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Stem Cell Research: Ethical and Legal Issues
Erin D. Williams
Specialist in Public Health and Bioethics
Edward C. Liu
Legislative Attorney
Judith A. Johnson
Specialist in Biomedical Policy
September 15, 2010
Congressional Research Service
7-5700
www.crs.gov
RL33554
CRS Report for Congress
P
repared for Members and Committees of Congress
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Stem Cell Research: Ethical and Legal Issues
Summary
Recent court decisions in the case of
Sherley v. Sebelius have called into question whether federal
law prohibits the award of federal funding for embryonic stem cell research (ESR). As explained
in the next paragraph, but for a brief period, federal funding has been available for research
using established embryonic stem cell (ES) lines, but not for the
establishment of ES lines. Neither the
Sherley case nor the affected federal policy restricts or regulates ESR conducted solely with
private, local, and/or state government funding, or with funding from other non-federal sources.
Since 1996, federal funding for research that involves the creation or destruction of human
embryos has been prohibited. This prohibition is due to the Dickey Amendment, a rider placed on
Health and Human Services’ (HHS) annual appropriation each year since FY1997. Federal policy
allowing research on established ES lines was based on an interpretation of Dickey, issued in
1999 by then-HHS General Counsel Harriet Rabb (HHS 1999 Opinion). The HHS 1999 Opinion
concluded that Dickey prohibited the use of HHS funds to
establish ES lines (which involves
embryo destruction), but not to conduct research
using ES from established lines (on the theory
that ES themselves are not embryos). In the context of the HHS 1999 Opinion, the Obama
Administration created its ES policy, which permits federal funding for research using established
ES lines that meet certain ethical requirements. The Obama ES policy is articulated in two 2009
documents: Executive Order 13505 (Obama EO), and National Institutes of Health guidelines
issued pursuant to the EO (NIH 2009 Guidelines). In
Sherley, the
court issued a preliminary
injunction, enjoining HHS from “implementing, applying, or taking any action whatsoever
pursuant to” the NIH 2009 Guidelines “or otherwise funding research involving human
embryonic stem cells as contemplated in the Guidelines,” holding that they violate Dickey. HHS
appealed and the Court of Appeals for the D.C. Circuit issued a stay of the preliminary injunction,
temporarily permitting federal funding of ESR to continue under the NIH 2009 Guidelines.
While the D.C. Circuit considers the appeal, Congress has four policy options. First, it could
sanction or expand federal funding for ESR by eliminating or modifying the Dickey Amendment,
or by passing other legislation (for example, H.R. 872, H.R. 873, S. 487, H.R. 4808, and S. 3766).
(Note that the effect of such legislation could be questioned if Dickey and the
Sherley holding are
affirmed.) Second, Congress could encourage possible alternatives to ESR through research
funding or tax incentives for activities that that do not involve the destruction of human embryos
(S. 99, S. 3751, H.R. 877, H.R. 1230, H.R. 1654, H.R. 2107, H.R. 6081, and H.R. 6083). Third, it
could restrict or eliminate ESR by prohibiting federal research funding, banning certain cloning
techniques, or giving embryos a constitutional right to life (H.R. 110, H.R. 227, S. 346, H.R. 881,
and H.R. 1050). (Enactment of a law banning federal ESR funding would preclude such funding
even if
Sherley were overturned or Dickey were eliminated.) Fourth, it could take no action,
which would permit federal ESR funding unless or until the
Sherley case is affirmed.
Many opinions about the ethics of ESR have been published. The positions could be broadly
categorized as
for or
against ESR; however, there is an array of finer distinctions that reveal more
subtle variation in ethical, moral, and factual beliefs. Breaking down ESR arguments according to
these finer distinctions demonstrates both the complexity of the issues and the points of resonance
among the opinions. The broadest discussion involves the balance of embryo destruction and
relief of human suffering. More subtle issues focus on the relative importance of embryo viability,
the purpose of embryo creation, new versus existing ES lines, donor consent, egg procurement,
possible alternatives, and federal funding. This report presents background concepts, outlines
legal arguments related to
Sherley, and details the ethical arguments that surround ESR.
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Contents
Introduction ................................................................................................................................ 1
Current Law and Policy............................................................................................................... 2
The Dickey Amendment........................................................................................................ 2
HHS 1999 Opinion ............................................................................................................... 3
The Obama EO ..................................................................................................................... 3
NIH 2009 Guidelines ............................................................................................................ 4
Part One (Scope of Guidelines) ....................................................................................... 4
Part Two (Eligibility of Human Embryonic Stem Cells for Research with NIH
Funding) ...................................................................................................................... 4
Part Three (Use of NIH Funds)........................................................................................ 5
Parts Four and Five (Research Using hESCs and/or Human Induced Pluripotent
Stem Cells That, Although the Cells May Come from Eligible Sources, is
Nevertheless Ineligible for NIH Funding; Other Research Not Eligible for NIH
Funding) ...................................................................................................................... 6
Sherley v. Sebelius................................................................................................................. 6
Historical Note: The Bush Policy .......................................................................................... 7
Policy Options for Congress........................................................................................................ 8
Discussion of Ethical Issues ........................................................................................................ 9
Proponents and Opponents .................................................................................................... 9
Embryo Destruction and Relief of Human Suffering............................................................ 11
Viability of Embryos ........................................................................................................... 11
Purpose of Embryo Creation ............................................................................................... 12
New and Existing Cell Lines ............................................................................................... 13
Consent of Donors .............................................................................................................. 14
Egg Procurement........................................................................................................... 15
Effectiveness of Alternatives ............................................................................................... 17
Generating Embryonic Stem Cells Without Destroying Human Embryos....................... 18
Use of Federal Funding ....................................................................................................... 19
Contacts
Author Contact Information ...................................................................................................... 21
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Stem Cell Research: Ethical and Legal Issues
Introduction
In order to fully understand the ethical and legal issues involved in stem cell research, it is useful
to be familiar with a few basic terms and concepts:1
•
Stem cells are those with the ability to divide for indefinite periods in culture and
to give rise to specialized cells. There are two main types of stem cells:
adult
stem cells and
embryonic stem cells.
• An
adult stem cell is thought to be an undifferentiated cell, found among
differentiated cells in a tissue or organ that can renew itself and can differentiate
to yield some or many of the major specialized cell types of the tissue or organ.
Adult stem cells have been identified in many organs and tissues, including brain,
bone marrow, peripheral blood, blood vessels, skeletal muscle, skin, teeth, heart,
gut, liver, ovarian epithelium, and testis. Blood-forming stem cells from bone
marrow have been used for 50 years to treat patients for a variety of blood-related
conditions.2
•
Embryonic stem cells (ES) are derived from embryos, and have the potential to
give rise to any type of specialized cell. (The process of obtaining ES from an
embryo causes the destruction of the embryo.) ES could be used to repair spinal
cord injury, or treat a variety of diseases such as Parkinson’s and diabetes.
•
ES lines consist of ES that have been cultured under
in vitro (laboratory)
conditions that allow proliferation without differentiation for months to years.
(This means that an embryo can be used to generate an ES line, which, once
established, can continue to produce ES for months to years.)
The topic of stem cell research claimed news headlines in August 2010 due to a federal district
court ruling in the case of
Sherley v. Sebelius.3 As described in the “Current Law and Policy”
section of this report, prior to
Sherley, ethical concerns about embryo research had prompted
certain restrictions on the expenditure of federal funds for ESR; however, limited funding had
been permitted and awarded since 2001. The
Sherley opinion would have effectively precluded
the award of federal funding for ESR if it had not been stayed by the Court of Appeals for the
D.C. Circuit pending appeal. As described in the “Policy Options for Congress” section of this
report, Congress has a range of policy options it could use to encourage, fund, restrict, or
discourage ESR funding, which could affect or potentially be affected by the ultimate outcome of
Sherley.
1 Reference to stem cells in this report refer only to
human stem cells unless otherwise specified. For further
information about the science of stem cell research, see CRS Report RL33540,
Stem Cell Research: Science, Federal
Research Funding and Regulatory Oversight, by Judith A. Johnson and Erin D. Williams.
Unless bracketed or otherwise noted, bulleted definitions and background information are from NIH,
Stem Cell
Information: Glossary, August 20, 2010, http://stemcells.nih.gov/StemCells/Templates/StemCellContentPage.aspx?
