Order Code RL31015
CRS Report for Congress
Received through the CRS Web
Stem Cell Research
Updated August 10, 2005
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

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Stem Cell Research
Summary
Embryonic stem cells have the ability to develop into virtually any cell in the
body, and they may have the potential to treat medical conditions such as diabetes
and Parkinson’s disease. In August 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.” The National
Institutes of Health (NIH) has established the Human Embryonic Stem Cell Registry,
which lists 78 stem cell lines that are eligible for use in federally funded research.
However, only 22 embryonic stem cell lines are currently available. Scientists are
concerned about the quality, and longevity of these stem cell lines. For a variety of
reasons, many believe research advancement requires new embryonic stem cell lines,
and for certain applications, stem cells derived from cloned embryos may offer the
best hope for progress in understanding and treating disease. A significant cohort of
pro-life advocates support stem cell research; those opposed are concerned that the
isolation of stem cells requires the destruction of embryos.
Some have argued that stem cell research be limited to adult stem cells obtained
from tissues such as bone marrow or umbilical cord blood. They argue that adult
stem cells should be pursued instead of embryonic stem cells because they believe
the derivation of stem cells from either embryos or aborted fetuses is ethically
unacceptable. Other scientists believe adult stem cells should not be the sole target
of research because of important scientific and technical limitations. Some scientists
are exploring the possibility of obtaining human embryonic stem cells that bypass the
destruction of living human embryos. The President’s Council on Bioethics cite four
potential alternative sources of human embryonic stem cells in a May 2005 paper.
On May 24, 2005, the House passed H.R. 810 (Castle) which would allow
federal support of research that utilizes 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.” The House also passed
H.R. 2520 (Christopher Smith) which would provide for the collection and
maintenance of human cord blood stem cells for the treatment of patients and for
research. On July 29, 2005, Senate Majority Leader Bill Frist announced his support
for H.R. 810/S. 471 (Specter); President Bush has threatened to veto the legislation.
Action on the Weldon bill (passed the House in the 107th and 108th and stalled in the
Senate) is likely; 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 argue that the measure would curtail
medical research and prevent Americans from receiving life-saving treatments
created overseas. S. 876, H.R. 1822 and S. 1520 ban only human reproductive
cloning. Bills focused on alternative sources of stem cells (H.R. 3144/S. 1557) have
also been introduced. This report will be updated as needed.

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Contents
Overview of Basic Research and Potential Applications . . . . . . . . . . . . . . . . 1
Embryonic Stem Cells from IVF Embryos or Fetal Tissue . . . . . . . . . . 1
Embryonic Stem Cells Obtained via SCNT (Cloning) . . . . . . . . . . . . . 1
Alternative Sources of Human Embryonic Stem Cells . . . . . . . . . . . . . 2
Stem Cells from Adult Tissue or Umbilical Cord Blood . . . . . . . . . . . . 5
Potential Applications of Stem Cell Research . . . . . . . . . . . . . . . . . . . . 6
Current Federal Regulatory Landscape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The Dickey Amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Clinton Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . 8
Bush Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . 9
Agency Regulation: FDA and NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Concerns Over Access to Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . 13
Reproductive Genetics Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Harvard Stem Cell Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Stanford Institute for Cancer/Stem Cell Biology . . . . . . . . . . . . . . . . . 14
UCSF Developmental and Stem Cell Biology Program . . . . . . . . . . . 14
Worldwide Survey of Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . 14
Congressional Letters on Bush Policy . . . . . . . . . . . . . . . . . . . . . . . . . 15
National Academies Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
State Actions on Embryonic Stem Cell Research . . . . . . . . . . . . . . . . . . . . 17
States that Prohibit Research on an Aborted Fetus or Embryo . . . . . . 17
States that Prohibit Research on Tissue Derived
from IVF or Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
State Initiatives to Encourage Stem Cell Research . . . . . . . . . . . . . . . 18
Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
International Actions on Embryonic Stem Cell Research . . . . . . . . . . . . . . 26
Ethical Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Embryo Destruction and Relief of Human Suffering . . . . . . . . . . . . . 32
Viability of Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Purpose of Embryo Creation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
New and Existing Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Consent of Donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Effectiveness of Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Generating Embryonic Stem Cells
Without Destroying Human Embryos . . . . . . . . . . . . . . . . . . . . . 37
Use of Federal Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
List of Tables
Table 1. National Institutes of Health Funding . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Table 2. NIH List of Human Embryonic Stem Cell Lines Eligible
for Use in Federal Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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Stem Cell Research
Overview of Basic Research and Potential Applications
Most cells within an animal or human being are committed to fulfilling a single
function within the body. In contrast, stem cells are a unique and important set of
cells that are not specialized. Stem cells retain the ability to become some or all of
the more than 200 different cell types in the body and thereby play a critical role in
repairing organs and body tissues throughout life. Although the term stem cells is
often used in reference to these repair cells within an adult organism, a more
fundamental variety of stem cells is found in the early stage embryo. Embryonic
stem cells may have a greater ability to become different types of body cells than
adult stem cells.

Embryonic Stem Cells from IVF Embryos or Fetal Tissue. Embryonic
stem cells were first isolated from mouse embryos in 1981 and from primate embryos
in 1995. Animal embryos were the only source for research on embryonic stem cells
until November 1998, when two groups of U.S. scientists announced the successful
isolation of human embryonic stem cells. One group, at the University of Wisconsin,
derived stem cells from five-day-old embryos produced via in vitro fertilization
(IVF).1 The work is controversial, in the opinion of some, because the stem cells are
located within the embryo and the process of removing them destroys the embryo.
The second group, at Johns Hopkins University, derived stem cells with very similar
properties from five- to nine-week-old embryos or fetuses obtained through elective
abortion.2 Both groups reported the human embryos or fetuses were donated for
research following a process of informed consent. The cells removed from embryos
or fetuses were manipulated in the laboratory to create embryonic stem cell lines that
may continue to divide for many months to years.
Embryonic Stem Cells Obtained via SCNT (Cloning). Another
potential source of embryonic stem cells is somatic cell nuclear transfer (SCNT), also
1 The IVF embryos were originally created for the treatment of infertility. Excess embryos
are often frozen for future use. A couple may elect to discard their excess embryos, donate
the embryos for research, or allow another couple to adopt an embryo. According to a survey
of over 430 infertility clinics performed by the Society for Assisted Reproductive
Technology and RAND, nearly 400,000 embryos are being stored in the United States; 88%
of the embryos are being held to help the couples have children at a later date.
2 Scientists and physicians use the term “embryo” for the first eight weeks after fertilization,
and “fetus” for the ninth week through birth. In contrast, the Department of Health and
Human Services (HHS) regulations define “fetus” as “the product of conception from the
time of implantation” (45 C.F.R. § 46.203).

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CRS-2
referred to as cloning.3 In SCNT the nucleus of an egg is removed and replaced by
the nucleus from a mature body cell, such as a skin cell. The cell created via SCNT
is allowed to develop for several days and then the stem cells are removed. In 1996,
scientists in Scotland used the SCNT procedure to produce Dolly the sheep, the first
mammalian clone.4
In May 2005 scientists at the Seoul National University in South Korea
announced they had achieved major advances in the efficiency of creating human
embryos using SCNT and in isolating human stem cells from the cloned embryos.5
Of the 11 new stem cell lines created by the South Korean team, nine were derived
from people who have spinal cord injuries, another line was derived from a six-year
old diabetes patient and another from a two-year old who has a genetic immune
deficiency. The team attributes their improved success rate in part to the use of
freshly harvested eggs from younger fertile women instead of eggs left over from
fertility treatments.6 These developments and the unsubstantiated announcement by
Clonaid in December 2002 of the birth of a cloned child have contributed to the
controversy over research on human embryos.7
Alternative Sources of Human Embryonic Stem Cells. Some scientists
have begun to explore ways of obtaining human embryonic stem cells that bypass the
destruction of living human embryos and therefore may be less troubling to some
individuals. The President’s Council on Bioethics identified four potential methods
in a paper released in May 2005.8 However, some council members expressed
concern that “this effort is a diversion from the simple task at hand which is to move
forward with the established laboratory techniques ... for studying embryonic stem
cell research and biomedical cloning” and that the four proposals would “use
financial resources that would be better devoted to proposals that are likely to be
more productive.”9 Each of the four methods would require additional research to
determine whether it could actually generate embryonic stem cells.
3 A somatic cell is a body cell. In contrast, a germ cell is an egg or sperm cell.
4 Dolly was euthanized in Feb. 2003 after developing a lung infection. Some claim her
death at 6 years was related to being a clone, but her ailment may also have occurred
because she was raised indoors (for security reasons) rather than as a pastured sheep, which
often live to 12 years of age. G. Kolata, “First Mammal Clone Dies,” New York Times, Feb.
15, 2003, p. A4.
5 Gretchen Vogel, “Korean Team Speeds Up Creation of Cloned Human Stem Cells,”
Science, vol. 308, May 20, 2005, pp. 1096-1097.
6 Ibid.
7 For further information, see CRS Report RL31358, Human Cloning, by Judith A. Johnson
and Erin Williams.
8 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, at [http://www.bioethics.gov/reports/white_paper/
index.html].
9 Ibid., Personal Statement of Michael S. Gazzaniga, p. 76 and Personal Statement of Dr.
Janet D. Rowley, p. 90.

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CRS-3
Dead Embryos. One possible method under discussion is deriving human
embryonic stem cells from dead embryos. Early embryos frequently fail to develop
in naturally occurring conceptions.

Slightly fewer than a third of all conceptions lead to a fetus that has a chance of
developing. In other words, if you were to choose [an embryo] at random and
follow it through the first week of development, the chances are less than one in
three that it would still be there at full term, even though there has been no
human intervention. Nature, it seems, performs abortions at a much higher rate
than human society. It is simply not true that most [embryos], if undisturbed,
will produce a human being. The probability that a conception will result in a
live birth is actually quite low. Note that since we have assumed that all
conceptions lead to cell division, we have almost surely overestimated the true
success rate.10
As many as 60% of IVF embryos produced by infertility clinics are judged to
be incapable of developing to live birth, due to abnormal appearance or failure to
divide appropriately, and are not used by the infertile couple. Although failure to
divide is often caused by genetic abnormalities and might seem to eliminate any
prospect of using these embryos even for research, several studies suggest that some
normal cells may be obtained from such organismically dead embryos and may be
useful in creating stem cell lines.
The possibility that normal cells removed from dead embryos could potentially
develop into an embryo (and if transferred into a uterus — a child) would be
disturbing to some individuals. In addition, such a possibility would likely preclude
federal funding for producing stem cell lines from such cells because of restrictions
contained in the Dickey Amendment (see subsection, below, Embryo Biopsy).
Research studies to determine the precise criteria for embryonic organismic death
would be needed; however, such “natural history” studies could not be conducted
with federal dollars. Federal funding of any type of research involving human
embryos, starting with IVF then later cloning and the creation of stem cell lines from
embryos, has been blocked by various policy decisions dating back more than 25
years and is currently controlled by the Dickey Amendment (see section, below, The
Dickey Amendment and Clinton Administration Stem Cell Policy).
The President’s Council points out that this method of obtaining stem cells from
dead embryos may not be acceptable to scientists because they understandably want
to work only with the best materials. Why would scientists want to use cells derived
from dead embryos, which may be abnormal, or even bother trying to create these
cell lines when they can use existing cell lines or derive new ones from IVF
embryos? The only advantage may be eligibility for federal funding. One Council
member points out that the proposal entails thawing out embryos to follow the
natural history of dead embryos, and because it’s unknown “which embryos will not
divide and which will, some portion (about half) will continue to divide and will be
healthy embryos. What happens to these healthy embryos? ... [I]t would be strange,
while allowing large numbers of unwanted but otherwise normal and viable IVF
10 Harold J. Morowitz and James S. Trefil, The Facts of Life: Science and the Abortion
Controversy (Oxford University Press, 1992), p. 51.

