Order Code RL33540
Stem Cell Research:
Federal Research Funding and Oversight
Updated April 18, 2007
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy Division

---

Stem Cell Research:
Federal Research Funding and Oversight
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.” NIH has established
a registry of 78 human embryonic stem cell lines that are eligible for use in federally
funded research, but only 21 cell lines are currently available. Scientists are
concerned about the quality and longevity of these 21 stem cell lines. NIH Director
Elias Zerhouni stated before a Senate subcommittee in March 2007 that research
advancement requires access to new human embryonic stem cell lines.
Some have argued that adult stem cells (from bone marrow or umbilical cord
blood) should be pursued instead of embryonic stem cells because they believe the
derivation of stem cells from embryos is ethically unacceptable. The NIH Director
and many other scientists believe adult stem cells should not be the sole target of
research because of important scientific and technical limitations. Reports issued by
NIH and the Institute of Medicine state that both embryonic and adult stem cell
research should be pursued. 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 cited four potential alternative
sources of human embryonic stem cells in a May 2005 paper. A number of pro-life
advocates support stem cell research; those opposed are concerned that stem cell
isolation requires embryo destruction.
On January 11, 2007, the House passed H.R. 3 (DeGette) on a vote of 253 to
174. H.R. 3 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, and thus negate the August 2001 Bush stem cell policy limitation. On April
11, 2007, the Senate passed S. 5 (Reid), which has the same text as H.R. 3 and an
additional section supporting research on alternative human pluripotent stem cells.
The Senate also passed S. 30 (Coleman) on April 11, 2007. Unlike H.R. 3 and S. 5,
S. 30 provides support only for research on alternative human pluripotent stem cells.
(The 109th Congress passed legislation identical to H.R. 3, H.R. 810 (Castle), but
President Bush vetoed it, the first veto of his presidency. An attempt in the House
to override the veto was unsuccessful.) On the related issue of human cloning, S. 812
(Hatch) would ban human reproductive cloning but allow for the therapeutic uses of
the technique provided that a number of ethical requirements are observed. In
contrast, the Weldon bill (which passed the House in the 107th and 108th Congresses)
and S. 1036 (Brownback) would ban 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 who is a human clone. Critics argue that the measure would curtail medical
research and prevent Americans from receiving life-saving treatments created
overseas. This report will be updated as needed.

---

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Basic Research and Potential Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Embryonic Stem Cells from IVF Embryos or Fetal Tissue . . . . . . . . . . . . . . 2
Embryonic Stem Cells Obtained via SCNT (Cloning) . . . . . . . . . . . . . . . . . 3
Stem Cells from Adult Tissue or Umbilical Cord Blood . . . . . . . . . . . . . . . . 4
Potential Applications of Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . 6
Current Regulatory Landscape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The Dickey Amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Clinton Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Bush Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Regulation of Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
National Academies Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
FDA Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
NIH Research Funding and Stem Cell Registry . . . . . . . . . . . . . . . . . . 12
State Laws that Restrict Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . 14
Concerns Over Access to Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Worldwide Survey of Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Congressional Letters on Bush Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Alternative Sources of Human Embryonic Stem Cells . . . . . . . . . . . . . . . . . . . . 18
Dead Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Embryo Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Biological Artifacts — Altered Nuclear Transfer . . . . . . . . . . . . . . . . . . . . 21
Dedifferentation of Somatic Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
List of Tables
Table 1. National Institutes of Health Funding . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Table 2. NIH List of Human Embryonic Stem Cell Lines
Eligible for Use in Federal Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

---

Stem Cell Research:
Federal Research Funding and Oversight
Introduction
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. However,
funding would be limited to stem cell lines that had been created prior to the date of
the policy announcement. Research involving human embryonic stem cells raises a
number of ethical issues because the stem cells are located inside the embryo, and the
process of removing them destroys the embryo.1
A relatively small amount of federal funding has been used to support human
embryonic stem cell research. The National Institutes of Health (NIH) identified 78
human embryonic stem cell lines that would be eligible for use in federally funded
research, but most were found to be either unavailable or unsuitable for research.
Twenty-one cell lines are currently available under the Bush policy. Scientists are
concerned about the quality and longevity of these 21 stem cell lines. Many believe
research advancement requires the use of new human embryonic stem cell lines.
The Director of NIH, Elias Zerhouni, stated in a hearing on March 19, 2007,
before the Senate Labor, Health and Human Services (HHS), Education, and Related
Agencies Appropriations Subcommittee that “It’s not possible for me to see how we
can continue the momentum of science and research with the stem cell lines we have
at NIH that can be funded.”2 When asked if other avenues of research should be
pursued instead, Dr. Zerhouni stated that “the presentations about adult stem cells
holding as much or more potential than embryonic stem cells, in my view, do not
hold scientific water. I think they are overstated.”3 He noted that competitors in
Europe, China, and India are investing heavily in human embryonic stem cell
research. “I think it is important for us not to fight with one hand tied behind our
back here. I think it’s time to move forward on this area. It’s time for policy makers
to find common ground, to make sure that NIH does not lose its historical
leadership.... To sideline NIH on such an issue of importance in my view is
shortsighted.”4
1 For further information, see CRS Report RL33554, Stem Cell Research: Ethical Issues, by
Judith A. Johnson and Erin D. Williams.
2 Drew Armstrong, “NIH Chief’s Opinion on Stem Cell Research Goes Afield of White
House Policy,” CQ Today, Mar. 19, 2007.
3 Ibid.
4 John Reichard, “Zerhouni Makes Strong Case Against Bush Policy on Stem Cells, NIH
(continued...)

