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WHERE DO WE DRAW THE LINES?
LORI P. KNOWLES*
It should be recalled that the purpose of bioethics is not to ban
upfront scientific advances, particularly in the field of medicine, but to
define the limits of the socially desirable and ethically permissible.
–Bioethics Advisory Committee of Israel National Academies of
Sciences and Humanities
Excitement about possible new life-saving treatments in medicine has
not abated since the announcement of the isolation of human embryonic
stem cells (hESC) and human embryonic germ cells.1 While stem cell
research continues in mouse embryo models and more recently, in human
embryo models, nations around the globe have struggled to develop policy
that will allow the science to proceed while respecting the values each
society holds dear. Finding the balance between these two goals requires
transparent and controversial political debate. A survey of selected
regulatory responses around the world reveals that while there are a number
of policy alternatives for regulating human embryonic stem cell research,
the resulting regulatory patchwork continues to evolve.2
hESC research requires the destruction of human embryos to isolate
the stem cells from the inner cell mass. For this reason hESC research
involving the derivation of stem cells is properly understood as a form of
human embryo research. International human embryo research policies
vary greatly from nation to nation. This variation also applies to
international hESC policies. Concerns about the acceptability and
*
1.
2.
Lori P. Knowles is a Research Associate of the Health Law Institute, University of
Alberta, Canada. She holds law degrees from Canada, the United Kingdom, and the
United States.
James A. Thomson et al., Embryonic Stem Cell Lines Derived from Human
Blastocysts, 282 SCI. MAG. 1145-47 (1998).
See generally Lori P. Knowles, A Regulatory Patchwork—Human ES Cell Research
Oversight, 22 NATURE BIOTECHNOLOGY 157 (Feb. 2004).
623
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permissibility of hESC research fall into three distinct but related areas.
The first issue is whether to allow the derivation of hESC from
human embryos. Countries that prohibit all human embryo research such as
Ireland, Austria and Norway also prohibit hESC research in totality. These
nations draw the logical line from their ethically-based objections to human
embryo research to the prohibition of hESC research.
A second issue is whether to allow the derivation of hESC from
surplus in vitro fertilization (IVF) embryos or from embryos created using
cloning technology. Research on hESC using cloning technology would be
useful in fulfilling the promise of autologous transplantation
(transplantation using tissues created with a patient’s own DNA to prevent
“rejection” phenomenon) that is often touted as the central benefit of hESC
research. A minority of countries allow this technology including the
United Kingdom, Belgium, South Korea and China. Countries that permit
the derivation of hESC from surplus embryos created by IVF for
reproductive projects but prohibit the creation of chimeras by cloning
include Canada, Australia, Spain, Finland and the Netherlands, among
others.
The third issue is whether any research on the hESC lines themselves
is permitted, even if derivation is not. Countries such as Germany and
France (until new legislation comes into effect later this year) do not permit
the derivation of hESC but permit the importation of cell lines derived in
other countries. The United States has a complicated stem cell policy that
forbids the use of federal funds on derivation of stem cells, but permits the
use of those funds for research on cell lines derived before August 9, 2001.3
While the policy initially anticipated that there were upwards of sixty stem
cell lines, it now appears that there may be fewer than twenty viable cell
lines for research many of which are not suitable for clinical applications.4
In the United States the private sector can conduct embryo research and,
therefore, hESC research, subject only to state legislative restrictions such
as exist in Louisiana and Florida.5 More recently, in response to growing
frustration with federal funding restrictions states such as California and
New Jersey have passed laws funding and/or encouraging stem cell
research. Other states such as Wisconsin, Maryland, New York and
3.
4.
5.
Id.
NAT’L INSTS. OF HEALTH, Stem Cell Information: NIH Human Embryonic Stem Cell
Registry, at http://stemcells.nih.gov/research/registry/PDFs/AvailableLines.pdf (last
modified Nov. 15, 2004); Elias Zerhouni, Stem Cell Programs, 300 SCI. MAG. 911
(May 9, 2003); Andis Robeznieks, Embyronic Stem Cell Line Found to be
Contaminated, AM. MED. NEWS, Feb. 14, 2005, available at http://www.amaassn.org/amednews/2005/02/14/prsd0214.htm.
FLA. STAT. ANN. § 390.0111(6) (1999); LA. REV. STAT. ANN. §§ 9:122-133 (2004).