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embryos to die, to ask scientists to make strenuous efforts to rescue cells, potentially
abnormal, only from those thawed embryos that have spontaneously stopped
dividing. ... This seems to me to be the height of folly.”11
Embryo Biopsy. A second potential method of obtaining embryonic stem
cells without destroying the embryo employs a technique used by IVF clinics that
offer pre-implantation genetic diagnosis (PGD). At the 6-8 cell stage, one or two
cells are removed from the embryo created via IVF; these cells are then screened for
genetic or chromosomal abnormalities before the embryo is transferred to a woman’s
uterus. More than 1,000 children have been born following PGD, though it is still
unclear whether subtle or late onset injuries may occur in children born following
PGD.12
It may be possible to create stem cell lines using cells obtained in this manner;
after cell removal, the embryo could presumably be used to initiate a pregnancy.
However, like the method described above, this approach is highly speculative and
has not yet been attempted. Although it is understandable that couples who are at
risk of having a child with a genetic disease may willingly agree to the potential
added risk of PGD, it is difficult to understand what circumstances might motivate
a couple to agree to such a procedure for the sole purpose of creating stem cell lines
for research. Research studies to determine if there is a risk of harm to a human
embryo by the cell biopsy procedure could not be funded with federal dollars due to,
as mentioned above, longstanding opposition to federal support for any type of
research involving human embryos. Furthermore, the possibility that a biopsied cell
may have “the potential to develop into an embryo and a child on its own” could
preclude federal funding for producing stem cell lines from such cells because of
restrictions contained in the Dickey Amendment (see section, below, The Dickey
Amendment and Clinton Administration Stem Cell Policy).13
Biological Artifacts — Altered Nuclear Transfer. A third possible
method involves using the techniques of genetic engineering and SCNT (cloning) to
obtain human embryonic stem cells from embryo-like groups of cells which are not,
in the strict sense, human embryos. In this newly proposed approach, called altered
nuclear transfer (ANT), genes in the nucleus of a somatic cell are altered, so that
normal embryo development is not possible, before the nucleus is placed with in an
egg cell. “Such an entity would be a ‘biological artifact,’ not an organism. Removal
of cells from, or even disaggregation of, this artifact would not be killing or harming,
for there is no living being here to be killed or harmed.”14 Critics are concerned over
the questionable morality of creating a biological artifact with a built in genetic
defect, or what might be considered as the deliberate creation of a doomed or
disabled human embryo. “Some find it aesthetically repulsive and ethically suspect
to be creating such neither-living-nor-nonliving, near-human artifacts, a practice they
11 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, p. 21 and p. 89.
12 Ibid., pp. 24-25.
13 Ibid., p. 29.
14 Ibid., p. 37.

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CRS-5
regard as ethically no improvement over destroying early embryos.”15 Given the
ethical uncertainties, it is unclear whether or not research involving ANT could be
supported with federal funds.
Although it has yet to be tested, some researchers believe ANT is scientifically
feasible and might serve as a temporary bridge until other technologies are
developed, such as dedifferentiation of somatic cells. Until then, if federal support
is provided, its proponents believe ANT would allow embryonic stem cell research
collaboration on a national level without the ethical concerns involved in using
leftover IVF embryos. Another obstacle, acquiring human eggs, is the subject of
intense scientific research. Researchers are trying to develop methods of obtaining
eggs without resorting to superovulation of female patients, an expensive procedure
that some find morally questionable. Others believe that the procedures involved in
ANT are quite complex (compared with deriving human embryonic stem cells from
normal blastocysts) and many scientists “would be reluctant to attempt such
challenging feats with no rational purpose other than to satisfy the ethical objections
of others.”16
Dedifferentiation of Somatic Cells. The fourth method identified by the
President’s Council on Bioethics involves the dedifferentiation of somatic cells,
literally reprogramming or winding back the clock on cell development to produce
cells with the capabilities of embryonic stem cells. This proposed method is totally
hypothetical and basic research is at a preliminary stage. Because embryos are not
involved, federal funding for research on this method would presumably not be
blocked by the Dickey Amendment. However, the President’s Council on Bioethics
expresses some concern that dedifferentiation might proceed too far, resulting in the
functional equivalent of an embryo. This possibility would raise serious ethical
issues for some, and presumably the Dickey Amendment may again preclude the use
of this method in the production of human embryonic stem cells for research.
Moreover, such an embryo would be a clone of the individual who donated the
somatic cell and any attempt to “save” such an embryo through the implantation in
a woman’s uterus would raise additional moral and ethical questions.
Stem Cells from Adult Tissue or Umbilical Cord Blood. Stem cells
obtained from adult organisms are also the focus of research. There have been a
number of recent publications on the abilities and characteristics of adult stem cells
from a variety of different sources, such as bone marrow and the umbilical cord
following birth. In fact, bone marrow transplantation, a type of adult stem cell
therapy, has been used for 30 years to successfully treat patients for a variety of
blood-related conditions. Several private companies (such as MorphoGen,
NeuralStem, Osiris Therapeutics, StemSource, ViaCell) are working on additional
therapeutic uses of adult stem cells.
Some advocate that adult instead of embryonic stem cell research should be
pursued because they believe the derivation of stem cells from either IVF embryos
or aborted fetuses is ethically unacceptable. Others believe that adult stem cells
15 Ibid, p. 41.
16 Ibid., p. 47.

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should not be the sole target of research because of important scientific and technical
limitations. Adult stem cells may not be as long lived or capable of as many cell
divisions as embryonic stem cells. Also, adult stem cells may not be as versatile in
developing into various types of tissue as embryonic stem cells, and the location and
rarity of the cells in the body might rule out safe and easy access. For these reasons,
many scientists argue that both adult and embryonic stem cells should be the subject
of research, allowing for a comparison of their various capabilities.
Potential Applications of Stem Cell Research. Stem cells provide the
opportunity to study the growth and differentiation of individual cells into tissues.
Understanding these processes could provide insights into the causes of birth defects,
genetic abnormalities, and other disease states. If normal development were better
understood, it might be possible to prevent or correct some of these conditions. Stem
cells could be used to produce large amounts of one cell type to test new drugs for
effectiveness and chemicals for toxicity. Stem cells might be transplanted into the
body to treat disease (diabetes, Parkinson’s disease) or injury (e.g., spinal cord). The
damaging side effects of medical treatments might be repaired with stem cell
treatment. For example, cancer chemotherapy destroys immune cells in patients,
decreasing their ability to fight off a broad range of diseases; correcting this adverse
effect would be a major advance.
Before stem cells can be applied to human medical problems, substantial
advances in basic cell biology and clinical technique are required. In addition, very
challenging regulatory decisions will be required on the individually created tissue-
based therapies resulting from stem cell research. Such decisions would likely be
made by the Center for Biologics Evaluation and Research (CBER) of the Food and
Drug Administration (FDA). The potential benefits mentioned above would be likely
only after many more years of research. Technical hurdles include developing the
ability to control the differentiation of stem cells into a desired cell type (like a heart
or nerve cell) and to ensure that uncontrolled development, such as a cancerous
tumor, does not occur. Some experiments may involve the creation of a chimera, an
organism that contains two or more genetically distinct cell types, from the same
species or different species.17 If stem cells are to be used for transplantation, the
problem of immune rejection must also be overcome. Some scientists think that the
creation of many more embryonic stem cell lines will eventually account for all the
various immunological types needed for use in tissue transplantation therapy. Others
envision the eventual development of a “universal donor” type of stem cell tissue,
analogous to a universal blood donor.
However, if the SCNT technique (cloning) was employed using a cell nucleus
from the patient, stem cells created via this method would be genetically identical to
the patient, would presumably be recognized by the patient’s immune system, and
thus would avoid any tissue rejection problems that could occur in other stem cell
17 Chimeras have been created by scientists in a variety of different ways and have been the
subject of research studies for many years. Human chimeras occur naturally when two eggs
become fertilized and, instead of developing into twins, they fuse in the uterus creating a
single embryo with two distinct sets of genes. For one example, see Constance Holden,
“Chimera on a Bike?” Science, June 24, 2005, p. 1864.

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therapeutic approaches. Because of this, many scientists believe that the SCNT
technique may provide the best hope of eventually treating patients using stem cells
for tissue transplantation.
Current Federal Regulatory Landscape
The Dickey Amendment. Prior to an August 2001 Bush Administration
decision (see below), no federal funds had been used to support research on stem
cells derived from either human embryos or fetal tissue.18 The work at the University
of Wisconsin and Johns Hopkins University was supported by private funding from
the Geron Corporation. Private funding for experiments involving embryos was
required because Congress attached a rider to legislation that affected FY1996
National Institutes of Health (NIH) funding. The rider, an amendment originally
introduced by Representative Jay Dickey, prohibited HHS from using appropriated
funds for the creation of human embryos for research purposes or for research in
which human embryos are destroyed. The Dickey Amendment language has been
added to each of the Labor, HHS, and Education appropriations acts for FY1997
through FY2005.19 For FY2006, the provision is found in Section 509 of the Labor,
HHS and Education, and Related Agencies Appropriations Act, 2006 (H.R. 3010, H.
Rept 109-143). 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; 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 under 45 CFR 46.208(a)(2) 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].
There is no similar federal prohibition on fetal tissue research; however, other
restrictions do apply.
18 However, federal funds have been provided for research on both human and animal adult
stem cells and animal embryonic stem cells.
19 The rider language has not changed significantly from year to year. The original rider can
be found 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. 104-208; FY1998, P.L. 105-78; FY1999, P.L. 105-277; FY2000, P.L. 106-113;
FY2001, 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.

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Clinton Administration Stem Cell Policy. Following the November 1998
announcement on the derivation of human embryonic stem cells, NIH requested a
legal opinion from HHS on whether federal funds could be used to support research
on human stem cells derived from embryos. The January 15, 1999, response from
HHS General Counsel Harriet Rabb found that the Dickey Amendment would not
apply to research using human stem cells “because such cells are not a human
embryo within the statutory definition.” The finding was based, in part, on the
determination by HHS that the statutory ban on human embryo research defines an
embryo as an organism that when implanted in the uterus is capable of becoming a
human being. Human stem cells are not and cannot develop into an organism; they
lack the capacity to become organisms even if they are transferred to a uterus. As a
result, HHS maintained that NIH could support research that uses stem cells derived
through private funds, but could not support research that itself, with federal funds,
derives stem cells from embryos because of the federal ban in the Dickey
Amendment.
Shortly after the opinion by the HHS General Counsel was released, NIH
disclosed that the agency planned to fund research on stem cells derived from human
embryos once appropriate guidelines were developed and an oversight committee
established. NIH Director Harold Varmus appointed a working group that began
drafting guidelines in April 1999. Draft guidelines were published in the Federal
Register on December 2, 1999. About 50,000 comments were received during the
public comment period, which ended February 22, 2000. On August 25, 2000, NIH
published in the Federal Register final guidelines on the support of human
embryonic stem cell research. The guidelines stated that studies utilizing “stem cells
derived from human embryos may be conducted using NIH funds only if the cells
were derived (without federal funds) from human embryos that were created for the
purposes of fertility treatment and were in excess of the clinical need of the
individuals seeking such treatment.” Under the guidelines, NIH would not fund
research directly involving the derivation of human stem cells from embryos; this
was prohibited by the Dickey Amendment.
Other areas of research ineligible for NIH funding under the guidelines include
(1) research in which human stem cells are utilized to create or contribute to a human
embryo; (2) research in which human stem cells are combined with an animal
embryo; (3) research in which human stem cells are used for reproductive cloning of
a human; (4) research in which human stem cells are derived using somatic cell
nuclear transfer, i.e., the transfer of a human somatic cell nucleus into a human or
animal egg; (5) research utilizing human stem cells that were derived using somatic
cell nuclear transfer; and (6) research utilizing stem cells that were derived from
human embryos created for research purposes, rather than for infertility treatment.
NIH began accepting grant applications for research projects utilizing human
stem cells immediately following publication of the guidelines; the deadline for
submitting a grant application was March 15, 2001. All such applications were to be
reviewed by the NIH Human Pluripotent Stem Cell Review Group (HPSCRG),
which was established to ensure compliance with the guidelines. James Kushner,
director of the University of Utah General Clinical Research Center, served briefly
as chair of the HPSCRG. Applications would also have undergone the normal NIH

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CRS-9
peer-review process.20 The first meeting of the HPSCRG was scheduled for April 25,
2001. The HPSCRG was to conduct an ethical review of human pluripotent stem
cell lines to determine whether the research groups involved had followed the NIH
guidelines in deriving the cell lines. However, in mid April 2001, HHS postponed
the meeting until a review of the Clinton Administration’s policy decisions on stem
cell research was completed by the new Bush Administration.21 According to media
sources, the 12 HPSCRG members, whose names were not made public, represented
a wide range of scientific, ethical and theological expertise and opinion, as well as
at least one “mainstream Catholic.”22
The Bush Administration conducted a legal review of the policy decisions made
during the Clinton Administration regarding federal support of stem cell research, as
well as a scientific review, prepared by NIH, of the status of the research and its
applications. The scientific review was released on July 18, 2001, at a hearing on
stem cell research held by the Senate Appropriations Subcommittee on Labor, Health
and Human Services and Education.23 The NIH report did not make any
recommendations, but argued that both embryonic and adult stem cell research
should be pursued.
Bush Administration Stem Cell Policy. 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 where the life and death decision has already been made.”24 President
Bush stated that the decision “allows us to explore the promise and potential of stem
cell research without crossing a fundamental moral line, by providing taxpayer
funding that would sanction or encourage further destruction of human embryos that
have at least the potential for life.” The President also stated that the federal
government would continue to support research involving stem cells from other
20 According to media sources, as of Apr. 2001 only three grant applications had been
submitted to NIH, and one was subsequently withdrawn. (Washington FAX, Apr. 19, 2001.)
Presumably, scientists were reluctant to invest the time and effort into preparing the
necessary paperwork for the NIH grant application process when the prospects of receiving
federal funding were uncertain under the new Bush Administration. (P. Recer, “Stem Cell
Studies Said Hurt by Doubt.” AP Online, May 2, 2001.) In a related development, one of
the leading U.S. researchers on stem cells, Roger Pederson of the University of California,
San Francisco, decided to move his laboratory to the United Kingdom for “the possibility
of carrying out my research with human embryonic stem cells with public support.” (Aaron
Zitner, “Uncertainty Is Thwarting Stem Cell Researchers.” Los Angeles Times, July 16,
2001, pp. A1, A8.) Human embryonic stem cell research was approved overwhelmingly by
the House of Commons in Dec. 2000 and the House of Lords in Jan. 2001.
21 Rick Weiss, “Bush Administration Order Halts Stem Cell Meeting; NIH Planned Session
to Review Fund Requests.” Washington Post, Apr. 21, 2001, p. A2.
22 Ibid.
23 National Institutes of Health, Department of Health and Human Services. Stem Cells:
Scientific Progress and Future Research Directions, June 2001. The NIH scientific report
can be found at [http://stemcells.nih.gov/info/scireport/]
24 The Aug. 9, 2001, Remarks by the President on Stem Cell Research can be found at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html].