---

CRS-2
Several states, such as California, Connecticut, Illinois, Maryland, and New
Jersey, have responded by moving forward with their own initiatives to encourage
or provide funding for stem cell research, and many others are considering similar
action.5 Proponents of these state stem cell research initiatives want to remain
competitive, as well as 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 efforts 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.
The new majority leadership of the 110th Congress indicated that it would
address the topic of stem cell research early in the first session. H.R. 3 (DeGette)
was introduced on January 5, 2007, with 211 cosponsors, and passed the House on
January 11, 2007. The bill 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, and thus negate the August 2001 Bush stem cell
policy limitation. During the first session of the 109th Congress, the House passed
identical legislation, H.R. 810 (Castle), in May 2005. In July 2006, the Senate passed
H.R. 810 and President Bush immediately vetoed it, the first veto of his presidency.
An attempt in the House to override the veto was unsuccessful.
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
4 (...continued)
Funding,” CQ Today, Mar. 19, 2005.
5 For further information, see CRS Report RL33524, Stem Cell Research: State Initiatives,
by Judith A. Johnson and Erin D. Williams.

---

CRS-3
via in vitro fertilization (IVF).6 The work is controversial because the stem cells are
located within the embryo and the process of removing them destroys the embryo.
Many individuals who are opposed to abortion are also opposed to research involving
embryos. The second group, at Johns Hopkins University, derived stem cells with
very similar properties from five- to nine-week-old embryos or from fetuses obtained
through elective abortion.7 Both groups reported the human embryos or fetuses were
donated for research following a process of informing one or more parents and
obtaining their 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. The vast majority of research on human
embryonic stem cells, both in the United States and overseas, utilizes cell lines
derived via the University of Wisconsin method.
Embryonic Stem Cells Obtained via SCNT (Cloning)
Another potential source of embryonic stem cells is somatic cell nuclear transfer
(SCNT), also referred to as cloning.8 For certain applications, stem cells derived
from cloned embryos may offer the best hope for understanding and treating disease.
In SCNT the nucleus of an egg is removed and replaced by the nucleus from a mature
body cell, such as a skin cell obtained from a patient. In 1996, scientists in Scotland
used the SCNT procedure to produce Dolly the sheep, the first mammalian clone.9
When SCNT is used to create another individual, such as Dolly, the process is called
reproductive cloning. In contrast, scientists interested in using SCNT to create
cloned stem cells would allow the cell created via SCNT to develop for a few days,
and then the stem cells would be removed for research. Stem cells created via SCNT
would be genetically identical to the patient, and thus would avoid any tissue
rejection problems that could occur if the cells were transplanted into the patient.
6 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. The Society for
Assisted Reproductive Technology and RAND conducted a survey of more than 430
infertility clinics to determine the number of frozen embryos in the United States; 340
clinics responded to the survey. Nearly 400,000 embryos have been frozen and stored since
the late 1970s. The vast majority of embryos are being held to help couples have children
at a later date. Patients have designated 2.8%, or about 11,000 embryos, for research.
Scientists estimate these 11,000 could form up to 275 stem cell lines, perhaps much less
[http://www.rand.org/pubs/research_briefs/RB9038/index1.html].
7 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).
8 A somatic cell is a body cell. In contrast, a germ cell is an egg or sperm cell.
9 Dolly was euthanized in February 2003 after developing a lung infection. Some claim her
death at six 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.

---

CRS-4
Creating stem cells using SCNT for research purposes is often referred to as
therapeutic cloning.
Charges of ethical and scientific misconduct have clouded the reputation of
scientists involved in deriving stem cells from cloned human embryos. In February
2004, scientists at the Seoul National University (SNU) in South Korea announced
the first isolation of stem cells from a cloned human embryo. In May 2005 they
announced major advances in the efficiency of creating cloned human embryos and
in isolating human stem cells from the cloned embryos. Concerns about the
achievements of the SNU group arose in November 2005 when a U.S. co-author of
the 2005 paper accused Hwang Woo Suk, the lead researcher of the SNU group, of
ethical misconduct.10 In December 2005 scientists in South Korea began questioning
the validity of scientific evidence presented in the 2005 paper and called for an
independent analysis of the data. Later that month a Korean co-author of the 2005
paper stated to the Korean media that the research was fabricated and the paper
should be retracted; Hwang agreed to the retraction. On January 10, 2006, SNU
stated that results of the 2004 paper were also a deliberate fabrication.11 On July 5,
Hwang was reported to have admitted full responsibility for the 2005 fabrication.12
Scientists at the University of Newcastle, the University of Edinburgh, Harvard
University, and the University of California at San Francisco are working on deriving
patient-matched stem cells from cloned human embryos.13 The ethical and scientific
misconduct developments in South Korea as well as 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.14
Stem Cells from Adult Tissue or Umbilical Cord Blood
Stem cells obtained from adult organisms are also the focus of research. Most
recently, a January 2007 report found that cells similar to embryonic stem cells can
be found in amniotic fluid. However, the lead author of the report, as well as others
in the field, caution that these cells are not a replacement for embryonic stem cells.15
There have been a number of other publications on the abilities and characteristics
10 Gretchen Vogel, “Collaborators Split over Ethics Allegations” Science, Nov. 18, 2005,
p. 1100.
11 Nicholas Wade and Choe Sang-Hun, “Researcher Faked Evidence of Human Cloning,
Koreans Report,” The New York Times, Jan. 10, 2006, p. A1.
12 Annie I. Bang, “Hwang Admits Fabricating Stem Cell Data,” The Korean Herald, Jul. 5,
2006.
13 Dennis Normile, Gretchen Vogel, and Constance Holden, “Cloning Researcher Says Work
is Flawed but Claims Results Stand,” Science, Dec. 23, 2005, p. 1886-1887; Carl T. Hall,
“UCSF Resumes Human Embryo Stem Cell Work,” The San Francisco Chronicle, May 6,
2006, p. A.1.
14 For further information, see CRS Report RL31358, Human Cloning, by Judith A. Johnson
and Erin Williams.
15 Rick Weiss, “Scientists See Potential in Amniotic Stem Cells; They Are Highly Versatile
And Readily Available,” The Washington Post, Jan. 8, 2007, p. A1, A5.