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Massachusetts are moving forward on similar initiatives. Two challenges
for a state-based funding of hESC research are how to institutionalize
similar standards and how to balance scientific and ethical issues
effectively.
In summary, there are a number of stem cell policy options:6
1. Prohibit embryo research (and hESC research);
2. Prohibit derivation of hESC but permit importation of stem cell
lines;
3. Permit use of certain cell lines (up to certain dates);
4. Permit hESC research with surplus IVF embryos; or
5. Permit hESC research with surplus embryos and with cloned
embryos.
Not included in this list are the policy choices of a number of
countries that lie between these lines such as current policy in the United
States. Additionally, a number of countries including Israel and India have
official embryo research policies that are stricter than either opinions
expressed by official expert bodies or than the science conducted in those
countries would indicate.7 Official rules and unofficial practices continue to
evolve and change.8
I. HESC RESEARCH AND HUMAN EMBRYO RESEARCH REGULATION
Thinking more broadly about implementing hESC policy it is
important to recall that hESC research falls into the embryo research
context. The most informative discussion revolves around how embryo
research is regulated internationally. There are a number of options for
human embryo research. These options include non-legislative regulation
that relies on ad hoc judicial precedent and regional or local regulation of
research protocols through institutional review boards. Practice guidelines
are another policy vehicle and allow professional self-governance to
regulate standards in the field. In this area the International Society for
Stem Cell Research (ISSCR) is working on developing ethical standards
for stem cell use. Additionally, it is possible to use guidelines for standard
setting in the context of a national regulatory scheme. So, New Zealand
recently passed the Human Assisted Reproductive Technology Act 2004,9
6.
7.
8.
9.
Cf. LeRoy Walters, Human Embryonic Stem Cell Research: An Intercultural
Perspective, 14 KENNEDY INST. OF ETHICS J. 3 (Mar. 2004).
BIOETHICS ADVISORY COMM., ISRAEL ACAD. OF SCIS. & HUMANITIES, THE USE OF
EMBRYONIC STEM CELLS FOR THERAPEUTIC RESEARCH 23 (Aug. 2001), available at
http://www.academy.ac.il/bioethics/PDF/Embryonic_Stem_Cells.pdf.
An excellent resource is compiled by William Hoffman and is available at
http://www.mbbnet.umn.edu/scmap.html (last updated Feb. 23, 2005).
Human Assisted Reproductive Technology Act of 2004 (N.Z.), Pub. Act No. 92
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which provides for an Advisory Committee to issue guidelines that will
guide the approvals of research that come before an Ethics Committee.10
These guidelines function more like regulatory strictures but leave
discretion about individual protocols to the ethics body.
Increasingly, countries are attempting to create statute-based
regulatory schemes that regulate either the entire assisted reproductive
technology (ART) enterprise or large portions of it. A number of these
national regulatory schemes are modeled on the UK’s Human Fertilisation
and Embryology Act of 1990,11 the first comprehensive ART legislation of
its kind. That act creates a regulatory scheme that regulates activities
pertaining to the use, storage, and creation of chimeras used in both
treatment and research. Certain activities are prohibited, including
reproductive cloning, and others are controlled activities that may only be
conducted pursuant to a license. The act creates a central non-departmental
governing body, the Human Fertilisation and Embryology Authority
(HFEA). The HFEA is responsible through several committees for granting
licenses, carrying out inspections and monitoring licensees, maintaining an
information registry of ART related births and patients, making policy
when faced with novel licensing applications, and communicating with
practitioners and the public.12
The wording of the U.K. legislation was initially too narrow to cover
applications for embryo research deriving hESC to explore their therapeutic
properties. In response to the potential hESC research holds, the U.K.
Parliament broadened the HFEA’s enabling legislation through an
amendment to its regulations. The amendment extended the HFEA’s
mandate to research for the purposes of developing treatments for diseased
or damaged tissues.13 In so doing, the act explicitly envisaged the
possibility of approval of research projects using cloning technology
(called cell nuclear transfer in the United Kingdom) to create embryos for
research purposes. This last addition to the act was especially controversial.
It was thought important to clearly prohibit reproductive cloning although
this was already in the act, so the Human Reproductive Cloning Act 2001
10.
11.
12.
13.
(2004), available at http://www.lexisnexis.com.au/nz/products/bulletins/legislation/
2004x092.txt.
Id.
