. During Bush's second term, in July 2006, he used his first Presidential veto on the Stem Cell Research Enhancement Act. The Stem Cell Research Enhancement Act was the name of two similar bills, and both were vetoed by President George W. Bush and were not enacted into law.
New Jersey New Jersey is a state in the Mid-Atlantic and Northeastern regions of the United States. It is bordered on the north and east by the state of New York; on the east, southeast, and south by the Atlantic Ocean; on the west by the Delaware ...
congressman Chris Smith wrote a
Stem Cell Therapeutic and Research Act of 2005 The Stem Cell Therapeutic and Research Act of 2005 () is a United States federal law that assigns the United States Secretary of Health and Human Services to create a national stockpile of cord blood stem cells, and rewrites provisions within the P ...
, which was signed into law by President Bush. It provided $265 million for adult stem cell therapy, umbilical cord blood and bone marrow treatment, and authorized $79 million for the collection of cord blood stem cells. By executive order on March 9, 2009, President
Barack Obama Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...
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 The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
) under the Omnibus Appropriations Act of 2009, remains prohibited under the
Dickey–Wicker Amendment 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 Se ...
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. In a speech before signing the executive order, President Obama noted the following: In 2011, a
United States District Court The United States district courts are the trial courts of the United States federal judiciary, U.S. federal judiciary. There is one district court for each United States federal judicial district, federal judicial district, which each cover o ...
"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.


State law


Legalization and funding

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 Constitutional Amendment 2 (The Missouri Stem Cell Research and Cures Initiative) was a state constitutional amendment initiative that concerned stem cell research and human cloning. It allows any stem cell research and therapy in the ...
( Missouri Amendment Two) was a 2006 law that legalized certain forms of embryonic stem cell research in the state.
California California is a U.S. state, state in the Western United States, located along the West Coast of the United States, Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the List of states and territori ...
voters in November 2004 approved Proposition 71, creating a
US$ The United States dollar (symbol: $; code: USD; also abbreviated US$ or U.S. Dollar, to distinguish it from other dollar-denominated currencies; referred to as the dollar, U.S. dollar, American dollar, or colloquially buck) is the official ...
3 billion state taxpayer-funded institute for stem cell research, the
California Institute for Regenerative Medicine The California Institute for Regenerative Medicine (CIRM) was created in 2004 after 59% of California voters approved California Proposition 71: the Research and Cures Initiative, which allocated $3 billion to fund stem cell research in California ...
. It hopes to provide $300 million a year. However, as of June 6, 2006, there were delays in the implementation of the California program and it is believed that the delays will continue for the significant future

On July 21, 2006,
Governor A governor is an administrative leader and head of a polity or political region, ranking under the head of state and in some cases, such as governors-general, as the head of state's official representative. Depending on the type of political ...
Arnold Schwarzenegger Arnold Alois Schwarzenegger (born July 30, 1947) is an Austrian and American actor, film producer, businessman, retired professional bodybuilder and politician who served as the 38th governor of California between 2003 and 2011. ''Time'' ...
(R-Calif.) authorized $150 million in loans to the Institute in an attempt to jump start the process of funding research. Several states, in what was initially believed to be a national migration of biotech researchers to California, have shown interest in providing their own funding support of embryonic and adult stem cell research. These states include
Connecticut Connecticut () is the southernmost state in the New England region of the Northeastern United States. It is bordered by Rhode Island to the east, Massachusetts to the north, New York to the west, and Long Island Sound to the south. Its cap ...
br>
Florida Florida is a state located in the Southeastern region of the United States. Florida is bordered to the west by the Gulf of Mexico, to the northwest by Alabama, to the north by Georgia, to the east by the Bahamas and Atlantic Ocean, and to ...
,
Illinois Illinois ( ) is a U.S. state, state in the Midwestern United States, Midwestern United States. Its largest metropolitan areas include the Chicago metropolitan area, and the Metro East section, of Greater St. Louis. Other smaller metropolita ...
,
Massachusetts Massachusetts (Massachusett language, Massachusett: ''Muhsachuweesut assachusett writing systems, məhswatʃəwiːsət'' English: , ), officially the Commonwealth of Massachusetts, is the most populous U.S. state, state in the New England ...
br>
Missouri Missouri is a U.S. state, state in the Midwestern United States, Midwestern region of the United States. Ranking List of U.S. states and territories by area, 21st in land area, it is bordered by eight states (tied for the most with Tennessee ...
,
New Hampshire New Hampshire is a U.S. state, state in the New England region of the northeastern United States. It is bordered by Massachusetts to the south, Vermont to the west, Maine and the Gulf of Maine to the east, and the Canadian province of Quebec t ...
,
New York New York most commonly refers to: * New York City, the most populous city in the United States, located in the state of New York * New York (state), a state in the northeastern United States New York may also refer to: Film and television * '' ...
,
Pennsylvania Pennsylvania (; ( Pennsylvania Dutch: )), officially the Commonwealth of Pennsylvania, is a state spanning the Mid-Atlantic, Northeastern, Appalachian, and Great Lakes regions of the United States. It borders Delaware to its southeast, ...
,
Texas Texas (, ; Spanish language, Spanish: ''Texas'', ''Tejas'') is a state in the South Central United States, South Central region of the United States. At 268,596 square miles (695,662 km2), and with more than 29.1 million residents in 2 ...
br>Around The Area
Washington Washington commonly refers to: * Washington (state), United States * Washington, D.C., the capital of the United States ** A metonym for the federal government of the United States ** Washington metropolitan area, the metropolitan area centered on ...
, and
Wisconsin Wisconsin () is a state in the upper Midwestern United States. Wisconsin is the 25th-largest state by total area and the 20th-most populous. It is bordered by Minnesota to the west, Iowa to the southwest, Illinois to the south, Lake M ...
.


