The findings drawn from our survey of the status quo,
as presented in Chapter 8, suggest that a number of serious
concerns may accompany the present and future uses of reproductive
and genetic biotechnologies, and that there are potential
deficiencies in our national system of monitoring, oversight,
and regulation. But shortcomings in the present arrangement
do not, in and of themselves, mean that new policies are
called for. Any new form of regulation would surely come
with costs, and in assessing prospective policies it is
important to weigh their potential costs as well as their
benefits; we must be sure that changes to the present system
are not worse than doing nothing.
The appeal of doing nothing in this arena is, frankly, rather great,
not only because the costs of regulation may be high (and, in their
full proportions, incalculable in advance) but also because the areas
of assisted reproduction, new genomic knowledge, and embryo research
are socially and politically quite sensitive. Some prospective policies
might touch on highly private matters of procreation, family life, and
infertility, and we Americans are loath to intrude in these areas, even
if our aim is to help and to protect those involved. Some potential
policies may also involve questions of the character and status of
human embryos—a crucial but highly charged subject in our politics.
Parties on all sides have strong convictions to defend that reach well
beyond the uses of reproductive biotechnologies; the ongoing national
debate and struggle over abortion are never far from the surface in any
discussion of reproduction and responsibility. Anyone contemplating new
regulation in this field must acknowledge that there is no easy avenue
to clear-cut policies or comfortable compromises, and perhaps that is
as it should be.
But if action, any action, in this field has its financial, social, and
political costs, inaction could surely prove costly as well. The most
obvious costs of leaving the status quo untouched are reflected in the
findings that have emerged from our survey of the field. These problems
are real, and they demand serious public deliberation if not also
improved public monitoring, oversight, or regulation.
Moreover, recognizing these problems, and detailing them as we have,
places a burden upon us. While much remains unknown about the present
state of technologies affecting human reproduction, we can no longer
claim to lack a sense of the circumstances surrounding their use. We
have a good grasp of the various concerns that mightarise in these
areas, and we have a sense of what sorts of benefits and difficulties
will emerge as assisted reproductive technology (ART) becomes more
integrated with the new genomic knowledge and technologies. We also
have a reasonably well-developed understanding of what sorts of
information we now lack. Having put together this picture of the status
quo, we cannot now recommend that nothing further needs to be done
without, in effect, declaring that the status quo is in all respects
better than any realistic alternative.
The issues raised and the concerns described in our survey of the field
make it difficult for us to make such a declaration; and it would be
premature to allow the difficulties that might accompany new policies
to foreclose any further discussion of regulatory or institutional
change. At the same time, we are in no position at this stage of our
inquiry to offer any comprehensive suggestions regarding what, if
anything, should be done regarding this field as a whole. Before
any such suggestions could be made, extensive further investigation and
consultation would be needed. Further testimony and advice would need
to be sought from the various identifiable stakeholders—including
research scientists and biotechnologists, ART practitioners and their
professional societies, disease and disability organizations and
advocates, religious organizations, bioethics and “watchdog”
organizations, and the various governmental institutions already
charged with some regulatory responsibility in this field—as well as
from ordinary citizens. We would also need to carry out a thorough
exploration of what could be done within the existing regulatory
framework, limited though it may at present be. To offer suggestions
that would be of genuine practical value, due attention would also have
to be paid to the constraints imposed on any new policy by the special
features of American political and economic life, medical and research
practices, personal privacy protections, and the realities of public
attitudes and domestic political struggles. To do this properly would
take at least several years.
In the absence of such a thoroughgoing inquiry, we can
however present in outline certain institutional options
that might be considered for the field as a whole, indicating
in general terms some of their strengths and weaknesses.
And, more modestly, we can revisit some of the findings
of our diagnostic assessment in order to consider certain
specific policy options that might command some attention,
even as people try to think through the desirability and
feasibility of more thorough institutional changes. The
remainder of this chapter takes up these matters in turn.
In each case, we are merely laying out the alternatives.
We are not here endorsing any one of them.
I. INSTITUTIONAL OPTIONS
What, then, might be done institutionally regarding this field as a
whole? We begin by briefly offering a sense of what sorts of
policy may be available to us. There is certainly something
counter-intuitive about discussing institutional arrangements in the
abstract without first articulating the substantive principles that
should guide their design and operation. But it is nonetheless useful
to approach the subject with a rough sense of the contents of our
toolbox, so as to better organize our thinking about which particular
substantive options are feasible. The actual design of oversight and
regulatory mechanisms must of course begin from the substantive aims
motivating the policy; but because such design is not our purpose at
this stage, review of possibilities may usefully begin at the more
general level of institutional forms.