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CRS-10
sources, such as umbilical cord blood, placentas, and adult and animal tissues,
“which do not involve the same moral dilemma.”
Under the Bush policy, federal funds may only be used for research on existing
stem cell lines that were derived (1) with the informed consent of the donors; (2)
from excess embryos created solely for reproductive purposes; and (3) without any
financial inducements to the donors.25 NIH was tasked with examining the derivation
of all existing stem cell lines and creating a registry of those lines that satisfy the
Bush Administration criteria. According to the White House, this will ensure that
federal funds are used to support only stem cell research that is scientifically sound,
legal, and ethical. Federal funds will not be used for (1) the derivation or use of stem
cell lines derived from newly destroyed embryos; (2) the creation of any human
embryos for research purposes; or (3) the cloning of human embryos for any purpose.
Agency Regulation: FDA and NIH. Many entities and individuals that
conduct research on humans (“human subjects” research) are both federally and
institutionally regulated. Ex vivo embryos (those not in a uterus) are not considered
“human subjects” for these purposes, though federally funded research on them is
regulated by the Dickey Amendment as described above. Stem cells and stem cell
lines are not considered “human subjects,” nor are they governed by the Dickey
Amendment.
Two HHS agencies, FDA and NIH, regulate some aspects of stem cell research,
even if research on stem cell lines is not classified as “human subjects” research.
FDA, the agency that ensures the safety and efficacy of food, drugs, medical devices
and cosmetics, regulates stem cell research aimed at the development of any
“product” subject to its approval. NIH, the medical and behavioral research agency
within HHS, regulates stem cell research that it funds in compliance with President
Bush’s 2001 policy. In accordance, NIH has created a Human Embryonic Stem Cell
Registry that lists the human embryonic stem cell lines that meet the eligibility
criteria as outlined in the Bush Administration stem cell policy.
FDA Regulation. All of the human embryonic stem cell lines listed on the
NIH Human Embryonic Stem Cell Registry (see Table 2) have been grown on beds
of mouse “feeder” cells. The mouse cells secrete a substance that prevents the human
embryonic stem cells from differentiating into more mature cell types (nerve or
muscle cells). Infectious agents, such as viruses, within the mouse feeder cells could
transfer into the human cells. If the human cells were transplanted into a patient,
these infected human cells may cause disease in the patient which could be
transmitted to close contacts of the patient and eventually to the general population.
Public health officials and regulatory agencies such as the FDA are specifically
concerned about retroviruses, which may remain hidden in the DNA only to cause
disease many years later, as well as any unrecognized agents which may be present
in the mouse cells.
25 The White House, Fact Sheet on Embryonic Stem Cell Research, Aug. 9, 2001, found at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html].

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CRS-11
The FDA defines “xenotransplantation” as “any procedure that involves the
transplantation, implantation, or infusion into a human recipient of either (a) live
cells, tissues, or organs from a nonhuman source, or (b) human body fluids, cells,
tissues or organs that have had ex vivo contact with live nonhuman animal cells,
tissues or organs.”26 So transplantation therapy involving Bush approved stem cell
lines, which all have been exposed to mouse feeder cells, would constitute
xenotransplantation. Xenotransplantation products are subject to regulation by the
FDA under Section 351 of the Public Health Service Act (42 USC 262) and the
Federal Food, Drug and Cosmetic Act (21 USC 321 et seq.). FDA has developed
guidance documents and the U.S. Public Health Service has developed guidelines on
infectious disease issues associated with xenotransplantation.27
During a Senate hearing on stem cell research held by the Health, Education,
Labor and Pensions Committee on September 5, 2001, HHS Secretary Thompson
stated that the FDA is overseeing 17 investigational protocols involving
xenotransplantation in other areas of clinical research that involve patients.
Therefore, the xenotransplantation-related public health concerns over the human
embryonic stem cell lines may not necessarily preclude the development of
treatments for patients. While the problems presented by xenotransplantation for
clinical research are neither unique to stem cell research nor insurmountable, many
scientists believe it will be preferable to use sterile cell lines when attempting to treat
patients via stem cell transplantation, and scientists have been successful in
developing human embryonic stem cells that can be maintained without the use of
mouse feeder cells.28
NIH Research Funding and Stem Cell Registry. The August 9, 2001,
Bush Administration policy statement on stem cell research and the NIH Stem Cell
Registry effectively replaced the NIH stem cell guidelines that were developed under
the Clinton Administration and never fully implemented. Grant proposals for
embryonic stem cell research undergo only the normal peer-review process without
the added review of the HPSCRG as had been specified under the Clinton NIH stem
cell guidelines. In February 2002, NIH announced the approval of the first
expenditures for research on human embryonic stem cells. Funding for stem cell
research by NIH is shown in Table 1. The NIH website provides additional
information about current stem cell activities and funding opportunities.29
The NIH Human Embryonic Stem Cell Registry lists stem cell lines that are
eligible for use in federally funded research and currently available to be shipped to
scientists.30 As shown in Table 2, the NIH registry originally listed universities and
26 Xenotransplantation Action Plan: FDA approach to the regulation of xenotransplantation.
Available at [http://www.fda.gov/cber/xap/xap.htm].
27 These documents are available at [http://www.fda.gov/cber/xap/xap.htm].
28 National Institutes of Health, Department of Health and Human Services, Stem Cells:
Scientific Progress and Future Research Directions, June 2001, pp. 95-96.
29 See [http://stemcells.nih.gov/research/funding/].
30 Information about the NIH Human Embryonic Stem Cell Registry is available at
[http://stemcells.nih.gov/research/registry/index.asp].

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CRS-12
companies that had derived a total of 78 human embryonic stem cell lines which
were eligible for use in federally funded research under the August 2001 Bush
Administration policy. However, many of these stem cell lines were found to be
either unavailable or unsuitable for research. As of August 11, 2004, the NIH
registry listed a total of 22 stem cell lines available from seven sources.
Table 1. National Institutes of Health Funding
($ in millions)
FY99
FY00
FY01
FY02
FY03
FY04
FY05
FY06
Stem cell research
$226
$256
$306
$387
$517
$553
$566
$568
Human embryonic
stem cell research
(0)
(0)
(0)
(10.7)
(20)
(24)
N/A
N/A
Source: NIH Budget Office, May 3, 2005.
Table 2. NIH List of Human Embryonic Stem Cell Lines Eligible
for Use in Federal Research
Number of stem cell
Namea
lines
Eligible
Available
BresaGen, Inc., Athens, GA
4
3
Cell & Gene Therapy Institute (Pochon CHA University), Seoul,
Korea
2
Cellaritis AB, Goteborg, Sweden
3
2
CyThera, Inc., San Diego, CA
9
0
ES Cell International, Melbourne, Australia
6
6
Geron Corporation, Menlo Park, CA
7
Goteborg University, Goteborg, Sweden
16
Karolinska Institute, Stockholm, Sweden
6
0
Maria Biotech Co. Ltd. — Maria Infertility Hospital Medical
Institute, Seoul, Korea
3
MizMedi Hospital — Seoul National University, Seoul, Korea
1
1
National Center for Biological Sciences/Tata Institute of
Fundamental Research, Bangalore, India
3
Reliance Life Sciences, Mumbai, India
7
Technion University, Haifa, Israel
4
3
University of California, San Francisco, CA
2
2
Wisconsin Alumni Research Foundation, Madison, WI
5
5
Total
78
22
a. Entities in italics do not have stem cell lines available for shipment to U.S. researchers because of
a variety of scientific, regulatory and legal reasons. The zeros entered in the “Available”
column indicate that “the cells failed to expand into undifferentiated cell cultures.”

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CRS-13
Concerns Over Access to Stem Cell Lines
Many scientists, disease advocates and others remain concerned that federally
supported research on human embryonic stem cells is limited to the number of cell
lines that meet the criteria of the August 9, 2001 Bush policy. As stated above,
currently 22 cell lines are available for research with federal dollars, and an
unpublished NIH report indicates that under a best case scenario, a total of 23 human
embryonic stem cell lines will ever be ready for use in research.31 Because the pre-
August 9 cell lines were developed in the early days of human stem cell research
using older 1990s techniques, the cell lines not only have the problems of
xenotransplantion (described in the previous section on FDA regulation), but they are
harder to work with, not well characterized, and somewhat unstable.
In reaction to the limitations imposed by the Bush policy, some U.S. research
groups have decided to develop additional human embryonic stem cell lines using
private funding.
Reproductive Genetics Institute. In June 2004, a team of scientists at the
Reproductive Genetics Institute, a private fertility clinic in Chicago, announced that
they had isolated 50 new human embryonic stem cell lines from frozen embryos that
were donated by patients following fertility treatment.32 By using genetic diagnosis
techniques, the Chicago team was able to create stem cell lines that carry the gene for
muscular dystrophy as well as stem cell lines with the gene for six other diseases.33
The new stem cell lines are to be used to understand the origins of disease-related
symptoms and to develop and test new treatments.
Harvard Stem Cell Institute. In March 2004, a Harvard University
laboratory headed by Douglas Melton announced that using private research dollars
they had isolated 17 new human embryonic stem cell lines.34 One year later the
Harvard team has increased that number to 28 new human embryonic stem cell
lines.35 In order to perform this work it was necessary to build a new laboratory so
that the group’s federally funded research would be conducted separately from
research on the new stem cell lines. Likewise, although the Harvard stem cell lines
are available for use by other laboratories, any research using the new stem cell lines
must be performed at a facility that does not receive federal support. The Harvard
group intends to raise $100 million in private funding to establish a stem cell research
institute in order to continue the work begun by Melton and his group of scientists;
31 Farhad Manjoo, “Thou Shalt Not Make Scientific Progress,” Salon.com, Mar. 25, 2004,
[http://www.salon.com/tech/feature/2004/03/25/stem_cells/index_np.html].
32 Gareth Cook, “Clinic in U.S. Isolates 50 Lines of Stem Cells,” Boston Globe, June 9,
2004, p. A1.
33 The six diseases are beta thalassemia, neurofibromatosis type 1, Marfan’s syndrome,
myotonic dystrophy, fragile X syndrome, and Fanconi’s anemia.
34 Rick Weiss and Justin Gillis, “New Embryonic Stem Cells Made Available,” Washington
Post, Mar. 4, 2004, p. A2.
35 Gareth Cook, “Harvard Provost OKs Procedure,” Boston Globe, Mar. 20, 2005, p. A29.
(Hereafter cited as Cook, “Harvard Provost OKs Procedure.”)