Bans and restrictions

Other states have (or have shown interest in) additional restrictions or even complete bans on embryonic stem cell research. These states include
Arkansas Arkansas ( ) is a landlocked state in the South Central United States. It is bordered by Missouri to the north, Tennessee and Mississippi to the east, Louisiana to the south, and Texas and Oklahoma to the west. Its name is from the Osage ...
,
Iowa Iowa () is a state in the Midwestern region of the United States, bordered by the Mississippi River to the east and the Missouri River and Big Sioux River to the west. It is bordered by six states: Wisconsin to the northeast, Illinois to the ...
,
Kansas Kansas () is a state in the Midwestern United States. Its capital is Topeka, and its largest city is Wichita. Kansas is a landlocked state bordered by Nebraska to the north; Missouri to the east; Oklahoma to the south; and Colorado to the ...
,
Louisiana Louisiana , group=pronunciation (French: ''La Louisiane'') is a state in the Deep South and South Central regions of the United States. It is the 20th-smallest by area and the 25th most populous of the 50 U.S. states. Louisiana is borde ...
,
Nebraska Nebraska () is a state in the Midwestern region of the United States. It is bordered by South Dakota to the north; Iowa to the east and Missouri to the southeast, both across the Missouri River; Kansas to the south; Colorado to the southwe ...
,
North Dakota North Dakota () is a U.S. state in the Upper Midwest, named after the Native Americans in the United States, indigenous Dakota people, Dakota Sioux. North Dakota is bordered by the Canadian provinces of Saskatchewan and Manitoba to the north a ...
,
South Dakota South Dakota (; Sioux language, Sioux: , ) is a U.S. state in the West North Central states, North Central region of the United States. It is also part of the Great Plains. South Dakota is named after the Lakota people, Lakota and Dakota peo ...
, and
Virginia Virginia, officially the Commonwealth of Virginia, is a state in the Mid-Atlantic and Southeastern regions of the United States, between the Atlantic Coast and the Appalachian Mountains. The geography and climate of the Commonwealth ar ...
.
''States play catch-up on stem cells''
''
USA Today ''USA Today'' (stylized in all uppercase) is an American daily middle-market newspaper and news broadcasting company. Founded by Al Neuharth on September 15, 1982, the newspaper operates from Gannett's corporate headquarters in Tysons, Virgini ...
'', December 2004)
Arkansas Arkansas ( ) is a landlocked state in the South Central United States. It is bordered by Missouri to the north, Tennessee and Mississippi to the east, Louisiana to the south, and Texas and Oklahoma to the west. Its name is from the Osage ...
,
Indiana Indiana () is a U.S. state in the Midwestern United States. It is the 38th-largest by area and the 17th-most populous of the 50 States. Its capital and largest city is Indianapolis. Indiana was admitted to the United States as the 19th s ...
,
Louisiana Louisiana , group=pronunciation (French: ''La Louisiane'') is a state in the Deep South and South Central regions of the United States. It is the 20th-smallest by area and the 25th most populous of the 50 U.S. states. Louisiana is borde ...
,
Michigan Michigan () is a state in the Great Lakes region of the upper Midwestern United States. With a population of nearly 10.12 million and an area of nearly , Michigan is the 10th-largest state by population, the 11th-largest by area, and the ...
(subsequently reversed by constitutional amendment),
North Dakota North Dakota () is a U.S. state in the Upper Midwest, named after the Native Americans in the United States, indigenous Dakota people, Dakota Sioux. North Dakota is bordered by the Canadian provinces of Saskatchewan and Manitoba to the north a ...
and
South Dakota South Dakota (; Sioux language, Sioux: , ) is a U.S. state in the West North Central states, North Central region of the United States. It is also part of the Great Plains. South Dakota is named after the Lakota people, Lakota and Dakota peo ...
have passed laws to "prohibit the creation or destruction of human embryos for medical research."