---

CRS-5
of adult stem cells from a variety of different sources, such as bone marrow and the
umbilical cord following birth. 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.
An opponent of embryonic stem cell research, David A. Prentice of the Family
Research Council, developed a list of 72 diseases that he claimed can be treated using
adult stem cells.16 However, a letter to the online journal of Science Magazine
refutes this claim, stating that “adult stem cell treatments fully tested in all required
phases of clinical trials and approved by the U.S. Food and Drug Administration are
available to treat only nine of the conditions on the Prentice list.”17
Opponents of stem cell research 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 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. Reports issued by the NIH and the Institute of Medicine (IoM) state that
both embryonic and adult stem cell research should be pursued.18
In FY2004, the Consolidated Appropriations Act, 2004 (P.L. 108-199) provided
$10 million to establish a National Cord Blood Stem Cell Bank within the Health
Resources and Services Administration (HRSA). HRSA was directed to use $1
million to contract with the IoM to conduct a study that would recommend an
optimal structure for the program. The study, Cord Blood: Establishing a National
Hematopoietic Stem Cell Bank Program, was released in April 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 IOM 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.
16 [http://www.stemcellresearch.org/facts/treatments.htm] accessed on Dec. 13, 2006.
17 Shane Smith, William Neaves and Steven Teitelbaum, “Adult Stem Cell Treatments for
Diseases?” Sciencexpress, July 13, 2006, p. 1 [http://www.sciencexpress.org].
18 National Institutes of Health, Department of Health and Human Services. Stem Cells:
Scientific Progress and Future Research Directions, June 2001. The NIH report can be
found at [http://stemcells.nih.gov/info/scireport/]. Institute of Medicine, Stem Cells and the
Future of Regenerative Medicine, 2002. The IoM report can be found at [http://www.nas.
edu].

---

CRS-6
On December 20, 2005, the President signed the Stem Cell Therapeutic and
Research Act of 2005 (P.L. 109-129). The act provides 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 FY2007, and authorizes $60 million
over FY2007-FY2010. The act also reauthorizes the national bone marrow registry
with $186 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.
Congress provided $9.941 million for the HRSA National Cord Blood Stem
Cell Bank program for FY2005 (P.L. 108-447), and $3,957,000 for FY2006 (P.L.
109-149). For FY2007, the Administration did not request any funds for the National
Cord Blood Inventory, the successor of the National Cord Blood Stem Cell Bank
program. The House also did not recommend funds for FY2007, noting that “more
than $22,000,000 remains available for obligation” from funds provided in prior
years (H.Rept. 109-515). The Senate recommended $3.96 million for FY2007.
Because Congress did not pass a Labor-HHS-Education appropriations bill for
FY2007, the Continuing Appropriations Resolution, 2007 (Division B of P.L. 109-
289), as amended, provides FY2007 funding for this program not to exceed the
FY2006 level of funding.
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 any 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 cancer, 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

---

CRS-7
different species.19 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, or therapeutic 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 might avoid any tissue rejection problems that could occur
in other stem cell 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 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.20 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 FY2007.21 Under the
terms of the Continuing Appropriations Resolution, 2007, (Division B of P.L. 109-
289) as amended, the provision (found in Section 509 of the Labor, HHS and
19 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.
20 However, federal funds have been provided for research on both human and animal adult
stem cells and animal embryonic stem cells.
21 The rider language has not changed significantly from year to year (however there was a
technical correction in P.L. 109-149). The original rider 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; FY2005, P.L. 108-447, FY2006, P.L.
109-149.

---

CRS-8
Education, and Related Agencies Appropriations Act, 2006) continues to control
funds provided in FY2007. 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 46.204(b) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)).
(b) For purposes of this section, the term ‘human embryo or embryos’ includes
any organism, not protected as a human subject under 45 CFR 46 [the Human
Subject Protection regulations] as of the date of enactment of this Act, that is
derived by fertilization, parthenogenesis, cloning, or any other means from one
or more human gametes [sperm or egg] or human diploid cells [cells that have
two sets of chromosomes, such as somatic cells].
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, HHS said, 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.

---

CRS-9
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
peer-review process.22 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.23 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.”24
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
22 According to media sources, as of April 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 January 2001.
23 Rick Weiss, “Bush Administration Order Halts Stem Cell Meeting; NIH Planned Session
to Review Fund Requests,” Washington Post, Apr. 21, 2001, p. A2.
24 Ibid.

---

CRS-10
and Human Services and Education.25 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.”26 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 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.27 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.
Regulation of Stem Cell Research
The Common Rule (45 CFR 46, Subpart A) is a set of regulations that govern
most federally funded research conducted on human beings. Its three basic
requirements are aimed at protecting research subjects: the informed consent of
research subjects, a review of proposed research by an Institutional Review Board
(IRB), and institutional assurances of compliance with the regulations. However, ex
vivo embryos (those not in a uterus) are not considered “human subjects” for these
purposes, but federally funded research on human embryos is regulated by the Dickey
Amendment as described above. Stem cells and stem cell lines are also not
considered “human subjects,” nor are they governed by the Dickey Amendment.
25 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/].
26 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].
27 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].