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CRS-14
as of March 2005 $26 million had been raised. In October 2004 media reports stated
that researchers at the newly formed Harvard Stem Cell Institute intend to produce
cloned human embryos for research studies on juvenile diabetes, Parkinson’s disease,
and several other diseases.36 In November 2003 Melton and collaborators submitted
their proposal to a Harvard committee composed of ethicists, scientists and public
policy experts. Permission to proceed with the research was granted in January 2005
provided that approval was received from the Standing Committee on the Use of
Human Subjects in Research.37
Stanford Institute for Cancer/Stem Cell Biology. In December 2002,
Stanford University announced that a gift of $12 million from an anonymous donor
would be used to establish an institute that will use expertise in stem cell biology and
cancer biology to develop novel treatments for cancer and other diseases.38 The new
institute is headed by Dr. Irving Weissman, a Professor in Cancer Biology at
Stanford. Scientists at the Institute for Cancer/Stem Cell Biology and Medicine are
developing new stem cell lines, some through the process of SCNT, to study the
disease process of a wide range of disorders including cancer, diabetes,
cardiovascular disease, autoimmune disease, allergies, and neurological disorders
such as Parkinson’s and Lou Gehrig’s disease. Initial studies are performed in mice;
however, the work may be extended to human cells and eggs. The new stem cell lines
may allow investigators to better understand the biological and genetic basis of a
disorder and thereby develop new treatments.
UCSF Developmental and Stem Cell Biology Program. In August
2002, the University of California at San Francisco established the UCSF
Developmental and Stem Cell Biology Program with a $5 million matching grant
from Andy Grove, the chairman of Intel Corporation. The program funds basic
studies (using both animal and human cells) in stem cell biology and their translation
into clinical practice with a goal of developing treatments for such diseases as
diabetes, cardiovascular disease, Parkinson’s disease, Alzheimer’s disease and spinal
cord injury. UCSF and the University of Wisconsin are the only two universities in
the United States that have derived human embryonic stem cell lines that qualified
for inclusion on the NIH Stem Cell Registry. This past winter, the new UCSF stem
cell program announced it had met the Grove “Stem Cell Challenge” and had raised
the total funding for the program to more than $11 million in gifts and matching
funds. The program recently awarded $50,000 grants to four scientists who are
studying various aspects of stem cell biology.39
Worldwide Survey of Stem Cell Lines. A worldwide survey of
laboratories conducted by the Boston Globe found that as of May 23, 2004, 128
36 Gareth Cook, “Harvard Team Wants OK to Clone; Human-Cell Work Would Be First in
Nation,” Boston Globe, Oct. 13, 2004, p. A1.
37 Cook, “Harvard Provost OKs Procedure.”
38 For further information, see the Stanford University Medical Center website at
[http://mednews.stanford.edu/stemcellQA.html].
39 UCSF News Office, UCSF Names First Director of its Stem Cell Biology Program, Apr.
26, 2004. See [http://pub.ucsf.edu/newsservices/releases/200404261/].

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CRS-15
human embryonic stem cell lines had been created since August 9, 2001; all would
be ineligible for use in federally funded research under the Bush policy on stem cell
research.40 More lines are being created in laboratories overseas than in the United
States, according to the survey. The survey found that 94 were created in labs outside
the United States and 34 were created in this country. Of the 128 lines, 51 of the new
stem cell lines are currently available for use, the remaining cell lines are not
available for a variety of technical or legal reasons. For example, some cell lines
have not yet been fully characterized to determine their stability or suitability for
research. However, eventually their status is to be determined by using laboratory
techniques. In Japan, stem cell lines are not allowed to be shipped to laboratories in
other countries. In the United Kingdom, stem cell lines cannot be shipped abroad
until they have been processed by the new UK Stem Cell Bank.41
Congressional Letters on Bush Policy. In response to concerns over
access to human embryonic stem cell lines, in April 2004, a group of over 200
Members of the House of Representatives sent a letter to President Bush requesting
that the Administration revise the current stem cell policy and utilize the embryos
that are created in excess of need during the treatment of infertile couples.42 The
letter points out that an estimated 400,000 frozen IVF embryos43 “will likely be
destroyed if not donated, with informed consent of the couple, for research.”
According to the letter,
scientists are reporting that it is increasingly difficult to attract new scientists to
this area of research because of concerns that funding restrictions will keep this
research from being successful. ... We have already seen researchers move to
countries like the United Kingdom, which have more supportive policies. In
addition, leadership in this area of research has shifted to the United Kingdom,
which sees this scientific area as the cornerstone of its biotech industry.
Under the direction of the White House, NIH Director Elias A. Zerhouni sent
a letter in response to the House Members which restates the Bush Administration
position against using federal funds for research involving the destruction of human
embryos.44 The letter from NIH Director Zerhouni did contain the following sentence
which some observers believe indicates a potential future policy shift: “And
although it is fair to say that from a purely scientific perspective more cell lines may
well speed some areas of human embryonic stem cell research, the president’s
40 Gareth Cook, “94 New Cell Lines Created Abroad since Bush Decision,” Boston Globe,
May 23, 2004, p. A14.
41 For further information on the UK Stem Cell Bank, see [http://www.nibsc.ac.uk/divisions/
cbi/stemcell.html].
42 See [http://www.house.gov/degette/news/releases/040428.pdf].
43 A survey conducted in 2002 and published in 2003 by the Society for Assisted
Reproductive Technology and RAND determined that nearly 400,000 frozen embryos are
stored in the United States, but most are currently targeted for patient use. See David I.
Hoffman et al., “Cryopreserved Embryos in the United States and Their Availability for
Research,” Fertility and Sterility, vol. 79, May 2003, pp. 1063-1069.
44 Rick Weiss, “Bush’s Stem Cell Policy Reiterated, but Some See Shift,” The Washington
Post, May 16, 2004, p. A18.

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CRS-16
position is still predicated on his belief that taxpayer funds should not ‘sanction or
encourage further destruction of human embryos that have at least the potential for
life.”45 Although White House spokesperson Claire Buchan stated that the sentence
does not indicate the president’s position has changed, supporters of stem cell
research point out that it concedes that science could benefit from additional stem
cell lines and that the president’s position now rests solely on ethical arguments.
A letter signed by 58 Senators urging President Bush to expand the current
federal policy concerning embryonic stem cell research was sent on June 4, 2004.46
The letter states that “despite the fact that U.S. scientists were the first to derive
human embryonic stem cells, leadership in this area of research is shifting to other
countries such as the United Kingdom, Singapore, South Korea and Australia.”
On July 14, 2004, HHS Secretary Thompson announced in a letter to Speaker
of the House Dennis Hastert that NIH would establish Centers of Excellence in
Translational Stem Cell Research.47 The new centers will be funded by $18 million
in grants over a four year period and will investigate how stem cells can be used to
treat a variety of diseases. NIH will also create a National Embryonic Stem Cell
Bank that will collect in one location many of the stem cell lines that are eligible for
federal research funding. In the letter to Speaker Hastert, Secretary Thompson stated
that “before anyone can successfully argue the stem cell policy should be broadened,
we must first exhaust the potential of the stem cell lines made available with the
policy.”48 In reaction to the announcement, the President of the Coalition for the
Advancement of Medical Research stated that “creating a bank to house stem cell
lines created before August 2001 does nothing to increase the wholly inadequate
supply of stem cell lines for research.”49
National Academies Guidelines. 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 each institution
conducting human embryonic stem cell research establish an oversight committee,
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
45 Letter from Elias A. Zerhouni, Director, National Institutes of Health, to The Honorable
Diana DeGette and The Honorable Michael Castle, May 14, 2004.
46 See [http://feinstein.senate.gov/04Releases/r-stemcell-ltr.pdf].
47 Andrew J. Hawkins, “NIH Stem Cell Bank, Centers of Excellence Will Fast-Track
Translational Research, Says Thompson,” Washington FAX, July 15, 2004.
48 Ibid.
49 Ibid.

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CRS-17
a national panel also be established to oversee the issue in general on a continuing
basis. The guidelines state that culture of any intact embryo, regardless of derivation
method, for more than 14 days should not be permitted at the present time. The
insertion of any embryonic stem cells into a human embryo or the insertion of human
embryonic stem cells into a nonhuman primate embryo should also not be permitted.
Such an organism containing two or more genetically distinct cell types, from the
same species or different species, is often called a chimera. The guidelines state that
chimeric 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.
State Actions on Embryonic Stem Cell Research
The Dickey Amendment restricts federal funding for embryo research; however,
states are the principal sources of direct regulation of non-federally funded embryo
research. State laws vary widely in their application and content.
States that Prohibit Research on an Aborted Fetus or Embryo. In
an effort to discourage abortion, 15 states restrict research on fetuses and embryos
that have been aborted, which may preclude some forms of stem cell research.
Among the states with such restrictions are California, which encourages stem cell
research in other law, Pennsylvania, which is considering pro-stem cell research
legislation, and Nebraska, which prohibits the use of state funds for stem cell
research. The restrictions on aborted fetal and embryonic tissue research vary in
scope among the states. Arizona, Indiana, North Dakota, Ohio, Oklahoma, and South
Dakota prohibit research on living and nonliving fetuses or embryos. Arkansas,
California, Florida, Montana, and Nebraska prohibit research on aborted live fetuses.
Massachusetts and Pennsylvania prohibit research on embryos and live fetuses.
Illinois prohibits research on aborted living and nonliving fetuses. Missouri prohibits
research on live fetuses before abortion. The remaining 35 states do not prohibit
research using aborted fetal tissue.
States that Prohibit Research on Tissue Derived from IVF or
Cloning. Thirteen states have restrictions on research using fetal or embryonic
tissue derived from processes other than abortion (such as in vitro fertilization (IVF)
or cloning), which may also preclude some forms of stem cell research. Among them
are Louisiana, which is considering pro-stem cell legislation, and North Dakota,
South Dakota and Illinois, which also prohibit research on fetuses and embryos.
Illinois prohibits research on fetuses and embryos. Louisiana prohibits research on
fetuses and embryos in utero and in vitro. Maine, New Mexico, Rhode Island, and
Utah prohibit research on fetuses or embryos born or extracted alive. This restriction
does not apply to pre-implantation in vitro fertilized embryos. South Dakota
prohibits research on embryos outside of a woman’s body or on cells or tissues
derived from an embryo outside a woman’s body. Minnesota prohibits research on
fetuses and on some live embryos. Michigan and North Dakota prohibit research on
live embryos and fetuses, or cloned embryos. The law in Virginia may prohibit

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CRS-18
research on cloned embryos or fetuses.50 Arkansas and Iowa prohibit research on
cloned embryos. Thirty-seven states have no such restrictions.
State Initiatives to Encourage Stem Cell Research. Despite federal
policy, many states are moving forward with their own initiatives to encourage or
provide funding for stem cell research (in some cases therapeutic cloning as well) in
order to remain competitive and prevent the relocation of scientists and
biotechnology firms to other states or overseas. However, without the central
direction and coordinated research approach that the federal government can provide,
many are concerned that the states’ actions will result in duplication of research effort
among the states, a possible lack of oversight for ethical concerns and ultimately a
loss of U.S. preeminence in this important area of basic research.
California. In September 2002 California enacted the nation’s first law that
expressly permits and encourages research involving the derivation of human
embryonic stem cells and cloned embryos (California Health and Safety Code §
123440, 24185, 12115-7, 125300-320). The law does not authorize practices that
were previously proscribed, but instead provides assurances to researchers and
sponsors hesitant to invest in embryonic stem cell research since the 2001 Bush
policy took effect. The law has reportedly enticed several prominent researchers to
move to California from other states.
In November 2004, with the endorsement of Governor Arnold Schwarzenegger,
Californians passed Proposition 71 with 59% of the vote, amending the state
Constitution to facilitate embryonic stem cell research. Proposition 71 establishes
a California Institute for Regenerative Medicine (CIRM), and generates $3 billion in
state-bond funding for embryonic stem cell research over the next 10 years. Ninety
percent of the funds will be spent on research, 10% will go toward facilities. All
grants will be limited to scientists and facilities in California. Funds may not be used
for reproductive cloning but may be used for therapeutic cloning.51 In early May
2005 the 29 member governing board of CIRM, the Independent Citizens Oversight
Committee (ICOC), announced the selection of San Francisco as the headquarters for
CIRM which is expected to employ about 50 people. CIRM’s first request for grant
applications will be for the training of postdocs and fellows in stem cell science.52
However, CIRM has had a few legislative and legal challenges that are holding
up the bond sale. CIRM officials reached a tentative agreement with state legislators
50 “Virginia law does not expressly prohibit research on cloned embryos, but it is forbidden
to possess the product of human cloning. Under the state human cloning statute human
cloning is defined as the creation of or attempt to create a human being by transferring the
nucleus from a human cell from whatever source into an oocyte from which the nucleus has
been removed. Human being is not defined as to whether it includes neonates, embryos or
fetuses only.” Alissa Johnson, “State Embryonic and Fetal Research Laws,” National
Council of State Legislatures, Jan. 27, 2004, at [http://www.ncsl.org/programs/health/
genetics/embfet.htm#b].
51 Proposition 71, at [http://www.voterguide.ss.ca.gov/propositions/prop71text.pdf].
52 Shirley Haley, “More Than Dollars, California Stem Cell Initiative Offers Predictability,”
Washington Fax, Apr. 29, 2005.