Bans and restrictions on relevant stem cell/cloning controversies


States with statutes specifically banning human reproductive and therapeutic cloning

* Arkansas, 003 SB 185 Ark. Code § 20- 16-1001 et. seq. (2004) * Indiana, Ind. Code § 1 6-18-2-5.5. -56.5, -128.5, -183.5 (2005) * Michigan, Mich. Comp. Laws §§ 333.26401-06, 333.16274, 16275, 20197, 750.430a (2004), reversed by constitutional amendment in proposal 2008-02. * North Dakota, 003 HB 1424 N.D. Cent. Code §§ 12.1-39-01, 12.1-39-02 (2004) * South Dakota, 2004 SB 184 * Virginia, Va. Code Ann. §§ 32.1-162.21- .22 (2004) (unclear whether therapeutic cloning is included in the ban)


States with statutes specifically banning human reproductive cloning

* Iowa, Iowa Code §§ 707C (2007) * Maryland, 2006 SB 144


States banning the use of public funding for reproductive and/or therapeutic cloning

* Arizona, HB 2221 (2005) (human reproductive and therapeutic cloning) * Missouri, Mo. Rev. Stat. § 1.217 (2004) (human reproductive cloning)


States with statutes specifically allowing therapeutic cloning

* California, Cal. Bus. & Prof. §§ 16004, 16105; Cal. Health & Safety §§24185-24187 (2004) * Missouri, Mo. Rev. Stat. § 1.217 (2004) * New Jersey, 003 SB 1909/2003 AB 2840 N.J. Stat. § 2C:11A-1 (2004) * Rhode Island, R.I. Gen. Laws §§ 23-16.4-1 - .4-4 (2004) (Sunset provision: July 7, 2010) * Connecticut, Public Act 05-149 (2005)


Policy stances of political parties and politicians

Policy stances on stem cell research of various political leaders in the United States have not always been predictable. As a rule, most
Democratic Party Democratic Party most often refers to: *Democratic Party (United States) Democratic Party and similar terms may also refer to: Active parties Africa *Botswana Democratic Party *Democratic Party of Equatorial Guinea *Gabonese Democratic Party *Demo ...
leaders and high-profile supporters and even rank and file members have pushed for laws and policies almost exclusively favoring embryonic stem cell research. President Bill Clinton supported the NIH's guidelines in 2000. Both the major candidates in 2008 had supported the 2005 and 2007 bills, in particular
Hillary Rodham Clinton Hillary Diane Rodham Clinton ( Rodham; born October 26, 1947) is an American politician, diplomat, and former lawyer who served as the 67th United States Secretary of State for President Barack Obama from 2009 to 2013, as a United States senat ...
, Bill Clinton's
First Lady First lady is an unofficial title usually used for the wife, and occasionally used for the daughter or other female relative, of a non-monarchical A monarchy is a form of government in which a person, the monarch, is head of state fo ...
, then U. S. Senator for New York, and
Barack Obama Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...
, then U.S. Senator for Illinois, who promised to sign the EFCA into law, and was a cosponsor of such bills.Obama condemned Bush's veto, claiming, "Democrats want this bill to pass. Conservative, pro-life Republicans want this bill to pass. By large margins, the American people want this bill to pass. It is only the
White House The White House is the official residence and workplace of the president of the United States. It is located at 1600 Pennsylvania Avenue NW in Washington, D.C., and has been the residence of every U.S. president since John Adams in 1800. ...
standing in the way of progress - standing in the way of so many potential cures.
Barack Obama's Statement of Support for Stem Cell Research
. See als

