Updated July 20, 2006
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy Division
In December 2005, an investigation by Seoul National University, South Korea,
found that scientist Hwang Woo Suk had fabricated results on deriving patient-
matched stem cells from cloned embryos — a major setback for the field. In May
2005 Hwang had announced a significant advance in creating human embryos using
cloning methods and in isolating human stem cells from cloned embryos. Theseth
developments have contributed to the debate in the 109 Congress on the moral and
ethical implications of human cloning. Scientists in other labs, including Harvard
University and the University of California at San Francisco, intend to produce
cloned human embryos in order to derive stem cells for medical research on diabetes,
Parkinson’s disease, and other diseases.
President Bush announced in August 2001 that for the first time federal funds
would be used to support research on human embryonic stem cells, but funding
would be limited to “existing stem cell lines.” Federal funds can not be used for the
cloning of human embryos for any purpose, including stem cell research. In July
2002 the President’s Council on Bioethics released its report on human cloning
which unanimously recommended a ban on reproductive cloning and, by a vote of
10 to 7, a four-year moratorium on cloning for medical research purposes. The
ethical issues surrounding reproductive cloning (commodification, safety, identity ),
and therapeutic cloning (embryos’ moral status, relief of suffering), impact various
proposals for regulation, restrictions, bans, and uses of federal funding. In January
2002, the National Academies released Scientific and Medical Aspects of Human
Reproductive Cloning. It recommended that the U.S. ban human reproductive
cloning aimed at creating a child. It suggested the ban be enforceable and carry
substantial penalties. The panel noted that the ban should be reconsidered within five
years. However, the panel concluded that cloning to produce stem cells should be
permitted because of the potential for developing new therapies and advancing
On May 24, 2005, the House passed H.R. 810 (Castle), which would allow
federal support of research that uses human embryonic stem cells regardless of the
date on which the stem cells were derived from a human embryo, thus negating the
Bush stem cell policy limitation on “existing stem cell lines.” In July of 2006, the
Senate passed H.R. 810 and President Bush vetoed it, the first veto of his presidency.
An attempt in the House to override the veto was unsuccessful. Action on theth
Weldon bill (which passed the House in the 108 Congress and stalled in the Senate)
is also possible; it was reintroduced in the 109th Congress as H.R. 1357 and S. 658
(Brownback). The bill bans the process of cloning as well as the importation of any
product derived from an embryo created via cloning. It bans not only reproductive
applications, but also research on therapeutic uses, which has implications for stem
cell research. Advocates of the legislative ban say that allowing any form of human
cloning research to proceed raises serious ethical issues and will inevitably lead to
the birth of a baby that is a human clone. Critics of the ban argue that the measure
would curtail medical research and prevent Americans from receiving life-saving
treatments created overseas. This report will be updated as needed.
Cloning Attempts in South Korea.............................1
Cloning Attempts in the United Kingdom and United States........3
Advanced Cell Technology..................................4
Others with Human Cloning Intentions.........................5
Federal Policy Involving Human Embryo Research...................6
Ethics Advisory Board......................................6
NIH Human Embryo Research Panel..........................6
Actions During the Current Bush Administration.................8
State Laws on Cloning.........................................10
Ethical and Social Issues.......................................14
Issues Involved in Cloning for Reproductive Purposes............16
Issues Involved in Cloning for Therapeutic Purposes.............18
Types of Restrictions......................................23
The term “cloning” is used by scientists to describe many different processes
that involve making copies of biological material, such as a gene, a cell, a plant or an
animal. The cloning of genes, for example, has led to new treatments developed by
the biotechnology industry for diseases such as diabetes and hemophilia. In the
context of this report, a human embryo produced via cloning involves the process
called somatic cell1 nuclear transfer (SCNT). In SCNT, the nucleus of an egg is
removed and replaced by the nucleus from a mature body cell, such as a skin cell.
In cloning, the embryo is created without sexual reproduction: there is no joining of
egg and sperm.
Concern over the possibility of producing a human clone increased with the
announcement on February 24, 1997, that scientists in Scotland had used SCNT in
1996 to produce the first cloned adult mammal, Dolly, the sheep. Ian Wilmut’s
group at the Roslin Institute in Edinburgh removed the nucleus from a sheep egg and
replaced it with the nucleus of a mammary gland cell from an adult sheep. The
resulting embryo was then transferred to the uterus of a surrogate sheep. A total of
277 such embryos were transferred, but only one lamb was born.2 Analyses of
Dolly’s genetic material confirmed that she was derived from the sheep mammary
cell. Dolly was euthanized on February 14, 2003, after developing a lung infection.
Although some claim that her somewhat early death at six years was related to being
a clone, scientists at the Roslin Institute believe her ailment may be due to the fact
that she was raised indoors (for security reasons) rather than as a pastured sheep,
which can live to 11 or 12 years of age.3
Although scientists have been successful in using SCNT to produce other
animals (such as a cat, goat, cow, horse, mule, pig, mouse, and rabbit), the efficiency
of the procedure is still very low and frequently results in abnormal development.
Proponents maintain that one day cloning may be very useful for a number of
agriculture applications, including the improvement of livestock. Currently, cloned
mice are used for basic research on human health applications.
Cloning Attempts in South Korea. Charges of ethical and scientific
misconduct have clouded the reputation of scientists involved in deriving stem cells
1 A somatic cell is a body cell, as opposed to a germ cell, which is an egg or sperm cell.
2 I. Wilmut et al., “Viable Offspring Derived from Fetal and Adult Mammalian Cells.”
Nature, vol. 385, Feb. 27, 1997, pp. 810-813.
3 G. Kolata, “First Mammal Clone Dies; Dolly Made Science History,” New York Times,
Feb. 15, 2003, p. A4.
from cloned human embryos. In February 2004 scientists at the Seoul National
University (SNU) in South Korea announced the first isolation of stem cells from a
cloned human embryo. In May 2005 this same group announced they had achieved
major advances in the efficiency of creating human cloned embryos using SCNT and
in isolating human stem cells from the cloned embryos. These eleven new stem cell
lines were derived using cells from patients with either spinal cord injury, diabetes,
or an immune deficiency and offered the hope of one day providing treatments with
patient-matched cells.4 The team attributed the improved success rate in part to the
use of freshly harvested eggs from younger fertile women instead of leftover eggs
from older women who received fertility treatments.5
However, serious concerns about the achievements of the SNU group began in
November 2005 when a co-author of the 2005 paper, Gerald Schatten of the
University of Pittsburgh, accused Woo Suk Hwang, the lead researcher of the SNU
group, of ethical misconduct.6 In violation of some ethical standards and contrary to
statements made in the 2005 paper, junior scientists in the SNU lab secretly donated
their own eggs for the experiments and they along with other women received
payment for their role. The accusation halted plans for a collaboration between the
SNU scientists and US and UK labs that had been announced only one month earlier
and resulted in Hwang resigning from all public positions on November 24, 2005.
On December 12, 2005, Schatten asked that his name be removed from the 2005
paper when he learned that the work may have been fabricated.7 In early December,
scientists in South Korea began questioning the validity of photographs and other
scientific evidence presented in the 2005 paper and called for an independent analysis
of the data. The University of Pittsburgh and SNU began separate investigations into
the charges. On December 15, 2005, another co-author of the 2005 paper, Sung Il
Roh, stated to the Korean media that the research had been fabricated and that the
2005 paper should be retracted. Hwang agreed to the retraction on December 16, but
continued to defend the scientific results.8
A preliminary report released on December 23, 2005, by SNU stated that nine
of the eleven stem cell lines described in the 2005 paper were deliberately fabricated
4 Gretchen Vogel, “Korean Team Speeds Up Creation of Cloned Human Stem Cells,”
Science, vol. 308, May 20, 2005, pp. 1096-1097.
5 In both cases, women receive a series of hormone injections that stimulate the ovaries to
produce multiple eggs which are removed via a surgical procedure. There is a small chance
(up to 5%) that a woman will over respond to the hormone injections resulting in
complications; in rare situations the outcome is fatal. The long-term consequences of the
hormone injections are unknown.
6 Gretchen Vogel, “Collaborators Split over Ethics Allegations” Science, Nov. 18, 2005, p.
7 The Associated Press, “South Korean’s Cloning Research Challenged,” The New York
Times, Dec. 13, 2005.
