Order Code RL31015
CRS Report for Congress
Received through the CRS Web
Stem Cell Research
Updated August 10, 2001
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
Stem Cell Research
Summary
On August 9, 2001, President Bush announced that for the first time federal
funds will be used to support research on human embryonic stem cells, but funding
will be limited to “existing stem cell lines.” According to the President’s speech, more
than 60 stem cell lines currently exist. However, a June 2001 National Institutes of
Health (NIH) report on stem cell research states that about 30 cell lines have been
derived from embryos or fetal tissue, another source of cells with very similar
properties. The NIH report also states that research studies “indicate that it is now
possible to grow these cells for up to two years” in the laboratory, implying that their
life span or utility may be limited.
Embryonic stem cells have the ability to develop into virtually any cell in the
body, and may have the potential to treat medical conditions such as diabetes and
Parkinson’s disease. In January 1999 the Department of Health and Human Services
determined that the current ban on federal funding of human embryo research does
not prohibit funding human embryonic stem cell research. NIH published guidelines
for support of such research in August 2000. These actions rekindled debate over the
difficult ethical and social issues surrounding embryo and fetal tissue research. Some
Members of Congress strongly disagreed with the HHS decision and believe such
research is banned by a rider that affected NIH funding for FY1996 and has been
attached to the Labor, HHS and Education appropriations acts for FY1997-FY2001.
In the past, President Bush had stated he did not support federal funding of
research on stem cells derived from either human embryos or fetal tissue obtained via
abortion but would support research using cells derived from fetal tissue obtained via
miscarriages. However, many scientists contend that such tissue is for the most part
unsuitable for research due to the presence of genetic defects. Others point to the
potential of adult stem cells obtained from tissues such as bone marrow. They argue
that adult stem cells should be pursued instead of embryonic stem cells because they
believe the derivation of stem cells from either embryos or aborted fetuses is ethically
unacceptable. Other scientists believe adult stem cells should not be the sole target
of research because of important scientific and technical limitations.
The 107th Congress has begun consideration of several bills on the topic of stem
cell research and the related area of human cloning. On July 31, 2001, the House
rejected H.R. 2172 (Greenwood) and passed H.R. 2505 (Weldon). H.R. 2172 would
ban human cloning only when it is used in human reproduction. In contrast, H.R.
2505 (S. 790, Brownback) would ban the process of human cloning when it is used
for reproductive purposes as well as research and therapeutic uses of human cloning
which would involve stem cells. S. 723 (Specter) and H.R. 2059 (McDermott) would
give NIH authority to fund the derivation of stem cells from embryos, an activity
forbidden under the NIH guidelines and prohibited by the appropriation bill rider.
These bills would prohibit support of embryo research unrelated to stem cells and
would therefore create a more permanent legislative prohibition than the
appropriations rider, which must be renewed each year. This report, which will be
updated as needed, discusses the status of research and key issues associated with
human embryonic stem cells.
Contents
Background: Basic Research and Potential Applications . . . . . . . . . . . . . . 1
Basic Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Potential Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Federal Funding of Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
HHS Legal Opinion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
NIH Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Stem Cell Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Cloning Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Ethical Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
List of Figures
Figure 1: Stem Cells via IVF Embryo or Fetal Tissue . . . . . . . . . . . . . . . . . . . . . 2
Figure 2: Stem Cells Via Somatic Cell Nuclear Transfer . . . . . . . . . . . . . . . . . . . 3
Stem Cell Research
Background: Basic Research and Potential Applications
Basic Research. Although most cells within an animal or human being are
committed to fulfilling a single function in an organ like the skin or heart, a unique and
important set of cells exists that is not so specialized. These stem cells – cells that
retain the ability to become many or all of the different cell types in the body – play
a critical role in repairing organs and body tissues throughout life. Although the term
“stem cells” refers to these repair cells within an adult organism, a more fundamental
variety of stem cells is found in the early stage embryo. These embryonic stem cells
may have a greater ability to become different types of body cells than adult stem
cells.