Massachusetts governor
Deval Patrick Deval Laurdine Patrick (born July 31, 1956) is an American politician, civil rights lawyer, author, and businessman who served as the 71st governor of Massachusetts from 2007 to 2015. He was first elected in 2006, succeeding Mitt Romney, who ...
is also a proponent of embryonic stem cell research. There have been some Democrats who have asked for boundaries be placed on human embryo use. For example,
Carolyn McCarthy Carolyn McCarthy ( Cook; born January 5, 1944) is an American politician who served as the United States House of Representatives, U.S. representative for from 1997 to 2015. She is a member of the Democratic Party (United States), Democratic Par ...
has publicly stated she only supports using human embryos "that would be discarded". 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.Christine Vestal, Staff Writer, Stateline.org, "Stem Cell Research at the Crossroads of Religion and Politics," Pew Forum paper, July 17, 2008, found a
Pew Forum website
Accessed April 13, 2009.
Prominent Republican leaders against embryonic stem cell research include
Sarah Palin Sarah Louise Palin (; Heath; born February 11, 1964) is an American politician, commentator, author, and reality television personality who served as the ninth governor of Alaska from 2006 until her resignation in 2009. She was the 2008 R ...
, Jim Talent, Rick Santorum, and Sam Brownback. In July 2001: 2008 GOP Presidential Candidate
John McCain John Sidney McCain III (August 29, 1936 – August 25, 2018) was an American politician and United States Navy officer who served as a United States senator from Arizona from 1987 until his death in 2018. He previously served two terms ...
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 ecause ofthe 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 Nancy Davis Reagan (; born Anne Frances Robbins; July 6, 1921 – March 6, 2016) was an American film actress and First Lady of the United States from 1981 to 1989. She was the second wife of president Ronald Reagan. Reagan was born in N ...
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 The surname Palin is a name of British origin, either English or Welsh. Possible derivations include an anglicization of the Welsh patronymic ''ap Heilyn'' ("son of Heilyn") or a reference to the English placenames Poling, West Sussex or Sea Pallin ...
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. A few moderates or
Libertarians Libertarianism (from french: libertaire, "libertarian"; from la, libertas, "freedom") is a political philosophy that upholds liberty as a core value. Libertarians seek to maximize autonomy and political freedom, and Minarchism, minimize the ...
support such research with limits. Lincoln Chafee supported federal funding for embryonic stem cell research.
Ron Paul Ronald Ernest Paul (born August 20, 1935) is an American author, activist, physician and retired politician who served as the U.S. representative for Texas's 22nd congressional district from 1976 to 1977 and again from 1979 to 1985, as well ...
, a Republican congressman,
physician A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...
, and Libertarian and Independent candidate for President, has sponsored much legislation, and has had quite complex positions.


Impact on science and innovation of changes in funding policies

Several studies have examined the impact of changing funding policies on scientific research in the US and the development of new cell therapies by industry. For example, studies have highlighted an immediate and sizable drop in research productivity of US-based researchers as compared to researchers based elsewhere during the years after the enactment in August 2001 of federal funding restrictions on research involving new embryonic stem cell lines. US knowledge production in the human embryonic stem cell field fell 35 to 40 percent below anticipated levels, and measured in terms of forward citations to core research publications in the field, US-based follow-on work in the human embryonic stem cell research field declined by nearly 59 percent relative to non-US-based research over the period 2001-2003. During this period US based firms were also less likely to launch new therapeutic product development projects in the cell therapy field than firms outside the US, and were more likely to discontinue clinical trials for new cell therapies that were already under way. All these effects were reversed as the funding environment for stem cell research in the US became more favorable during the second half of the 2000s.