8 Gordan Fairclough, “South Korean Scientist Denies Falsifying Stem-Cell Research,” The
Wall Street Journal, Dec. 17, 2005, p. A4.
and the remaining two stem cell lines were still under investigation.9 On December
29, 2005, Seoul National University stated that the remaining stem cell lines were not
patient-matched and were not derived through cloning.10 On January 10, 2006, SNU
stated that results of the 2004 paper, which reported the first derivation of stem cells
from a cloned human embryo, were also a deliberate fabrication.11
Cloning Attempts in the United Kingdom and United States.
Scientists in the United Kingdom, at the University of Newcastle and the University
of Edinburgh, and scientists in the United States, at Harvard University, Advanced
Cell Technology and the University of California in San Francisco, are working on12
deriving patient-matched stem cells from cloned human embryos.
In the United Kingdom, scientists performing human cloning and embryonic
stem cell research are regulated by the Human Fertilization and Embryology
Authority (HFEA). A team of scientists headed by Alison Murdoch at the University
of Newcastle received permission from HFEA to start therapeutic cloning13
experiments in August 2004. In May 2005, the team announced that it had created
a cloned human embryo but has not yet reported success in isolating stem cells from
a cloned human embryo. A research team headed by Ian Wilmut at the University
of Edinburgh also is seeking permission from HFEA to begin working on SCNT
experiments using human embryos.
Scientists at the Harvard Stem Cell Institute intend to produce cloned human
embryos for research studies on juvenile diabetes, Parkinson’s disease, and several14
other diseases. In November 2003, the research group, headed by Douglas Melton
and Kevin Eggan, submitted their proposal to a Harvard committee composed of
ethicists, scientists and public policy experts. Preliminary permission to proceed
with the research was granted in January 2005, provided that a number of specific
restrictions were followed and approval was received from a second committee
charged with safeguarding the use of human subjects in research.15 The restrictions
include limitations on the developmental age of the cloned embryos used in
experiments, a prohibition on reproductive cloning, and a limitation on paying only
9 Rick Weiss, “Korean Stem Cell Lines Faked,” The Washington Post, December 23, 2005,
10 Choe San-Hun, “Panel further discredits Stem Cell Work of South Korean Scientist,” The
New York Times, Dec. 29, 2005, p. 9.
11 Nicholas Wade and Choe Sang-Hun, “Researcher Faked Evidence of Human Cloning,
Koreans Report,” The New York Times, Jan. 10, 2006, p. A1.
12 Dennis Normile, Gretchen Vogel, and Constance Holden, “Cloning Researcher Says Work
is Flawed but Claims Results Stand,” Science, Dec. 23, 2005, p. 1886-1887; Carl T. Hall,
“UCSF Resumes Human Embryo Stem Cell Work,” The San Francisco Chronicle, May 6,
13 Emily Singer, “Stem Cells Reborn,” Technology Review, May/June, 2006, p. 58-65.
14 Gareth Cook, “Harvard Team Wants OK to Clone; Human-Cell Work Would Be First in
Nation,” Boston Globe, Oct. 13, 2004, p. A1.
15 Gareth Cook, “Harvard Provost OKs Procedure,” Boston Globe, Mar. 20, 2005, p, A29.
for the medical expenses of women who donate eggs. In June 2006, after more than
2½ years, the Harvard group announced that they had received final approval in the
review process that looked at ethical, legal and intellectual property issues and
involved eight different boards and committees at five separate institutions.16
In May 2006, scientists at the University of California in San Francisco (UCSF)
and Advanced Cell Technology (ACT) in Worcester, MA, independently announced
that they would resume their efforts to produce cloned human embryos for research
purposes.17 Both UCSF and ACT (see below) had been working separately on such
experiments prior to the February 2004 South Koreans’ announcement of cloning
success, but subsequently suspended their work; in the case of ACT due to lack of
funding and in the case of UCSF due to lack of success.
Clonaid. On December 27, 2002, a representative of Clonaid announced the
birth of the first cloned human, a seven-pound baby girl nicknamed Eve. The baby
was born on December 26, 2002, at an undisclosed location outside the United
States. Although the company offered no proof of its claim, Dr. Brigette Boisselier,
Managing Director of Clonaid, stated that genetic tests would show that the baby is
the clone of the 31-year-old American woman who is the birth mother. To date the
test results have not been released; the company claims that the parents fear the test18
results could lead to legal actions and loss of custody of the child. The Clonaid
website indicates that “13 cloned babies are now alive,” and that “each month,19
between 10 and 15 implantations will be performed” in the Clonaid laboratory.
Clonaid was founded in 1997 by the leader of the Raelians, an international sect of
55,000 people in 84 countries, which claims that life on Earth was created via genetic
engineering by a human extraterrestrial race.20
The Food and Drug Administration (FDA) is investigating the company’s
actions; the agency would consider any human cloning activity to be illegal if
performed in the United States.21 In April 2001 FDA investigated a Clonaid22
laboratory in Nitro, WV; the laboratory closed shortly thereafter.
Advanced Cell Technology. On November 25, 2001, Advanced Cell
Technology (ACT) of Massachusetts announced that it had created the world’s first
16 Sylvia Pagan Westphal, “Harvard Joins New U.S. Push in Stem Cells,” The Wall Street
Journal, Jun. 7, 2006, p. B1.
18 K. Chang, “Scientist in Clone Tests Says Hoax Is Possible,” New York Times, Jan. 7,
20 For further information, see [http://www.clonaid.com] and [http://www.rael.org].
21 L. Greenhouse, “FDA Exploring Human Cloning Claim,” New York Times, Dec. 30,
22 G. Kolata and K. Chang, “For Clonaid, a Trail of Unproven Claims,” New York Times,
Jan. 1, 2003, p. A13.
human embryos produced via cloning.23 ACT used two techniques, SCNT and
parthenogenesis, to produce human embryos. ACT researchers obtained eggs from
seven women, ages 24 to 32, who were paid $3,000 to $5,000. In the SCNT
approach, scientists removed the nucleus from 19 eggs and replaced it with a nucleus
from another adult cell. The nucleus of a skin cell was used for 11 eggs, and for the
remaining eight eggs, cumulus cells were used. Eggs that received a skin cell nucleus
did not divide; seven of the eggs with the cumulus cell nucleus began to divide but
division stopped at the four-to-six-cell stage. In parthenogenesis, an egg cell is
treated with chemicals causing it to divide without being fertilized by a sperm. ACT
exposed 22 human eggs to the chemicals. After five days, six eggs had matured into
a larger mass of cells before division stopped. None of the embryos developed by
ACT divided sufficiently to produce stem cells. ACT suspended its work in 2004.
The goal of ACT’s work was to produce human embryonic stem cells and
develop new therapies for diseases such as diabetes and Parkinson’s disease.24
Scientists believe that stem cells transplanted into a patient could treat disease or
injury by replacing damaged tissue. If the cell nucleus used in SCNT is from the
patient, the stem cells would be genetically identical to the patient, recognized by the
patient’s immune system, and would avoid any tissue rejection problems that could
occur in other stem cell therapeutic approaches. Because of this, many scientists
believe the SCNT technique may provide the best hope of eventually treating patients
using stem cells for tissue transplantation.
Others with Human Cloning Intentions. Within a year of the Dolly
announcement, concerns over human cloning were heightened when Dr. Richard
Seed, a Chicago scientist, announced on January 7, 1998, his intention to clone ath
human being. In response, bills were introduced in the 105 Congress that would
have banned human cloning indefinitely or imposed a moratorium. The legislation
was opposed by a number of medical organizations, the biotechnology industry and
many scientists and was not enacted.
Others who have expressed an interest in reproductive cloning include Dr. Panos
Zavos, of the University of Kentucky, and Dr. Severino Antinori, director of a
fertility clinic in Rome. At one time, Dr. Zavos and Dr. Antinori were working
together to help infertile couples have children via cloning. In April 2002, there were
unconfirmed reports in the media that Dr. Antinori had implanted cloned human
embryos in women. Dr. Antinori claimed there were three such pregnancies of six-
to nine-weeks’ duration, two in Russia and one in an Islamic state. His claim was
disputed by his former partner Dr. Zavos. In January 2004 Dr. Zavos announced that
he had implanted a cloned embryo into a woman’s uterus; two weeks later he stated25
that the pregnancy had failed.
23 J. B. Cibelli, et al., “Somatic Cell Nuclear Transfer in Humans: Pronuclear and Early
Embryonic Development,” Journal of Regenerative Medicine, vol. 2, Nov. 26, 2001, pp. 25-31.