The earliest embryonic stem cells are referred to as totipotent, indicating that
they can develop into an entire organism because they can produce both the embryo
and the tissues required to support it in the uterus. Later in development, embryonic
stem cells lose the ability to form these supporting tissues, but are still able to develop
into almost any cell type found in the body. These pluripotent embryonic stem cells
are the current focus of intense research interest.
Possible Sources of Stem Cells
– 1-week-old embryos created via IVF for the treatment of infertility
– 5- to 9-week-old embryos or fetuses obtained through elective abortion
– embryos created via IVF for research purposes
– embryos created via SCNT (somatic cell nuclear transfer, or cloning)
– adult tissues (bone marrow, umbilical cord blood)
Embryonic stem cells were first isolated from mice in 1981, and until recently,
scientists have used only animal embryonic stem cells in research. In November 1998,
two groups published the results of their work on human stem cells from embryos or
fetuses.1 In both cases, the embryos and fetuses were donated for research purposes
following a process of informed consent. University of Wisconsin researchers derived
stem cells from 1-week-old embryos, also called blastocysts, produced via in vitro
1 For human development, the term embryo is used for the first 8 weeks after fertilization, and
fetus for the 9th week through birth. In contrast, HHS regulations define fetus as “the product
of conception from the time of implantation.” (45 CFR 46.203)
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fertilization (IVF) for the treatment of infertility.2 Because the stem cells are located
within the embryo, the process of removing the cells destroys the embryo. Johns
Hopkins University investigators derived cells with very similar properties from 5- to
9-week-old embryos or fetuses obtained through elective abortions.
Figure 1: Stem Cells via IVF Embryo or Fetal Tissue
Source: Figure 1 is based on a figure contained in a May 2000 report by the National
Institutes of Health entitled Stem Cells: A Primer, which can be found at:
[http://www.nih.gov/news/stemcell/primer.htm].
The Jones Institute for Reproductive Medicine, located in Norfolk, Virginia,
announced in July 2001 that it had created human embryos via IVF for the purpose
of deriving human embryonic stem cells.3 Although the Jones Institute work, which
was begun in 1997, does not represent a research advance, according to experts in
academia and industry, it “might be the first time in the United States that a human
embryo had been created solely for research” rather than for the treatment of infertile
couples.4 A representative of the Jones Institute, Dr. William E. Gibbons, states that
several ethics panels approved the work, and contends that such “fresh” embryos may
have advantages over the frozen embryos remaining after infertility treatment. Unlike
couples utilizing fertility clinics, the egg donors were younger, “possibly yielding more
robust embryos.” The egg and sperm donors underwent psychological and medical
evaluation and were informed of the research goals.
Another potential source of embryonic stem cells is somatic5 cell nuclear transfer
(SCNT), the cloning procedure used to produce Dolly, the sheep. Geron
Corporation, a Menlo Park, California biotechnology company, and Advanced Cell
2 IVF embryos that are produced in excess of need are usually frozen in liquid nitrogen for
future use by the couple. If the couple decides that their family is complete, they may elect
to discard the embryos, donate the embryos for research, or allow another couple to adopt the
embryo.
3 Stolberg, Sheryl Gay. Scientists Create Scores of Embryos to Harvest Cells. The New York
Times, July 11, 2001, pp. A1, A15.
4 Ibid., p. A15.
5 A somatic cell is a body cell, as opposed to a germ cell, which is an egg or sperm cell.
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Technology Co. of Worcester, Massachusetts, are currently funding work on stem
cells created via this process.6 In SCNT, the nucleus of an egg is removed and
replaced by the nucleus from a mature body cell, such as a skin cell. The cell created
via SCNT would be allowed to reach the 1-week (blastocyst) stage and the stem cells
would then be removed, as in the University of Wisconsin work. An alternate SCNT
approach is the fusion of adult human cells with egg cells of other animals. In 1996,
researchers at the University of Massachusetts fused a human cheek cell with a cow
egg cell. The resulting hybrid cell had “embryo-like” characteristics and was
generated for the purpose of making stem cells. This method was at one time being
pursued by Advanced Cell Technology Co.7
Figure 2: Stem Cells Via Somatic Cell Nuclear Transfer
Source: Figure 2 is from a May 2000 report by the National Institutes of Health entitled
Stem Cells: A Primer, which can be found at:
[http://www.nih.gov/news/stemcell/primer.htm].