Human Fertilisation and Embryology Act, 1990, ch. 37 (Eng.), available at
http://www.hmso.gov.uk/acts/acts1990/ukpga_19900037_en_1.htm.
See HUM. FERTILISATION & EMBRYOLOGY AUTH., Frequently Asked Questions, at
http://www.hfea.gov.uk/AboutHFEA/FAQs (last visited Feb. 16, 2005).
Statutory Instrument 2001 No. 188. The Human Fertilisation and Embryology
(Research Purposes) Regulations 2001, available at http://www.hmso.gov.uk/si/
si2001/20010188.htm.
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was also passed by Parliament.14 To date there have been two licenses
awarded for research cloning, the latest of which was awarded to Roslin
Institutes where Dolly the sheep was cloned.15
Several other countries have recently enacted embryo research
regulation because the therapeutic possibilities that may flow from hESC
research have helped galvanize or reshape efforts to create ART policy.
This is the case for France, Australia, New Zealand and Canada.16 While
Canada, New Zealand and France’s legislation differ in some respects, they
are each clearly modeled on the U.K. legislation. Unlike these other
statutes, Australia’s embryo research statute deals only with research on
surplus IVF embryos and does not govern other ART activities.
While differences abound between human embryo and hESC policy
initiatives, there are a number of common guiding principles that frame
policy in this area and there is significant harmonization of prohibited
activities and controls on uses of human embryos in research. Most every
region with ART regulation has struggled to develop clear policies with
respect to embryo research and in many cases the road to policy
implementation has been long and tortuous. The question of whether to
permit embryo research is characterized everywhere by a tension between
the desire for therapeutic benefits derived from that research and the need
to prevent unacceptable uses of human embryos. The move toward
internationally accepted norms will likely continue as the validity and
reputation of human embryo research depends on the standards under
which it is performed. Countries in which there is little formal regulation of
embryo research, such as China, often face an uphill battle gaining
recognition and respect for their research results. In addition, as research is
increasingly conducted in multicenter trials and with international
cooperation, harmonization of standards becomes increasingly important
and part of the regulatory landscape.
II. COMMON PRINCIPLES, RESTRICTIONS AND PROHIBITIONS IN
HESC POLICY
The task of developing policy in the area of hESC research is fraught
with difficulty in large part due to the great diversity of opinions on the
moral status of the human embryo.17 The determination of moral status
14.
15.
16.
17.
Human Reproductive Cloning Act, 2001, c. 23 (Eng.) (prohibiting human
reproductive cloning from occurring in the United Kingdom), available at
http://www.legislation.hmso.gov.uk/acts/acts2001/20010023.htm.
Britain Grants ‘Dolly’ Scientist Cloning License, N.Y. TIMES, Feb. 9, 2005, at A6.
Bill C-6, Assisted Human Reproduction Act, 37th Parliament, 3d Sess. (Can. 2004),
available at http://laws.justice.gc.ca/en/A-13.4/notinforce.html.
It is important to note, however, that this is not the only ethical issue involved. Issues
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requires certain responses to questions about the permissibility, restrictions
and prohibitions of and on embryo research. Despite cultural, social and
religious differences within and among the nations examined, it is possible
to find significant overlap in guiding principles, conditions under which
research may be conducted and in the prohibited uses of embryos.
A central finding from public consultation about embryo research is
that there is a lack of consensus on the moral status of human embryos and
therefore, the protections that should be afforded them.18 Scientific tools
cannot resolve this seemingly threshold issue however; a majority of
nations adopt a position that elects to permit embryo research within limits.
This approach balances the scientific, medical and moral costs of not
pursing embryo research with the moral cost of permitting such research.
While a decision to pursue embryo research within limits is often cast as a
compromise, it is actually a choice to reject the position that human
embryos have the same status and rights of full human beings. Countries
that prohibit embryo research choose to imbue embryos with the same
rights to protection against harmful research as are enjoyed by full human
persons.
In those countries in which embryo research is permitted, diverse
nations adopt common principles to guide the formation of embryo
research regulation. Chief among these is respect for human life and
dignity. The concept of human dignity is widely accepted and understood
outside the United States, but remains controversial in this country as it is
surprisingly hard to define.19 Despite U.S. resistance to the adoption of this
concept and a corresponding resistance to formalizing the language of
human rights, respect for human dignity informs other widely shared
principles such as non-commercialization of reproduction.20 This principle
is part of the Canadian, Australian and continental European approach to
reprogenetic technology applications. By contrast, the United States has an
embedded tradition of commercialization. This applies to many realms of
18.