NRMODE=Published&NRNODEGUID=%7b3C35BAB6-0FE6-4C4E-95F2-2CB61B58D96D%7d&
NRORIGINALURL=%2finfo%2fglossary%2easp&NRCACHEHINT=NoModifyGuest#embryonicline; and NIH,
Stem
Cell Information: Stem Cells and Diseases, August 19, 2010, http://stemcells.nih.gov/info/health.asp.
2 Frederick R. Appelbaum, “Hematopoietic-Cell Transplantation at 50,” The New England Journal of Medicine, v. 357,
October 11, 2007, pp. 1472-1475.
3 Sherley v. Sebelius, Civ. No. 1:09-cv-1575 RCL (D.D.C. Aug. 23, 2010) (preliminary injunction order).
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The legal issues and policy options related to stem cell research are informed in part by the
ethical issues. As described in the “Discussion of Ethical Issues” section of this report, what is
now more than a decade of debate and writing about the ethics of ESR reveals a range of nuanced
opinions about a variety of subtle issues. These include the relative importance of the viability of
embryos, the purpose of embryo creation, new versus existing cell lines, the consent of donors,
the ethics of egg procurement, the effectiveness of alternatives, and the use of federal funding,
among others.
This report contains an overview of current law and policy (including an analysis of the
Sherley
case), presents policy options for Congress, and then details a range of ethical arguments that
relate to stem cell research.
Current Law and Policy
Federal regulation of ESR primarily consists of the Dickey Amendment, the Department of
Health and Human Services (HHS) 1999 Opinion, the Obama EO (13505), and the NIH 2009
Guidelines as potentially affected by
Sherley v. Sebelius.4 Each of these addresses the use of
federal funding to support ESR. None of these restricts or regulates ESR conducted solely with
private, local and/or state government funding, or with funding from other non-federal sources.
None of the restrictions apply to adult stem cell research. For historical purposes, a description of
the previous Administration’s ES policy, which had been established by the George W. Bush
Administration, is presented below at “Historical Note: The Bush Policy”.
The Dickey Amendment
Since 1996, the Dickey Amendment has prohibited the use of HHS funds for the creation of
human embryos for research purposes, or research in which a human embryo or embryos are
destroyed. The Dickey Amendment precludes the use of federal funding to derive stem cells from
embryos, which typically are produced via in vitro fertilization (IVF). Whether it precludes the
use of federal funds for research on existing ES lines was the topic of the HHS 1999 Opinion as
well as the 2010
Sherley case.
The Dickey Amendment language has been added to each of the Labor, HHS, and Education
appropriations acts for FY1997 through FY2009.5 Funding for FY2010 is provided in the
Consolidated Appropriations Act, 2010 (P.L. 111-117). The Dickey Amendment is found in
Section 509 of Division D—Departments of Labor, Health and Human Services, and Education,
and Related Agencies Appropriations Act, 2010, of P.L. 111-117. It states that:
4 Sherley v. Sebelius, Civ. No. 1:09-cv-1575 RCL (D.D.C. Aug. 23, 2010). For further information, see CRS Report
RL33540,
Stem Cell Research: Science, Federal Research Funding and Regulatory Oversight, by Judith A. Johnson
and Erin D. Williams.
5 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; FY2007, P.L. 110-5; FY2008, P.L. 110-161; FY2009, P.L.
111-8.
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(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 [development from an egg without fertilization], 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].
HHS 1999 Opinion
In 1999, HHS General Counsel Harriet Rabb issued an opinion as to whether the Dickey
Amendment precluded federal funding for ESR (HHS 1999 Opinion).6 The HHS 1999 Opinion
concluded that federal funding for research performed with embryonic stem cells is not
proscribed by the Dickey Amendment on the theory that ES themselves are not embryos. Thus,
the HHS 1999 Opinion effectively permitted federal funding for ESR on established lines, but not
for the establishment of those lines.
As described in the sections that follow, it was in the context of the HHS 1999 Opinion that the
Obama Administration developed its ESR-funding policy, which includes the NIH 2009
guidelines. And it was the HHS 1999 Opinion that was examined in the
Sherley case, which
temporarily halted the award of federal funds under the NIH 2009 Guidelines.
The Obama EO
On March 9, 2009, President Barack Obama issued Executive Order 13505 regarding federal
funding for stem cell research (Obama EO).7 The Obama EO authorized the HHS Secretary,
including the NIH, “to support and conduct responsible, scientifically worthy human stem cell
research, including human embryonic stem cell research, to the extent permitted by law.” The
executive order also directed the NIH to review existing NIH guidance and other widely
recognized guidelines on human stem cell research, including provisions establishing appropriate
safeguards, and issue new NIH guidance on such research that is consistent with the executive
order.8
6 Harriet Rabb, HHS General Counsel,
HHS, Office of the Secretary, Letter to Harold Varmus re Federal Funding for
Research Involving Human Pluripotent Stem Cells, Washington, DC, January 15, 1999.
7 Executive Order 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” 74
Federal Register 10667, March 11, 2009.
8 On the same day that the executive order was issued, President Obama issued a memorandum on scientific integrity
directing the head of the White House Office of Science and Technology Policy “to develop a strategy for restoring
scientific integrity to government decision making.” The White House, Office of the Press Secretary, Remarks of
President Barack Obama-As Prepared for Delivery, Signing of Stem Cell Executive Order and Scientific Integrity
Presidential Memorandum, March 9, 2009, http://www.whitehouse.gov/the_press_office/Remarks-of-the-President-As-
(continued...)
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On July 30, 2009 (following NIH’s publication of its guidelines, as described below), President
Obama issued a memorandum directing the heads of executive departments and agencies that
support and conduct stem cell research to adopt NIH’s guidelines, to the fullest extent practicable
in light of legal authorities and obligations.9 Departments and agencies were to submit to the
Director of the Office of Management and Budget (OMB) any proposed additions or revisions to
any other guidance, policies, or procedures related to human stem cell research. The OMB
Director, in coordination with the NIH Director, was to review proposals to ensure consistent
implementation of the executive order and the July 30 memorandum.
NIH 2009 Guidelines
Pursuant to the Obama EO, on July 7, 2009, NIH issued its guidelines (National Institutes of
Health Guidelines for Research Using Human Stem Cells), specifying the requirements to receive
federal funding for ESR.10 On December 2, 2009, the NIH director announced the approval of the
first 13 embryonic stem cell (ES) lines for use in NIH-funded research under the NIH 2009
Guidelines.11 As of July 25, 2010, there were 75 eligible lines listed in the NIH Human
Embryonic Stem Cell Registry.12 The NIH 2009 Guidelines have five parts, which are
summarized below.
Part One (Scope of Guidelines)
Part one specifies that the guidelines apply to expenditures of NIH funds for research using
human ES lines. It also references HHS regulations for the Protection of Human Subjects, which
would apply to ESR that (1) involves testing on living people, and/or (2) in which ES can be
linked to specific living individuals by the investigators.13
Part Two (Eligibility of Human Embryonic Stem Cells for Research with NIH
Funding)
Part two specifies the requirements that must be met for an ES line to be eligible for use in NIH-
funded research.14 It also states that NIH will establish a new registry, listing ES lines eligible for
(...continued)
Prepared-for-Delivery-Signing-of-Stem-Cell-Executive-Order-and-Scientific-Integrity-Presidential-Memorandum/.
9 The President, “Memorandum of July 30th, 2009, Guidelines for Human Stem Cell Research: Memorandum for the
Heads of Executive Departments and Agencies,” 74
Federal Register 38885 - 38886, August 5, 2009.
10
National Institutes of Health Guidelines for Research Using Human Stem Cells in National Institutes of Health,
“National Institutes of Health Guidelines for Human Stem Cell Research,” 74
Federal Register 128, July 7, 2009
(hereinafter
Guidelines).
11 Jenny Haliski,
First Human Embryonic Stem Cell Lines Approved for Use Under New NIH guidelines, NIH, Office
of Communications and Public Liaison, December 2, 2009, http://www.nih.gov/news/health/dec2009/od-02.htm.
12 NIH, Office of Extramural Research,
NIH Human Embryonic Stem Cell Registry, August 25, 2010, 2010,
http://grants.nih.gov/stem_cells/registry/current.htm.
13
Protection of Human Subjects is located at 45 C.F.R. § 46. For further information, see CRS Report RL32909,
Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA
Regulations and the HIPAA Privacy Rule, by Erin D. Williams.
14 This part of the guideline also defines “human embryonic stem cells” to mean “cells that are derived from the inner
cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in
culture, and are known to develop into cells and tissues of the three primary germ layers. Although hESCs are derived
(continued...)