Stem cells obtained from adult organisms are also the focus of research. There
have been a number of recent publications on adult stem cells from a variety of
different sources, such as bone marrow and the umbilical cord following birth. Some
advocate that this path should be pursued instead of embryonic stem cells because
they believe the derivation of stem cells from either IVF embryos or aborted fetuses
is ethically unacceptable. However, other scientists believe 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 versatile in developing into various types of tissue as
embryonic stem cells, and the location of the cells in the body might rule out safe and
easy access. For these reasons, they argue that both adult and embryonic stem cells
should be the subject of research.
6 Weiss, Rick. Embryo Work Raises Spector of Human Harvesting. The Washington Post,
June 14, 1999. p. A01; and, Stolberg, Sheryl Gay. Company Using Cloning to Yield Stem
Cells. The New York Times, July 13, 2001, p. A13.
7 Hall, Stephen S. The Recycled Generation. The New York Times Magazine, January 30,
2000. p. 30-35, 46, 74, 78-79.
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Potential Applications. Stem cell research was chosen by Science magazine
in 1999 as its “breakthrough of the year.” Stem cells provide the opportunity to study
the growth and differentiation of individual cells. 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 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 making it difficult 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. The potential
benefits mentioned previously are 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, if stem cells are to be
used for transplantation, the problem of immune rejection must also be overcome.
However, if the SCNT technique (cloning) was employed using a cell nucleus from
the patient, stem cells created via this method would be genetically identical to the
patient and would presumably be recognized by the patient’s immune system, thus
avoiding any tissue rejection problems.
Federal Funding of Research
On August 9, 2001, President Bush announced that federal funds will be used
to support research on human embryonic stem cells, but funding will be limited to
“existing stem cell lines.” According to the President’s speech, more than 60 stem cell
lines currently exist. However, a scientific review, prepared by NIH, of the status of
the research and its applications states that about 30 cell lines have been derived from
embryos or fetal tissue. The scientific review was released on July 18, 2001, at a
hearing on stem cell research held by the Senate Appropriations Subcommittee on
Labor, Health and Human Services and Education.8 The NIH report also states that
research studies “indicate that it is now possible to grow these cells for up to two
years” in the laboratory, implying that their life span or utility may be limited and that
additional cell lines beyond those existing to date may be needed if this line of
research is to be pursued. The NIH report does not make any recommendations, but
argues that both embryonic and adult stem cell research should be pursued. (See also
Congressional Actions section of this report.)
In the past, President Bush has indicated that he does not support the federal
funding of research on stem cells derived from either human embryos or fetal tissue
8 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://www.nih.gov/news/stemcell/scireport.htm].
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obtained from abortions.9 He has indicated his support for stem cell research using
cells derived from fetal tissue obtained from spontaneous abortions (miscarriages).
However, scientists contend that such tissue is for the most part unsuitable for
research due to the presence of genetic defects or other anomalies. At one time,
Secretary of HHS Tommy G. Thompson stated that he is very much in favor of stem
cell research.10 Secretary Thompson is the former Governor of Wisconsin, and as
noted above, University of Wisconsin researchers published in November 1998 the
results of their work in deriving stem cells from 1-week-old embryos produced via
IVF for the treatment of infertility.
To date, no federal funds have been used to support research on stem cells
derived from either source.11 The work at the University of Wisconsin and Johns
Hopkins University was supported by private funding from Geron Corporation.
Private funding for experiments involving embryos was required because Congress
attached a rider to legislation that affected FY1996 NIH funding. This rider,
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. This same rider has been attached
to the Labor, HHS and Education appropriations acts for FY1997 through FY2001.12
The current rider, Section 510 of the FY2001 Labor, HHS and Education
Appropriations Act, included in the Consolidated Appropriations Act, 2001 (P.L.
106-554), prohibits HHS from using FY2001 appropriated funds for:
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed, discarded, or
knowingly subjected to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)). 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] ...
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].