19.
20.
of access to potential benefits from hESC research are also of significance. See, e.g.,
Ruth R. Faden et al., Public Stem Cell Banks: Considerations of Justice in Stem Cell
Banks and Therapy, HASTINGS CTR. REP., Nov.-Dec. 2003, at 13.
See generally Royal COMMISSION ON NEW REPRODUCTIVE TECHNOLOGIES, PROCEED
WITH CARE: THE FINAL REPORT OF THE ROYAL COMMISSION ON NEW REPRODUCTIVE
TECHNOLOGIES (Canadian Gov’t Publ’g 1993); DEP’T OF HEALTH & SOCIAL
SECURITY, REPORT OF THE COMMITTEE OF INQUIRY INTO HUMAN FERTILISATION AND
EMBRYOLOGY (Her Majesty’s Stationary Office, London 1988).
Timothy Caulfield, Human Cloning Laws, Human Dignity and the Poverty of the
Policy Making Dialogue, BMC MED. ETHICS (July 29, 2003), at http://www.
biomedcentral.com/1472-6939/4/3.
See Lori P. Knowles, The Lingua Franca of Human Rights and the Rise of a Global
Bioethic, 10 CAMBRIDGE Q. HEALTHCARE ETHICS 253, 256 (2001).
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human reproduction, from sales of ova and commercial surrogacy, to sales
of gender selection technologies and parental DNA testing. Restrictions on
commercialization in the United States are viewed with suspicion as is
much government regulation. Current government restrictions on funding
of hESC research continue to be controversial.21
Other guiding principles include: Ensuring high quality medical
treatments; respect for free and informed consent; minimizing harms and
maximizing benefits from reproductive medical interventions; relief of
human suffering; freedom of scientific research; the promotion of health
and well-being of women and children; and in the case of hESC research,
access to benefits from that research. How one balances these principles in
designing specific embryo and hESC research legislation is the heart of the
challenge in creating hESC policy.
Finding that balance is particularly challenging as some guiding
principles point in different directions with respect to the strengths of
constraints that should be placed on both scientific investigation and
market exploitation of benefits flowing from hESC research. For example,
respect for scientific freedom and the relief of human suffering suggest
policy initiatives in which constraints on developing treatments or
applications of stem cell science should be applied in the least invasive
way. A principle of non-commercialization, however, mandates strict
limitation on market exploitation, particularly of health benefits that flow
from hESC research. Despite differing emphasis on principles that should
guide regulation of this research there is widespread agreement that some
regulation is needed. What remains controversial is what the scope and
content of that regulation should be.
Although there is no consensus about the moral status of the embryo,
there is agreement that if embryo research is permissible limitations are
necessary. Such limitations are a means of addressing concerns about
inappropriate uses of embryos in research. Legislated limits represent an
acknowledgement that public fears about abuses are respected and
recognition that human embryos are distinct from other human tissue—a
distinction that merits special treatment. Support for oversight of embryo
research is in part a desire to ensure that objectionable scientific research is
not being conducted out of sight. Many of the fears about abuse in embryo
research are widely shared and have resulted in considerable consensus
about what uses should be prohibited. There is less consensus, although
some commonality about the limitations that should be imposed on the use
of human embryos in order to strike a balance between allaying public
concerns, promoting beneficial research and respecting the connection
21.
Address to the Nation on Stem Cell Research, 2 PUB. PAPERS 953 (Aug. 9, 2001),
available at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html.
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between human embryos and the rest of the human community.
Limitations commonly imposed on those using human embryos in
research include the need to obtain specific informed consent from the
sources of the gametes or embryos. This has been suggested with reference
to hESC research as it is not related to the reproductive or medical
treatment of the source(s). Securing such consent respects personal wishes
about disposition, or attachments to the embryo that may be deeply held.
Given the possible choices for dispositions of gametes and embryos—
including donation, indefinite storage, destruction and adoption—consent
to use in research, including disclosure of the nature of that research, is
appropriate.