24 For more information about stem cells, see CRS Report RL31015, Stem Cell Research,
by Judith A. Johnson and Erin Williams.
25 David Derbyshire and Oliver Poole, “I Am Doing God’s Work, Insists Maverick Fertility
Expert Who Wants to Clone Babies,” Daily Telegraph, Feb. 14, 2004, p. 4.
Federal Policy Involving Human Embryo Research
At the present time, no U.S. laws or regulations would prohibit all cloning
research. However, federal funding of any type of research involving human
embryos, starting with in vitro fertilization (IVF) then later cloning and the creation
of stem cell lines from embryos, had been blocked by various policy decisions dating
back 25 years.
Ethics Advisory Board. Following the birth of the first IVF baby, Louise
Brown, in July 1978, the federal Ethics Advisory Board (EAB) was tasked with
considering the scientific, ethical, legal, and social issues surrounding human IVF.26
The EAB released its report on May 4, 1979, which found that IVF research was
acceptable from an ethical standpoint and could be supported with federal funds. The
EAB’s recommendations were never adopted by HHS, the EAB was dissolved in
1980, and no other EAB was ever chartered. Because federal regulations that govern
human subject research (45 C.F.R. Part 46) stipulated that, at the time, federally
supported research involving human IVF must be reviewed by an EAB, a so-called
“de facto moratorium” on human IVF research resulted. Other types of embryo
research ensuing from the development and use of IVF, such as cloning and stem
cells, were therefore also blocked. The de facto moratorium was lifted with the
enactment of the National Institutes of Health (NIH) Revitalization Act of 1993 (P.L.
§ 46.204(d)) requiring EAB review of IVF proposals.
NIH Human Embryo Research Panel. In response, the NIH established
the Human Embryo Research Panel to assess the moral and ethical issues raised by
this research and to develop recommendations for NIH review and conduct of human
embryo research. The NIH Panel released a report providing guidelines and
recommendations on human embryo research in September 1994. The panel
identified areas of human embryo research it considered to be unacceptable, or to
warrant additional review. It determined that certain types of cloning27 without
transfer to the uterus warranted additional review before the Panel could recommend
whether the research should be federally funded. However, the Panel concluded that
federal funding for such cloning techniques followed by transfer to the uterus should
be unacceptable into the foreseeable future. The NIH Panel recommended that some
areas of human embryo research should be considered for federal funding, including
SCNT, stem cells and, under certain limited conditions, embryos created solely for
26 The EAB was created in 1978 by the Department of Health Education and Welfare
(HEW), the forerunner of the Department of Health and Human Services (HHS). The EAB
was formed at the recommendation of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. The National Commission operated from
1974 to 1978 and issued 10 reports, many of which formed the basis of federal regulations
for research involving human subjects (45 C.F.R. Part 46).
27 These were blastomere separation, where a two- to eight-cell embryo is treated causing
the cells (blastomeres) to separate; and, blastocyst division, in which an embryo at the more
advanced blastocyst stage is split into two.
the purpose of research.28 The Panel’s report was unanimously accepted by the NIH
Advisory Committee to the Director (ACD) on December 2, 1994.
After the ACD meeting on December 2, 1994, President Clinton directed NIH
not to allocate resources to support the “creation of human embryos for research
purposes.” The President’s directive did not apply to research involving so-called
“spare” embryos, those that sometimes remain from clinical IVF procedures
performed to assist infertile couples to become parents. Nor did it apply to human
parthenotes, eggs that begin development through artificial activation, not through
fertilization. Following the Clinton December 2, 1994 directive to NIH, the agency
proceeded with plans to develop guidelines to support research using spare embryos.
Dickey Amendment. NIH plans to develop guidelines on embryo research
were halted on January 26, 1996, with the enactment of P.L. 104-99, which contained
a rider that affected FY1996 funding for NIH. The rider prohibited HHS from using
appropriated funds for the creation of human embryos for research purposes or for
research in which human embryos are destroyed. This same rider, often referred to
as the Dickey Amendment, has been attached to the Labor, HHS and Education29
Appropriations Acts for FY1997 through FY2006. For FY2006, the provision is
found in Section 509 of the Labor, HHS and Education and Related Agencies
Appropriations Act, 2006 (P.L. 109-149). It states that:
(a) None of the funds made available in this Act may be used for —
(1) the creation of a human embryo or embryos for research purposes;
(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 under 45 CFR 46.204(b) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)).
(b) For purposes of this section, the term “human embryo or embryos” includes
any organism, not protected as a human subject under 45 CFR 46 [the Human
Subject Protection regulations] as of the date of enactment of this Act, that is
derived by fertilization, parthenogenesis, cloning, or any other means from one
or more human gametes [sperm or egg] or human diploid cells [cells that have
two sets of chromosomes, such as somatic cells].
28 National Institutes of Health, Report of the Human Embryo Research Panel, Sept. 27,
29 The rider language has not changed significantly from year to year (however, there was
a technical correction in P.L. 109-149). The original rider, introduced by Rep. Jay Dickey,
is in Section 128 of P.L. 104-99; it affected NIH funding for FY1996 contained in P.L. 104-
91. For subsequent fiscal years, the rider is found in Title V, General Provisions, of the
Labor, HHS and Education Appropriations Acts in the following public laws: FY1997, P.L.
P.L. 106-554; FY2002, P.L. 107-116; FY2003, P.L. 108-7; FY2004, P.L. 108-199; and,
FY2005, P.L. 108-447.
One month after the Dolly announcement, on March 4, 1997, President Clinton
sent a memorandum to the heads of all executive departments and agencies making
it “absolutely clear that no federal funds will be used for human cloning.” This
action extended the congressional ban beyond HHS to all federally supported
research. Clinton also urged the private sector to adopt a voluntary ban on the
cloning of human beings. The NIH Guidelines on Stem Cell Research, published by
the Clinton Administration in August 2000, would not have funded research in
which: human stem cells are used for reproductive cloning of a human; human stem
cells are derived using SCNT; or, human stem cells that were derived using SCNT
are utilized in a research project.
Actions During the Current Bush Administration. On August 9, 2001,
President Bush announced that for the first time federal funds would be used to
support research on human embryonic stem cells, but funding would be limited to
“existing stem cell lines.” In the speech, President Bush stated that he strongly
opposes human cloning. Although not mentioned specifically in the August 9
speech, a fact sheet on the White House website states that federal funds will not be
used for “the cloning of human embryos for any purpose.”30 In his speech, President
Bush announced his intention to name a President’s council, chaired by Dr. Leon
Kass of the University of Chicago, “to consider all of the medical and ethical
ramifications of biomedical innovation.” The President’s Council on Bioethics, was
established for a period of up to two years by Executive Order 13237 on November
28, 2001. The White House announced the other 17 members of the council on
January 16, 2002.
The first topic addressed by the Council was human cloning.31 Although all
Council members voted in opposition to reproductive cloning, they could not come
to an agreement on articulating the precise nature of their objection, whether solely
safety concerns or which of the various moral objections were most important. In an
informal vote on the issue of therapeutic cloning, about half of the 18 members of the
Council voiced their support for the therapeutic use of human cloning. Dr. Kass
proposed that the Council’s final report reflect both the arguments supporting cloning
for the purpose of medical treatment and those against.
At the June 20, 2002, meeting, nine Council members voted to support cloning
for medical research purposes, without a moratorium, provided a regulatory32
mechanism was established. Because one member of the Council had not attended
the meetings and was not voting, the vote seemed to be nine to eight in favor of
research cloning. However, the draft report sent to Council members on June 28,
2002, indicated that two of the group of nine members had changed their votes in
favor of a moratorium. Both made it clear that they have no ethical problem with
cloning for biomedical research, but felt that a moratorium would provide time for
30 The White House Fact Sheet on embryonic stem cell research is available at
[ ht t p: / / www.whi t e house.gov/ news/ r el eases/ 2001/ 08/ 20010809-1.ht ml ] .
31 Transcripts of the Council meetings and papers developed by staff for discussion during
the meetings can be found at [http://www.bioethics.gov].