---

CRS-11
Because of the current lack of federal regulation of stem cell research, the
National Academies has developed voluntary guidelines for deriving, handling and
using human embryonic stem cells. 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. 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.
National Academies Guidelines. In July 2004 the National Academies
established the committee on Guidelines for Human Embryonic Stem Cell Research
to develop voluntary guidelines for deriving, handling and using human embryonic
stem cells due to the current lack of federal regulation of such research. 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
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
creation of a chimera by 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. 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.
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.

---

CRS-12
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.”28 Under FDA guidelines, 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.29
During a Senate hearing on stem cell research held by the Health, Education,
Labor and Pensions Committee on September 5, 2001, the HHS Secretary stated that
the FDA was overseeing 17 investigational protocols involving xenotransplantation
in other areas of clinical research that involve patients. Therefore, he said, 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.30
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.31
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
28 Xenotransplantation Action Plan: FDA approach to the regulation of xenotransplantation.
Available at [http://www.fda.gov/cber/xap/xap.htm].
29 These documents are available at [http://www.fda.gov/cber/xap/xap.htm].
30 National Institutes of Health, Department of Health and Human Services, Stem Cells:
Scientific Progress and Future Research Directions, June 2001, pp. 95-96; Susanne Rust,
“UW Grows Animal-Free Stem Cell Lines,” The Milwaukee Journal Sentinel, Jan. 2, 2006,
p. A1.
31 See [http://stemcells.nih.gov/research/funding/].

---

CRS-13
scientists.32 As shown in Table 2, the NIH registry originally listed universities and
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 February 19, 2007, the NIH
registry listed a total of 21 stem cell lines available from seven sources.
Table 1. National Institutes of Health Funding
($ in millions)
Stem Cell Research
FY03
FY04
FY05
FY06
FY07
FY08
Human Embryonic
20
24
40
38
37
37
Non-Human Embryonic
113
89
97
110
110
109
Human Non-Embryonic
191
203
199
206
206
205
Non-Human Non-Embryonic
192
236
273
289
288
287
Total, Stem Cell Research
517
553
609
643
641
639
Source: NIH Budget Office, February 5, 2007.
Table 2. NIH List of Human Embryonic Stem Cell Lines
Eligible for Use in Federal Research
Number of stem cell lines
Namea
Eligible
Available
BresaGen, Inc., Athens, GA
4
3
Cell & Gene Therapy Institute (Pochon CHA University),
2
Seoul, Korea
Cellartis 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
3
Institute, Seoul, Korea
MizMedi Hospital — Seoul National University, Seoul, Korea
1
0
National Center for Biological Sciences/Tata Institute of
3
Fundamental Research, Bangalore, India
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
21
Source: [http://stemcells.nih.gov/research/registry/eligibilityCriteria.asp].
a. Six table entries 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.”
32 Information about the NIH Human Embryonic Stem Cell Registry is available at
[http://stemcells.nih.gov/research/registry/index.asp].

---

CRS-14
State Laws that Restrict Stem Cell Research33
Many states restrict research on aborted fetuses or embryos, but research is often
permitted with consent of the parent or parents. Almost half of the states also restrict
the sale of fetuses or embryos. Louisiana is the only state that specifically prohibits
research on in vitro fertilized (IVF) embryos. Illinois and Michigan also prohibit
research on live embryos. Arkansas, Indiana, Iowa, Michigan, North Dakota and
South Dakota prohibit research on cloned embryos. Virginia may also ban research
on cloned embryos, but the statute may leave room for interpretation because human
being is not defined. (There may be disagreement about whether human being
includes blastocysts, embryos or fetuses.) California, Connecticut, Massachusetts,
New Jersey and Rhode Island have laws that prohibit cloning for the purpose of
initiating a pregnancy, but allow cloning for research.
Several states limit the use of state funds for cloning or stem cell research.
Missouri forbids the use of state funds for reproductive cloning but not for cloning
for the purpose of stem cell research, and Maryland’s statutes prohibit state-funded
stem cell researchers from engaging in reproductive cloning. Arizona law prohibits
the use of public monies for reproductive or therapeutic cloning. Nebraska statutes
limit the use of state funds for embryonic stem cell research. Restrictions only apply
to state healthcare cash funds provided by tobacco settlement dollars. State funding
available under Illinois Executive Order 6 (2005) may not be used for reproductive
cloning or for research on fetuses from induced abortions.
Despite restrictive federal and state policies, many states are encouraging or
providing funding for stem cell research (in some cases therapeutic cloning as well),
as they seek to remain competitive and prevent the relocation of scientists and
biotechnology firms to other states or overseas. For further information, please see
CRS Report RL33524, Stem Cell Research: State Initiatives.
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 21 cell lines are available for research with federal dollars. 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 genetically unstable compared to
newer stem cell lines.
33 The information in this section was obtained from “State Embryonic and Fetal Research
Laws,” National Council of State Legislatures website, at [http://www.ncsl.org/programs/
health/genetics/embfet.htm], visited Mar. 30, 2007.