It is worth emphasizing that we take a broad view of the meaning
of the term “regulation.” In employing that term, we do
not refer merely to restrictions or enforced prohibitions,
but to a broad range of potential actions that might be
undertaken to encourage, facilitate, protect, oversee, restrain,
or restrict a given activity. A government’s regulatory
stance may range from promoting (through funding), to permitting
without restriction, to tolerating or permitting within
enforceable limits, to discouraging (by withholding funding),
to prohibiting. And particular regulatory policies may range
from information-gathering and reporting, to monitoring,
to oversight, to setting hortatory guidelines, to providing
rules and regulations with penalties for violation, among
others. An analogous range of regulatory stances and policy
options (with some differences) is open also to professional
societies and institutional ethics committees.
The array of national-level policy options that present themselves, and
that have been examined by observers and critics in the past, may be
divided roughly into five categories of potential institutional change:
(1) a new regulatory agency; (2) new authority granted to existing
regulatory agencies; (3) specific legislative action; (4) the use of
government funding as a regulatory lever; and (5) increased oversight
and self-regulation by the relevant professional societies. Let us
briefly describe each of these in institutional terms, highlighting
also what might be said for or against each alternative.
A. A New Regulatory Agency
One possibility, suggested by a number of observers and evident in the
policies of several foreign countries, is the creation of a new
administrative agency of the executive branch that would be authorized
to monitor and administer the uses of biotechnologies discussed in this
report. Such an agency would be charged by Congress with a number of
specific tasks but would be also given some leeway in applying its
mandate to particular circumstances that might arise. Its creation
would therefore involve some delegation of regulatory authority. This,
for instance, is the idea behind the Human Fertilization and Embryology
Authority (HFEA) in Britain and the Assisted Human Reproduction Agency
(AHRA) in Canada.
The logic of this approach is fairly straightforward: by creating a
body whose business it is to oversee this arena of research and
practice, we might ensure that the problems that worry us are at least
noticed and at best addressed with appropriate policies. Many issues
involved in assisted reproduction, genetic testing and screening,
embryo research, and related fields are new and unprecedented, and they
do not fall naturally into the purview of any existing government body
or agency. Existing agencies, like the federal Food and Drug
Administration (FDA), the National Institutes of Health (NIH), the
Centers for Disease Control (CDC), to name just the most prominent
ones, were designed and have evolved to serve different purposes, and
authorizing them to oversee this field might not adequately address the
important concerns that have emerged from our review of the present
state of affairs.
Such a new agency would be granted some degree of latitude
in making judgments in particular cases, so that each controversy
in this emerging field would not turn into a legislative
question requiring prolonged congressional debate.i
A new agency dedicated exclusively to monitoring or regulating this
arena might ensure that all the relevant concerns are addressed. But
the costs of such an agency, financial and otherwise, could be quite
high. It would be very difficult for an institution along the lines of
the British HFEA to function in the American system, since our
approaches to embryology and human genetics, the practice of medicine,
the financing of health care, private enterprise, reproductive
freedoms, government regulation, and scientific progress are different
from those of the British.
The potential wisdom or utility of such an agency would have to be
judged in light of the tasks it would need to carry out. In purely
institutional terms, designing and establishing it would be a complex
undertaking. It therefore marks the most ambitious of the potential
institutional options before us.
B. Augmentation of Existing Agencies
Rather than establish a new agency, Congress might expand the scope and
jurisdiction of one or more existing federal agencies to authorize them
to exercise oversight over this field.
A number of potential candidates present themselves. The FDA, as
discussed in our overview of the status quo, already exercises some
limited oversight over certain elements of reproductive biotechnology,
and its reach in this arena might reasonably be extended somewhat. In
addition, the NIH, along with several of its subsidiary institutions
(for example, the Recombinant DNA Advisory Committee, or RAC), might
also be given some authority to monitor or even to regulate specific
areas of research and, to a limited extent, of clinical applications.
The CDC is already charged by statute with the task of gathering and
publishing data on assisted reproductive technologies, and its
authority in this regard, as well as other related ones, could be
It may in principle be possible to delegate all or nearly all of the
regulatory and oversight authority deemed appropriate in this field to
one of these (or other) federal agencies. Alternatively, such authority
might be divided among several existing agencies.