32 S.S. Hall, “President’s Bioethics Council Delivers,” Science, vol. 297, July 19, 2002, pp.
additional discussion.33 The changed vote took many Council members by surprise,
and some on the Council believe that the moratorium option, as opposed to a ban,
was thrown in at the last minute and did not receive adequate discussion. In addition,
some on the Council believe that the widely reported final vote of 10 to 7 in favor of
a moratorium does not accurately reflect the fact “that the majority of the council has
no problem with the ethics of biomedical cloning.”34 The final report, Human
Cloning and Human Dignity: An Ethical Inquiry, was released on July 11, 2002.
In March 2001, the FDA sent letters to the research community stating that the
creation of a human being using cloning is subject to FDA regulation under the
Public Health Service Act and the Food, Drug and Cosmetic Act.35 FDA stated that
such research could only occur when an investigational new drug application (IND)
is in effect. Some legal scholars believe that there is no legal basis for the regulation
of cloning by FDA.36 They find little evidence to support FDA’s position that cloned
human embryos are “drugs.” However, the biotechnology industry and the American
Society for Reproductive Medicine believe FDA has the authority to regulate cloning
and legislation is unnecessary because FDA regulation is preferred to any new action
On January 18, 2002, the National Academies released its report, entitled
Scientific and Medical Aspects of Human Reproductive Cloning.38 The panel
recommended that the U.S. ban human reproductive cloning. The panel was
concerned for the safety of both the woman and the fetus and judged the procedure
to be too dangerous for use in humans at the present time. The ban should be legally
enforceable, rather than voluntary, and carry substantial penalties. The ban should
be reconsidered in five years, but only if compelling new data on safety and efficacy
are presented and a national dialogue on the social and ethical issues suggests that a
review is warranted. However, the panel concluded that research using SCNT to
produce stem cells should be permitted because of the considerable potential for
developing new therapies and advancing biomedical knowledge. This position is in
agreement with a previous National Academies’ report entitled Stem Cells and the
Future of Regenerative Medicine, which was released on September 11, 2001.39
33 Ibid., p. 324.
34 Ibid., p. 322.
35 The FDA position statement and letters to the research community are available at
[ h t t p : / / www.f d a . go v/ c b e r / ge n e t he r a py/ c l one .ht m] .
36 R. Weiss, “Legal Barriers to Human Cloning May Not Hold Up,” Washington Post, May
38 The National Academies are the National Academy of Sciences, the National Academy
of Engineering, the Institute of Medicine, and the National Research Council. The report
on human cloning is available at [http://www.nap.edu/catalog/10285.html?onpi_topnews_
39 The National Academies’ report on stem cell research is available at [http://www.nap.edu/
catalog/10195.html ? onpi_topnews_091101].
Because of the current lack of federal regulation, the National Academies
established in July 2004 the Committee on Guidelines for Human Embryonic Stem
Cell Research to develop voluntary guidelines for deriving, handling and using
human embryonic stem cells. The stated position of the National Academies is that
there should be a global ban on human reproductive cloning and therefore the
guidelines will focus only on therapeutic and research uses of human embryonic stem
cells and somatic cell nuclear transfer.
The Committee released its “Guidelines for Human Embryonic Stem Cell
Research” on April 26, 2005. The guidelines recommend that institutions conducting
human embryonic stem cell research should establish oversight committees,
including experts in the relevant areas of science, ethics and law, as well as members
of the public, to review all proposed experiments. The guidelines recommend that a
national panel should be established to oversee the issue in general on a continuing
basis. However, the guidelines state that certain types of research should not be
permitted at the present time: (1) culture of any intact embryo, regardless of
derivation method, for more than 14 days; (2) the insertion of any embryonic stem
cells into a human embryo or the insertion of human embryonic stem cells into a
nonhuman primate embryo. In addition, animals in which human embryonic stem
cells have been introduced, at any stage of development, should not be allowed to
breed. The document also provides guidance on informed consent of donors and
states that there should be no financial incentives in the solicitation or donation of
embryos, sperm, eggs, or somatic cells for research purposes.
The U.S. Supreme Court has recognized in past cases certain personal rights as
being fundamental and protected from government interference.40 Some legal
scholars believe a ban on human cloning may be struck down by the Supreme Court
because it would infringe upon the right to make reproductive decisions which is
“protected under the constitutional right to privacy and the constitutional right to
liberty.”41 Other scholars do not believe that noncoital, asexual reproduction, such
as cloning, would be considered a fundamental right by the Supreme Court. A ban
on human cloning research may raise other constitutional issues: scientists’ right to
personal liberty and free speech. In the opinion of some legal scholars, any
government limits on the use of cloning in scientific inquiry or human reproduction
would have to be “narrowly tailored to further a compelling state interest.”42
State Laws on Cloning
As of April 18, 2006, 15 states have passed laws pertaining to human cloning.
Arkansas, California, Connecticut, Indiana, Iowa, Maryland, Massachusetts,
Michigan, New Jersey, North Dakota, Rhode Island, South Dakota, and Virginia have
40 For further discussion of these issues and their relationship to human cloning, see CRS
Report RL31422, Substantive Due Process and a Right to Clone, by Jon O. Shimabukuro.
41 L. B. Andrews, “Is There a Right to Clone? Constitutional Challenges to Bans on Human
Cloning,” Harvard Journal of Law and Technology, summer 1998, pp. 643-680.
42 Ibid., p. 667.
all enacted measures to prohibit reproductive cloning.43 Arizona and Missouri have
passed laws that address the use of public funds for cloning. In addition, Louisiana
has enacted legislation prohibiting reproductive cloning but the law expired in July
2003. Six of the states also prohibit cloning for research or therapeutic purposes
(Arkansas, Indiana, Iowa, Michigan, North Dakota, South Dakota). The Virginia law
may also prohibit therapeutic cloning, “but it may be unclear because the law does
not define the term ‘human being’ which is used in the definition of human
cloning.”44 The California and New Jersey laws specifically permit cloning for
research purposes. The Rhode Island law is silent on therapeutic cloning and cloning
for research purposes, and has a sunset date of July 7, 2010.
The 109th Congress addressed the issue of cloning and embryo research in the
Labor, HHS and Education Appropriations Act of 2006 (P.L. 109-149) by again
including the Dickey Amendment, which has banned, since FY1996, almost all
publically funded human embryo research. In addition, the Science, Justice and
Commerce Appropriations Act, 2006 (P.L. 109-108) bars the Patent and Trademark
Office from spending money “to issue patents on claims directed to or encompassing
a human organism.” This restriction, which was first included in the Consolidated
Appropriations Act, 2004 (P.L. 108-199), and in the Consolidated Appropriations
Act, 2005 (P.L. 108-447), could potentially deter human embryo research and stem
cell research because researchers might not be able to claim ownership of their work.
H.R. 810 (Castle), the Stem Cell Research Enhancement Act, passed the House
on May 24, 2005, on a vote of 238-194. It would amend the Public Health Service
Act and direct the Secretary of HHS to conduct and support research that utilizes
human embryonic stem cells regardless of the date on which the stem cells were
derived from a human embryo. Stem cell lines derived after enactment must meet
ethical guidelines established by the NIH. Only embryos that were originally created
for fertility treatment purposes and in excess of clinical need are eligible for stem
cell derivation. Only embryos that the individuals seeking fertility treatments have
determined will not be implanted in a woman and will be discarded are eligible for
stem cell derivation. Written consent is required for embryo donation. The Secretary
in consultation with the Director of NIH shall promulgate guidelines 60 days after
enactment. No federal funds shall be used to conduct research on unapproved stem
cell lines. The Secretary shall annually report to Congress about stem cell research.
A companion bill, S. 471 (Specter), was introduced on February 28, 2005.
On June 29, 2006, Senate Majority Leader Bill Frist announced an agreement
on scheduling a vote in the Senate on stem cell research legislation, more than a year
after the House passed H.R. 810. Under the agreement, amendments were not
allowed on a package of three bills; each needed 60 votes to pass: H.R. 810, S. 2754
(Santorum) the Alternative Pluripotent Stem Cell Therapies Enhancement Act, and
S. 3504 (Santorum) the Fetus Farming Prohibition Act. S. 3504 does not address the
43 National Conference of State Legislatures, State Human Cloning Laws, July 17, 2006, at
[http://www.ncsl.org/ programs/health/genetics/rt-shcl.htm] .
issue of stem cell research but rather the use of tissue from a later stage embryo or
The second bill in the agreement, S. 2754, was introduced on May 5, 2006. It
would amend the Public Health Service Act adding a new Section 409J “Alternative
Human Pluripotent Stem Cell Research.” The bill would require the Secretary of
HHS to develop techniques for the isolation, derivation, production, or testing of
stem cells that are capable of producing all or almost all of the cell types of the
developing body and may result in improved understanding of treatments for diseases
and other adverse health conditions, but are not derived from a human embryo.