---

CRS-15
In reaction to the limitations imposed by the Bush policy, several U.S. research
groups have decided to develop additional human embryonic stem cell lines using
private funding. Some research groups are using state funds as well.34
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.35 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.36 The new stem cell lines
are to be used to understand the origins of disease-related symptoms and to develop
and test new treatments.37
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.38 One year later the Harvard team had increased that
number to 28 new human embryonic stem cell lines.39 In order to perform this work
Harvard considered it 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
private funding to continue the work begun by Melton and his group of scientists as
well as produce cloned human embryos for research studies on juvenile diabetes,
Parkinson’s disease, and several other diseases.40
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.41 The Institute for Stem Cell Biology and Regenerative
Medicine is headed by Dr. Irving Weissman, a professor in cancer biology at
Stanford. The institute is developing new stem cell lines, some through the process
34 See CRS Report RL33524, Stem Cell Research: State Initiatives, by Judith A. Johnson
and Erin D. Williams.
35 Gareth Cook, “Clinic in U.S. Isolates 50 Lines of Stem Cells,” Boston Globe, June 9,
2004, p. A1.
36 The six diseases are beta thalassemia, neurofibromatosis type 1, Marfan’s syndrome,
myotonic dystrophy, fragile X syndrome, and Fanconi’s anemia.
37 For further information, see [http://www.reproductivegenetics.com].
38 Rick Weiss and Justin Gillis, “New Embryonic Stem Cells Made Available,” Washington
Post, Mar. 4, 2004, p. A2.
39 Gareth Cook, “Harvard Provost OKs Procedure,” Boston Globe, Mar. 20, 2005, p. A29.
(Hereafter cited as Cook, “Harvard Provost OKs Procedure.”)
40 For further information, see [http://www.stemcell.harvard.edu].
41 For further information, see the Stanford University Medical Center website at
[http://mednews.stanford.edu/stemcellQA.html].

---

CRS-16
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.42
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.
Worldwide Survey of Stem Cell Lines
A worldwide survey of laboratories conducted by the Boston Globe found that
as of May 23, 2004, 128 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.43 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.44
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.45 The letter points out that an estimated 400,000 frozen IVF
42 For further information, see [http://stemcell.stanford.edu/].
43 Gareth Cook, “94 New Cell Lines Created Abroad since Bush Decision,” Boston Globe,
May 23, 2004, p. A14.
44 For further information on the UK Stem Cell Bank, see [http://www.ukstemcellbank.
org.uk/].
45 See [http://www.house.gov/degette/news/releases/040428.pdf].

---

CRS-17
embryos46 “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.47 The letter from NIH Director Zerhouni did contain the following sentence
which some observers believed in 2004 indicated 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
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.”48 At the time, White House spokesperson Claire Buchan stated that the
sentence did not indicate the president’s position had 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, 2004.49
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.50 The new centers are to investigate how stem
cells can be used to treat a variety of diseases. A National Embryonic Stem Cell
Bank is to 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
46 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.
47 Rick Weiss, “Bush’s Stem Cell Policy Reiterated, but Some See Shift,” The Washington
Post, May 16, 2004, p. A18.
48 Letter from Elias A. Zerhouni, Director, National Institutes of Health, to The Honorable
Diana DeGette and The Honorable Michael Castle, May 14, 2004.
49 See [http://feinstein.senate.gov/04Releases/r-stemcell-ltr.pdf].
50 Andrew J. Hawkins, “NIH Stem Cell Bank, Centers of Excellence Will Fast-Track
Translational Research, Says Thompson,” Washington FAX, July 15, 2004.

---

CRS-18
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.”51 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.”52 On October 3, 2005, NIH announced that
it had awarded $16.1 million over four years to the WiCell Research Institute in
Wisconsin to fund the National Stem Cell Bank.53 NIH also awarded $9.6 million
over four years to fund two new Centers of Excellence in Translational Human Stem
Cell Research, one at the University of California, Davis and the other at
Northwestern University.
Alternative Sources
of Human Embryonic Stem Cells
Most scientists involved in human embryonic stem cell research are focused on
using stem cells derived from human embryos via the methods developed by
scientists at the University of Wisconsin. However, a small number of 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 those
who object to the research on moral and ethical grounds. The President’s Council
on Bioethics identified four potential methods in a paper released in May 2005.54
The four alternative methods would require additional research to determine whether
human embryonic stem cells could be generated.
Some council members, however, expressed concern that work on alternative
sources 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.”55
Laurie Zoloth, professor of Medical Humanities and Bioethics, and of Religion at
Northwestern University’s Feinberg School of Medicine, maintains that public
funding should not be used to satisfy the moral qualms of a minority and proposes
that private religious groups should consider funding research on alternative sources
51 Ibid.
52 Ibid.
53 NIH Press Office, “NIH Awards a National Stem Cell Bank and New Centers of
Excellence in Translational Human Stem Cell Research,” Oct. 3, 2005, [http://www.nih.
gov/news/pr/oct2005/od-03.htm]. The website for WiCell and the National Stem Cell Bank
can be found at [http://www.wicell.org/].
54 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].
55 Ibid., Personal Statement of Michael S. Gazzaniga, p. 76 and Personal Statement of Dr.
Janet D. Rowley, p. 90.

---

CRS-19
of human embryonic stem cells just as Jehovah’s Witnesses supported efforts to
develop blood-saving surgical techniques to avoid transfusions.56
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.57
As many as 60% of IVF embryos produced by infertility clinics are judged to
be incapable of developing to live birth, according to IVF clinics, 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, above, The
Dickey Amendment).
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, asks the council, or even bother trying
56 Molly Laas, “Alternative Stem Cell Derivation Methods Should Be Funded By Private
Religious Groups,” Research Policy Alert, Nov. 10, 2005.
57 Harold J. Morowitz and James S. Trefil, The Facts of Life: Science and the Abortion
Controversy (Oxford University Press, 1992), p. 51.