9 Kondracke, M. M. Bush wisely orders study of fetal, stem cell issues. Roll Call, February
1, 2001; and, Kornblut, A. E. Bush says he opposes using fetal tissue from abortions. The
Boston Globe, January 27, 2001.
10 Healy, P. HHS chief decries nomination lag. The Boston Globe, May 22, 2001.
11 However, federal funds have been provided for research on adult stem cells. In FY2000,
the total amount spent by NIH on stem cell research was $256 million. The total can be
broken down as follows: human adult stem cell research, $147 million; animal adult stem cell
research, $79 million; animal embryonic stem cell research, $30 million.
12 The rider language has not changed significantly from year to year. The original rider can
be found in Section 128 of P.L. 104-99; it affected NIH funding for FY1996 contained in P.L.
104-91. For subsequent fiscal years, the rider is found in Title V, General Provisions, of the
Labor, HHS and Education appropriations acts in the following public laws: FY1997, P.L.
104-208; FY1998, P.L. 105-78; FY1999, P.L. 105-277; FY2000, P.L. 106-113; and
FY2001, P.L. 106-554.
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There is no similar federal prohibition on fetal tissue research; however, other
restrictions do apply (see below).
HHS Legal Opinion. 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 or fetal tissue. The January 15, 1999, response from HHS
General Counsel Harriet Rabb found that current law prohibiting the use of HHS
appropriations for human embryo research (the above-mentioned rider) 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 HHS’s
determination 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 pluripotent stem cells are not and cannot develop into an organism; they lack
the capacity to become organisms even if they are transferred to a uterus. As a result,
HHS maintained that NIH could support research that uses stem cells derived through
private funds, but could not support research that itself, with federal funds, derives
stem cells from embryos because of the federal ban in the rider.
Regarding research using stem cells derived from fetal tissue, HHS found that
to the extent human stem cells are legally considered fetal tissue, they would be
subject to certain other restrictions that safeguard against the inappropriate use of
fetuses. For example, a statutory ban on sale for valuable consideration prohibits
researchers with federal support from paying for the tissue, except reasonable
payments associated with transportation, implantation, processing, preservation,
quality control or storage of the tissue or cells. Other restrictions include the criminal
prohibition on the directed donation of fetal tissue and restrictions on fetal tissue
transplantation research conducted or funded by HHS.13
In addition, such research may be conducted only in accordance with applicable
state or local law.14 According to a report published by the National Bioethics
Advisory Commission, nine states – FL, LA, ME, MA, MI, MN, ND, PA and RI, – ban
IVF embryo research entirely.15 Six states – AZ, IN, ND, OH, OK, and SD – ban
research on aborted fetuses or embryos.16 However, in December 2000, the AZ law
13 The NIH Revitalization Act of 1993 (P.L. 103-43) allows federal support of human fetal
tissue transplantation research using tissue from induced abortions under certain conditions
only if the transplantation is for therapeutic purposes. The Act contains several provisions
intended to decouple the decision to have the abortion from the choice to donate the tissue for
transplantation and to insulate the decision from financial considerations.
14 See 45 CFR 46.210.
15 Andrews, Lori B. State Regulation of Embryo Stem Cell Research. In National Bioethics
Advisory Commission, Ethical Issues in Human Stem Cell Research, v. II, Commissioned
Papers, January 2000.
16 Ibid.
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was overturned by a federal court.17 A number of states ban payment for either IVF
embryos or aborted fetuses or embryos.
NIH Guidelines. Shortly after the opinion by the HHS General Counsel, NIH
disclosed that the agency planned to fund research on pluripotent stem cells derived
from human embryos and fetal tissue once appropriate guidelines were developed and
an oversight committee established. NIH Director Harold Varmus appointed a
working group which 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 23, 2000, NIH released final guidelines on the support of human
embryonic and fetal stem cell research; Federal Register publication occurred on
August 25, 2000.18 The guidelines state that “studies utilizing pluripotent 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.” The NIH will not fund research directly involving the
derivation of human stem cells from embryos; this is currently prohibited by the
previously mentioned appropriation rider. In this respect, the NIH is more restrictive
than other groups such as the National Bioethics Advisory Commission (NBAC)19 and
an expert British panel,20 which both recommended support for the derivation of stem
cells from such embryos. The NIH guidelines allow funding of research to derive
stem cells from fetal tissue, as well as research utilizing such stem cells; this is in
agreement with NBAC recommendations and current law.