Other common limits on embryo use in research include restrictions
on the time during which an embryo may be used in research (generally not
after fourteen days, not including time in cryopreservation) and peer review
to determine whether use of embryos in a particular protocol is both
necessary and appropriate. For example, if the experiment can be
conducted using animal models, human embryos should not be used. Most
ART policy, even in very laissez-faire systems still incorporates protocol
review. The more decentralized the policy, the greater the likelihood that
protocol review will be local rather than national. Of course, the existence
of regulatory oversight itself also represents a limit on the use of human
embryos in research.
One limit about which there is disagreement is the need to limit the
use of embryo research, and hESC research, to those embryos that are
surplus to reproductive projects—surplus IVF embryos created in pursuit of
infertility treatment. Many countries limit embryo research to only those
embryos.22 As much of the potential benefit of hESC research is from the
ability to create embryos using cloning technology in order to enable
autologous transplantation, the issue over creation of chimeras for research
purposes is a major dividing line among countries with hESC policy.
The primary objection to creating embryos specifically for research is
based on both the intentions of the person creating the embryo and the
corresponding chance that the embryo might be implanted. Objections to
the creation of chimeras for research appeal to notions of respect for human
dignity and avoidance of instrumental use of human embryos. Some
believe that the creation of chimeras without the intention of implantation
22.
This is clearly the case in Canada, France, Australia, and the seventeen European
countries that have ratified the Council of Europe Convention on Human Rights and
Biomedicine. Council of Europe, Convention for the Protection of Human Rights and
Dignity of the Human Being with Regard to the Application of Biology and
Medicine: Convention on Human Rights and Biomedicine, Jan. 12, 1998, 36 I.L.M.
817, 821, available at http://conventions.coe.int/Treaty/en/Treaties/Html/168.htm.
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does not adequately respect the potential in the human embryo or the
connection to the rest of the human community. The other side of the
argument does not accept the difference between creating embryos for the
purposes of reproduction and creating them for research, as in the former
situation there is still a significant chance that the embryos will not be
implanted.
As this is becoming a major issue in the regulation of hESC research,
particularly with respect to creation by means of cloning technology
(research cloning), there are a few points to keep in mind. First, the
creation of chimeras may be crucial to conducting certain important
research, such as research on certain disease models.23 Second, as
techniques for IVF improve, it is possible that in the future the need to
create surplus embryos will be significantly reduced or even eliminated;
one of the frequently approved uses of embryo research is the improvement
of IVF techniques.
Alternatively, if the research supply is limited to surplus embryos
from IVF, two other results are possible. First, in light of the tremendous
interest in hESC research, there is little doubt that demand for embryos and
ova for research will increase. Increased demand will only augment
incentives for infertility clinics and researchers to ensure that a supply of
ova is available. This is particularly true where physicians and clinics are
conducting embryo research themselves, and if ova and embryos can be
bought and sold between clinics and research institutions. Clearly, one
solution to this last issue is to institute clear conflict of interest guidelines
that ensure that infertility clinics cannot benefit financially for providing
surplus embryos to other researchers. There are a number of safeguards that
impose distance between scientific benefit, procurement and consent
procedures with respect to tissue collection and use in research.24 These
might provide a good template for policy development in this area.
Demand for ova or embryos could translate into pressure on women
undergoing IVF to “donate” ova or embryos specifically for research when
undergoing infertility treatments. Relationships between doctors and
patients are notoriously prone to imbalances in power, and this is especially
true in infertility clinics. Mix in a real desire and enthusiasm for research
23.
24.
Mark Henderson, Stem Cell Bank Gives New Hope to Victims of Inherited Disease,
THE TIMES (London), Feb.15, 2005, at 11, available at http://www.timesonline.co.uk/
article/0,,8122-1484657,00.html.
See, for example, protections on fetal tissue transplantation research prohibiting
directed donation and setting up a scheme to manage conflicts of interest. See
Regulations for the Protections of Human Subjects, 45 C.F.R. §§ 46.101-46.409
(2004); see also National Institutes of Health Revitalization Act of 1993, Pub. L. 10343, §§ 111, 112, 107 Stat. 122 (1993) (amending Public Health Service Act, 42
U.S.C. § 289g-1, 289g-2).
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that will alleviate infertility issues on the part of the clinician researcher
and a desire to be a compliant and agreeable patient and it may not seem
possible to refuse consent to obtain extra ova or embryos for research.
Unfortunately, while it might be tempting to regulate a maximum number
of embryos that can be created, or ova that can be retrieved, this would not
benefit the many women who try to get pregnant through several cycles of
IVF. In fact, such a maximum could increase the number of surgeries
women would need to retrieve ova for subsequent treatments of IVF.