---

CRS-20
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 is 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 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.”58
Embryo Biopsy
A second 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. According to the
American Society for Reproductive Medicine, more than 2,000 children have been
born in the United States following PGD, though it is still unclear whether subtle or
late onset injuries may occur in children born following PGD.59
In August 2006, researchers at Advanced Cell Technology (ACT) in Worcester,
Massachusetts, reported that they had created human embryonic stem cell lines using
individual cells obtained from 8-cell-stage embryos that were produced via IVF for
fertility treatment purposes.60 This work builds on ACT’s prior success, announced
in October 2005, in deriving mouse embryonic stem cells by removing one cell from
an eight-cell mouse embryo.61 Following implantation into a surrogate mouse
mother, the seven-cell embryos developed into healthy mice at the same rate as
embryos that had not been biopsied. Creation of the mouse stem cell lines was much
less efficient than when a later-stage embryo was used.
Skeptics of this new method point out that 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, couples may not agree to such a procedure for the
sole purpose of creating stem cell lines for research when the emotional and financial
stakes of in vitro fertilization and PGD are so very high. Research studies to
58 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, p. 21 and p. 89.
59 Nicholas Wade, “In New Method for Stem Cells, Viable Embryos,” The New York Times,
Aug. 24, 2006.
60 Irina Klimanskaya et al., “Human Embryonic Stem Cell Lines Derived from Single
Blastomeres,” Nature, published online Aug. 23, 2006; and Press Release, “Advanced Cell
Technology Announces Technique to Generate Human Embryonic Stem Cells the Maintains
Developmental Potential of Embryo,” Aug. 23, 2006, [http://www.advancedcell.com/].
61 Nicholas Wade, “Stem Cell Test Tried on Mice Saves Embryo,” The New York Times,
Oct. 17, 2005.

---

CRS-21
determine if there is a risk of harm to a human embryo by the cell biopsy procedure
probably would 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, research suggests, a single cell from a sheep or rabbit 4- or
8-cell embryo is potentially capable of developing into a normal sheep or rabbit. The
possibility that a biopsied human 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, above, The Dickey Amendment).62
Biological Artifacts — Altered Nuclear Transfer
A third possible method involves using the techniques of genetic engineering
and SCNT (cloning) to obtain embryonic stem cells from embryo-like groups of cells
which are not, in the strict sense, human embryos. In this approach, called altered
nuclear transfer (ANT), a gene in the nucleus of the somatic cell is altered, so that
normal embryo development is not possible, before the nucleus is placed within an
enucleated egg. In October 2005, scientists at the Massachusetts Institute of
Technology reported success in generating mouse embryonic stem cells utilizing the
ANT approach.63 A gene was disabled that allows for embryo implantation; gene
function can be restored later so the stem cell line is unaffected. As is the case with
SCNT, if the ANT approach is ever used to generate human embryonic stem cells a
major obstacle would be obtaining an adequate supply of human eggs. This is the
subject of intense scientific research. Researchers are trying to develop methods of
obtaining human eggs without resorting to superovulation of female patients, an
expensive procedure that some find morally questionable.
Some researchers believe ANT 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. Others believe that the procedures involved in ANT
are more complex than deriving human embryonic stem cells from normal embryos,
and many scientists “would be reluctant to attempt such challenging feats with no
rational purpose other than to satisfy the ethical objections of others.”64
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 regard as ethically no improvement over destroying
62 The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, p. 29.
63 Nicholas Wade, “Stem Cell Test Tried on Mice Saves Embryo,” The New York Times,
Oct. 17, 2005.
64 Ibid., p. 47.

---

CRS-22
early embryos.”65 Proponents of the ANT approach argue that “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.”66 Given the ethical uncertainties, it is unclear
whether or not research involving ANT to generate human embryonic stem cells
could be supported with federal funds.
Dedifferentation 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. In August 2005, researchers at Harvard announced qualified success at
producing a hybrid cell that has some of the characteristics of an embryonic stem
cell.67 The Harvard group fused human skin cells with human embryonic stem cells,
but the process is very inefficient — 50 million skin cells and 50 million embryonic
stem cells yielded only 10 to 20 fused cells — and all the hybrid cells have twice the
normal amount of DNA. However, Yuri Verlinski and his team at the Reproductive
Genetics Institute in Chicago claim to have created 10 patient-matched embryonic
stem cell lines, called stembrids, with the normal amount of DNA. First the nucleus,
which contains the DNA, is removed from the human embryonic stem cells and then
these enucleated cells are fused with cells from a patient.68 Alan Trounson at Monash
University in Melbourne, Australia, is working on a similar method involving cell
fusion.69
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 a cell that has the capability of developing into 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.
65 The President’s Council on Bioethics, White Paper, p. 41.
66 Ibid., p. 37.
67 Rick Weiss, “Skin Cells Converted to Stem Cells,” The Washington Post, Aug. 22, 2005,
p. A1.
68 Michael LePage and Rowan Hooper, “Double Triumph in Stem Cell Quest,” New
Scientist, May 28, 2005, p. 8.
69 Rick Weiss, “Stem Cell Advances May Make Moral Issue Moot,” The Washington Post,
June 6, 2005, p. A7.