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;
17 Stolberg, Sheryl Gay. Washington Not Alone in Cell Debate. The New York Times, July
23, 2001, p. A12.
18 The NIH guidelines can be found at:
[http://www.nih.gov/news/stemcell/stemcellguidelines.htm].
19 The September 1999 NBAC report, Ethical Issues in Human Stem Cell Research, can be
found at [http://www.bioethics.gov]. NBAC was established by Executive Order 12975 on
October 3, 1995; a September 16, 1999 executive order extended the NBAC charter until
October 2001. NBAC makes recommendations to the National Science and Technology
Council on bioethical issues arising from research on human biology and behavior. The
commission has already completed reports on human cloning, the use of human biological
materials, and treating persons with mental disorders. On November 14, 1998, President
Clinton requested NBAC to conduct a review of the issues associated with stem cell research.
20 The British report Stem Cell Research: Medical Progress With Responsibility, was
released along with nine recommendations on August 16, 2000. Full text of the report can be
found at: [http://www.doh.gov.uk/cegc/stemcellreport.htm]. On December 19, 2000, the
House of Commons voted (366-174) to allow stem cell research using embryos up to 14 days
old. (Washington FAX, December 21, 2000.) On January 22, 2001, the House of Lords also
voted (212-92) in favor of allowing research on human embryonic stem cells. (Washington
FAX, January 24, 2001.)
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(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. The NBAC report
is silent on areas 1-3 and in agreement with the guidelines on areas 4-6.
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 are to be
reviewed by the new 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, will serve as chair
of the HPSCRG. Applications will also undergo the normal NIH peer-review process.
In mid-April 2001, HHS announced that it was postponing the first meeting of
the HPSCRG until the review of policy decisions on stem cell research made during
the Clinton Administration is completed.21 The group’s first meeting had been
scheduled for April 25, 2001. According to media sources, only three grant
applications were submitted to NIH, and one was subsequently withdrawn.22
Presumably, scientists are 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 are so uncertain. In a related development, one of the
leading U.S. researchers on stem cells, Roger Pederson of the University of
California, San Francisco, is reportedly moving his laboratory to the United Kingdom
for “the possibility of carrying out my research with human embryonic stem cells with
public support.”23 Human embryonic stem cell research was approved
overwhelmingly by the House of Commons in December 2000 and the House of
Lords in January 2001.24
Congressional Actions
The January 15, 1999 opinion by HHS General Counsel Harriet Rabb and the
decision by NIH to fund human embryonic stem cell research in the near future was
strongly opposed by many Members of Congress. In a February 11, 1999 letter from
70 Members to HHS Secretary Donna Shalala, they stated that “any NIH action to
initiate funding of such research would violate both the letter and the spirit of the
federal law banning federal support for research in which human embryos are harmed
or destroyed.” The authors of the letter also objected to HHS General Counsel
Rabb’s definition of human embryo: “an entity is an embryo only if one can show that
21 Boahene, A. K. Stem cell research group cancels inaugural meeting pending HHS review
of NIH research guidelines. Washington FAX, April 19, 2001.
22 Recer, P. Stem Cell Studies said Hurt by Doubt. AP Online, May 2, 2001.
23 Zitner, Aaron. Uncertainty is thwarting stem cell researchers. Los Angeles Times, July 16,
2001, pp. A1, A8.
24 See footnote 20.
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it is capable, if implanted in the womb, of becoming a born human being.” The letter
stated that “this narrow definition has no support whatsoever in federal law.”
In a February 23, 1999 letter, Secretary of HHS Donna Shalala responded that
the definition of embryo used in the HHS opinion “relies on the definition provided
in the statute itself.” Secretary Shalala’s letter stated that the federal ban only applies
to research in which human embryos are discarded or destroyed but “not to research
preceding or following on such projects [in which human embryos are discarded or
destroyed]. Moreover, ... there is nothing in the legislative history to suggest that the
provision was intended to prohibit funding for research in which embryos – organisms
– are not involved.”