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use in NIH-funded research. Lines can become eligible in one of three ways, depending on the
date and location of embryo donation. The first path to funding eligibility applies to ES lines
established from embryos donated in the United States on or after the policy date. ES lines in this
category may be used for NIH-sponsored research if all of the following requirements are met:
• the cells were derived from donated human embryos created using in vitro
fertilization (IVF) for reproductive purposes, but no longer needed for that
purpose;
• donors gave voluntary informed consent; and
• assurances and documentation can be provided that (1) options available in the
facility where treatment was sought pertaining to use of embryos were explained
to the potential donor(s); (2) donors were not offered payments, cash or in kind,
for making donations; (3) facilities where embryos were donated had policies
stating that neither consent nor refusal to consent would affect donors’ quality of
care; (4) there was a clear separation between the decisions to create and donate
embryos as specified in the policy; and (5) donors consented to the donation at
the time of donation and signed consent forms that included specified criteria.
The second path applies to ES lines established from embryos donated in the United States before
the policy date. Such ES lines may be used for NIH funded research if they meet the requirements
set forth in the first path, or if an applicant submits certain materials to a Working Group of the
Advisory Committee to the Director (ACD) [of NIH]. Materials must demonstrate that ES lines
came from spare embryos that were created with IVF for reproductive purposes, and that were
donated with voluntary informed consent. The ACD will make funding eligibility
recommendations to the NIH Director, who will make the final decision regarding eligibility.
The third path to funding eligibility applies to ES lines established from embryos donated outside
the United States. If the embryo was donated before the policy date, applicants may comply with
the requirements of either of the first two eligibility paths. If the embryo was donated after the
policy date, a line may become eligible by meeting the requirements of the first path, or by
submitting to the ACD an assurance and supporting documentation that the alternative procedural
standards of the foreign country where the embryo was donated provide protections at least
equivalent to those of the first path.
Part Three (Use of NIH Funds)
Part three requires that prior to receiving funding, recipients should provide assurances, when
endorsing applications and progress reports to NIH, that the ES lines used for the project are the
ones listed in the registry.
(...continued)
from embryos, such stem cells are not themselves human embryos.”
Guidelines at 32174
.
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Parts Four and Five (Research Using hESCs and/or Human Induced
Pluripotent Stem Cells That, Although the Cells May Come from Eligible
Sources, is Nevertheless Ineligible for NIH Funding; Other Research Not
Eligible for NIH Funding)
Parts four and five specify that the following types of research are not eligible for NIH funding,
regardless of whether they use ES lines listed in the registry: (1) ESR in which human embryonic
stem cells or human induced pluripotent stem cells are introduced into non-human primate
blastocysts; (2) research involving the breeding of animals where the introduction of human
embryonic stem cells or human induced pluripotent stem cells may have contributed to the germ
line; (3) the derivation of stem cells from human embryos, as prohibited by the Dickey
Amendment; and (4) research using human embryonic stem cells derived from other sources,
including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research
purposes.
Sherley v. Sebelius
On August 23, 2010, a federal district court issued a preliminary injunction enjoining HHS from
“implementing, applying, or taking any action whatsoever pursuant to” the NIH 2009 Guidelines
described above, “or otherwise funding research involving human embryonic stem cells as
contemplated in the Guidelines.”15 The court issued the injunction upon the motion of two
researchers of adult stem cells16 who argued that the guidelines violated the Dickey Amendment,
which prohibits federal funding of “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 federal law].”17 In response, HHS sought appellate review and the
Court of Appeals for the D.C. Circuit
issued a stay of the preliminary injunction pending its
consideration of the merits of the government’s appeal.18 Although federal funding of ESR is
currently permitted to continue while the stay is effective, NIH had ceased all internal ESR and
had stopped reviewing new ESR grant applications as well as pending grant renewals in the time
period between the issuance of the preliminary injunction and the stay by the appellate court.19
HHS argues that the Dickey Amendment barred federal funding of the activities in which
embryonic stem cells were derived, but did not prohibit federal funding of subsequent research
15 Sherley v. Sebelius, Civ. No. 1:09-cv-1575 RCL (D.D.C. Aug. 23, 2010) (preliminary injunction order).
16 The case had initially been dismissed for lack of standing. Sherley v. Sebelius, 686 F. Supp. 2d 1 (D.D.C. 2009).
However, the case was reinstated after an appellate court ruled that the researchers had sufficiently alleged that they
would suffer increased competition for NIH grants if more embryonic stem cell lines were made eligible for federal
funds. Sherley v. Sebelius, 610 F.3d 69 (D.C. Cir. 2010).
17 P.L. 111-8, div. F, § 509(a)(2).
18 Sherley v. Sebelius, Civ. No. 1:09-cv-1575 RCL (D.D.C. August 31, 2010) (notice of appeal); and Sherley v.
Sebelius, No. 10-5287 (D.C. Cir. Sept. 9, 2010) (granting stay of preliminary injunction). The district court had earlier
declined to stay its own injunction. Sherley v. Sebelius, Civ. No. 1:09-cv-1575 RCL (D.D.C. Sept. 7, 2010) (order
denying defendants’ emergency motion to stay preliminary injunction pending appeal).
19 NIH, Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell
Lines for Eligibility Consideration, available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-126.html;
and Jocelyn Kaiser, NIH Orders Immediate Shutdown of Intramural Human Embryonic Stem Cell Research, SCIENCE,
available at http://news.sciencemag.org/scienceinsider/2010/08/nih-orders-immediate-shutdown.html (quoting email
sent to NIH staff by Michael Gottesman, M.D., Deputy Director for Intramural Research, NIH).
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which uses those embryonic stem cell lines. The district court disagreed, holding that the use of
the word “research” in the Dickey Amendment unambiguously referred to “a systematic
investigation, including research development, testing and evaluation, designed to develop or
contribute to generalizable knowledge.”20 The court further reasoned that:
Despite defendants’ attempt to separate the derivation of ESC’s [embryonic stem cells] from
research on ESCs, the two cannot be separated. Derivation of ESCs from an embryo is an
integral step in conducting ESC research. Indeed, it is just one of the many steps in the
“systematic investigation” of stem cell research.
Simply because ESC research involves
multiple steps does not mean that each step is a separate ‘piece of research’ that may be
federally funded, provided the step does not result in the destruction of an embryo. If one
step or “piece of research” of an ESC research project results in the destruction of an
embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker
Amendment.21
Upon appeal, the issues before the appellate court are likely to include (1) whether the plaintiffs
have met the criteria for a preliminary injunction; (2) whether the language of the Dickey
Amendment contains any ambiguity; and (3) whether the district court afforded the appropriate
amount of deference to HHS’s interpretation of the Dickey Amendment.22 The appeal may also
raise questions about the extent to which recent legislative history should inform application of
the Dickey Amendment. For example, federal funds have been available for some types of ESR
since 2001 under both the George W. Bush and Obama Administrations. During the same period,
Congress has continued to annually enact the same Dickey Amendment language that is found in
the most recent Labor-HHS appropriations act. Based on this history of co-existence between the
Dickey Amendment and federal funding of ESR, one might argue that Congress has not intended
to prohibit federal funding of those categories of ESR which have historically been eligible for
federal funds under executive branch policies.
Historical Note: The Bush Policy
Prior to the Obama EO, ESR had been regulated by the policy that President George W. Bush had
established in August 2001 (Bush policy). The Bush policy had, for the first time, allowed federal
money to be used to support ESR. It had also restricted that funding to research using ES lines
created (1) with appropriate informed consent of the donors, (2) using embryos created for
reproductive purposes, and (3) before the date of the policy. This date restriction was the most
controversial component of the Bush policy. President Bush had later issued a companion policy
in the form of
Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible
Ways (E.O. 13435), which had directed the NIH to fund research on sources of pluripotent stem
cells that did not involve the destruction of embryos.23 President Bush had issued E.O. 13435 on
June 20, 2007, which was the same day that he vetoed a bill to expand federal funding for ESR
(S. 5, 110th Congress).
20 Sherley v. Sebelius, Civ. No. 1:09-cv-1575 RCL, slip op. at 10 (D.D.C. Aug. 23, 2010).
21
Id. at 12 (emphasis added).
22
See Chevron v. Natural Res. Defense Council, Inc., 467 U.S. 837 (1984) (executive agencies’ interpretations of
statutes are entitled to deference if statutory language is ambiguous and should not be disturbed unless they are
unreasonable).
23 George W. Bush, Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible Ways, June 20,
2007, http://georgewbush-whitehouse.archives.gov/news/releases/2007/06/20070620-6.html.