National Academies Guidelines for Human Embryonic Stem Cell Research

In 2005, the
United States National Academies The National Academies of Sciences, Engineering, and Medicine (also known as NASEM or the National Academies) are the collective scientific national academy of the United States. The name is used interchangeably in two senses: (1) as an umbrell ...
released its ''Guidelines for Human Embryonic Stem Cell Research''. These Guidelines were prepared to enhance the integrity of human embryonic stem cell research in the public's perception and in actuality by encouraging responsible practices in the conduct of that research. The National Academies has subsequently named the Human Embryonic Stem Cell Research Advisory Committee to keep the Guidelines up-to-date. The guidelines preserve two primary principles. First, that hESC research has the potential to improve our understanding of human health and discover new ways to treat illness. Second, that individuals donating embryos should do so freely, with voluntary and informed consent. The guidelines implement executive order 13505, and apply to hESC research receiving funds from the NIH. The guidelines detail safeguards to protect donating individuals by acquiring informed consent and protecting their identity. In addition, the guidelines contain multiple sections applying to embryos donated in the US and abroad, both before and after the effective date of the guidelines. 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. For the purposes of section II of the NIH guidelines, the following requirements must be met. First, the hESCs should have been derived from embryos created using an in vitro fertilization procedure for reproductive purposes, and no longer needed for this purpose. Second, the donors who sought reproductive treatment have given written consent for the embryos to be used for research purposes. Third, all written consent forms and other documentation must be provided. Documentation must be provided regarding the following: All options available to the healthcare facility regarding the embryos in question were explained to the individual who sought reproductive treatment. No payments of any kind may be offered for the donated embryos. Policies and procedures must be in place at the facility where the embryos were donated to ensure that neither donation nor refusal to donate affects quality of care received by the patient. 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. 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. Applicants seeking to use stem cell lines established before the effective date of the guidelines may use lines published on the NIH registry, or establish eligibility by complying with the requirements listed above. Alternately, researchers may submit materials to a working group of the Advisory Committee to the Director. The working group will review submitted materials and submit recommendations to the Advisory Committee, which will in turn make recommendations to the NIH director. A final decision regarding eligibility for funding is then made by the NIH director. The materials submitted to the working group must demonstrate that the stem cells were derived from embryos created for reproductive purposes, and are no longer needed. Also, the materials must demonstrate that the stem cells were donated by donors who had granted voluntary written consent. 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.