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CRS-19
regarding concerns over conflicts of interest and the need for open meetings: Other
concerns involving intellectual property and patent rights are yet to be resolved.53
Three lawsuits have been filed by various anti-abortion groups: one claims that the
CIRM program violates the rights of human embryos; a second charges the program
violates the state constitution because it lacks proper state oversight; and the third
claims that individuals on the ICOC have conflicts of interest that impede the ICOC’s
ability to fairly allocate money.54 Some believe resolution of the lawsuits could take
as long as 18 months. CIRM is currently funded by a $3 million state loan and a $5
million grant from the Dolby Foundation. Bridge financing in the form of bond
anticipation notes were offered to institutional investors. Because there were no
interested buyers, CIRM has approached philanthropic groups with the proposal for
$200 million in anticipation notes but this plan is likely to be challenged in court.
Wisconsin. In response to the California initiative, Wisconsin Governor Jim
Doyle announced on November 17, 2004, that the state was providing nearly $750
million in public-private investment for biotechnology, health sciences and stem cell
research over the next several years.55 The Wisconsin investment strategy includes
$375 million for a new research institute, the Wisconsin Institute for Discovery, on
the University of Wisconsin, Madison campus. WiCell, a foundation that is using
private and federal funds to support stem cell research, will be a part of the Institute.
The state also plans to invest $105 million over the next five years in research,
education, and public health efforts at the University of Wisconsin Medical School
and the Medical College of Wisconsin for stem cell research as well as regenerative
medicine, molecular medicine, neuroscience, and cancer research.
In June 2005, however, the Wisconsin State Assembly passed a bill prohibiting
both reproductive and therapeutic cloning. The Senate won’t address the bill until
September. Governor Doyle states he will veto the bill, which has had a chilling
effect on the state’s biotechnology sector making it difficult to recruit scientists and
venture capitol.56
New Jersey. In January 2004 New Jersey became the second state in the
nation to enact a law that specifically permits embryonic stem cell research. The
state law bans human cloning for reproductive purposes but permits the use of cloned
embryos for stem cell research (NJ Permanent Statutes, Title 26:2Z-2). Like the
2002 California law, New Jersey’s stem cell statute provides assurances to
researchers and sponsors and does not contradict the 2001 Bush policy which only
limits federal funding.
53 Carl T. Hall, “Stem Cell Group Ready to Disburse Funds; Institute, Critics Near
Agreement on Conflicts, Meetings,” San Francisco Chronicle, July 2, 2005, p. B1.
54 Steve Johnson, “Lawsuits Will Delay Stem-Cell Research,” The Mercury News, Aug. 2,
2005, p. 1.
55 [http://www.wisgov.state.wi.us/journal_media_detail_print.asp?prid=832]
56 Kathleen Gallagher, “Economics Enters Cloning Debate,” The Milwaukee Journal
Sentinel, July 13, 2005, p. A1.

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CRS-20
In May 2004, Governor James McGreevey signed a bill to create the first
state-funded embryonic stem cell research center, a $25 million endeavor.57 The
legislature funded the measure on June 25, 2004, passing a state budget that allocates
$11.5 million to the newly chartered Stem Cell Institute of New Jersey.58 The state
money is supposed to attract private investment, which Dr. Ira Black, the Institute’s
founding Director, says has already happened.59
In a January 11, 2005, State of the State speech, Acting Governor Richard
Codey called for $380 million for stem cell research.60 The plan entails using $150
million to construct a facility for the Stem Cell Institute of New Jersey near the
Rutgers University campus in New Brunswick; the money would come from the
state’s share of the national tobacco settlement. The remaining $230 million for
research grants would be raised by putting a bond initiative on the November 2005
ballot; the bond initiative would require legislative approval. The plan was tabled
until the lame duck legislative session after the November 2005 elections.61
Massachusetts. In March 2005, the Massachusetts legislature overwhelming
approved a bill (Senate 35-2, House 117-37) that clarifies state law on research
involving human embryonic stem cells and therapeutic cloning and ensures that such
research is permitted within a regulatory framework. On May 27, 2005, Governor
Mitt Romney vetoed the stem cell bill; he is opposed to the therapeutic cloning
portion of the bill. On May 31, 2005, the House overrode the Governor’s veto on a
vote of 112 to 42, the Senate did the same later that day on a vote of 35-2.62
Mechanisms for state funding of research are under consideration.
Maryland. On March 28, 2005, in an 81-53 vote the Maryland House
approved a bill that would provide $23 million each year for human embryonic stem
cell research, including therapeutic cloning, beginning in FY2007. However, the bill
died in the Senate in April 2005 on the last day of the legislative session due to a
threatened filibuster.63 Governor Robert L. Ehrlich had not indicated his support or
opposition to the bill.
57 “U.S. States Making Stem Cell Policies,” Bionews, no. 258, May 5, 2004.
58 Barbara Mantel, “Analysis: New Jersey Is First State to Fund Research on Stem Cell,”
NPR: All Things Considered, June 25, 2004.
59 Ibid.
60 Andrew J. Hawkins, “NJ Stem Cell Initiative Supports Research Institute, Grant Making,
Governor Codey Says,” Washington Fax, Jan. 12, 2005.
61 Josh Margolin, “Watchdog Agency Regains Its Bite,” The Star-Ledger, July 13, 2005,
p. 13.
62 Raphael Lewis, “Stem Cell Bill Override Turns to Talk of Research Support,” The Boston
Globe, June 1, 2005, p. A1.
63 David Nitkin, Sumathi Reddy, and Ivan Penn, “Stem-cell Bill Dies in Senate Threatened
Filibuster on Research Funding Spelled End For Legislation,” Baltimore Sun, Apr. 12, 2005,
p. A1.

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CRS-21
Illinois. Following the defeat of several stem cell research measures during the
spring session of the Illinois legislature, on July 12, 2005, Governor Rod Blagojevich
signed an executive order authorizing $10 million in funding for adult, cord blood,
and embryonic stem cell research. The money was added to the budget of the Illinois
Department of Public Health.64
Connecticut. In January 2005, Connecticut Governor M. Jodi Rell proposed
$20 million in funding for human embryonic stem cell research; the funds would
come from a $315 million state budget surplus.65 Both Yale University and the
University of Connecticut at Storrs have labs engaged in stem cell research. In
March 2005 the Storrs lab announced that, in collaboration with Chinese scientists,
it has become the first lab to create embryonic stem cells from cloned cattle
embryos.66 The Storrs lab wants to begin a human therapeutic cloning program. The
lab chief, Xiangzhong “Jerry” Yang, is being recruited by the National Center for
Stem Cell Research in Beijing to head their stem cell effort; Yang threatened to leave
for China if state funding was not provided. On June 15, 2005, Governor Rell signed
legislation that provides $100 million over 10 years for human embryonic stem cell
research.67
Ohio. The Center for Stem Cell and Regenerative Medicine was started in
2003 with a $19.5 million in funding from the state of Ohio.68 The Center is
composed of researchers from Case Western Reserve University, University
Hospitals of Cleveland, The Cleveland Clinic Foundation, Athersys, Inc., and Ohio
State University. The Center uses adult human stem cells and tissue engineering
technology to develop treatments for human disease. On June 30, 2005, Governor
Bob Taft vetoed language in the state budget that would have prevented state
research funds from being used for human embryonic stem cell research. The veto
allows state funds to be used for research on human embryonic stem cell lines that
existed before August 2001 in accordance with Bush Administration policy.69
Other states, including Delaware, Pennsylvania, Texas, New York, and Florida,
are considering available options to remain competitive and prevent the relocation
of their scientists and biotechnology firms.70
64 John Chase, “Governor slips stem-cell grant by lawmakers,” Chicago Tribune, July 13,
2005, p. 1.
65 Marcel Przymusinski and Susie Poppick, “Locals Seek More Stem Cell Funds,” Yale
Daily News, Jan. 26, 2005.
66 William Hathaway, “State Lab Nears Cloning Goal, UConn Scientist: Creating Human
Embryonic Cells is Within Sight,” The Hartford Courant, Mar. 25, 2005, A1.
67 Fran Silverman, “$100 million Commitment for Stem Cell Research,” The New York
Times, June 19, 2005, p. 2.
68 [http://ora.ra.cwru.edu/stemcellcenter/]
69 “Ohio Governor Vetoes Stem Cell Budget Limitations,” Research Policy Alert, July 6,
2005.
70 Kelly Rayburn, “States Grapple with Stem Cell Research,” The Wall Street Journal, Dec.
24, 2004, p. A4; Martin Kasindorf, “Calif. Moves Fast on Stem Cell Grants,” USA Today,

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Congressional Actions
Legislative action during the 109th Congress may include efforts to alter or
abolish the Dickey Amendment, during consideration of Labor, HHS, and Education
appropriations, in order to permit embryo research and the development of stem cell
lines with federal support. Also likely is passage of the Weldon bill, which passed
the House in the 107th and the 108th and stalled in the Senate. Given the changed
composition of the Senate, it is more likely that this legislation would move forward
for a vote in that body during the 109th Congress.
The 108th Congress addressed the issue of stem cell research in the Consolidated
Appropriations Act, 2005 (P.L. 108-447) by again including the Dickey Amendment,
which has banned, since FY1996, almost all publically funded human embryo
research. The act also 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), could potentially deter human stem cell research because researchers
might not be able to claim ownership of their work.
In FY2004, the Consolidated Appropriations Act, 2004 (P.L. 108-199) provided
$10,000,000 to establish a National Cord Blood Stem Cell Bank within the Health
Resources and Services Administration (HRSA). HRSA was directed to use
$1,000,000 to contract with the Institute of Medicine (IoM) to conduct a study that
would recommend the optimal structure for the cord blood program. The IoM study,
Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program, was
released on April 14, 2005. The blood cell forming stem cells found in cord blood
can be used as an alternative to bone marrow transplantation in the treatment of
leukemia, lymphoma, certain types of anemia, and inherited disorders of immunity
and metabolism. The report provides the logistical process for establishing a national
cord blood banking system, establishes uniform standards for cord blood collection
and storage, and provides recommendations on ethical and legal issues associated
with cord blood collection, storage and use. For FY2005, the Consolidated
Appropriations Act, 2005 (P.L. 108-447) provides $9,941,000 for the National Cord
Blood Stem Cell Bank Program in HRSA.

On May 24, 2005, the House passed H.R. 2520 (Christopher Smith), the Stem
Cell Therapeutic and Research Act of 2005, on a vote of 431-1. H.R. 2520 would
provide for the collection and maintenance of human cord blood stem cells for the
treatment of patients and for research. It stipulates that amounts appropriated in
FY2004 or FY2005 for this purpose shall remain available until the end of FY2006
(about $18.9 million, see above paragraph), and authorizes $60 million over FY2007-
FY2010. The Act also reauthorizes the national bone marrow registry with $158
million over FY2006-FY2010. In addition, it creates a database to enable health care
workers to search for cord blood and bone marrow matches and links all these
functions under a new name, the C.W. Bill Young Cell Transplantation program.
H.R. 596 (Christopher Smith) is an earlier version of this legislation.
Dec. 17, 2004, p. A3; Andrew J. Hawkins, State Stem Cell Efforts Gain Momentum in Wake
of California’s Prop 71, Washington Fax, Jan. 18, 2005.

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A bill similar to H.R. 2520, S. 1317 (Hatch), the Bone Marrow and Cord Blood
Therapy and Research Act of 2005, was introduced in the Senate on June 27, 2005.
S. 1317 was reported (without a written report) with an amendment in the nature of
a substitute by the Committee on Health, Education, Labor, and Pensions on July 11,
2005. S. 681 (Hatch) is an earlier version of this legislation.
H.R. 162 (Millender-McDonald), the Stem Cell Replenishment Act of 2005,
was introduced on January 4, 2005. H.R. 162 would authorize the use of federal
funds for research on human embryonic stem cells irrespective of the date on which
the derivation process for the stem cells was initiated or completed. The bill would
direct the Director of NIH to review the guidelines and notices published by NIH
with respect to human embryonic stem cell research and revise the guidelines and
notices to ensure the availability of not less than 60 stem cell lines that are able to be
used for scientific research. H.R. 162 was referred to the House Committee on
Energy and Commerce.
On May 24, 2005, the House passed H.R. 810 (Castle), the Stem Cell Research
Enhancement Act of 2005, on a vote of 238-194. H.R. 810 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.
H.R. 1650 (Nancy Johnson), the Stem Cell Research Investment Act of 2005,
was introduced on April 14, 2005. The bill would amend the Internal Revenue Code
of 1986 to allow tax credits to holders of stem cell research bonds. It would make
available $10 billion in bonding authority to the states over calendar years 2006
through 2008. H.R. 1650 has been referred to the House Ways and Means
Committee.
H.R. 3144 (Bartlett), the Respect for Life Pluripotent Stem Cell Act of 2005,
was introduced on June 30, 2005. H.R. 3144 would amend the Public Health Service
Act to provide for a program at NIH to conduct and support stem cell research that
does not harm human embryos. Such research may include research on animal
embryos or human postnatal tissues or umbilical cord blood. The bill specifically
prohibits research that (1) involves the use of human embryos; (2) involves the use
of stem cells not otherwise eligible for funding by NIH; (3) involves the use of any
stem cell to create or to attempt to create a human embryo; or (4) poses a significant
risk of creating a human embryo by any means. H.R. 3144 authorizes $15 million
for research in FY2006 and such sums as may be necessary for FY2007 through
FY2010. H.R. 3144 was referred to the House Committee on Energy and Commerce.