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The Obama EO revoked Bush’s E.O. 13435, thus reversing the Bush policy and allowing for the
possibility of federal funding for ESR using many more stem cell lines than were previously
eligible. While the Obama EO did not mandate funding for alternatives to ESR, it specifically
authorized support for non-embryonic as well as embryonic stem cell research.
Policy Options for Congress
Congress has four broad types of policy options regarding ESR: (1) permitting or expanding
federal ESR funding; (2) incentivizing activities that avoid ESR; (3) prohibiting ESR; and (4)
taking no action.
Congress’s first set of options involves permitting or expanding federal ESR funding. Congress
could accomplish this by passing legislation that would enact into law the authority to expend
federal funds on ESR. Examples in the 111th Congress include, H.R. 872 H.R. 873, S. 487, H.R.
4808, and S. 3766. Enactment of any of these bills, even if consistent with the current executive
policy, would clarify the intent of Congress with respect to funding ESR, and could thus nullify
the potential effect of the
Sherley case. Passage of any of these bills would also limit or eliminate
the opportunity for the executive branch to set the ESR policy via executive order in the future.
None of these bills contains the August 2001 date restriction that had been imposed by the Bush
policy. Congress could also expand federal funding for ESR by passing HHS appropriations
legislation without the Dickey Amendment, or with a modified version of it. Depending on the
final text, this option could allow the use of federal funds for the establishment of ES lines, and/or
for the creation of embryos for ESR, and would likely nullify the potential effect of the
Sherley case.
Congress’s second set of options involves incentivizing activities that avoid ESR, as proposed
during the 111th Congress in S. 99, S. 3751, H.R. 877, H.R. 1230, H.R. 1654, H.R. 2107, H.R.
6081, and H.R. 6083. Some of these bills would require federal support or tax benefits for
research or activities that avoid damaging embryos. Others would create additional oversight for
the conduct of ESR. Still others would create a bank of non-embryonic stem cells from amniotic
fluid and placentas, or would encourage cord blood collection and donation.
Congress’s third set of options involves limiting or eliminating ESR, as effectively proposed
during the 111th Congress in H.R. 227, S. 346, H.R. 881, and H.R. 1050. Some of these bills
would place the language of the Dickey Amendment in statute, and/or extend it by prohibiting
federal funding using stem cells derived in violation of the other restrictions. Others would allow
funding only in very specific circumstances, such as when using techniques with non-living
embryos created for reproductive purposes. Still others would amend other law (such as that
governing the right to life, organ transplantation,24 cloning, or the creation of animal-human
hybrids) to prohibit ESR or restrict some aspect its conduct.
A fourth option is for Congress to take no action, thus allowing the effect of the
Sherley case to
persist, permitting federal funding for ESR unless and until the district court’s decision is
affirmed. Note that the result of taking no action may be dependent on the appellate court’s
ultimate decision in
Sherley. For example, if the D.C. Circuit reverses the lower court and holds
24For further information about 42 U.S.C. 274e and valuable consideration, see CRS Report RL33902,
Living Organ
Donation and Valuable Consideration, by Erin D. Williams, Bernice Reyes-Akinbileje, and Kathleen S. Swendiman.
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that federal funding is permitted under the terms of the NIH 2009 Guidelines, taking no action
would permit federally funded research to continue, and would allow the executive branch some
latitude to change the ESR policy in the future. In contrast, if the D.C. Circuit affirms the lower
court, the preliminary injunction would be reinstated and could effectively bar federal funding of
ESR.
Discussion of Ethical Issues
Detailed review of the assorted reports and statements reveals that while positions on ESR may
be broadly categorized as
for or
against, there is an array of finer distinctions present. These finer
distinctions, in turn, reveal the variation in ethical and moral as well as factual beliefs. The
following discussion breaks down the arguments about ESR according to these finer distinctions,
demonstrating both the complexity of the issues and the points of resonance among the groups.
Proponents and Opponents
In the ES debate, the Obama Administration, George W. Bush Administration (Bush
Administration), a group of Representatives, a group of Senators, and a group of Nobel Laureates
have each presented their respective positions on ESR. In addition, various other organizations,
individuals, and councils have issued opinions and reports on the topic. Some groups, such as the
National Academies,25 the Coalition for the Advancement of Medical Research (CAMR),26
former First Lady Nancy Reagan,27 former Presidents Gerald Ford, Jimmy Carter, and Bill
Clinton,28 and the Union of Orthodox Jewish Congregations of America (UOJCA),29 favor federal
support of ESR that is generally keeping with the Obama EO. Other groups, such as the Christian
Legal Society,30 Focus on the Family,31 and the Christian Coalition,32 favor restrictions on ESR,
25 The National Academies brings together “committees of experts in all areas of scientific and technological endeavor”
as “advisors to the Nation.” For statements on ESR and cloning, see National Research Council, Institute of Medicine,
National Academies,
Stem Cells and the Future of Regenerative Medicine (Washington: National Academies, 2001);
and Committee on Science, Engineering and Public Policy and Global Affairs Division, et al.,
Scientific and Medical
Aspects of Human Reproductive Cloning (Washington, National Academy Press, 2002)
http://www.nationalacademies.org/about/#org.
26 CAMR was formed in 2001 to ensure that the voices of patients, scientists, and physicians were heard in the debate
over stem cell research and the future of regenerative medicine http://www.camradvocacy.org/about_us.aspx. For a
statement on ESR, see Coalition for the Advancement of Medical Research,
A Catalyst for Cures: Embryonic Stem Cell
Research, January 12, 2009, http://www.camradvocacy.org/resources/camr_wp.pdf.
27 “Nancy Reagan plea on stem cells,”
BBC News, May 10, 2004, http://news.bbc.co.uk/2/hi/americas/3700015.stm;
Letter from Nancy Reagan to Senator Orrin Hatch, May 1, 2006, http://www.camradvocacy.org/resources/
Nancy_Reagan.pdf.
28 Ibid.
29 Letter from Harvey Blitz, President, UOJCA et al., to President George W. Bush, July 26, 2001, http://www.ou.org/
public/statements/2001/nate34.htm. (Hereafter cited as UOJCA letter.)
30 The Christian Legal Society is a “national grassroots network of lawyers and law students, committed to ...
advocating biblical conflict reconciliation, public justice, religious freedom and the sanctity of human life,”
http://www.clsnet.org/society/about-cls/statement-faith.
31
Focus on the Family was founded in 1977 by Dr. James Dobson to promote the teachings of Jesus Christ. See
http://www.focusonthefamily.com/.
32 The Christian Coalition is “the largest and most active conservative grassroots political organization in America,”
http://www.cc.org.
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and had supported the Bush policy. Still others, such as the National Right to Life Committee33
and the United States Conference of Catholic Bishops,34 oppose all ESR.
Two presidential bioethics advisory panels have considered the issues involved in ESR. The
President’s Council on Bioethics (President’s Council)35 published one report directly on the
topic,
Monitoring Stem Cell Research,36 in which it sought to characterize the issues. While the
council made no recommendations there, in two other reports it has recommended that “Congress
should ... [p]rohibit the use of human embryos in research beyond a designated stage in their
development (between 10 and 14 days after fertilization),”37 and unanimously recommended “a
ban on cloning-to-produce-children,” with a 10-member majority also favoring “a four-year
moratorium on cloning-for-biomedical-research,” and a seven-member minority favoring
“regulation of the use of cloned embryos for biomedical research.”38 In 2005, the President’s
Council published
Alternative Sources of Human Pluripotent Stem Cells, a white paper exploring
the ethics of four proposals to attempt to generate human embryonic stem cells “without creating,
destroying, or harming human embryos.”39 A predecessor to the President’s Council, the National
Bioethics Advisory Commission (NBAC),40 recommended federal funding for stem cell research
using “embryos remaining after infertility treatments,” but not for the “derivation or use of
embryos ... made for research purposes.”41
33 The National Right to Life Committee was founded in 1973 to “restore legal protection to innocent human life,”
http://www.nrlc.org/Missionstatement.htm.
34 The United States Conference of Catholic Bishops “is an assembly of the hierarchy of the United States and the U.S.
Virgin Islands who jointly exercise certain pastoral functions on behalf of the Christian faithful of the United States,”
http://www.usccb.org/whoweare.shtml.
35 The
President’
s Council was created by President Bush in November 2001 to “advise the President on bioethical
issues that may emerge as a consequence of advances in biomedical science and technology.” George W. Bush,
“Creation of The President’s Council on Bioethics,” Executive Order 13237, November 28, 2001.
36 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004.