---

CRS-23
Congressional Actions
Stem Cell Research
Members of the 110th Congress indicated weeks prior to the start of the new
Congress that they would address the topic of stem cell research early in the first
session. This prediction was fulfilled; stem cell research was one of the topics
addressed in the first 100 hours of the 110th Congress.
H.R. 3 (DeGette), the Stem Cell Research Enhancement Act of 2007, was
introduced on January 5, 2007, with 211 cosponsors. The House passed H.R. 3 on
a vote of 253 to 174 on January 11, 2007. The text of H.R. 3 is identical to
legislation introduced in the 109th Congress, H.R. 810 (Castle). It would amend the
Public Health Service Act by adding a new Section 498D, “Human Embryonic Stem
Cell Research.” The new section would 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. 5 (Reid), was introduced on January 4, 2007, with 30
cosponsors. A star print of S. 5 was ordered on March 29, 2007,70 and the measure
laid before Senate by unanimous consent on April 10, 2007. On April 11, 2007, the
Senate passed S. 5 (Reid) on a vote of 63 to 34, and (Coleman) on a vote of 70 to 28.
The text of S. 5 is the same as H.R. 3, except that the Senate bill contains an added
provision that would direct the Secretary of HHS to conduct and support research on
alternative human pluripotent stem cells. This added provision is very similar to
H.R. 322 and portions of S. 30 (see below). S. 5 would amend the Public Health
Service Act by adding a new Section 498E, “Alternative Human Pluripotent Stem
Cell Research.” S. 5 would require the Secretary of HHS to develop techniques for
the isolation, derivation, production, and testing of stem cells that are capable of
producing all or almost all of the cell types of a developing body, and may result in
improved understanding of treatments for diseases and other adverse health
conditions, but that are not derived from a human embryo. Within 90 days of
enactment, the Secretary, after consulting with the Director of NIH, would be
required to (1) provide guidance concerning the next steps required for additional
research, including the extent to which additional basic or animal research is
required; (2) prioritize research that holds the greatest potential for near-term clinical
benefit; and (3) take into account techniques outlined by the President’s Council on
70 The star print of S. 5 is identical to S. 997 (Harkin). S. 997 (Harkin) was introduced on
March 27, 2007.

---

CRS-24
Bioethics and any other appropriate techniques and research. The Secretary would
be required to prepare and submit to the appropriate committees of Congress an
annual report describing the activities and research conducted. The only difference
between the added provision in S. 5 and H.R. 322 is the definition of the term human
embryo. S. 5 would define “human embryo” as having the same meaning as found
within the applicable appropriations act with respect to the fiscal year in which
research is to be supported. S. 5 authorizes such sums as may be necessary for
FY2008 through FY2010.
S. 30 (Coleman), the Hope Offered through Principled and Ethical Stem Cell
Research Act, or HOPE Act, was introduced on March 29, 2007. On April 11, 2007,
the Senate passed S. 30 (Coleman) on a vote of 70 to 28 and S. 5 (Reid) on a vote of
63 to 34. Parts of S. 30 are similar to H.R. 322 (and therefore similar to parts of S.
5 as well). S. 30 would amend the Public Health Service Act by adding a new
Section 498D, “Human Pluripotent Stem Cell Research.” The bill would require the
Secretary of HHS to develop techniques for the isolation, derivation, production, or
testing of stem cells that have the flexibility of embryonic stem cells and that may
result in improved understanding of treatments for diseases and other adverse health
conditions. Such work will not involve the creation of a human embryo for research
purposes or the destruction or discarding of, or risk of injury to, a human embryo
other than those that are naturally dead. Naturally dead is defined as having naturally
and irreversibly lost the capacity for integrated cellular division, growth, and
differentiation that is characteristic of an organism, even if some cells of the former
organism may be alive in a disorganized state. Within 90 days of enactment, the
Secretary, after consulting with the Director of NIH, would be required to (1) provide
guidance concerning the next steps required for additional research, including the
extent to which additional animal research is required; (2) prioritize research that
holds the greatest potential for near-term clinical benefit; (3) take into account
techniques outlined by the President’s Council on Bioethics and any other
appropriate techniques and research; and (4) in the case of stem cells from a naturally
dead embryo, require certain assurances from the researchers. The Secretary would
be required to prepare and submit to the appropriate committees of Congress an
annual report describing the activities and research conducted. The bill authorizes
such sums as may be necessary to carry out Section 498D. Lastly, S. 30 would direct
the Secretary of HHS to contract with the Institute of Medicine (IOM) to conduct a
study to recommend an optimal structure for an amniotic and placental stem cell bank
program. The IOM is to complete the study and submit a report to HHS and
Congress no later than 180 days after enactment.
H.R. 322 (Bartlett), the Alternative Pluripotent Stem Cell Therapies
Enhancement Act of 2007, was introduced on January 9, 2007. The text of H.R. 322
is similar to legislation introduced in the 109th Congress, H.R. 5526 (Bartlett) and S.
2754 (Santorum). H.R. 322 would amend the Public Health Service Act by adding
a new Section 409J, “Alternative Human Pluripotent Stem Cell Research.” The bill
would require the Secretary of HHS to develop techniques for the isolation,
derivation, production, and testing of stem cells that are capable of producing all or
almost all of the cell types of a developing body, and may result in improved
understanding of treatments for diseases and other adverse health conditions, but that
are not derived from a human embryo. Within 90 days of enactment, the Secretary,
after consulting with the Director of NIH, would be required to (1) provide guidance