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CRS-24
H.R. 2574 (Bartlett), the Respect for Life Embryonic Stem Cell Act of 2005,
introduced on May 24, 2005, appears to be an earlier version of this legislation. A
companion bill, S. 1557 (Coburn), was introduced on July 29, 2005.
S. 1373 (Brownback), the Human Chimera Prohibition Act of 2005, was
introduced on July 11, 2005. S. 1373 amends the federal criminal code to prohibit
and to set penalties for (1) creating or attempting to create a human chimera (a being
with human and non-human tissue as specified in this Act); (2) transferring or
attempting to transfer a human embryo into a non-human womb, or a non-human
embryo into a human womb; or (3) transporting or receiving a human chimera. S.
1373 defines a human chimera as (A) a human embryo into which a non-human cell
or cells (or the component parts thereof) have been introduced to render its
membership in the species Homo sapiens uncertain through germline or other
changes; (B) a hybrid human/animal embryo produced by fertilizing a human egg
with non-human sperm; (C) a hybrid human/animal embryo produced by fertilizing
a non-human egg with human sperm; (D) an embryo produced by introducing a
non-human nucleus into a human egg; (E) an embryo produced by introducing a
human nucleus into a non-human egg; (F) an embryo containing haploid sets of
chromosomes from both a human and a non-human life form; (G) a non-human life
form engineered such that human gametes develop within the body of a non-human
life form; or (H) a non-human life form engineered such that it contains a human
brain or a brain derived wholly or predominantly from human neural tissues. S. 1373
was referred to the Senate Committee on the Judiciary. S. 659, introduced on March
17, 2005, was an earlier version of this legislation.
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 that 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.71 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
71 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.

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CRS-25
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.).72 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 46,73 or Parts 50 and
56 of 21 C.F.R.74 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
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
72 Because they amend different titles of the U.S. Code, the bills would likely be subject to
different committee jurisdiction.
73 This provision specifies protections due to human beings who participate in research
conducted or supported by HHS and many other departments.
74 This provision specifies protections due to human beings who participate in research
involved in testing a drug or medical device for FDA approval.

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CRS-26
Judiciary Committee. H.R. 1822 has been referred to the House Energy and
Commerce Committee.
S. 1520 (Feinstein), the Human Cloning Ban Act of 2005, was introduced on
July 27, 2005. S. 1520 is the same as S. 876 except that it does not require oversight
reports prepared by the Comptroller General and does not delineate specific ethical
requirements on the separate topic of SCNT research.
Supporters of a total ban on human cloning, such as that contained in H.R. 1357,
argue that a partial ban on human cloning, like the one in S. 876, would be
impossible to enforce. Critics of the total 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 overseas.
The U.S. Supreme Court has recognized in past cases certain personal rights as
being fundamental and protected from government interference.75 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.”76 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.”77
However, no case involving these issues is scheduled to come before the Supreme
Court this term.
International Actions on Embryonic Stem Cell Research
The international community has taken a variety of action regarding stem cell
research. In November 2004, the UNGA “averted a divisive vote” on two
international conventions against human cloning by adopting Italy’s proposal “to take
up the issue again as a declaration at a resumed February session.”78 “A convention
is a legally binding treaty, coming into force upon ratification by a certain number of
States. A declaration is not legally binding but carries moral weight because it is
75 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.
76 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.
77 Ibid., p. 667.
78 Press Release GA/L/3270 “Legal Committee Text Calls for Further Discussions on
Human Cloning aimed at ‘Declaration’,” United Nations, November 19, 2004, at
[http://www.un.org/News/Press/docs/2004/gal3270.doc.htm].

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CRS-27
adopted by the international community.”79 Two convention proposals had been
under consideration. One, introduced by Costa Rica and backed by the United States,
aimed to proscribe all human embryonic cloning. A second proposal, introduced by
Belgium, sought to proscribe only reproductive cloning. Both convention proposals
were supplanted by the adoption of the Italy’s proposal for a declaration. On March
8, 2005, the United Nations General Assembly (UNGA)80 approved a nonbinding
resolution urging member states to adopt legislation “to prohibit all forms of human
cloning in as much as they are incompatible with human dignity and the protection
of human life.” The resolution passed with a vote of 84 to 34 and 37 abstentions; the
United States voted for the measure.
The European Union (EU) clarified its stem cell rules in November 2003,
smoothing the path for EU funding and support for human embryonic stem cell
research.81 Under the terms of its sixth research framework program(FP6), the EU
may fund embryonic stem cell research regardless of the date that the stem cells were
procured from embryos. A cut-off date, which would have created a restriction
similar to the one in the 2001 Bush policy, was under consideration, but was
dropped.82 FP6 allows funding for research on tissue derived from “spontaneous or
therapeutic abortion,” but not for the creation of human embryos for the purpose of
stem cell procurement.83 FP6 implies but does not state that it will allow funding for
research on embryos that remain after IVF, in that it “no longer requir[es] parental
consent where embryos have to be destroyed in order to produce embryonic stem cell
lines.”84 According to Members of the European Parliament, FP6 funding decisions
should depend “both upon the contents of the scientific proposal and the legal
framework of the Member States involved.”85
79 United Nations, “Human Rights at Your Fingertips,” 1997 at [http://www.un.org/
rights/50/game.htm#28].
80 The General Assembly is the main deliberative organ of the United Nations. It is
composed of representatives of all 191 member states, each of which has one vote.
Decisions on important questions, such as those on peace and security, admission of new
Members and budgetary matters, require a two-thirds majority. Decisions on other questions
are reached by a simple majority, at [http://www.un.org/ga/58/ga_background.html].
81 Committee on Industry, External Trade, Research and Energy, “Integrating and
Strengthening the European Research Area” (2002-2006) (COM(2003) 390 —
C5-0349/2003 — 2003/0151(CNS)) European Parliament (A5-0369/2003), Nov. 4, 2003.
82 John T. Softcheck, “European Union Moves Close to Funding Stem Cell Research with
Two Parliament Votes,” Washington Fax, Nov. 10, 2003.
83 Ibid.
84 “Sixth Framework Programme,” Bulletin EU 11-2003, Research and technology (8/10),
Nov. 26, 2003, at [http://europa.eu.int/abc/doc/off/bull/en/200311/p103069.htm].
85 John T. Softcheck, “European Union Moves Close to Funding Stem Cell Research with
Two Parliament Votes,” Washington Fax, Nov. 10, 2003.

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EU member states have a range of legislation on the subject. According to the
European Commission, the following distinctions can be made as of July 2004:86
! Allowing for the procurement of human embryonic stem cells
from excess IVF embryos87 by law under certain conditions:
Belgium, Denmark, Finland, France, Greece, the Netherlands,
Spain,88 Sweden, Switzerland,89 and the United Kingdom.90
! Allowing some research activities on excess IVF embryos, but
having no specific reference to human embryonic stem cell
research: Estonia, Hungary, Latvia and Slovenia.
! Prohibiting the procurement of human ES cells from excess IVF
embryos but allowing by law for the import and use of human
embryonic stem cell lines under certain conditions: Germany.
The import and use of human ES cell lines is not explicitly
prohibited in, e.g., Austria and Italy.
! Prohibiting the procurement of human ES cells from excess IVF
embryos: Austria, Ireland Lithuania, Poland and Slovak Republic.
! No specific legislation regarding human embryo research or
human ES cell research: Czech Republic, Luxembourg, Malta,
Portugal and the republic of Cyprus.
! Allowing by law for the creation of human embryos for research
purposes: UK and Belgium are for the moment the only Member
86 Matthiessen-Guyader, ed., “Survey on Opinions from National Ethics Committees or
Similar Bodies, Public Debate and National Legislation in Relation to Human Embryonic
Stem Cell Research and Use,” European Commission, Directorate General: Research, July
2004, at [http://www.europa.eu.int/comm/research/biosociety/pdf/mb_states_230804.pdf].
87 The European Commission used the term “supernumerary” rather than “excess IVF”
throughout their description.
88 Spain “will initially have two ES cell research centers.” “Spain to Begin ES Cell
Research,” Bionews, no. 278, Sept. 27-Oct. 3, 2004, at [http://www.bionews.org.uk/
new.lasso?storyid=2292]. In October 2004, Spain’s new Socialist government “made it
easier for stem cell research to be undertaken” by providing a “framework for granting
authorization for embryo use as well as setting out requirements for corresponding embryo
studies.” Xavier Bosch, “Spain Eases Embryo Research,” The Scientist, Nov. 1, 2004, at
[http://www.the-scientist.com/news/20041101/01].
89 In November 2004, Swiss voters “endorsed legislation on stem cell research that forbids
the cloning of human embryos but allows scientists to extract the cells from unwanted
embryos to use in research.” “Swiss Voters Back Stem Cell Research,” Los Angeles Times,
Nov. 29, 2004, A4.
90 The UK opened “the world’s first embryonic stem cell bank,” in May 2004, and two
months later “founded a new £16.5 million (USD $30 million) stem cell center in Cambridge
... with a commitment to fundamental research on both human embryonic and adult stem
cells as a precursor to studying therapeutic applications.” Philip Hunter, “UK to Open Stem
Cell Center,” The Scientist, June 22, 2004, at [http://www.the-scientist.com/news/
20040622/04]. In August 2004, the UK’s Human Fertilisation and Embryology Authority
granted the first license to create embryonic stem cells using SCNT. “HFEA Grants the
First Therapeutic Cloning License for Research” HFEA, Aug. 11, 2004, at
[http://www.hfea.gov.uk/PressOffice/Archive/1092233888].

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States, which allow by law for the creation of human embryos either
by fertilization of an egg by a sperm, or by somatic cell nuclear
transfer (SCNT, also called therapeutic cloning) for stem cell
procurement. The Dutch Embryo Act of 2002 includes a five-year
moratorium for the creation of embryos for research purposes
including by SCNT.
! Prohibiting the creation of human embryos for research
purposes and for the procurement of stem cells by law or by
ratification of the Convention of the Council of Europe on
Human rights and Biomedicine signed in Oviedo on April 4,
1997: Austria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Italy,91 Ireland, Netherlands,
Lithuania, Portugal, Slovak Republic, Slovenia and Spain.
Other countries’ activities designed to regulate and promote stem cell research
have come to the attention of Congress.92 For example, in March 2004, the Canadian
government enacted legislation allowing stem cell and other research to be conducted
on donated embryos created but no longer needed for reproductive purposes.93 Japan
allows the creation of embryos for stem cell and other research, so that its researchers
can “obtain intellectual property rights based on such research.”94 Australia permits
the use of spare IVF embryos for stem cell research,95 and its government has
reportedly allotted $57.9 million to its National Stem Cell Centre.96 Singapore,
which allows scientists to clone human embryos and keep them alive for up to 14
days to extract the stem cells, is reported to have “research-friendly policies and
generous government funding have already helped jump-start the tiny city-state’s
nascent stem cell sector. ... Singapore and the New York-based Juvenile Diabetes
91 A 2003 Italian law prohibits experiments on human embryos, the production of embryos
for research purposes, and any destruction of human embryos. Guidelines for the Italian
law’s implementation, revealed in July 2004, have been criticized by some, and have
buttressed calls “for the resignation of Health Minister, Girolamo Sirchia,” a supporter of
the law. The new law compels couples using IVF to transfer all fertilized embryos to the
uterus (including those with genetic disorders), despite the fact that, once implanted, they
could legally aborted. Criticism has also arisen due to the law’s chilling effect on stem cell
research. Rosella Lorsnzi, “Italian Minister in Trouble,” The Scientist, Sept. 9, 2004, at
[http://www.the-scientist.com/news/20040909/04]; Rosella Lorsnzi, “Outrage Over Italian
Law,” The Scientist, Aug. 2, 2004, at [http://www.the-scientist.com/news/20040802/03].
92 See, e.g., Letter from 58 Senators to President George W. Bush, June 4, 2004; Letter from
206 Members of the House of Representatives to President George W. Bush, Apr. 28, 2004.
93 Assisted Human Reproduction Act (Canadian Bill No. C-6, 2004), LS-466E.
94 “Embryo Stem Cell Research OK’d,” The Japan Times, Feb. 14, 2004, available online
at [http://search.japantimes.co.jp/print/news/nn02-2004/nn20040214b1.htm]; See also,
“Japan Allows for Creation of Embryos for Research,” BioNews no. 269, July 26-Aug. 1,
2004, at [http://www.bionews.org.uk/new.lasso?storyid=2209].
95 Research Involving Human Embryos Act, no. 145, 2002.
96 “The National Stem Cell Centre,” Commonwealth of Australia’s Department of
Education, Science and Training, June 2, 2004, at [http://backingaus.innovation.gov.au/
2004/commercial/stem_cell.htm].