The stem cell research issue threatened to hold up passage of the FY2000 Labor,
Health and Human Services and Education appropriations bill. In the House,
Representative Jay Dickey proposed an amendment to restrict federally funded stem
cell research to work on cells derived from fetal tissue. Representative Dickey, the
author of the congressional funding ban on embryo research, withdrew his amendment
at the request of House leadership who were concerned that controversial
amendments might slow down passage of the appropriation bill. In the Senate, the
issue held up passage of the FY2000 LHHS appropriation bill until Senate leadership
agreed to drop language endorsing the research and take it up as a separate bill in the
second session.
On February 4, 2000, a group of 20 Republican Senators sent a letter to DHHS
in opposition to the proposed NIH guidelines for support of human embryonic stem
cell research asserting that such support is contrary to the requirements of the
agency’s appropriations language. The authors of the letter asked that NIH withdraw
the proposed guidelines, and indicated that should the NIH adopt the draft guidelines,
further steps might be taken to oppose them, including a possible lawsuit to enforce
the federal ban.25
On July 17, 2001, a hearing on stem cell research was held by the House
Government Reform Subcommittee on Criminal Justice, Drug Policy and Human
Resources. Testifying at the hearing were two couples who gave birth to children
following the adoption of surplus frozen embryos created at fertility clinics. The
Subcommittee also heard testimony from Gerald Fischbach, former director of the
National Institute of Neurological Diseases and Stroke, and currently in the health and
biomedical sciences department at Columbia University. Dr. Fischbach stated at the
hearing that “it is irresponsible to claim that adult stem cells are superior to embryonic
cells in their ability to proliferate or in the diversity of their descendants.”26 He also
warned against a compromise proposal that would limit federal funding of stem cell
research to a small number of stem cell lines. “Unfortunately, this would cripple
research ... Stem cell lines derived from different fertilized eggs are not identical, and
the same line may not be optimal for all disorders.”
25 Brainard, Jeffrey. Twenty GOP Senators Urge NIH Not to Finance Stem-Cell Research.
The Chronicle of Higher Education, February 25, 2000. p. A40.
26 Davis, Matthew. Divisive House Hearing Brings Out Emotional Views on Embryonic Stem
Cell Research. Washington Fax, July 18, 2001.
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On July 18, 2001, a hearing on stem cell research was held by the Senate
Appropriations Subcommittee on Labor, Health and Human Services and Education.
As mentioned previously, at the hearing the NIH released the scientific review of stem
cell research that was prepared for the Bush administration. The report does not
make any recommendations. The NIH report indicates that at the time the report was
written, there were 30 cell lines of human stem cells that had been derived from either
human embryos or fetal tissue, and that the cell lines are capable of growing under
laboratory conditions for up to 2 years. The report states that adult stem cells are rare
and often difficult to identify, isolate and purify. When grown under laboratory
conditions, most adult stem cells are unable to proliferate in an unspecialized state for
long periods of time. When researchers have been able to grow adult stem cells for
long periods of time under laboratory conditions, they have not been able to direct the
adult stem cells to become specialized as functionally useful cells. Such a setback
would need to be overcome in order to provide cells useful for transplantation into
patients to treat medical conditions such as diabetes or spinal cord injury.
Also at the July 18 Senate hearing, Senator Bill Frist announced his position in
favor of federal funding for stem cell research and outlined a 10-point plan for
allowing such research to proceed. Senator Frist is said to be advising President Bush
on the issue. The 10 points delineated in Senator Frist’s statement before the
Subcommittee are as follows:27
1. The creation of human embryos solely for research purposes should be
strictly prohibited.
2. Strengthen and codify the current ban on federal funding for the
derivation of embryonic stem cells.
3. Prohibit all human cloning to prevent the creation and exploitation of
life for research purposes.
4. Increase federal funding for research on adult stem cells to ensure the
pursuit of all promising areas of stem cell research.
5. Allow federal funding for research using only those embryonic stem cells
derived from blastocysts that are left over after IVF and would otherwise
be discarded.