In light of the foregoing, a country attempting to draft ART regulation
ought to consider endorsing the use of spare embryos where possible and to
permit the creation of chimeras for research, where research is dependent
on that creation to achieve its objectives, or in situations in which access to
spare embryos is not possible. This does not fully address the concerns over
possible coercion of infertility patients; these concerns require greater
analysis and specific guidelines or recommendations.
While limits on the use of embryos in research differ to greater and
lesser degrees, there are several commonly prohibited practices. The chief
challenge in defining prohibited practices is the more comprehensive the
list of prohibited activities, the more difficult it is to get public and political
agreement. For this reason, it is tempting to draft a response to a particular
practice on which there is widespread agreement about its prohibition.
Although it is generally easier to get agreement with respect to a specific
technique, this leads to a regulatory patchwork with respect to different
technologies that does not aid the development of comprehensive, dynamic,
adaptive regulation of a field of scientific endeavor.
In a controversial area such as restricting options for human
reproduction, international condemnation for the practice and research on
human reproductive cloning stands as one of two examples of international
accord. There is agreement that the practice of reproductive cloning should
not only be prohibited, but criminalized in most nations. Similarly, the
implantation of human/animal chimeric embryos has been universally
condemned. One area in which there is disagreement between Europe and
North America on one hand and Asia on the other is the acceptability of
creating animal human chimeric embryos. South Korea and China have
used mouse and rabbit ova and human sperm to create embryos that can be
used in stem cell research. This would be unacceptable in most other
countries in which there is human embryo regulation. Other prohibited
practices include the introduction of inheritable genetic modifications (also
known as germ line interventions) and the use of fetal eggs. Outside the
United States, non-commercialization of human reproduction is a
recognized norm, as is the prohibition on the use of genetic sex selection
for non-medical purposes.
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III. CONCLUDING CONSIDERATIONS FOR POLICY-MAKERS
Given the areas of consensus on guiding principles, research
restrictions and prohibited activities, there are many options to consider
when framing hESC policy. It should be noted, however, that the exercise
is fraught not only with political challenge, but also with financial and
structural challenges. Creating a policy that attempts to monitor and
regulate the use of human embryos in hESC research requires substantial
commitment of political will, financial resources and forethought about
setting up complementary and supporting infrastructure. These
considerations are consistent regardless of the policy-making venue, be it
federal or state.
Where a licensing scheme is part of hESC research oversight it is
necessary not only to create a licensing board but also to provide that board
with the ability to conduct inspections, audits, revocations and suspensions.
Ancillary information systems are also needed to ensure confidentiality of
donor information and track embryos and cell lines, as well as outcomes for
any patients ultimately used in research protocols. HESC policy requires
additional attention to issues of access and appropriate uses of derived cell
lines. Several regions have set up stem cell banks for future research or
research into specific diseases. Existing ART regulations that apply to
derivation of stem cells from embryos may not cover secondary use of the
stem cell lines once derived. If this is the case, as in the United Kingdom,
specific legislation or amendment of the comprehensive act may be
warranted.
Alternatively, new oversight bodies may need to be created to handle
access to and uses of banked stem cell lines. In the United Kingdom the
National Institute for Biological Standards and Control houses the U.K.
Stem Cell Bank and it is the Steering Committee of that bank that creates
practice guidelines to guide decisions regarding the secondary use of
derived stem cell lines.25 In Canada the Canadian Institutes of Health
Research, through a Stem Cell Oversight Committee (SCOC), makes
decisions about funding stem cell research. It is expected that the newly
formed regulatory agency under the Assisted Human Reproduction Act will
work together with the SCOC in the future.
New initiatives aimed at hESC research may require changing or
developing policy in areas such as intellectual property of stem cell lines,
oocyte donation laws and reproductive cloning legislation. It is clear that
setting up an hESC research policy is bound to be difficult, time consuming
25.
NAT’L INST. FOR BIOLOGIAL STANDARDS & CONTROL, The UK Stem Cell Bank at
NIBSC: An Overview, at http://www.nibsc.ac.uk/divisions/cbi/stemcell.html (last
visited Mar. 16, 2005).
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and costly. In addition, on the frontier of human reproduction and genetics,
where science and public opinion continually evolve, policy initiatives
need to be adaptive and open to review.