Within 90 days of enactment, the Secretary would be required to: (1) provide
guidance concerning the next steps required for additional research; (2) prioritize
research with the greatest potential for near-term clinical benefit; and (3) take into
account techniques outlined by the President’s Council on Bioethics and any other
appropriate techniques and research. The Secretary would be required to prepare and
submit to the appropriate committees of Congress an annual report describing the
activities and research conducted. The bill authorizes such sums as may be necessary
for FY2007 through FY2009. A companion bill, H.R. 5526 (Bartlett), was
introduced on June 6, 2006.
The third bill, S. 3504, was introduced on June 13, 2006. It would amend the
Public Health Service Act to prohibit the solicitation or acceptance of human fetal
tissue obtained from a human pregnancy that was deliberately initiated to provide
such tissue, or tissue obtained from a human embryo (or fetus) that was implanted
in the uterus of a nonhuman animal. The bill was referred to the Senate Health,
Education, Labor and Pensions Committee. A companion bill, H.R. 5719 (Weldon),
was introduced on June 29, 2006, and referred to the House Energy and Commerce
On July 18, 2006, the Senate passed H.R. 810 (63 to 37), S. 2754 (100-0) and
S. 3504 (100-0). On the same day, the House passed S. 3504 (100-0) but failed to
pass S. 2754 with the required 2/3 vote (273-154). On July 19, 2006, President Bush
signed S. 3504 and vetoed H.R. 810, the first veto of his six years in office. An
attempt in the House on July 19 to override the veto of H.R. 810 did not receive the
required 2/3 vote (235-193).
H.R. 1357 (Dave Weldon), the Human Cloning Prohibition Act of 2005, was
introduced on March 17, 2005. H.R. 1357 amends Title 18 of the United States Code
and would ban the process of human cloning as well as the importation of any
product derived from an embryo created via cloning. Under this measure, cloning
could not be used for reproductive purposes or for research on therapeutic purposes,
which would have implications for stem cell research. H.R. 1357 includes a criminal
penalty of imprisonment of not more than 10 years and a civil penalty of not less than
$1 million. H.R. 1357 is essentially identical to the measure which passed the House
in the 107th Congress (H.R. 2505) and the 108th Congress (H.R. 534). H.R. 1357 was
referred to the House Committee on the Judiciary.
A companion bill, S. 658 (Brownback), was introduced on March 17, 2005. It
is similar to H.R. 1357, except that (1) it does not contain the ban on importation of
products derived from therapeutic cloning; and (2) it amends Title 4 of the Public
Health Service Act (42 U.S.C. §§ 289 et seq.) instead of Title 18 of the United States
Code.45 S. 658 includes a criminal penalty of imprisonment of not more than 10
years and a civil penalty of not less than $1 million. It requires GAO to conduct a
study to assess the need (if any) for any changes of the prohibition on cloning in light
of new developments in medical technology, the need for SCNT to produce medical
advances, current public attitudes and prevailing ethical views on the use of SCNT
and potential legal implications of research in SCNT. The study is to be completed
within four years of enactment. S. 658 has been referred to the Senate Health,
Education, Labor, and Pensions Committee.
S. 876 (Hatch), the Human Cloning Ban and Stem Cell Research Protection Act
of 2005, was introduced on April 21, 2005. A similar bill, H.R. 1822 (Bono), the
Human Cloning Ban and Stem Cell Research Protection Act of 2005, was introduced
on April 26, 2005. S. 876 amends Title 18 of the United States Code and H.R. 1822
amends the Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.).46 Both bills
would ban human reproductive cloning but allow cloning for medical research
purposes, including stem cell research. S. 876 and H.R. 1822 include a criminal
penalty of imprisonment of not more than 10 years; S. 876 has a civil penalty of not
less than $1 million, H.R. 1822 has a civil penalty not to exceed $10 million.
S. 876 requires the Comptroller General to prepare a series of four reports
within one year of enactment. The first report describes the actions taken by the
Attorney General to enforce the prohibition on human reproductive cloning, the
personnel and resources used to enforce the prohibition, and a list of any violations
of the prohibition. A second report describes similar state laws that prohibit human
cloning and actions taken by the states’ attorney general to enforce the provisions of
any similar state law along with a list of violations. A third report describes the
coordination of enforcement actions among the federal, state and local governments.
A fourth report describes laws adopted by foreign countries related to human cloning.
H.R. 1822 requires a similar set of three reports to be prepared by the Secretary of
Health and Human Services.
S. 876 and H.R. 1822 would amend the Public Health Service Act by requiring
that human SCNT be conducted in accordance with the ethical requirements (such
as informed consent, examination by an Institutional Review Board, and protections
for safety and privacy) contained in subpart A of 45 C.F.R. Part 46,47 or Parts 50 and
56 of 21 C.F.R.48 S. 876 and H.R. 1822 have a prohibition on conducting SCNT on
fertilized human eggs (oocytes), and both state that “unfertilized blastocysts” shall
not be maintained after more than 14 days from its first cell division, aside from
45 By seeking to amend Title 18 of the U.S. Code rather than the Public Health Service Act,
S. 658 would likely be subject to different committee jurisdiction.
46 Because they amend different titles of the U.S. Code, the bills would likely be subject to
different committee jurisdiction.
47 This provision specifies protections due to human beings who participate in research
conducted or supported by HHS and many other departments.
48 This provision specifies protections due to human beings who participate in research
involved in testing a drug or medical device for FDA approval.
storage at temperatures less that zero degrees centigrade. S. 876 and H.R. 1822
stipulate that a human egg may not be used in SCNT research unless the egg is
donated voluntarily with the informed consent of the woman donating the egg. Both
bills also specify that human eggs or unfertilized blastocysts may not be acquired,
received or otherwise transferred for valuable consideration if the transfer affects
interstate commerce. In addition, SCNT may not be conducted in a laboratory in
which human eggs are subject to assisted reproductive technology treatments or
procedures, such as in vitro fertilization for the treatment of infertility. Violation of
these provisions in S. 876 and H.R. 1822 regarding ethical requirements would result
in a civil penalty of not more than $250,000. S. 876 has been referred to the Senate
Judiciary Committee. H.R. 1822 has been referred to the House Energy and
Supporters of a ban on human cloning, such as that contained in H.R. 1357,
argue that a partial ban on human cloning, like the one contained in S. 876, would be
impossible to enforce. Critics of the ban on human cloning argue that SCNT creates
a “clump of cells” rather than an embryo, and that the ban would curtail medical
research and prevent Americans from receiving life-saving treatments created
Ethical and Social Issues
The possibility of using cloning technology not just for therapeutic purposes but
also for reproducing human beings raises profound moral and ethical questions. As
previously mentioned, the Bush Administration and the National Academies have
made their positions clear. In July 2002, the President’s Council on Bioethics issued
its report, Human Cloning and Human Dignity, which contained two opinions and
sets of recommendations: one of the 10-7 majority, and one of the minority.49 The
majority and minority both opposed reproductive cloning. It was on the topic of
therapeutic cloning, which the majority opposed and the minority favored, that the
Council was split.
49 At the June 20, 2002, meeting, 9 of 17 Council members voted to support cloning for
medical research purposes, without a moratorium, provided a regulatory mechanism was
established. Because one member of the Council had not attended the meetings and was not
voting, the vote seemed to be nine to eight in favor of research cloning. However, draft
versions of the Council report sent to Council members on June 28, 2002, indicated that two
of the group of nine members had changed their votes in favor of a moratorium. Both made
it clear that they have no ethical problem with cloning for biomedical research, but felt that
a moratorium would provide time for additional discussion. The changed vote took many
Council members by surprise, and some on the Council believe that the moratorium option,
as opposed to a ban, was thrown in at the last minute and did not receive adequate
discussion. In addition, some on the Council believe that the widely reported final vote of
10 to 7 in favor of a moratorium does not accurately reflect the fact “that the majority of the
council has no problem with the ethics of biomedical cloning.” (Transcripts of the Council
meetings and papers developed by staff for discussion during Council meetings can be found
at [http://www.bioethics.gov]; S.S. Hall, “President’s Bioethics Council Delivers,” Science,
vol. 297, July 19, 2002, pp. 322-324.) “Wise Words from Across the Pond?” BioNews, no.