37 The President’s Council on Bioethics,
Reproduction and Responsibility, March 2004, p. xlviii.
38 The President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002, pp. xxxv-xxxviii). Note: At
the June 20, 2002, meeting, 9 of 17 Council members voted to support cloning for medical research purposes, without a
moratorium, provided a regulatory mechanism was established. Because one member of the Council had not attended
the meetings and was not voting, the vote seemed to be 9 to 8 in favor of research cloning. However, draft versions of
the Council report sent to Council members on June 28, 2002, indicated that 2 of the group of 9 members had changed
their votes in favor of a moratorium. Both made it clear that they have no ethical problem with cloning for biomedical
research, but felt that a moratorium would provide time for additional discussion. The changed vote took many Council
members by surprise, and some on the Council believe that the moratorium option, as opposed to a ban, was thrown in
at the last minute and did not receive adequate discussion. In addition, some on the Council believe that the widely
reported final vote of 10 to 7 in favor of a moratorium does not accurately reflect the fact “that the majority of the
council has no problem with the ethics of biomedical cloning.” (Transcripts of the Council meetings and papers
developed by staff for discussion during Council meetings can be found at http://www.bioethics.gov; S. S. Hall,
“President’s Bioethics Council Delivers,”
Science, vol. 297, July 19, 2002, pp. 322-324.) “Wise Words from Across the
Pond?,”
BioNews, no. 252, March 29, 2004.
39 President’s Council on Bioethics,
White Paper: Alternative Sources of Human Pluripotent Stem Cells , May 2005,
http://bioethics.georgetown.edu/pcbe/reports/white_paper/ (hereinafter, PCBE White Paper).
40 In 1995, President Clinton created the National Bioethics Advisory Commission by Executive Order, to advise him
on bioethical issues. The Order expired in 2001. The Presidential Commission for the Study of Bioethical Issues,
Former Bioethics Commissions, http://www.bioethics.gov/commissions/.
41 National Bioethics Advisory Commission,
Ethical Issues in Human Stem Cell Research, vol. 1, September 1999, pp.
70-71.
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Embryo Destruction and Relief of Human Suffering
Most positions on ESR rest at least in part on the relative moral weight accorded to embryos and
that accorded to the prospect of saving, prolonging, or improving others’ lives. For some, the
inquiry begins and ends with this question. For instance, one opponent of the research, the
American Life League, posits that “human life begins at conception/fertilization and that there is
never an acceptable reason for intentionally taking an innocent human life.”42 Similarly, the
United States Conference of Catholic Bishops states that the research is immoral because it
“relies on the destruction of some defenseless human beings for the possible benefit to others.”43
Some groups explore the moral standing of human embryos, and also consider the “duty to
relieve the pain and suffering of others.”44 Others take the position that embryos do not have the
same moral status as persons. They acknowledge that embryos are genetically human, but hold
that they do not have the same moral relevance because they lack specific capacities, including
consciousness, reasoning, and sentience.45 They also argue that viewing embryos as persons
would “rule out all fertility treatments that involve the creation and discarding of excess
embryos,” and further assert that we do not have the same “moral or religious” response to the
natural loss of embryos (through miscarriage) that we do to the death of infants.46 Some have also
rooted their arguments in religious texts, which inform them that an “isolated fertilized egg does
not enjoy the full status of person-hood and its attendant protections.”47 They conclude that
performing research to benefit persons justifies the destruction of embryos. Acceptance of the
notion that the destruction of embryos can be justified in some circumstances forms the basis of
pro-ESR opinions—including those of the Bush and Obama Administrations—and is usually
modified with some combination of the distinctions and limitations that follow.
Viability of Embryos
Some proponents of ESR base their support on the question of whether an embryo is viable. The
relevance of the viability distinction rests on the premise that it is morally preferable for embryos
that will not grow or develop beyond a certain stage and/or those that would otherwise be
discarded to be used for the purpose of alleviating human suffering.
The Obama EO does not reference the viability of embryos, but the NIH 2009 Guidelines require
that only ESR on embryos no longer needed for reproductive purposes (and thus in one sense, not
viable) be used in federally funded research.48 In a similar manner, the Bush policy had
referenced viability, requiring, among other things, use of stem cells derived from only excess
42 American Life League,
The Bush Stem Cell Decision, 2001, http://www.all.org/article.php?id=10746&search=2001.
43 Office of Communications, United States Conference of Catholic Bishops,
Catholic Bishops Criticize Bush Policy on
Embryo Research (August 9, 2001), http://www.usccb.org/comm/archives/2001/01-142.shtml.
44 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004, pp. 58, 62.
45 Presentation by B. Steinbock, Department of Philosophy, SUNY, Albany, NY, NIH Human Embryo Research Panel
Meeting, February 3, 1994.
46 Michael Sandel, “Embryo Ethics—The Moral Logic of Stem-Cell Research,”
New England Journal of Medicine, vol.
351, no. 3, July 15, 2004, p. 208.
47 UOJCA letter.
48 While the implementation of the Obama policy and NIH guidelines was enjoined by a federal district court in the
Sherley case (as discussed above), the content and ethical implications of the policy and guidelines themselves have not
been modified, and remain relevant to this discussion.
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embryos for federally funded research. One report of the President’s Council explores the moral
significance of viability that is based upon “human choices” rather than an embryo’s “own
intrinsic nature,” but draws no conclusions.49 A second report broaches the subject of viability,
recommending that Congress ban both the transfer of a human embryo to a woman’s uterus for
any purpose other than to produce a live-born child, and also research conducted on embryos
more than 10 to 14 days after fertilization.50 The NBAC report touches on the moral status of
embryos in utero and those in vitro,51 though NBAC does not specify whether viability was a key
rationale for its recommendations. A group of Representatives,52 a group of Senators,53 and
CAMR imply but do not state a distinction based on viability by expressly calling for the use of
“excess” embryos developed for IVF, and making no mention of those in utero.54 UOJCA makes
a similar argument in its letter. By contrast, the National Academies and the group of Nobel
Laureates more broadly support research on embryos, making no mention of viability.
Purpose of Embryo Creation
A separate distinction that often leads to the same conclusions as viability is the purpose for
which embryos are created. This distinction draws an ethical line based upon the intent of the
people creating embryos. In the view of some, it is permissible to create an embryo for
reproductive purposes (such as IVF), but impermissible to create one with the intention of
destroying it for research. Others worry that moral lines will erode quickly—from using only
“spare” embryos left over in fertility clinics to creating human embryos solely for research to
creating (or trying to create) cloned embryos solely for research.55
As is the case regarding embryo viability, the Obama EO does not reference the purpose of
embryo creation. However, the NIH 2009 Guidelines require that embryos have been created for
reproductive purposes to receive federal funding, and they also require documentation to assure
that this was the case. Most groups at least note the potential ethical significance of reproductive
versus research motives for creating embryos. The Bush policy had drawn a motive distinction by
including a requirement that federally funded research be conducted only on embryonic stem cell
lines derived from embryos created solely for reproductive purposes. NBAC draws the same
distinction by recommending that federal funding be used for embryos remaining after infertility
treatment but not for research involving the derivation or use of stem cells from embryos made
for research purposes or from cloned embryos produced by SCNT.56 UOJCA argues similarly that
49 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004, p. 87.
50 The President’s Council on Bioethics,
Reproduction and Responsibility, March 2004.
51 National Bioethics Advisory Commission,
Ethical Issues in Human Stem Cell Research, vol. 1, September 1999, p.
50.
52 Letter from 206 Members of the House of Representatives to President George W. Bush, April 28, 2004. (Hereafter
cited as Letter from 206 Members of the House of Representatives.)
53 Letter from 58 Senators to President George W. Bush, June 7, 2004, http://feinstein.senate.gov/04Releases/r-
stemcell-ltr.pdf. (Hereafter cited as Letter from 58 Senators.)
54 International Society for Stem Cell Research, “Alternative Methods of Producing Stem Cells: No Substitute for
Embryonic Stem Cell Research,”
Press Release, (August 2, 2005), http://www.isscr.org/press_releases/
camr_alternatives.htm.
55 See, e.g., Eric Cohen and Robert George, “Stem Cells Without Moral Corruption: Congress Can Give Research a
Boost Without Supporting the Misuse of Human Embryos,”
Washington Post, July 6, 2006, p. A21.
56 National Bioethics Advisory Commission,
Ethical Issues in Human Stem Cell Research, vol. 1, September 1999, pp.
70-72. 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
(continued...)