There would be several advantages to delegating any new authority to
existing institutions. For one thing, it would circumvent the need to
create a new federal regulatory body—a difficult and costly
undertaking, with uncertain prospects of success and potential
unintended consequences if it were to be established. A delegation of
authority to an existing agency could probably be put into effect more
quickly, as the basic mechanisms for oversight and enforcement would
likely already exist, and the institutional resources for action would
not need to be created from scratch. In addition, the authority could
be delegated by integrating the new areas of oversight and regulation
into existing patterns of regulatory activity, rather than, again, by
beginning with a blank slate.
On the other hand, the delegation of oversight authority over
reproductive biotechnologies to an existing federal agency would mean
that no institution would have this arena as its prime or exclusive
portfolio, and hence that the questions and concerns we have raised
would not be anyone’s principal business. In addition, the structure,
authority, experience, and expertise of existing federal agencies might
not be quite suitable for regulating in this area. Each existing
federal agency was created, and has evolved, to oversee a particular
sort of activity, and the issues that concern us may not be a good
match with any of them. The questions before us do not, for the most
part, involve food or drugs, the control of disease, or the funding of
scientific research, for instance. While they touch on these subjects,
these questions should not be understood primarily through lenses
developed for viewing other problems. There is also the further
difficulty, intrinsic to all attempts at regulation, that the
regulators may be co-opted by the interests they seek to regulate.
If Congress deems it necessary to delegate some new regulatory
authority over the technologies we have discussed, the choice
between delegating such power to a new federal agency or
to an existing agency or agencies should come down to the
question of whether this arena of technology and activity
raises (or is likely to raise) fundamentally new and different
sorts of questions and challenges from those that have been
dealt with by existing federal agencies in the past. This
is a complex question that certainly cannot be answered
in the abstract; rather, it must be considered with regard
to each particular target of potential oversight and regulation.
C. Particular Legislative Action
The two previous options assume some degree of delegation of authority
by Congress for the regulation of these technologies in particular
instances. Congress, however, may also decide to address particular
issues directly and specifically through legislation. Acts of Congress
are necessarily broader and blunter instruments than the particular
case-by-case decisions of a regulatory agency, but they can also speak
with greater force and authority in the public eye.
Of course, the delegation of power to a regulatory agency would
itself be an act of Congress, but what we have in mind in
this category of potential institutional change is the passage
of laws that lay down distinct and precise rules that do
not require a great deal of complex regulation, or much
case-by-case judgment to enforce them. The issues would
be dealt with legislatively rather than administratively.
Such policies could involve limitations or prohibitions,
but they might also involve means of support for certain
technologies and practices, or offers of funding that might
be made available through existing funding agencies.ii
Several advantages may be gained by proceeding through acts of
Congress, rather than delegating judgment to an administrative agency.
Such a process would be more democratic and more directly answerable to
public wishes and concerns.
However, proceeding by acts of Congress would also limit the potential
flexibility of oversight and legislation in this arena. It would make
cast-iron prohibitions more likely and case-by-case judgment more
difficult. It would also, of course, be slow and arduous, as past and
present efforts to legislate policy regarding human cloning, genetic
discrimination, and embryo research have already demonstrated. It may
well be the appropriate means to achieve some potentially desirable
reforms, but its limitations are apparent.
D. Federal Funding as a Regulatory Lever
A fourth institutional means for regulation involves the
use of federal funding to encourage desirable practices
and (by withholding funding) to discourage troubling ones.
Federal funding can also be used as a more nuanced regulatory
mechanism, since Congress can attach requirements to funding
and compel all recipients to abide by certain rules. Indeed,
this is an important way in which scientific research is
currently regulated by the federal government. Researchers
who receive federal funds, or whose institutions do, are
required to abide by certain basic guidelines regarding
clinical standards, human subject protections, the need
to obtain informed consent, and other issues. Many people,
including some members of this Council,iii
believe that the current paucity of oversight in this field
is owed mainly to the absence of federal funding of in vitro
fertilization (IVF) research, and that it is only through
federal funding that the public can gain some control over
this sensitive area of biotechnology.
The question of funding is, however, quite complex and
controversial. By offering funding for a practice, the government
at least implicitly expresses a public endorsement, in effect
pronouncing the practice worthy of a share of taxpayer money.
This becomes a problem when the work in question is controversial,
or when it is deemed unethical or otherwise unacceptable
by some significant portion of the public. Those who oppose
the practice neither want their own tax money used to support
it nor wish to have their government express approval of
it. It is largely for this reason that much of the work
in the fields taken up in this report has never been supported
with federal funds.iv
Of course, to refrain from offering funds is also a kind of policy
decision, and certainly an act of Congress that expressly forbids
federal funding of specific practices (as is the case with embryo
research, for instance) is an explicit policy and a form of regulation.