A predecessor to the President’s Council, the National Bioethics Advisory
Commission (NBAC), recommended, in Cloning Human Beings,50 the continuation
of a moratorium on federal funding for reproductive purposes with a call for
voluntary compliance from the private sector. It further recommended the enactment
of legislation with a three- to five-year sunset clause banning cloning for reproductive
purposes. However, it made clear that all measures taken should “be carefully
written so as not to interfere with other important areas of scientific research.”51
Various other organizations, individuals, and councils have issued opinions and
reports on cloning as well. Some, such as The United States Conference of Catholic
Bishops (USCCB)52 oppose human cloning for any purpose: “The cloning procedure
is so dehumanizing that some scientists want to treat the resulting human beings as
subhuman, creating them solely so they can destroy them for their cells and tissues.”53
Others, such as a group of forty Nobel Laureates,54 former First Lady Nancy
Reagan,55 and former President Gerald Ford,56 would allow regulated cloning for
therapeutic purposes, but disallow it for reproductive ones. Still others, such as such
as Dr. Severino Antinori, and Clonaid,57 favor cloning for reproductive purposes, and
even claim to have created human clones via SCNT.58
The human cloning debate centers around number of different ethical and
pragmatic issues. Exploration of these issues reveals variation in ethical and moral
50 National Bioethics Advisory Commission, Cloning Human Beings, June 1997.
51 Ibid., p. iv.
52 The United States Conference of Catholic Bishops is “is an assembly of the hierarchy of
the United States and the U.S. Virgin Islands who jointly exercise certain pastoral functions
on behalf of the Christian faithful of the United States,” at [http://www.nccbuscc.org/
53 Bishop Gregory, President of the United States Conference of Catholic Bishops, quoted
in “Bishops’ President Says Cloning Turns Human Reproduction into a Manufacturing
Process, United States Conference of Catholic Bishops Communications, Nov. 27, 2001, at
[http://www.usccb.org/ comm/ ar chives/2001/01-205.shtml ].
54 The American Society for Cell Biology statement by the 40 Nobel Laureates is available
55 Complete text of a letter from Mrs. Reagan to Senator Orrin Hatch specifying her position
on cloning can be found at [http://hatch.senate.gov/index.cfm?FuseAction=PressReleases.
56 L. Hafner, “Revised Feinstein/Kennedy Cloning Bill Has Criminal and Civil Penalties,
Requires Research Review,” Washington Fax, May 2, 2002.
57 “CLONAID™ ,the first human cloning company in the world, was founded in Feb. 1997,
by RAËL and a group of investors who created the Valiant Venture Ltd Corporation based
in the Bahamas.” The organization was founded by the leader of the Raelian Movement,
“the world’s largest UFO-related organization.” “A Historical Background,” Clonaid, at
[http://www.clonaid.com/content.php?content], accessed July 1, 2004.
58 See, for example, “Alive and Well,” Clonaid, at [http://www.clonaid.com/news.php], visited
July 1, 2004; Abu Dhabi, “Human Cloning Project Claims Progress,” Gulf News Online Edition,
Apr. 3, 2002, at [http://www.gulf-news.com/Articles/news.asp?ArticleID=46275].
as well as factual beliefs. The following discussion breaks down the arguments
surrounding human cloning according to these issues, demonstrating both the
complexity of the issues and the points of resonance among the groups.
Issues Involved in Cloning for Reproductive Purposes. As Clonaid
advertised and the President’s Council acknowledged, supporters of reproductive
cloning favor it because it might “allow infertile couples to have genetically-related
children,”59 enable families to avoid genetic disease in their genetically-related
children, facilitate the replication of specific persons (such as lost loved ones), or to
create ideal transplant donors.60 Likewise, the NBAC recognized that some of the
principles that underlie these purposes are a “presumption in favor of individual
liberty,” that “human reproduction [is] particularly personal and should remain free
of constraint, ... [and] as a society, we ought not limit the freedom of scientific
inquiry.”61 However, for a number of other reasons, the idea of cloning for
reproductive purposes is presently rejected by most groups and organizations,
including the President’s Council and NBAC. Of the groups and individuals listed
in the Ethical and Social Issues section, only Clonaid and Dr. Antinori favor
reproductive cloning at this time. Despite the apparent uniformity of views rejecting
reproductive cloning, there is a great deal of variation in the lines of reasoning
underlying such objections.
Procreation Without Conjugal Union. According to the USCCB, Donum
Vitae62 instructs that “attempts or hypotheses for obtaining a human being without
any connection with sexuality through ‘twin fission,’ cloning or parthenogenesis are
to be considered contrary to the moral law, since they are in opposition to the dignity
both of human procreation and of the conjugal union.”63 This objection to
reproductive cloning, that procreation should be limited to conjugal unions, is not
supported by most groups. If accepted, it would lead to a rejection of other forms of
assisted reproduction, such as in vitro fertilization (IVF). Of the groups and
individuals listed above, only UCCSB cites the need for a conjugal union as a
persuasive argument against reproductive cloning.
Safety. The most agreed upon objection to human reproductive cloning is one
of safety. The President’s Council on Bioethics concluded that, “[g]iven the high
59 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p.
xxvii. (Hereafter cited as President’s Council, Human Cloning.)
60 See, for example, President’s Council on Bioethics, Human Cloning and Human Dignity, July
content.6], accessed July 9, 2004.
61 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 72.
62 Donum Vitae, (“The Gift of Life”), which addresses the Catholic view of morality of
many modern fertility procedures, was issued in 1987 by the Sacred Congregation for the
Doctrine of the Faith at [http://www.nccbuscc.org/prolife/tdocs/donumvitae.htm], accessed
July 9, 2004.
63 John Haas, “Begotten Not Made: A Catholic View of Reproductive Technology,” United
States Conference of Catholic Bishops, Pro Life Activities, June 2003, at [http://www.usccb.org/
prolife/programs/rlp/98rlphaa.htm], accessed July 9, 2004.
rates of morbidity and mortality in the cloning of other mammals, we believe that
cloning-to-produce-children would be extremely unsafe, and that attempts to produce
a cloned child would be highly unethical.”64 The National Bioethics Advisory
Commission reached a consensus in its objection to reproductive cloning “because
current scientific information indicate[d] that this technique [was] not safe in
humans....”65 The National Academies agrees with this line of reasoning, given that
animal experimentation has demonstrated that “only a small percentage of attempts
are successful,” “many of the clones die during gestation,” and “newborn clones are
often abnormal, or die.”66 While these objections about safety are widely held, they
may be temporary in nature. As research advances, it may become less risky, and
thus some may find it less objectionable to attempt reproductive human cloning.
Unlike concerns about safety, other types of objections, while not so widely
held, may be more lasting because they are not likely to be alleviated by scientific
progress. These tend to be philosophical in nature. These concerns, listed in the
following paragraphs, have been acknowledged by the President’s Council, NBAC,
UCSSB, and the National Academies. According to the President’s Council,
“[d]ifferent Council members give varying moral weight to [the following] different
concerns.”67 Only the UCSSB found the concerns persuasive in total.
Identity. Some objections to reproductive cloning are based upon fears that
cloned children will have difficulty with their identities “because each will be
genetically virtually identical to a human being who has already lived and because
the expectations for their lives may be shadowed by constant comparisons to the life68
of the ‘original.”’ These concerns are dismissed by others, who point out that this
argument rests largely on “the crudest genetic determinism.”69 They cite both the
effect that environment plays on individual development, and the lack of difficulty
with identity experienced by naturally occurring identical twins.70
Commodification. Other philosophical objections have to do with a fear that
cloned children “might come to be considered more like products of a designed
64 President’s Council, Human Cloning, p. xxiii.
65 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. iii.
66 Scientific and Medical Aspects of Human Reproductive Cloning (Washington: National
Academies Press, 2002), p. 93. The report on human cloning is available at
[http://www.nap.edu/catalog/10285.html ?onpi _topnews_011802].
67 The number of Council members who give moral weight to each argument, and the
amount of weight they give to each issue is not specified. President’s Council on Bioethics,
Human Cloning and Human Dignity, July 2002, p. xxviii.
68 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p.
69 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 65.
Note: genetic determinism is the idea that a person’s identity and development are primarily
or entirely the result of his or her genetic makeup. Genetic determinism is generally viewed
as a flawed concept because of its failure to acknowledge the impact of environmental
factors and the opportunity for individual choice.