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Research Foundation International launched a $3 million funding program to support
stem cell research [in Singapore], ... [and in May 2004, Singapore unveiled] its
resort-like Biopolis, created to give biotech researchers and their families a place to
live and work.”97 South Korea, the home of the doctor who announced in February
2004 that he had cloned human embryos and extracted stem cells from them,
subsequently enacted legislation to regulate and license reproductive cloning.98
Ethical Issues
Stem cell research is controversial not because of its goals, but rather because
of the means of obtaining some of the cells. Research involving most types of stem
cells, such as those derived from adult tissues and umbilical cord blood, is
uncontroversial, except when its effectiveness as an alternative to embryonic stem
cells is debated. The crux of the debate centers around embryonic stem cells, which
enable research that may facilitate the development of medical treatments and cures,
but which require the destruction of an embryo to derive.99 In addition, because
cloning is one method of producing embryos for research, the ethical issues
surrounding cloning are also relevant.
As previously mentioned, the Bush Administration, a group of Representatives,
a group of Senators, and a group of Nobel Laureates have each presented their
respective positions on embryonic stem cell research. In addition, various other
organizations, individuals, and councils have issued opinions and reports on the
topic. Some groups, such as the Christian Legal Society,100 Focus on the Family,101
and the Christian Coalition,102 support the 2001 Bush policy. Others, such as the
National Academies,103 the Coalition for the Advancement of Medical Research
97 “Singapore Hosts Stem Cell Meeting” MSNBC, May 19, 2004, at the MSNBC website
[http://msnbc.msn.com/id/3341644/].
98 “Stem Cells Extracted from Human Clone,” MSNBC, Feb. 12, 2004, at [http://www.
msnbc.msn.com/id/4244988/], visited July 12, 2004; Dr. Hwuang, the South Korean
scientist referenced herein, stated on July 13, 2004 that he is still awaiting his license from
the South Korean Government to continue his cloning and stem cell research. Dr. Wu-Suk
Hwuang, Press Conference on Stem Cell Research, Gijon, Spain, July 13, 2004, 10:30 AM.
99 For an overview of various religious perspectives on embryonic stem cell research, see
LeRoy Walters, “Human Embryonic Stem Cell Research: An Intercultural Perspective,”
Kennedy Institute of Ethics Journal, vol. 14, no. 1 (Mar. 2004), p. 3.
100 The Christian Legal Society is a “national grassroots network of lawyers and law
students, committed to ... advocating biblical conflict reconciliation, public justice, religious
freedom and the sanctity of human life.” [http://www.clsnet.org/clsPages/vision.php],
visited July 15, 2005.
101 Focus on the Family was founded in 1977 by Dr. James Dobson to promote teachings of
Jesus Christ. [http://www.family.org].
102 The Christian Coalition is “the largest and most active conservative grassroots political
organization in America,” [http://www.cc.org].
103 The National Academies brings together “committees of experts in all areas of scientific
and technological endeavor” as “advisors to the Nation.” For statements on embryonic stem
cell research and cloning, see National Research Council, Institute of Medicine, National

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(CAMR),104 former First Lady Nancy Reagan,105 former Presidents Gerald Ford,
Jimmy Carter, Bill Clinton,106 and the Union of Orthodox Jewish Congregations of
America (UOJCA),107 favor more embryonic stem cell research than the Bush policy
allows. Still others, such as the National Right to Life Committee108 and the United
States Conference of Catholic Bishops,109 oppose all embryonic stem cell research.
Two presidential bioethics advisory panels have considered the issues involved
in embryonic stem cell research. The President’s Council on Bioethics (President’s
Council)110 published one report directly on the topic, Monitoring Stem Cell
Research,111 in which it sought to characterize the issues. While the Council made
no recommendations there, in two other reports it has recommended that “Congress
should ... [p]rohibit the use of human embryos in research beyond a designated stage
in their development (between 10 and 14 days after fertilization),”112 and
unanimously recommended “a ban on cloning-to-produce-children,” with a 10-
member majority also favoring “a four-year moratorium on
cloning-for-biomedical-research,” and a seven-member minority favoring “regulation
Academies, Stem Cells and the Future of Regenerative Medicine (Washington: National
Academies, 2001); Committee on Science, Engineering and Public Policy and Global
Affairs Division et al., Scientific and Medical Aspects of Human Reproductive Cloning,
(Washington National Academy Press, 2002) at [http://www.nationalacademies.org/
about/#org].
104 CAMR is a nonprofit organization comprised of patient organizations, universities,
scientific societies, foundations, and individuals with life-threatening illnesses and
disorders, [http://www.camradvocacy.org/fastaction/]. For a statement on embryonic stem
cell research, see Coalition for the Advancement of Medical Research, “Embryonic Stem
Cell Research,” talking points [http://www.camradvocacy.org/fastaction/news.asp?id=167],
visited May 14, 2004.
105 “Nancy Reagan Urges Stem Cell Research,” MSNBC, May 9, 2004, at
[http://www.msnbc.msn.com/id/4937850/], visited May 14, 2004.
106 Ibid.
107 Letter from Harvey Blitz, President, UOJCA, et al., to President George W. Bush, July
26, 2001, at [http://www.ou.org/public/statements/2001/nate34.htm], visited July 14, 2005.
(Hereafter cited as UOJCA letter.)
108 The National Right to Life Committee was founded in 1973 to “restore legal protection
to innocent human life,” at [http://www.nrlc.org/Missionstatement.htm].
109 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/
whoweare.htm].
110 The President’s Council was created by President Bush in Nov. 2001 to “advise the
President on bioethical issues that may emerge as a consequence of advances in biomedical
science and technology.” George W. Bush, “Creation of The President’s Council on
Bioethics,” Executive Order 13237, Nov. 28, 2001.
111 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004.
112 The President’s Council on Bioethics, Reproduction and Responsibility, Mar. 2004,
p. xlviii.

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of the use of cloned embryos for biomedical research.”113 More recently, the
President’s Council published Alternative Sources of Human Pluripotent Stem Cells,
a white paper exploring the ethics of four proposals to attempt to generate human
embryonic stem cells “without creating, destroying, or harming human embryos.”114
A predecessor to the President’s Council, the National Bioethics Advisory
Committee (NBAC),115 recommended federal funding for stem cell research using
“embryos remaining after infertility treatments,” but not for the “derivation or use of
embryos ... made for research purposes.”116
Detailed review of the assorted reports and statements reveals that, while
positions on embryonic stem cell research may be broadly categorized as for or
against, there is an array of finer distinctions present. These finer distinctions in turn
reveal the variation in ethical and moral as well as factual beliefs. The following
discussion breaks down the arguments about embryonic stem cell research according
to these finer distinctions, demonstrating both the complexity of the issues and the
points of resonance among the groups.
Embryo Destruction and Relief of Human Suffering. Most positions
on embryonic stem cell research rest at least in part on the relative moral weight
accorded to embryos and that accorded to the prospect of saving, prolonging, or
improving others’ lives. For some, the inquiry begins and ends with this question.
For instance, one opponent of the research, the American Life League, posits that
113 The President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002,
pp. xxxv- xxxviii). Note: At the June 20, 2002, meeting, nine 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. 252, Mar. 29, 2004.
114 The President’s Council on Bioethics, Alternative Sources of Human Pluripotent Stem
Cells, (May 2005) at [http://www.bioethics.gov/reports/white_paper/index.html], visited
July 14, 2005.
115 In 1995, President Clinton created the National Bioethics Advisory Commission by
Executive Order, to advise him on bioethical issues. The Order expired in 2001. “Former
Bioethics Commissions,” President’s Commission on Bioethics website, at [http://www.
bioethics.gov/reports/past_commissions/index.html], visited Jun. 30, 2004.
116 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, pp. 70-71.

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“human life begins at conception / fertilization and that there is never an acceptable
reason for intentionally taking an innocent human life.”117 Similarly, the United
States Conference of Catholic Bishops states that the research is immoral because it
“relies on the destruction of some defenseless human beings for the possible benefit
to others.”118
Some groups explore the moral standing of human embryos, and also consider
the “duty to relieve the pain and suffering of others.”119 Others take the position that
embryos do not have the same moral status as persons. They acknowledge that
embryos are genetically human, but hold that they do not have the same moral
relevance because they lack specific capacities, including consciousness, reasoning
and sentience.120 They also argue that viewing embryos as persons would “rule out
all fertility treatments that involve the creation and discarding of excess embryos,”
and further assert that we do not have the same “moral or religious” response to the
natural loss of embryos (through miscarriage) that we do to the death of infants.121
Some have also rooted their arguments in religious texts, which inform them that an
“isolated fertilized egg does not enjoy the full status of person-hood and its attendant
protections.”122 They conclude that performing research to benefit persons justifies
the destruction of embryos. Acceptance of the notion that the destruction of embryos
can be justified in some circumstances forms the basis of pro-stem cell research
opinions, and is usually modified with some combination of the distinctions and
limitations that follow.
Viability of Embryos. Some proponents of embryonic stem cell research
base their support on the question of whether an embryo is viable. The relevance of
the viability distinction rests on the premise that it is morally preferable for embryos
that will not grow or develop beyond a certain stage and/or those that would
otherwise be discarded to be used for the purpose of alleviating human suffering.
The 2001 Bush policy requires, among other things, use of only excess (non-
viable) embryos for federally funded research. One report of the President’s Council
explores the moral significance of viability that is based upon “human choices” rather
than an embryo’s “own intrinsic nature,” but draws no conclusions.123 A second
report broaches the subject of viability, recommending that Congress ban both the
117 American Life League, Analysis of George W. Bush’s Stem Cell Decision, 2001, at
[http://www.all.org/issues/scanalyz.htm] visited May 11, 2004.
118 Office of Communications, United States Conference of Catholic Bishops, Catholic
Bishops Criticize Bush Policy on Embryo Research (Aug. 9, 2001), at [http://www.usccb.
org/comm/archives/2001/01-142.shtml].
119 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, pp. 58, 62.
120 Presentation by B. Steinbock, Dept. Of Philosophy, SUNY, Albany, NY, NIH Human
Embryo Research Panel Meeting, Feb. 3, 1994.
121 Michael Sandel, “Embryo Ethics — The Moral Logic of Stem-Cell Research,” New
England Journal of Medicine, vol. 351, no. 3, July 15, 2004, p. 208.
122 UOJCA letter.
123 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, p. 87.

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transfer of a human embryo to a woman’s uterus for any purpose other than to
produce a live-born child, and also research conducted on embryos more than 10 to
14 days after fertilization.124 The NBAC report touches on the moral status of
embryos in utero and those in vitro,125 though NBAC does not specify whether
viability was a key rationale for its recommendations. A group of Representatives,
a group of Senators,126 and CAMR imply but do not state a distinction based on
viability by expressly calling for the use of “excess” embryos developed for IVF, and
making no mention of those in utero.127 UOJCA makes a similar argument in its
letter. By contrast, the National Academies and the group of Nobel Laureates more
broadly support research on embryos, making no mention of viability.
Purpose of Embryo Creation. A separate distinction that often leads to the
same conclusions as viability is the purpose for which embryos are created. This
distinction draws an ethical line based upon the intent of the people creating
embryos. In the view of some, it is permissible to create an embryo for reproductive
purposes (such as IVF), but impermissible to create one with the intention of
destroying it for research.
Most groups at least note the potential ethical significance of reproductive
versus research motives for creating embryos. The 2001 Bush policy draws a motive
distinction by including a requirement that federally funded research be conducted
only on embryonic stem cell lines derived from embryos created solely for
reproductive purposes. NBAC draws the same distinction by recommending that
federal funding be used for embryos remaining after infertility treatment but not for
research involving the derivation or use of stem cells from embryos made for
research purposes or from embryos made using cloning (SCNT).128 UOJCA argue
similarly that they “believe it is entirely appropriate to utilize for this research
existing embryos, such as those created for IVF purposes that would otherwise be
discarded but for this research. We think it another matter to create embryos ab initio
for the sole purpose of conducting this form of research.”129
The President’s Council recommends that Congress ban attempts at conception
by any means other than the union of egg and sperm (essentially banning cloning via
SCNT) but does not specify whether embryos might be created in vitro specifically
124 The President’s Council on Bioethics, Reproduction and Responsibility, Mar. 2004.
125 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 50.
126 Letter from 58 Senators to President George W. Bush, June 4, 2004. (Hereafter cited as
Letter from 58 Senators.)
127 Letter from 206 Members of the House of Representatives to President George W. Bush,
Apr. 28, 2004. (Hereafter cited as Letter from 206 Members of the House of Representatives.)
128 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, pp. 70-72.
129 UOJCA letter.