Timeline

* 1993 - As per the National Institutes of Health Revitalization Act, Congress and President
Bill Clinton William Jefferson Clinton ( né Blythe III; born August 19, 1946) is an American politician who served as the 42nd president of the United States from 1993 to 2001. He previously served as governor of Arkansas from 1979 to 1981 and agai ...
give the NIH direct authority to fund human embryo research for the first time. * 1995 - The U.S. Congress passes an appropriations bill attached to which is a rider, the
Dickey–Wicker Amendment 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 Se ...
which prohibited federally appropriated funds to be used for research where human embryos would be either created or destroyed. President Clinton signs the bill into law. This predates the creation of the first human embryonic stem cell lines. * 1999 - After the creation of the first human embryonic stem cell lines in 1998 by James Thomson of the
University of Wisconsin A university () is an institution of higher (or tertiary) education and research which awards academic degrees in several academic disciplines. Universities typically offer both undergraduate and postgraduate programs. In the United States, t ...
, Harriet Rabb, the top lawyer at the Department of Health and Human Services, releases a legal opinion that would set the course for Clinton Administration policy. Federal funds, obviously, could not be used to derive stem cell lines (because derivation involves embryo destruction). However, she concludes that because human embryonic stem cells "are not a human embryo within the statutory definition," the Dickey–Wicker Amendment does not apply to them. The NIH was therefore free to give federal funding to experiments involving the cells themselves. President Clinton strongly endorses the new guidelines, noting that human embryonic stem cell research promised "potentially staggering benefits." And with the guidelines in place, the NIH begins accepting grant proposals from scientists. * 2001–2006 - On August 9, 2001,
U.S. President The president of the United States (POTUS) is the head of state and head of government of the United States of America. The president directs the executive branch of the federal government and is the commander-in-chief of the United States ...
George W. Bush George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd president of the United States from 2001 to 2009. A member of the Republican Party, Bush family, and son of the 41st president George H. W. Bush, he ...
signs an executive order which restricts federally funded stem cell research on embryonic stem cells to the already derived cell lines. He supports federal funding for embryonic stem cell research on the already existing lines of approximately $100 million, $250 million for research on adult and animal stem cells, and creates the President's Council on Bioethics led by Dr. Leon Kass of the University of Chicago to "monitor stem cell research, to recommend appropriate guidelines and regulations, and to consider all of the medical and ethical ramifications of biomedical innovation." * November 2, 2004 -
California California is a U.S. state, state in the Western United States, located along the West Coast of the United States, Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the List of states and territori ...
voters approve Proposition 71, which provides $3 billion in state funds over ten years to human embryonic stem cell research. * May 5, 2006 - Senator Rick Santorum introduces bill number S. 2754, or the ''Alternative Pluripotent Stem Cell Therapies Enhancement Act'', into the
U.S. Senate The United States Senate is the upper chamber of the United States Congress, with the House of Representatives being the lower chamber. Together they compose the national bicameral legislature of the United States. The composition and powe ...
. * July 18, 2006 - The U.S. Senate passes the Stem Cell Research Enhancement Act H.R. 810 and votes down Senator Santorum's S. 2754. * July 19, 2006 -
President President most commonly refers to: *President (corporate title) *President (education), a leader of a college or university *President (government title) President may also refer to: Automobiles * Nissan President, a 1966–2010 Japanese ful ...
George W. Bush George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd president of the United States from 2001 to 2009. A member of the Republican Party, Bush family, and son of the 41st president George H. W. Bush, he ...
vetoes House Resolution 810 '' Stem Cell Research Enhancement Act'', a bill that would have reversed the Dickey–Wicker Amendment which made it illegal for federal money to be used for research where stem cells are derived from the destruction of an embryo. * November 7, 2006 - The people of the U.S. state of
Missouri Missouri is a U.S. state, state in the Midwestern United States, Midwestern region of the United States. Ranking List of U.S. states and territories by area, 21st in land area, it is bordered by eight states (tied for the most with Tennessee ...
passed Amendment 2, which allows usage of any stem cell research and therapy allowed under federal law, but prohibits human reproductive cloning. * February 16, 2007 – The California Institute for Regenerative Medicine became the biggest financial backer of human embryonic stem cell research in the United States when they awarded nearly $45 million in research grants. * November 4, 2008 - The people of the U.S. state of
Michigan Michigan () is a state in the Great Lakes region of the upper Midwestern United States. With a population of nearly 10.12 million and an area of nearly , Michigan is the 10th-largest state by population, the 11th-largest by area, and the ...
passed Proposal 08-2, allowing Michigan researchers to make embryonic stem cell cultures from excess embryos donated from fertility treatments. * January 23, 2009 - The United States
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
approves clinical trials for human embryonic stem cell therapy. * March 9, 2009 -
President President most commonly refers to: *President (corporate title) *President (education), a leader of a college or university *President (government title) President may also refer to: Automobiles * Nissan President, a 1966–2010 Japanese ful ...
Barack Obama Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...
signs an executive order reversing federal opposition to embryonic Stem Cell research. * August 2010 - Judge Royce Lamberth of the U.S. District Court for the District of Columbia issued a temporary injunction blocking the federal government from implementing the current NIH guidelines "...ruling that experiments with such cells fall under an "unambiguous" 1996 law by Congress that prohibits federal funding of research that destroys human embryos." This new injunction would not block new funding but it would also interfere with the research allowed under the Bush administration. * April 2011 - See
Dickey–Wicker Amendment 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 Se ...
, "In the 2-1 opinion of April 29, 2011, the appeals panel said that the Dickey–Wicker Amendment was "ambiguous" and that the National Institutes of Health had "reasonably concluded" that although federal funds could not be used to directly destroy an embryo, the amendment does not prohibit funding a research project using embryonic stem cells. This is an important distinction under the law, because for federal funds to be used directly to support the destruction of embryos."


See also

* Christian views on cloning * Ira Black, stem cell advocate *
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 controversy * Stem cell laws and policy in Iran


References


Further reading

* Frank Bellomo, ''The Stem Cell Divide: The Facts, Fiction, and the Fear Driving the Greatest Scientific, Political, and Religious Debate of Our Time'' (American Management Association, New York 2006) . * Pam Solo and Gasil Gressberg, ''The Promise and Politics of Stem Cell Research'' (Praeger, Westport, Connecticut, 2007) .


External links


Is Stem Cell Therapy Legal In The United States?
{{DEFAULTSORT:Stem Cell Laws And Policy In The United States Law of the United States Laws And Policy In The United States United States biotechnology law Political controversies in the United States United States federal policy