6. To ensure that blastocysts used for stem cell research are only those that
would otherwise be discarded, require a comprehensive informed consent
process establishing a clear separation between potential donors’ primary
decision to donate blastocysts for adoption or to discard blastocysts and
their subsequent option to donate blastocysts for research purposes. Such
a process, modeled in part on well-established and broadly accepted organ
27 Senator Frist’s principles on human stem cell research can be found at:
[http://www.senate.gov/~frist/Press_Center/News_Releases/01-144/Stem_Cell_Research_
Standards/stem_cell_research_standards.html].
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and tissue donation practices, will ensure that donors are fully informed of
all their options.
7. Restrict federally-funded research using embryonic stem cells derived
from blastocysts to a limited number of cell lines. In addition, authorize
federal funding for embryonic stem cell research for 5 years to ensure
ongoing congressional oversight.
8. Establish appropriate public oversight mechanisms, including a national
research registry, to ensure the transparent, in-depth monitoring of
federally-funded and federally-regulated stem cell research and to promote
ethical, high quality research standards.
9. Establish an ongoing scientific review of stem cell research by the
Institute of Medicine (IOM) and create an independent Presidential
advisory panel to monitor evolving bioethical issues in the area of stem cell
research. In addition, require the Secretary of HHS to report to Congress
annually on the status of federal grants for stem cell research, the number
of stem cell lines created, the results of stem cell research, the number of
grant applications received and awarded, and the amount of federal funding
provided.
10. Because stem cell research would be subject to new, stringent federal
requirements, ensure that informed consent and oversight regulations
applicable to federally-funded fetal tissue research are consistent with these
new rules.
Stem Cell Legislation. S. 723 (Specter), introduced on April 5, 2001, would
give NIH authority to fund the derivation of stem cells from surplus IVF embryos, an
activity forbidden under the NIH guidelines and prohibited by the appropriation bill
rider. In contrast, the bill broadly prohibits support of embryo research unrelated to
stem cells. By amending the Public Health Service Act, this provision represents a
more permanent legislative prohibition than the appropriations rider (which must be
renewed each year) banning support of research involving the destruction of human
embryos. A companion bill, H.R. 2059 (McDermott) was introduced in the House
on June 5, 2001. On January 30, 2001, H.Res. 17 (Maloney) was introduced
“expressing the sense of the Congress supporting federal funding of pluripotent stem
cell research.”
H.R. 2096 (Smith), introduced on June 7, 2001, authorizes the Secretary of
HHS to establish a National Stem Cell Donor Bank in order to make “qualifying
human stem cells” available for research and therapeutic purposes. Qualifying human
stem cells are defined in the bill as “human stem cells obtained from human placentas,
umbilical cord blood, organs or tissues of a living or deceased human being who has
been born, or organs or tissues of unborn human offspring who died of natural causes
(such as spontaneous abortion).”
Cloning Legislation. On July 19, 2001, the House Judiciary Subcommittee
on Crime approved H.R. 2505 (Weldon) by voice vote. H.R. 2505 would ban the
process of human cloning, called somatic cell nuclear transfer (SCNT), when it is used
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for reproductive purposes as well as for research and therapeutic uses, which would
involve stem cells. The bill's language specifically bans the importation of any product
derived from an embryo created via SCNT, and therefore would presumably prevent
U.S. citizens from receiving treatments for diabetes, cancer, or Parkinson’s disease
that were created overseas. The bill includes a criminal penalty of imprisonment of
not more than 10 years and a civil penalty of not less than $1 million and not more
than 2 times the gross gain of the violator. A companion bill, S. 790 (Brownback),
has been introduced in the Senate.
On July 24, 2001, the House Judiciary Committee approved H.R. 2505 by a vote
of 18 to 11 and defeated a substitute that was identical to H.R. 2172 (Greenwood)
by a vote of 11 to19. H.R. 2172 would ban only human reproductive cloning but
contains the same criminal and civil penalties as H.R. 2505 when SCNT is used “with
the intent to initiate a pregnancy.” The ban contained in H.R. 2172 would sunset
after 10 years. The Bush Administration announced its approval of H.R. 2505 on
July 24, 2001.