70 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p. 103.
manufacturing process than ‘gifts’ whom their parents are prepared to accept as they
are. Such an attitude toward children could also contribute to increased
commercialization and industrialization of human procreation.”71 This, in turn, may
fuel a new eugenics in which parents select not only whether to have a child, but
which child to have.72 Others point out that these types of concerns were raised about
most forms of assisted reproduction (such as in vitro fertilization and preimplantation
genetic diagnosis), which have not led to objectification. In addition, if being born
is a considered to be a benefit to the one born, “to the extent that the technology is
used to benefit the child ... no objectification of the child takes place.”73
Familial Relationships. A complicated lineage has also been introduced as
an objection to reproductive cloning: “By confounding and transgressing the natural
boundaries between generations, cloning could strain the social ties between them.
Fathers could become “twin brothers” to their “sons”; mothers could give birth to
their genetic twins; and grandparents would also be the “genetic parents” of their
grandchildren. Genetic relation to only one parent might produce special difficulties74
for family life.” Others point out that children “born through assisted reproductive
technologies may also have complicated relationships to genetic, gestational, and
rearing parents ... [yet] there is no evidence that confusion over family roles has
harmed children born through assisted reproductive technologies, although the75
subject has not been carefully studied.”
Societal View of Children. Concerns have been voiced about the effects of
cloning on society: “Cloning-to-produce-children would affect not only the direct
participants but also the entire society that allows or supports this activity. Even if
practiced on a small scale, it could affect the way society looks at children and set a
precedent for future nontherapeutic interventions into the human genetic endowment
or novel forms of control by one generation over the next.”76 This objection is
rejected by others, who argue that “people can, and do, adapt in socially redeeming
ways to new technologies ... [A] child born through somatic cell nuclear transfer77
could be loved and accepted like any other child....”
Issues Involved in Cloning for Therapeutic Purposes.78 Cloning for
therapeutic purposes is more broadly supported than reproductive cloning, and the
issues involved are somewhat different. The safety concerns of reproductive cloning
71 Ibid., pp. xxviii-xxix.
72 Ibid., p. xxix.
73 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 70.
74 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p. xxix.
75 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 66.
76 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p. xxix.
77 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 67.
78 For purposes of this section, the term “therapeutic purposes” is meant to include the use
of cloning technology for both the research underlying treatments and the treatments
do not apply in therapeutic cloning, placing much of the scientific community, such
as the National Academies, in favor of it. In addition, the NBAC, a minority of the
President’s Council, the group of Nobel Laureates, Nancy Reagan, and Gerald Ford
also generally support cloning for therapeutic purposes. Opponents include a
majority of the President’s Council, and the USCCB.
Relief of Human Suffering and Moral Status of Cloned Embryos.
The central debate over therapeutic cloning rests on the relative weight ascribed to
potential research benefits, and that ascribed to cloned embryos themselves. All
sides generally agree that research involving cloning may generate biomedical
advancements that relieve human suffering. As described the President’s Council,
the research “may offer uniquely useful ways of investigating and possibly treating79
many chronic debilitating diseases and disabilities, providing relief to millions.”
Yet a majority of Council members were dissuaded from the research, arguing that
“[i]f we permit this research to proceed, we will effectively be endorsing the
complete transformation of nascent human life into nothing more than a resource80
tool.” Similar arguments are made by the USCCB.
The Council’s minority offered an opposing viewpoint: “We believe there are
sound moral reasons for not regarding the embryo, in its earliest stages as the moral
equivalent of a human person” but rather as having a “developing and intermediate
moral worth that commands our special respect.”81 The minority based its opinion
on the fact that, at the blastocyst stage (the one useful for stem cell research, for
example), the cells are still undifferentiated and could still be split and develop into
two separate twinned embryos, “suggesting that the earliest stage embryo is not yet
an individual.”82 Furthermore, they note that the possibility for the development of
a human child from a cloned embryo would require its transference to a uterus, as is
currently the case with IVF.83 IVF often results in the creation of embryos that
remain unimplanted, and is permitted in the United States. For all of the above
reasons, the Council minority, NBAC, Nancy Reagan, Gerald Ford, and the Nobel
Laureates support therapeutic cloning.
In July 2004, Dr. Paul McHugh, a member of the President’s Council who
objects to the destruction of human embryos and who had voted with the Council
majority for a moratorium on cloning-for-biomedical research, argued in a medical
journal article that SCNT “resembles a tissue culture,” and that the products of SCNT
should be available for research once regulations are in place to ensure that SCNT
is conducted ethically.84 At the December 2004 Council meeting, Dr. William
79 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, pp.
80 Ibid., p. xxxiii.
81 Ibid., p. xxxi
82 Ibid., p. 136.
84 Paul McHugh, “Zygote and ‘Clonote’ — The Ethical Use of Embryonic Stem Cells,” New
Hurlbut, another Council member who objects to the destruction of human embryos
and voted for the moratorium, made a proposal to explore the possibility of using
SCNT in combination with techniques to ensure that the group of cells created cannot
give rise to human life but can generate embryonic stem cells. Dr. Hurlbut explained,
“using the technique of nuclear transfer, it may be possible to produce embryonic
stem cells within a limited cellular system that is biologically and morally akin to a
complex tissue culture and thereby bypass moral concerns about the creation and
disruption of human embryos.”85 Some have criticized Dr. Hurlbut’s proposal to
create something that is not an embryo, yet generates embryonic stem cells, as one
focused on a “semantic issue, not a scientific one.”86 Others have lauded Dr.
Hurlbut’s proposal as a potential scientific solution to a moral problem. Included
among them is Dr. Leon Kass, the Chair of the Council and a well-known opponent
of embryo destruction, who said the proposal raises the possibility that, “the partisans
of scientific progress and the defenders of nascent human life can go forward in
partnership without anyone having to violate things they hold dear.”87
Deliberate Creation for Use/Destruction. A second set of considerations
underlying the debate have to do with a moral aversion to the prospect of creating life
in order to destroy it. As a majority of the President’s Council pointed out, cloning
for therapeutic purposes requires “the creation of human life expressly and
exclusively for the purpose of its use in research, research that necessarily involves
its destruction, ... transform[ing] nascent human life into nothing more than a88
resource tool.” The USCCB agrees with this characterization.
The Council minority countered that the “embryos would not be ‘created for
destruction,’ but for use in the service of life and medicine.”89 Further, the”practice
of sacrificing the life of the unborn in order to save the live of the pregnant woman
— while not a moral parallel to the case of using cloned embryos for biomedical
research — shows that there is some moral precedent for subordinating nascent
human life to more developed human life.”90 The NBAC, Nancy Reagan, Gerald
Ford, and the Nobel Laureates agree with this characterization.
England Journal of Medicine, vol. 351, no. 3 (July 15, 2004), p. 210, at [http://content.nejm.
85 President’s Council on Bioethics, Presentation of Dr. William Hurlbut in “Transcript of
the President’s Council on Bioethics,” Dec. 3, 2004, Washington, D.C., at
86 Kirsty Horsey, “When Is an Embryo Not an Embryo?” BioNews, no. 287, Dec. 6, 2004,
87 David Brown, “Two Stem Cell Options Presented; Human Embryos Wouldn’t Be Killed,”
Washington Post, Dec. 4, 2004, A1.
88 President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, p.
89 Ibid., p. xxxi.
90 Ibid., pp. 137-138.
Moral Harm or Benefit to Society. The effect of therapeutic cloning upon
society has been debated by opponents and proponents alike. The President’s
Council majority fear negative effects, such as the subjugation of weak members of
society, or genetic manipulation of developing life: “As much as we wish to alleviate
suffering now and to leave our children in a world where suffering can be more
effectively relieved, we also want to leave them in a world ... that honors moral
limits, that respects all life whether strong or weak, and that refuses to secure the
good of some human beings by sacrificing the lives of others.”91 Approving
therapeutic cloning would harm society by “crossing the boundary from sexual to
asexual reproduction, thus approving in principle the genetic manipulation and92
control of nascent human life.” USCCB also shares this point of view.