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they “believe it is entirely appropriate to utilize for this research existing embryos, such as those
created for IVF purposes that would otherwise be discarded but for this research. We think it
another matter to create embryos ab initio for the sole purpose of conducting this form of
research.”57
The President’s Council recommended that Congress ban attempts at conception by any means
other than the union of egg and sperm (essentially banning cloning via SCNT) but does not
specify whether embryos might be created in vitro specifically for research purposes.58 Two
council members expressed a dissenting opinion in a medical journal article, arguing that SCNT
“resembles a tissue culture” and that the products of SCNT should be available for research.59 A
group of Representatives, a group of Senators, and CAMR imply but do not state that embryos
should not be created for research purposes. They overtly call for the use of “excess” embryos
developed for IVF and make no mention of embryos created expressly for research.60 By contrast,
the National Academies supports the creation of embryos for research purposes, including via
cloning (SCNT), to “ensure that stem cell-based therapies can be broadly applied for many
conditions and people [by] overcoming the problem of tissue rejection.”61 Mrs. Nancy Reagan,
her supporters, and the group of Nobel Laureates also take this position.
New and Existing Cell Lines
A further distinction has been drawn based upon the timing of the creation of embryonic stem cell
lines. Here, the premise is that it is unacceptable to induce the destruction of embryos for the
creation of new lines. However, in cases in which embryos have already been destroyed and the
lines already exist, it is morally preferable to use those lines for research to improve the human
condition.
The Obama EO itself does make a distinction based on the timing of when ES lines were created.
The NIH 2009 Guidelines do draw a distinction—one of process more than eligibility—based on
when and where the embryo was donated for research. (Embryos donated in the United States
after the policy date must meet more specific requirements, while those donated before, or those
donated in another country, may receive funding at the discretion of the NIH Director.) The
timing of ES-line creation was one central concept in the Bush policy, in that E.O. 13435 had
limited the use of federal funding to research on lines derived on or before the date of the policy.
Supporters of a distinction based on timing favor this distinction as a compromise because it
allows research on some embryonic stem cell lines and deters the future destruction of embryos
for research. The President’s Council wrote that a policy based on timing mixes “prudence” with
“principle, in the hope that the two might reinforce (rather than undermine) each other.”62 The
(...continued)
first mammalian clone.
57 UOJCA letter.
58 The President’s Council on Bioethics,
Reproduction and Responsibility, March 2004, p. xlviii.
59 Paul McHugh, “Zygote and ‘Clonote’—The Ethical Use of Embryonic Stem Cells,”
New England Journal of
Medicine, vol. 351, no. 3, July 15, 2004, p. 210.
60 Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
61 National Research Council, Institute of Medicine, National Academies,
Stem Cells and the Future of Regenerative
Medicine (Washington: National Academies, 2001), p. 58.
62 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004, pp. 33-34.
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council notes that a timing-based policy is supported by what it titled a
moralist’s notion of when
one may benefit from prior bad acts (referring to embryo destruction): it prevents the government
from complying in the commission of or encouraging the act in the future, and it reaffirms the
principle that the act was wrong.63 The same report also contains alternative analyses that
characterize the act of drawing a distinction between new and existing cell lines as “arbitrary,”
“unsustainable,” and “inconsistent.”64 The council itself takes no position in the report on this or
any other issue.
Opponents of any distinction based on timing come from both sides of the issue. They view the
distinction between new and existing stem cell lines with reproach. One side, which includes the
National Right to Life Committee and the United States Conference of Catholic Bishops, objects
because the distinction validates destruction of embryos, and rewards those who did so first with
a monopoly. The other side, which includes the National Academies, a group of Representatives,
a group of Senators, Nancy Reagan and her supporters, Gerald Ford, CAMR, and the group of
Nobel Laureates, objects because the distinction limits the number of embryonic stem cell lines
available for research, particularly since the number of authorized lines are dwindling65 and are
“contaminated with mouse feeder cells.”66 Likewise, though NBAC recognized the distinction
between destroying embryos and using ones previously destroyed (e.g., “derivation of [embryonic
stem] cells involves destroying the embryos, whereas abortion precedes the donation of fetal
tissue and death precedes the donation of whole organs for transplantation”),67 it still
recommended future development of embryonic stem cell lines. UOJCA also recognizes a
distinction between new and existing lines: “research on embryonic stem cells must be conducted
under careful guidelines [that] ... relate to where the embryonic stem cells to be researched upon
are taken from.”68
Consent of Donors
There is consensus throughout a wide array of viewpoints about ESR that embryos should only be
obtained for research with the consent of their biological donors. This consent requirement
necessitates that embryos be taken only with donors’ knowledge, understanding, and uncoerced
agreement, which may, in fact, be complicated by conflicting studies regarding the long-term
health effects of egg donation.69 The donor consent requirement is consistent with the rules
governing human beings’ participation in research, and with individuals’ general legal authority to
make decisions regarding embryos they procreate. A potential drawback of the requirement is that
it may restrict the number of embryos available for research purposes.
63 Ibid.
64 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004, pp. 63-67.
65 Bridget M. Kuehn, “Genetic Flaws Found in Aging Stem Cell Lines,”
Journal of the American Medical Association,
vol. 294, no. 15 (October 2005), p. 1883.
66 Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
67 National Bioethics Advisory Commission,
Ethical Issues in Human Stem Cell Research, vol. 1, September 1999, p.
49.
68 UOJCA letter.
69 Kathy Hudson, “International Society for Stem Cell Research Draft Guidelines,”
Genetics & Public Policy Center
ENews, Issue 10 (July 2006), http://www.dnapolicy.org/news.enews.article.nocategory.php?action=detail&
newsletter_id=13&article_id=31. (Note that finalized guidelines are available: International Society for Stem Cell
Research,
Guidelines for the Conduct of Human Embryonic Stem Cell Research, December 21, 2006,
http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf.)
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While the Obama EO does not explicitly require the consent of the donors, it does require that
NIH support ESR conducted responsibly, which may include informed consent requirements.70
The resulting NIH 2009 Guidelines specify elements that must be included in the informed
consent document, and several focused on both sharing information and avoiding potential
conflicts in the consent process. The Bush policy had contained a donor consent requirement that
had limited approved stem cell lines to those derived with the informed consent of the donors,
and obtained without any financial inducements to the donors. Despite the policy, a 2008 report
raised questions about whether one-quarter of the lines eligible for federal funding actually met
the policy’s informed consent requirements.71
Like the Bush policy, the NBAC, the President’s Council, and the UOJCA also favor donor
consent requirements. The National Academies notes the importance of informed consent in its
discussion of stem cell research oversight requirements.72 A group of Representatives and a group
of Senators mention and imply their support for donor consent requirements.73
Egg Procurement
Egg procurement from women has raised a number of issues, most notably, those of informed
consent and payment. The topic of informed consent in egg procurement came to the public’s
attention in November 2005 with allegations that some human eggs used in South Korean
scientist Dr. Hwang’s laboratory had been obtained under coercive conditions. Informed consent
can be undermined when a coercive situation prevents a free choice from being made, or when
insufficient information is provided to the person making a decision. The situation alleged in Dr.
Hwang’s laboratory raises the issue of coercion both because subordinate women in the
laboratory allegedly donated eggs, and because some women were allegedly paid for their eggs. A
2002 study conducted by a University of Pennsylvania student raised the issue of insufficient
information, finding that a number of programs seeking donor eggs for reproductive purposes
downplayed the risks involved in egg retrieval.74 The wide consensus regarding the need for
informed consent necessarily implies similar consensus on the need for an information-rich,
coercion-free method of obtaining eggs, however there is some disagreement on the specifics of
whether payment for eggs necessarily constitutes coercion.
Paying women for their eggs, which has been debated in the context of seeking donor eggs both
for reproductive purposes (for example, to enable women who do not produce their own eggs to
become pregnant), and for research purposes, is not unheard of in the United States. According to
a 2000 study by the American Society of Reproductive Medicine (ASRM), some IVF programs
reportedly offered as much as $5,000 for one egg retrieval cycle, though $2,500 appeared to be a
more common amount.75 Offers of much higher amounts ($50,000-$100,000) have been reported
70 The HHS regulations that generally require informed consent for research involving human subjects research do not
generally apply to gametes, embryos, or other tissue, once donated or discarded. (See 45 C.F.R. § 46, subparts A & B.)
71 See the “Consent of Donors” section of this report for more information.
72 National Research Council, Institute of Medicine, National Academies,
Stem Cells and the Future of Regenerative
Medicine (Washington: National Academies, 2001), p. 53.