On July 31, 2001, the House passed H.R. 2505 by a vote of 265-162. Prior to
the vote on H.R. 2505, the House defeated a substitute amendment, H.R. 2172, by
a vote of 178 to 249. During debate, supporters of H.R. 2505 argued that a partial
ban on human cloning, such as H.R. 2172, would be impossible to enforce. Critics
of H.R. 2505 argued that SCNT creates a “clump of cells” rather than an embryo, and
that the measure would curtail medical research and prevent Americans from
receiving life-saving treatments created overseas.
Some legal scholars believe a congressional ban on human cloning may be
unconstitutional because it would infringe upon the right to make reproductive
decisions which is “protected under the constitutional right to privacy and the
constitutional right to liberty.”28 More importantly for the issue of stem cell research,
a ban on human cloning for research purposes raises other constitutional issues:
scientists’ right to personal liberty and right to free speech.29 In the opinion of some
legal scholars, any limits the government might place on the use of cloning in scientific
inquiry or human reproduction would have to be “narrowly tailored to further a
compelling state interest.”30
As stated previously (under NIH Guidelines section of this report), in their
current form, the NIH Guidelines on Stem Cell Research would not fund research in
which: human stem cells are used for reproductive cloning of a human; human stem
cells are derived using cloning (SCNT – somatic cell nuclear transfer, i.e., the transfer
of a human somatic cell nucleus into a human or animal egg); or, human stem cells
that were derived using cloning (SCNT) are utilized in a research project.
28 Andrews, L. B. Is There a Right to Clone? Constitutional Challenges to Bans on Human
Cloning. Harvard Journal of Law and Technology, summer 1998. p. 643-680.
29 Ibid., p. 661.
30 Ibid., p. 667.
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Ethical Issues
The central controversy surrounding human stem cell research is the source of
the cells. The debate primarily arises from differences in deeply held religious and
philosophic views. For most who believe that the embryo is a human being from the
moment of fertilization, the derivation of stem cells from either very early or pre-
implantation embryos created by IVF or from the tissues of aborted fetuses is ethically
unacceptable. From this viewpoint, even though the proposed guidelines do not
support activities which directly destroy embryos, support of research on components
of the embryo would tacitly endorse such destruction.
Supporters of this view argue therefore that the guidelines would violate federal
bans on human embryo research. From this perspective, the possible benefits of stem
cell research cannot and should not justify the actions necessary to obtain the cells.
Opponents of stem cell research propose that research on adult stem cells, which they
claim could provide similar therapeutic benefits without the need for fetal cells, be
supported instead. Not all scientists agree, however, that adult stem cells hold as
much potential as embryonic stem cells.
Those who support embryonic stem cell research believe that pre-implantation
embryos do not have the same moral and legal status as persons. They acknowledge
that embryos are genetically human, but hold that they do not have the same moral
relevance because they lack specific capacities, including consciousness, reasoning
and sentience.31 The NBAC received testimony from witnesses of many religious
traditions that were open to the use of early embryos (remaining from infertility
treatments) for stem cell research as well as many who were opposed. “Jewish and
Islamic ethicists supported stem cell research while Protestant and Catholics were
mixed. ... [W]hile the early human embryo is worthy of respect, it ought not to be
given personal moral status until there has been sufficient development of the
embryo.”32
Supporters argue that the potential human health and scientific benefits the
research holds should be an ethical argument for its support. Patient groups have also
asserted that, because of the potential of human stem cells for the treatment of
disease, it is immoral to discourage such research because it could save many lives.
In addition, supporters believe that the oversight which would come with federal grant
support would result in better and more ethically controlled research in the field than
if funding was from private sources alone. Supporters also argue that the efforts of
both federally supported and privately supported researchers are necessary to keep
the United States at the forefront of what they believe is a very important, cutting
edge area of science.
31 Presentation by Steinbock, B., Department of Philosophy, SUNY, Albany, New York. NIH
Human Embryo Research Panel Meeting. February 3, 1994.
32 Wildes, Kevin W. The Stem Cell Report. America, October 16, 1999. p. 12-14.