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for research purposes.130 Two Council members expressed a dissenting opinion in
a medical journal article, arguing that SCNT “resembles a tissue culture” and that the
products of SCNT should be available for research.131 A group of Representatives,
a group of Senators, and CAMR imply but do not state that embryos should not be
created for research purposes. They overtly call for the use of “excess” embryos
developed for IVF and make no mention of embryos created expressly for research.132
By contrast, the National Academies supports the creation of embryos for research
purposes, including via cloning (SCNT), to “ensure that stem cell-based therapies can
be broadly applied for many conditions and people [by] overcoming the problem of
tissue rejection.”133 Mrs. Nancy Reagan, her supporters, and the group of Nobel
Laureates also take this position.
New and Existing Cell Lines. A further distinction has been drawn based
upon the timing of the creation of embryonic stem cell lines. Here, the premise is
that it is unacceptable to induce the destruction of embryos for the creation of new
lines. However, in cases in which embryos have already been destroyed and the lines
already exist, it is morally preferable to use those lines for research to improve the
human condition.
This was one central distinction drawn in the 2001 Bush policy, which limited
the use of federal funding to research on lines derived on or before the date of the
policy. Supporters of the Bush policy on both sides of the issue favor this distinction
as a compromise. It allows research on some embryonic stem cell lines. It deters the
future destruction of embryos for research. The President’s Council writes that the
Bush policy mixes “prudence” with “principle, in the hope that the two might
reinforce (rather than undermine) each other.”134 The Council notes that the policy
is supported by what it titles a moralist’s notion of when one may benefit from prior
bad acts (referring to embryo destruction): it prevents the government from
complying in the commission of or encouraging the act in the future, and it reaffirms
the principle that the act was wrong.135 The same report also contains analyses of the
Bush policy that characterize distinction between new and existing cell lines as
“arbitrary,” “unsustainable,” and “inconsistent.”136 The Council itself takes no
position in the report on this or any other issue.
Opponents of the Bush policy on both sides of the issue view the distinction
between new and existing stem cell lines with reproach. One side, which includes
130 The President’s Council on Bioethics, Reproduction and Responsibility, Mar. 2004, p.
xlviii.
131 Paul McHugh, “Zygote and “Clonote” — The Ethical Use of Embryonic Stem Cells,”
New England Journal of Medicine, vol. 351, no. 3, July 15, 2004, p. 210.
132 Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
133 National Research Council, Institute of Medicine, National Academies, Stem Cells and
the Future of Regenerative Medicine (Washington: National Academies, 2001), p. 58.
134 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, pp. 33-34.
135 Ibid.
136 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, pp. 63-67.

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The National Right to Life Committee and the United States Conference of Catholic
Bishops, objects because the distinction validates destruction of embryos, and in fact
rewards those who did so first with a monopoly. The other side, which includes the
National Academies, a group of Representatives, a group of Senators, Nancy Reagan
and her supporters, Gerald Ford, CAMR, and the group of Nobel Laureates, objects
because the distinction limits the number of embryonic stem cell lines available for
research, particularly since the number of authorized lines are dwindling and are
“contaminated with mouse feeder cells.”137 Likewise, though NBAC recognized the
distinction between destroying embryos and using ones previously destroyed (e.g.,
“derivation of [embryonic stem] cells involves destroying the embryos, whereas
abortion precedes the donation of fetal tissue and death precedes the donation of
whole organs for transplantation”),138 it still recommended future development of
embryonic stem cell lines. UOJCA also recognizes a distinction between new and
existing lines: “research on embryonic stem cells must be conducted under careful
guidelines [that] ... relate to where the embryonic stem cells to be researched upon
are taken from.”139
Consent of Donors. There is consensus throughout a wide array of
viewpoints about embryonic stem cell research that embryos should only be obtained
for research with the consent of their biological donors. This consent requirement
necessitates that embryos be taken only with donors’ knowledge, understanding, and
uncoerced agreement. The donor consent requirement is consistent with the rules
governing human beings’ participation in research, and with individuals’ general
legal authority to make decisions regarding embryos they procreate. A drawback of
the requirement is that it may restrict the number of embryos available for research
purposes.
The 2001 Bush policy contains a donor consent requirement. It limits approved
stem cell lines to those derived with the informed consent of the donors, and obtained
without any financial inducements to the donors. The NBAC, the President’s
Council, and the UOJCA also favor donor consent requirements. The National
Academies notes the importance of informed consent in its discussion of stem cell
research oversight requirements.140 A group of Representatives and a group of
Senators mention and imply their support for donor consent requirements.141
Effectiveness of Alternatives. One factual distinction that has been used
to support competing ethical viewpoints is the efficacy of alternatives to embryonic
stem cell research. The promise of stem cell therapies derived from adult tissue and
umbilical cord blood have buttressed opposition to embryonic stem cell research.
Alternatives such as those proposed for consideration by the PCBE are discussed in
137 Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
138 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 49.
139 UOJCA letter.
140 National Research Council, Institute of Medicine, National Academies, Stem Cells and
the Future of Regenerative Medicine (Washington: National Academies, 2001), p. 53.
141 Letter from 206 Members of the House of Representatives; Letter from 58 Senators.

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the next section. These opponents argue that therapies and cures can be developed
without the morally undesirable destruction of embryos. However, not all scientists
agree that adult stem cells hold as much potential as embryonic stem cells. Most
supporters of embryonic stem cell research believe that it is the quickest and, perhaps
in some cases, the only path that will yield results. Supporters also stress that
embryonic and other stem cell research should be conducted collaboratively, so that
they can inform one another. On a related note, some have pointed out that benefits
from one alternative to embryonic stem cell research, umbilical cord blood banking,
may only be available to families who can afford to pay private companies’ storage
fees.
Findings regarding the effectiveness of alternatives to embryonic stem cell
research are mixed. The President’s Council notes that there is a “debate about the
relative merits of embryonic stem cells and adult stem cells.”142 Focus on the Family
cites promising non-embryonic stem cell research: “adult stem cells may be as
“flexible” as embryonic ones and equally capable of converting into various cell
types for healing the body.”143 By contrast, the National Academies finds that the
“best available scientific and medical evidence indicates that research on both
embryonic and adult human stem cells will be needed.”144 NBAC finds in its
deliberations that “the claim that there are alternatives to using stem cells derived
from embryos is not, at the present time, supported scientifically.”145 CAMR
supports both embryonic and adult stem cell research, and adds that “many scientists
believe and studies show that embryonic stem cells will likely be more effective in
curing diseases because they can grow and differentiate into any of the body’s cells
and tissues and thus into different organs.”146 Mrs. Nancy Reagan and her supporters
favor expedient approaches including embryonic stem cell research.147
Generating Embryonic Stem Cells Without Destroying Human
Embryos. As described in the introductory section of the report, the President’s
Council in 2005 released a white paper that discussed four potential methods of
obtaining embryonic stem cells without having to destroy embryos.148 Those
methods, the scientific and practical merits of which remain far from settled, are (1)
142 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, p. 10.
143 Carrie Gordon Earll, “Talking Points on Stem Cell Research,” Focus on the Family,
Sept. 17, 2003 at [http://www.family.org/cforum/fosi/bioethics/faqs/a0027980.cfm].
144 National Research Council, Institute of Medicine, National Academies, Stem Cells and
the Future of Regenerative Medicine (Washington: National Academies, 2001), p. 56.
145 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 53.
146 Coalition for the Advancement of Medical Research, “Embryonic Stem Cell Research,”
talking points [http://www.camradvocacy.org/fastaction/news.asp?id=167].
147 “Nancy Reagan Urges Stem Cell Research,” MSNBC, May 9, 2004, available online at
[http://www.msnbc.msn.com/id/4937850/].
148 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, online at [http://www.bioethics.gov/reports/white_paper/
index.html].

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extracting cells from organismically dead embryos; (2) non-harmful biopsy of living
embryos; (3) bioengineering embryo-like artifacts; and (4) dedifferentiating somatic
cells.
In the white paper, the President’ Council examined the ethical acceptability of
each method. The first two seek to avoid the destruction of embryos either by
developing standards for declaring an embryo “dead” when its cells have stopped
dividing or by removing a cell from an embryo without destroying the embryo itself.
The other two methods would avoid having to use an embryo altogether, by
attempting to obtain embryonic stem cells through the destruction of something that
is not an embryo.
The Council concluded that the use of organismically dead embryos raises a
number of ethical questions that have yet to be answered. They include whether it
is possible to be certain that an embryo is really dead, whether the proposal would put
embryos at additional risk, and whether IVF practitioners would be encouraged to
create extra embryos. Regarding the use of non-harmful biopsy, the Council found
that it would be ethically unacceptable to test in humans because risks should not be
imposed on living embryos destined to become children for the sake of getting stem
cells for research.
The Council also concluded that bioengineering embryo-like artifacts raises
many serious ethical concerns, including whether the artifact would really be a very
defective embryo, the ethics of egg procurement, concerns about ANT (the use of
genetic engineering) itself, and the possibility if its use creating a “slippery slope.”
Finally, the Council found the proposal to dedifferentiate somatic cells to be ethically
acceptable if and when it became scientifically practical, provided that de facto
embryos were not created.
Although some Council members expressed their support for efforts to identify
means of obtaining human embryonic stem cells for biomedical research that do not
involve killing or harming human embryos, not all of the members agreed. Some
expressed concern that all four methods would “use financial resources that would
be better devoted to proposals that are likely to be more productive.” One member
wrote that he did not support publishing the white paper “with the implied
endorsement that special efforts be made in the scientific areas described. While
some of the suggestions could be explored in a scientific setting, most are high-risk
options that only have an outside chance of success and raise their own complex set
of ethical questions.”
Use of Federal Funding. Some division over the support for and opposition
to embryonic stem cell research focuses on the question of whether the use of federal
funding is appropriate. Those who oppose federal funding argue that the government
should not be associated with embryo destruction.149 They point out that embryo
destruction violates the “deeply held moral beliefs of some citizens,” and suggest that
149 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 57.

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“funding alternative research is morally preferable.”150 Proponents of federal funding
argue that it is immoral to discourage life-saving research by withholding federal
funding. They point out that consensus support is not required for many federal
spending policies, as it “does not violate democratic principles or infringe on the
rights of dissent of those in the minority.”151 They argue that the efforts of both
federally supported and privately supported researchers are necessary to keep the
United States at the forefront of what they believe is a very important, cutting edge
area of science. Furthermore, supporters believe that the oversight that comes with
federal dollars will result in better and more ethically controlled research in the field.
Groups’ positions on federal funding tend to mirror their positions on stem cell
research generally. The Bush policy authorizes federal funding for some embryonic
stem cell research. The President’s Council does not take a position on the issue, but
notes the pros and cons and stresses that there is a “difference between prohibiting
embryo research and refraining from funding it.”152 Focus on the Family generally
supports the President Bush and his policy, but is “disappointed by his decision to
allow federal funding of research on the existing stem cell lines.”153 NBAC finds the
arguments in favor of federal funding more persuasive than those against it.154 The
National Academies, a group of Representatives, a group of Senators, Mrs. Nancy
Reagan and her supporters, CAMR, the Nobel Laureates, and the UOJCA favor
federal funding for embryonic stem cell research.155
150 Ibid.
151 Ibid.
152 The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, p. 37.
153 Carrie Gordon Earll, “Talking Points on Stem Cell Research,” Focus on the Family,
Sept. 17, 2003 at [http://www.family.org/cforum/fosi/bioethics/faqs/a0027980.cfm].
154 National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 70.
155 See, e.g., National Research Council, Institute of Medicine, National Academies, Stem
Cells and the Future of Regenerative Medicine (Washington: National Academies, 2001),
p. 49.

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