73 Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
74 “Egg Donation Ethics Study Wins Award,”
Research at Penn, (March 7, 2005), http://www.upenn.edu/
researchatpenn/article.php?113&soc.
75 American Society of Reproductive Medicine, “Financial Incentives in Recruitment of Oocyte Donors,”
Fertility and
Sterility, vol. 74, no. 2 (August 2000), p. 216.
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elsewhere.76 Dr. Hwang’s laboratory reportedly made payments of $1,400 to each woman who
donated eggs.77 Payments are not illegal in the United States, nor were they illegal in South Korea
at the time Dr. Hwang’s laboratory allegedly made them. The questions remain, is payment for
egg donation ever acceptable, and if so, in what amount?
Several arguments have been put forth in favor of payment for egg donation, many focused on
donation for reproductive purposes.78 First, some have argued that payment creates incentives to
increase the number of egg donors, thus facilitating research and benefitting infertile couples.
Second, some reason that payment for eggs gives women parity with sperm donors, who may be
compensated for donating gametes at a lower rate given that they require a much less involved
procedure. In addition, some argue that participants should be offered an amount commensurate
with the time, inconvenience, discomfort, and risks of the procedure, as is the general practice in
biomedical research.79 Third, some allege that fairness dictates that women who donate eggs
ought to be able to benefit from their action. Fourth, some claim that pressures created by
financial incentives may be no greater than those experienced by women asked to make altruistic
egg donations for relatives or friends, and may thus not rise to the level of coercion. These are the
types of arguments that led ASRM to recommend in 2000 that sums of up to $5,000 may be
appropriate for typical egg donation, while sums of up to $10,000 may possibly be justified if
there are particular difficulties a woman must endure to make her donation.
Several arguments have also been put forth against payment for egg donation. First, some voiced
fears that payment might lead to the exploitation of women, particularly poor women, and the
commodification of reproductive tissues.80 Second, some have argued that payment for eggs for
research purposes might undermine public confidence in endeavors such as human ESR.81
Arguments such as these prompted both the National Academies and the President’s Council to
recommend that women not be paid for donating their eggs for research purposes. It also led the
President’s Council to note that in theory, there is the possibility that eggs could be procured from
ovaries harvested from cadavers, which might at least alleviate concerns related to coercion.
It is worth noting that a woman may choose to undergo egg retrieval for her own reproductive
purposes, which would effectively take the process of egg procurement out of the research arena
and avoids the question of payment entirely. (For example, this could be an option for a woman
seeking IVF because her fallopian tubes are blocked.) While not making specific
recommendations about payment for research-related egg donation, several groups’
recommendations that only embryos left over from IVF procedures be used for stem cell research
76 See e.g., “Egg Donation Ethics Study Wins Award,”
Research at Penn, (March 7, 2005), http://www.upenn.edu/
researchatpenn/article.php?113&soc.
77 James Brooke, “Korean Leaves Cloning Center in Ethics Furor ,”
The New York Times, November 25, 2005,
http://www.nytimes.com/2005/11/25/international/asia/25clone.html?_r=1.
78 Unless otherwise noted, these arguments can be found, among other places, at American Society of Reproductive
Medicine, “Financial incentives in recruitment of oocyte donors,”
Fertility and Sterility, vol. 74, no. 2 (August 2000),
p. 218; and Caludia Kalb, “Ethics, Eggs and Embryos,”
Newsweek, June 20, 2005, http://www.newsweek.com/id/
50156?tid=relatedcl.
79 Kathy Hudson, “International Society for Stem Cell Research Draft Guidelines,”
Genetics & Public Policy Center
ENews, Issue 10 (July 2006), http://www.dnapolicy.org/news.enews.article.nocategory.php?action=detail&
newsletter_id=13&article_id=31.
80 See e.g., PCBE White Paper, pp. 40-41.
81 National Academies,
Guidelines for Human Embryonic Stem Cell Research, (Washington, DC: National Academies
Press, p. 87, http://books.nap.edu/books/0309096537/html/87.html.
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(noted above in the
Purpose of Embryo Creation section) effectively take the process of egg
procurement from women out of the research arena. As is the case regarding other issues, the
Obama EO does not reference the topic of egg donation directly. However, the NIH 2009
Guidelines keep the consent process for egg retrieval separate from donation by funding research
only on lines derived from embryos originally created for fertility treatments. The Bush policy
had done the same. On a related note, the NIH 2009 Guidelines also prohibit the use of federal
funding for ESR unless documentation ensures that no payment, cash or in kind, was offered for
the embryo donation.
Effectiveness of Alternatives
One factual distinction that has been used to support competing ethical viewpoints is the efficacy
of alternatives to ESR. The promise of stem cell therapies derived from adult tissue and umbilical
cord blood has buttressed opposition to ESR. A report that stem cells similar to embryonic stem
cells can be found in amniotic fluid may do the same, although the lead scientist conducting
research on the amniotic cells and others have stated that amniotic cells will not make embryonic
stem cells irrelevant.82 Perhaps more promising, scientists claim to have generated pluripotent
stem cells from adult cells, though technical and safety concerns regarding the cells’ therapeutic
use remain unresolved.83 Alternatives such as those proposed for consideration by the President’s
Council are discussed in the next section. Some opponents of the current method of obtaining
embryonic stem cells argue that therapies and cures can be developed without the morally
undesirable destruction of embryos. The Obama EO neither requires nor precludes research into
ESR alternatives explicitly, but does require that research be responsible and scientifically
worthy. The NIH 2009 Guidelines do not address the issue. By contrast, the Bush
Administration’s E.O. 13435 had affirmatively directed the pursuit of alternative methods of
deriving embryonic stem cells.
Findings regarding the effectiveness of alternatives to ESR are mixed. The President’s Council
noted that there is a “debate about the relative merits of embryonic stem cells and adult stem
cells.”84 Focus on the Family cites promising non-embryonic stem cell research: “adult stem cells
may be as ‘flexible’ as embryonic ones and equally capable of converting into various cell types
for healing the body.”85 By contrast, the National Academies finds that the “best available
scientific and medical evidence indicates that research on both embryonic and adult human stem
cells will be needed.”86 NBAC finds in its deliberations that “the claim that there are alternatives
to using stem cells derived from embryos is not, at the present time, supported scientifically.”87
CAMR supports both embryonic and adult stem cell research, and adds that access to ES cells “is
crucial to continued progress. These pluripotent cells that can self-renew are an unmatched
research tool for understanding the body and what goes wrong in disease. Researchers refer to
82 Rick Weiss, “Scientists See Potential In Amniotic Stem Cells,”
Washington Post, January 8, 2007, p. A1,
http://www.washingtonpost.com/wp-dyn/content/article/2007/01/07/AR2007010700674.html.
83 Junying Yu et al., “Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells,”
Science, vol. 318, no.
5858 (21 December 2007; originally published in
Science Express on 20 November 2007).
84 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004, p. 10.
85 Carrie Gordon Earll, “Talking Points on Stem Cell Research,”
Focus on the Family, September 17, 2003.
86 National Research Council, Institute of Medicine, National Academies,
Stem Cells and the Future of Regenerative
Medicine (Washington: National Academies, 2001), p. 56.
87 National Bioethics Advisory Commission,
Ethical Issues in Human Stem Cell Research, vol. 1, September 1999, p.
53.
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them as ‘the gold standard’ because these are the cells with the greatest potential for making any
cell type in the body.”88
Several laws have supported the development of stem cells from sources other than embryos. For
each of fiscal years 2004 through 2006, Congress allocated money in the HHS appropriations for
the establishment and continuation of a National Cord Blood Stem Cell Bank within the Health
Resources and Services Administration. In 2005, Congress enacted P.L. 109-129 for the collection
and maintenance of human cord blood stem cells for the treatment of patients and for research.
Generating Embryonic Stem Cells Without Destroying Human Embryos
One possible alternative to ESR as it has typically been conducted, the ability to generate
embryonic stem cells without destroying human embryos, was explored by the a President’s
Council white paper developed in 2005 during the Bush Administration.89 The white paper
discusses four potential methods of obtaining embryonic stem cells without having to destroy
embryos. Those methods, the scientific and practical merits of which remain far from settled, are
(1) extracting cells from organismically dead embryos; (2) non-harmful biopsy of living embryos;
(3) bioengineering embryo-like artifacts; and (4) dedifferentiating somatic cells.90
In the white paper, the President’s Council examined the ethical acceptability of each method
mentioned above. The first two seek to avoid the destruction of embryos either by developing
standards for declaring an embryo “dead” when its cells have stopped dividing or by removing a
cell from an embryo without destroying the embryo itself. The other two methods would avoid
having to use an embryo altogether, by attempting to obtain embryonic stem cells through the
destruction of something that is not an embryo.