Counter arguments have been made by those who note that “[h]istorically,
scientific inquiry has been protected and even encouraged because of the great
societal benefit the public recognizes in maintaining the sanctity of knowledge and
the value of intellectual freedom.”93 In addition, they note that cloning is replication,
rather than transformation: “In an important sense, cloning is not the most radical
thing on the horizon. Much more significant ... would be the ability to actually alter
or manipulate the genome of offspring, ... which could then lead to a child being born
with characteristics other than it would have had....”94 The Council minority, NBAC,
Nancy Reagan, Gerald Ford, and the Nobel Laureates share this perspective.
Going Too Far or Drawing Appropriate Limitations. Some, such as the
majority of the President’s Council and USCCB, believe that policies allowing
therapeutic cloning would create a slippery slope, “opening the door to other moral
hazards, such as cloning-to-produce-children or research on later-stage embryos and95
fetuses.” Others, such as the Council minority, NBAC, Nancy Reagan, Gerald
Ford, and the Nobel Laureates, believe that it is possible to circumscribe acceptable
practices with good policy. “Both the federal government and the states already
regulate the researchers’ methods in order to protect the rights of research subjects96
and community safety.” Government might regulate “the secure handling of
embryos, licensing and prior review of research projects, the protection of egg97
donors, and the provision of equal access to benefits.”
Egg Procurement. The topic of egg procurement came to the public’s
attention in November 2005 with allegations that some human eggs used in South
Korean scientist Dr. Hwang’s laboratory had been obtained under coercive
91 Ibid., p. xxxiv.
92 Ibid., p. xxxiv.
93 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 75.
94 J.A. Robertson, “A Ban on Human Cloning Research Is Unjustified,” Testimony before
the National Bioethics Advisory Commission (Mar. 14, 1997), in National Bioethics
Advisory Commission, Cloning Human Beings, June 1997, p. 68.
95 President’s Council, Human Cloning, p. xxxiv.
96 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 75.
97 President’s Council, Human Cloning, p. xxxviii.
conditions. The alleged situation in Dr. Hwang’s laboratory raises the issue of
coercion both because subordinate women in the laboratory allegedly donated eggs,
and because some women were allegedly paid for their eggs. A 2002 study
conducted by a University of Pennsylvania student raised the issue of insufficient
information, finding that a number programs seeking donor eggs for reproductive
purposes were not up front about the risks involved in egg retrieval. The wide
consensus regarding the need for informed consent necessarily implies similar
consensus on the need for an information-rich, coercion-free method of obtaining
eggs; however, there is some disagreement on the specifics of whether payment for
eggs necessarily constitutes coercion.
The prospect of paying women for their eggs, which has been debated in the
context of seeking donor eggs both for reproductive purposes (for example, to enable
women who do not produce their own eggs to become pregnant), and for research
purposes, is not unheard of in the United States. According to a 2000 study by the
American Society of Reproductive Medicine (ASRM), some IVF programs
reportedly offered as much as $5,000 for one egg retrieval cycle, though $2,500
appeared to be a more common amount. Offers of much higher amounts
($50,000-$100,000) have been reported elsewhere. Dr. Huang’s laboratory
reportedly made payments of $1,400 to each woman who donated eggs. Payments
are not illegal in the Unites States, nor were they illegal in South Korea at the time
Dr. Huang’s laboratory allegedly made them. The questions are, is payment for egg
donation ever acceptable, and if so, what amount is appropriate?
Several arguments have been put forth in favor of payment for egg donation,
many focused on donation for reproductive purposes. First, some have argued that
payment creates incentives to increase the number of egg donors, thus facilitating
research and benefitting infertile couples. Second, some reason that payment for
eggs gives women parity with sperm donors, who may be compensated for donating
gametes at a lower rate, given that they require a much less involved procedure.
Third, some allege that fairness dictates that women who donate eggs ought to be
able to benefit from their action. Fourth, some claim that pressures created by
financial incentives may be no greater than those experienced by women asked to
make altruistic egg donations for relatives or friends, and may thus not rise to the
level of coercion. These are the types of arguments that led ASRM to recommend
in 2000 that sums of up to $5,000 may be appropriate for typical egg donation, while
sums of up to $10,000 may possibly be justified if there are particular difficulties a
woman must endure to make her donation.
Several arguments have also been put forth against payment for egg donation.
First, some voiced fears that payment might lead to the exploitation of women,
particularly poor women, and the commodification of reproductive tissues. Second,
some have argued that payment for eggs for research purposes might undermine
public confidence in endeavors such as human ESR. Arguments such as these have
prompted both the NAS and the PCBE to recommend that women not be paid for
donating their eggs for research purposes. It also led the PCBE to note that in theory,
there is the possibility that eggs could be procured from ovaries harvested from
cadavers, which might at least alleviate concerns related to coercion.
It is worth noting that a woman may choose to undergo egg retrieval for her own
reproductive purposes, which would effectively take the process of egg procurement
out of the research arena and avoid the question of payment entirely. (For example,
this could be an option for a woman seeking IVF because her fallopian tubes are
Types of Restrictions. One final set of arguments center around the types
of actions that the government may take with respect to therapeutic and/or
reproductive cloning. These include permitting, regulating, funding, discouraging,
and temporarily or permanently banning the practices. As a starting point, NBAC
offers: “In the United States, governmental policies that prohibit or regulate human
actions require justification because of a general presumption against governmental98
interference in individual activities.” As may be expected, the opinions regarding
appropriate courses of action are largely linked to points of view about the
appropriateness of the various endeavors.
The most permissive approach available, permitting cloning with no restrictions,
is not supported by any of the individuals or organizations referenced herein. By
contrast, the next most permissive approach, regulating cloning, is supported by the
Council minority, NBAC, Nancy Reagan, Gerald Ford, and the Nobel Laureates as
appropriate for therapeutic cloning, so as to enable it to continue in accordance with
socially accepted scientific research practices. As summarized by the Council
minority, “We believe that this research could provide relief to millions of
Americans, and that the government should therefore support is, within sensible99
limits imposed by regulation.”
A voluntary prohibition, the third most permissive approach, was recommended
by NBAC as the appropriate immediate response to reproductive cloning by the
private sector. NBAC called for “an immediate request to all firms, clinicians,
investigators, and professional societies in the private and non-federally funded100
sectors to comply voluntarily with the intent of the federal moratorium.”
As a longer term approach, NBAC recommended the fourth most permissive
approach, a temporary ban on reproductive cloning. “Federal legislation [should] be
enacted to prohibit anyone from attempting, whether in a research or clinical setting,
to create a child through somatic cell nuclear transfer. It is critical, however, that
such legislation include a sunset clause to ensure that Congress will review the issue
after a specified time period (three to five years) in order to decide whether the101
prohibition continues to be needed.” Readers may be interested to note that, if
enacted in 1997 when NBAC’s report was published, a five-year ban on reproductive
cloning would have expired in 2002. The National Academies also recommended
a ban on reproductive cloning, and did not call it temporary but did add that it should
be reconsidered every five years. On the topic of therapeutic rather than reproductive
98 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 78.
99 President’s Council, Human Cloning, p. xxxviii.
100 National Bioethics Advisory Commission, Cloning Human Beings, June 1997, p. 105.
cloning, a majority of the Council recommended a temporary moratorium as the
proper approach, because it would “reaffirm the principle that science can progress
while upholding the community’s moral norms, and would therefore reaffirm the
community’s moral support for science and biomedical technology.”102
The most restrictive approach to cloning, a permanent ban, was proposed by the
Council minority and majority, and Nancy Reagan as appropriate for reproductive
cloning. “By permanently banning cloning-to-produce children, this policy gives
force to the strong ethical verdict against [it], unanimous in the Council ... and widely
supported by the American people.”103 This approach is also favored by the USCCB
not only for reproductive cloning, but also for therapeutic cloning.
One related issue, that of the use of federal funding for therapeutic cloning, has
also been discussed. No proposals have been made by any of the groups or
individuals listed above for the use of federal funding for reproductive cloning.
Opponents of funding therapeutic cloning, such as the Council majority, have
expressed concern that use of federal funding for therapeutic cloning would put “the
federal government in the novel and unsavory position of mandating the destruction
of nascent human life.”104 Proponents of federal funding for therapeutic cloning,
such as the Council minority, NBAC, Nancy Reagan, Gerald Ford, and the Nobel
Laureates, cite as support the advancements that might be powered by the infusion
of federal dollars into the research, as well as the ethical protections that would attach
with the money.
102 President’s Council, Human Cloning, p. xxxvii.
103 President’s Council, Human Cloning, p. xxxiv.
104 President’s Council, Human Cloning, p. xxxvi