---

CRS-25
concerning the next steps required for additional research; (2) prioritize research that
holds the greatest potential for near-term clinical benefit; and (3) take into account
techniques outlined by the President’s Council on Bioethics and any other
appropriate techniques and research. The Secretary would be required to prepare and
submit to the appropriate committees of Congress an annual report describing the
activities and research conducted. The bill would define term human embryo as any
organism not protected as a human subject under part 46 of title 45, Code of Federal
Regulations, as of the bill’s date of enactment, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human gametes or
human diploid cells. The bill authorizes such sums as may be necessary for FY2008
through FY2010. H.R. 322 was referred to the House Committee on Energy and
Commerce.
H.R. 457 (Paul), the Cures Can Be Found Act of 2007, was introduced on
January 12, 2007. It amends the Internal Revenue Code to allow tax credits for (1)
an amount equal to the contribution paid by the taxpayer within the tax year to stem
cell research or storage facilities; (2) $2,000 for each umbilical cord blood donation
made by the taxpayer within the tax year. The bill allows credits only for donations
to facilities that do not engage in research on stem cells derived from human
embryos. H.R. 457 allows a business tax credit for stem cell research and storage
expenses. The bill was referred to the House Ways and Means Committee.
H.R. 1892 (Lipinski), was introduced on April 17, 2007. The bill would direct
the Secretary of HHS to provide for the establishment and maintenance of a National
Amniotic and Placental Stem Cell Bank.
S. 51 (Isakson), the Pluripotent Stem Cell Therapy Enhancement Act of 2007,
was introduced on January 4, 2007. It would amend the Public Health Service Act
requiring the Secretary of HHS to develop techniques for the isolation, derivation,
production, or testing of pluripotent stem cells that have the flexibility of embryonic
stem cells for the improved understanding of, or treatments for, diseases and other
adverse health conditions. Such techniques must not involve (1) the creation of a
viable human embryo for research purposes; or (2) the destruction or discarding of
a human embryo or embryos; or (3) knowingly subjecting a human embryo or
embryos to risk of injury or death greater than that allowed for federal research on
fetuses in utero under current law. The bill would require the Secretary to (1) provide
guidance concerning the next steps required for additional research; (2) prioritize
research with the greatest potential for near-term clinical benefit; and (3) take into
account techniques outlined by the President’s Council on Bioethics and any other
appropriate techniques and research. S. 51 was referred to the Senate HELP
Committee.
S. 362 (Coleman), the Stem Cell Research Expansion Act, was introduced on
January 23, 2007. The bill states that HHS may provide funding for research on
embryonic stem cell lines created prior to January 23, 2006, that does not result in the
use of federal funding to destroy an embryo or embryos. S. 362 was referred to the
Senate Health, Education, Labor, and Pensions Committee.
S. 363 (Coleman), the Hope Offered through Principled, Ethically-Sound Stem
Cell Research Act, was introduced on January 23, 2007. The bill directs the

---

CRS-26
Secretary of HHS to conduct research to develop techniques for the isolation,
derivation, production, and testing of pluripotent stem cells that have the flexibility
of embryonic stem cells. Such research will not involve the creation of human
embryos for research purposes or the destruction or discarding of human embryos.
Research may include methods that use cells derived from altered nuclear transfer or
cells derived from organismically dead embryos; adult stem cells from various
sources; the direct reprogramming of adult cells; and the derivation of stem cells
from human germ cells and other methods that do not harm or destroy human
embryos. Within 90 days of enactment, the Secretary will issue final guidelines that
provide the next steps required for additional research, prioritize research, and take
into account techniques outlined by the President’s Council on Bioethics and any
other appropriate techniques and research. The bill establishes a National Stem Cell
Research Review Board, which will monitor research, prioritize research, and ensure
fair consideration of both embryonic stem cell and adult stem cell research for
funding. The bill also contains provisions on informed consent, privacy of
individually identifiable information, and a prohibition on profiteering from
commerce involving human embryos. The bill authorizes $5 billion for research for
FY2008 through FY2017. S. 363 was referred to the Senate Health, Education,
Labor, and Pensions Committee.
S. 957 (Burr), the Amniotic Fluid and Placental Stem Cell Banking Act of 2007,
was introduced on March 22, 2007. The bill provides for the collection and
maintenance of amniotic fluid and placental stem cells for the treatment of patients
and research. S. 957 was referred to the Senate Health, Education, Labor, and
Pensions Committee.
Cloning
S. 812 (Hatch), the Human Cloning Ban and Stem Cell Research Protection Act
of 2007, was introduced on March 8, 2007. The text of S. 812 is identical to
legislation introduced in the 109th Congress, S. 876 (Hatch). S. 812 would amend
Title 18 of the United States Code to ban human reproductive cloning but allow
cloning for medical research purposes, including stem cell research. S. 812 includes
a criminal penalty of imprisonment of not more than 10 years and a civil penalty of
not less than $1 million. S. 812 would require 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 state attorneys 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.
S. 812 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

---

CRS-27
and privacy) contained in subpart A of 45 C.F.R. Part 46,71 or Parts 50 and 56 of
21 C.F.R.72 S. 812 would prohibit conducting SCNT on fertilized human eggs
(oocytes), and would implement a “Fourteen-Day Rule” that an “unfertilized
blastocyst 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. 812
stipulates 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. The
bill also specifies 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
the provisions in S. 812 regarding ethical requirements would result in a civil penalty
of not more than $250,000. S. 812 was referred to the Senate Judiciary Committee.
S. 1036 (Brownback), the Human Cloning Prohibition Act of 2007, was
introduced on March 29, 2007. The text of S. 1036 is identical to legislation
introduced in the 109th Congress, S. 658 (Brownback). It would amend Title 4 of the
Public Health Service Act (42 U.S.C. §§ 289 et seq.) and 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. S. 1036 includes a criminal penalty of imprisonment of not more than 10
years and a civil penalty of not less than $1 million. It would require the Government
Accountability Office (GAO) to conduct a study to assess the need (if any) for any
changes in the prohibition on cloning in light of new developments in medical
technology, the need for SCNT to produce medical advances, current public attitudes
and prevailing ethical views on the use of SCNT, and potential legal implications of
research in SCNT. The study is to be completed within four years of enactment. S.
1036 has been referred to the Senate Health, Education, Labor, and Pensions
Committee.
71 This provision specifies protections due to human beings who participate in research
conducted or supported by HHS and many other departments.
72 This provision specifies protections due to human beings who participate in research
involved in testing a drug or medical device for FDA approval.

---