The council concluded that the use of organismically dead embryos raises a number of ethical
questions that have yet to be answered. They include whether it is possible to be certain that an
embryo is really dead, whether the proposal would put embryos at additional risk, and whether
IVF practitioners would be encouraged to create extra embryos. A September 2006 report that a
team based in Serbia and England had derived stem cells from “dead” embryos prompted
precisely these types of questions, as well some regarding whether the stem cells might carry
some defect that had made the embryos non-viable.91
Regarding the use of non-harmful biopsy, the council found that it would be ethically
unacceptable to test in humans because risks should not be imposed on living embryos destined to
become children for the sake of getting stem cells for research. This same response was prompted
by an August 2006 report in the journal
Nature that a California company had used the non-
harmful biopsy method to derive stem cells.92 In addition, the technique was criticized on one side
88 Coalition for the Advancement of Medical Research,
A Catalyst for Cures: Embryonic Stem Cell Research,
Washington, DC, January 12, 2009, p. 2, http://www.camradvocacy.org/resources/camr_wp.pdf.
89 President’s Council on Bioethics,
White Paper: Alternative Sources of Human Pluripotent Stem Cells , May 2005,
http://bioethics.georgetown.edu/pcbe/reports/white_paper/ (PCBE White Paper).
90 For more information, see CRS Report RL33540,
Stem Cell Research: Science, Federal Research Funding and
Regulatory Oversight, by Judith A. Johnson and Erin D. Williams.
91 See, e.g., Rick Weiss “Researchers Report Growing Stem Cells From Dead Embryos,”
Washington Post, September
23, 2006, p. A03, http://www.washingtonpost.com/wp-dyn/content/article/2006/09/22/AR2006092201377.html.
92 See e.g., Nicholas Wade, “Stem Cell News Could Intensify Political Debate,”
New York Times, August 24, 2006,
http://www.nytimes.com/2006/08/24/science/24stem.html?ex=1164862800&en=1d51ef92cddc3e82&ei=5070.
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for effectively “creating a twin and then killing that twin,”93 and on the other for being an
inefficient method for deriving stem cell lines.94 In November 2006,
Nature issued an addendum
to the August article to clarify that, while the company’s lead scientist maintained that his method
could be used to derive stem cells without destroying embryos, in fact, he had destroyed all of the
embryos during his own experiments.95
The council also concluded that bioengineering embryo-like artifacts raises many serious ethical
concerns, including whether the artifact would really be a very defective embryo, the ethics of
egg procurement, concerns about the use of genetic engineering itself, and the possibility of its
use creating a “slippery slope.” Finally, the council found the proposal to dedifferentiate somatic
cells to be ethically acceptable if and when it became scientifically practical, provided that de
facto embryos were not created.
Although some council members expressed their support for efforts to identify means of
obtaining human embryonic stem cells for biomedical research that do not involve killing or
harming human embryos, not all of the members agreed. Some expressed concern that all four
methods would “use financial resources that would be better devoted to proposals that are likely
to be more productive.” One member wrote that he did not support publishing the white paper
“with the implied endorsement that special efforts be made in the scientific areas described.
While some of the suggestions could be explored in a scientific setting, most are high-risk options
that only have an outside chance of success and raise their own complex set of ethical questions.”
As is generally the case regarding alternatives to ESR, on its face the Obama EO neither requires
nor precludes funding research to obtain ES without destroying embryos, but does require that
research be responsible and scientifically worthy. Likewise, the NIH 2009 Guidelines do not
address the issue. By contrast, the Bush Administration’s E.O. 13435 had specifically directed the
HHS Secretary to consider the techniques outlined by the President’s Council, and to fund
attempts to generate sources of pluripotent stem cell therapies that were not derived from human
embryos.
Use of Federal Funding
Some division over the support for and opposition to ESR focuses on the question of whether the
use of federal funding is appropriate. Those who oppose federal funding argue that the
government should not be associated with embryo destruction.96 They point out that embryo
destruction violates the “deeply held moral beliefs of some citizens,” and suggest that “funding
alternative research is morally preferable.”97 Proponents of federal funding argue that it is
immoral to discourage life-saving research by withholding federal funding. They point out that
consensus support is not required for many federal spending policies, as it “does not violate
93 Ibid.
94 See e.g., Josephine Quintavalle, “The Lanza Protocol: Damned With Very Faint Praise,”
BioNews, vol. 373, (August
22-28, 2006), http://www.bionews.org.uk/page_37894.asp.
95 Robert Laza et al., “Human Embryonic Stem Cell Lines Derived from Single Blastomeres,”
Nature, vol. 444, p. 481
(November 23, 2006), http://www.nature.com/nature/journal/v444/n7118/full/nature05366.html.
96 National Bioethics Advisory Commission,
Ethical Issues
in Human Stem Cell Research, vol. 1, September 1999, p.
57.
97 Ibid.
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democratic principles or infringe on the rights of dissent of those in the minority.”98 They argue
that the efforts of both federally supported and privately supported researchers are necessary to
keep the United States at the forefront of what they believe is a very important, cutting edge area
of science. Furthermore, supporters believe that the oversight that comes with federal dollars will
result in better and more ethically controlled research in the field. Requirements attached to
federal funding are one traditional mechanism that Congress has used to regulate scientific
research that might otherwise be conducted without federal oversight.99
Groups’ positions on federal funding tend to mirror their positions on stem cell research generally.
The Obama EO authorizes federal funding for ESR, and requires funded research be responsible
and scientifically worthy. It also requires that research be funded only to the extent permitted by
law, thus adopting the restrictions of the Dickey Amendment and precluding federal funding for
the establishment of ES lines. The NIH 2009 Guidelines further specify requirements for
obtaining federal funding for ESR, and overtly refer to the Dickey Amendment. The Bush policy
had also authorized federal funding, but not in a way designed to affect how stem cell lines were
established.100 The 2005 President’s Council did not take a position on the issue, but noted the
pros and cons and stressed that there is a “difference between
prohibiting embryo research and
refraining from funding it.”101 Focus on the Family opposes ESR, including federal funding for
it.102 NBAC finds the arguments in favor of federal funding more persuasive than those against
it.103 The National Academies, a group of Representatives, a group of Senators, Mrs. Nancy
Reagan and her supporters, CAMR, the Nobel Laureates, and the UOJCA favor federal funding
for ESR.104
98 Ibid.
99 For further information about Congressional regulation of research involving human subjects, see CRS Report
RL32909,
Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with
FDA Regulations and the HIPAA Privacy Rule, by Erin D. Williams.
100 Because the Bush policy only allowed funding for work with previously established ES lines, researchers who had
created stem cell lines before the policy took effect could not have been influenced by its ethical constraints regarding
the derivation of stem cells from embryos, as their work preceded the policy. Similarly, researchers who created stem
cell lines after the policy took effect would not have been motivated to follow the Bush policy’s ethical guidelines
regarding the creation of stem cell lines, because the results of their work would have remained ineligible for federal
funding regardless of their methodology. By contrast, E.O. 13435 may have affected the future derivation of embryonic
stem cells to the extent that it encouraged that such activities take place without creating embryos for research or
harming, endangering, or destroying them.
101 The President’s Council on Bioethics,
Monitoring Stem Cell Research, January 2004, p. 37.
102
Stem Cell Research: Our Position (Stem Cells), Focus on The Family, 2009, http://www.focusonthefamily.com/
socialissues/sanctity_of_life/stem_cell_research/our_position.aspx. The group had previously expressed general
support for President Bush and his ESR policy, but was “disappointed by his decision to allow federal funding of
research on the existing stem cell lines.” Carrie Gordon Earll, “Talking Points on Stem Cell Research,”
Focus on the
Family, September 17, 2003.
103 National Bioethics Advisory Commission,
Ethical Issues in Human Stem Cell Research, vol. 1, September 1999, p.
70.
104 See, e.g., National Research Council, Institute of Medicine, National Academies,
Stem Cells and the Future of
Regenerative Medicine (Washington: National Academies, 2001), p. 49.
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Author Contact Information
Erin D. Williams
Judith A. Johnson
Specialist in Public Health and Bioethics
Specialist in Biomedical Policy
ewilliams@crs.loc.gov, 7-4897
jajohnson@crs.loc.gov, 7-7077
Edward C. Liu
Legislative Attorney
eliu@crs.loc.gov, 7-9166
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