Moreover, institutions that receive federal funds may sometimes be
required to submit to government regulations even in their privately
funded activities, so that the government can still reach and regulate
those activities it does not fund directly. In such cases the costs of
compliance to recipient institutions can be huge.
Federal funds, in one way or another, may therefore be used as a means
of encouraging or opposing certain practices that are deemed to require
government supervision. At the same time, there is no necessary
relationship between regulation and direct funding: the government can
and does regulate activities it does not fund.
E. Increased Oversight and Self-Regulation by Practitioners
and Professional Societies
Finally, the status quo might be improved by augmenting and improving
the mechanisms for self-regulation by practitioners and by the relevant
professional societies. There is currently a fairly complex framework
of self-regulation for the practice of assisted reproduction,
administered by very well-organized and influential professional
societies. These existing structures could be strengthened through
increased oversight, enhanced penalties for noncompliance, and
substantive changes to the content of the regulations themselves.
The potential benefits of this approach are manifold. First, because
professional societies and practitioners have great institutional
competence and expertise in the technical and practical aspects of
their fields, they are uniquely situated to craft fitting and effective
regulations and safeguards. Second, it would be symbolically very
valuable to have the practitioners themselves draw boundaries and erect
protective measures to defend against abuses and injuries to parents,
to children, and to society at large. It would demonstrate that the
mainstream community of practitioners is committed to preserving the
human goods at stake and will not tolerate the transgression of ethical
boundaries by irresponsible clinicians or scientists. Moreover,
effective self-regulation could potentially insulate the mainstream
community of clinicians and researchers from public criticism and from
the possibly overbroad legislative response that might follow any
disasters or tragedies flowing from the actions of renegade
practitioners. Finally, it is likely (and reasonable) that
practitioners would prefer to be regulated by their peers rather than
by some external governmental body.
The possible drawbacks of self-regulation are fairly straightforward.
There is the danger that some practitioners will not follow
standards they regard as unduly burdensome, or that the
professional societies will not enforce them.
II. SUBSTANTIVE OPTIONS
As we have already indicated, we are not now prepared to reach
conclusions as to the best form of general regulation, not only because
much remains unknown about the field, but also (and especially) because
we must first decide what problems, if any, are sufficiently great to
call for government action and, when they are, what sorts of action, if
any, would be most beneficial. Nevertheless, the findings of our
diagnostic inquiry identify several substantive areas of ethical and
social concern that are of sufficient magnitude to warrant a
consideration of the policy options currently available to address
them. Once again, we describe these options, and their perceived
strengths and weaknesses, without endorsing any of them.
The following, then, are some concerns that emerge from the diagnosis
and findings laid out in Chapters 2 through 7, and some suggestions for
possible ways of dealing with them. As will become apparent, in some
instances we describe a variety of possible options, some of which may
be mutually contradictory. In many cases, we do not yet have enough
information to make a choice among the options (thus, the options
include the gathering of such information). In other cases, there
remain deep disagreements over matters of principle or between
competing priorities. Our aim in presenting the following policy
options is to map the landscape so that public discussion on these
matters might proceed in a more informed manner, and to see whether
some limited, specific, but perhaps much-needed action might be
recommended by the Council.
A. Safety and Well-Being of Children Born Using ART
Among the ethical issues raised by the use of ARTs, the concern for the
safety and well-being of children conceived through these technologies
seems the one most in need of greater attention. Together with the
safety of the women involved, it ought to be the first consideration
(though surely not the only one) guiding the use of ART. But for
various reasons described above, it appears to us that these concerns
have not received sufficient attention.
It would of course be incorrect to say that no care at all is presently
taken for the well-being of children later born, or to assume in any
way that clinicians do not seek the well-being of the children who are
to be conceived using ART. But institutional or public oversight in
this area is limited, and those rules that have been set by
professional societies tend to be vague and unenforced, although most
clinicians are conscientious and try to follow them. And while most
institutions, wary of malpractice suits, clearly try to avoid
irresponsible or risky practices, we simply do not know how well they
attend to the outcomes of interest here.
Several options for policy seem feasible in this arena:
1. Improved Annual Monitoring of ART Techniques
The federal government could gather and compile more copious
and specific data regarding the various techniques used
and the outcomes related to such techniques in assisted
reproduction procedures. The mechanism for collecting such
information is already in place, through the CDC, and it
could fairly easily be expanded or relocated as deemed necessary.v
This information would provide more detailed data about
what methods and materials are used in assisted reproduction
procedures, with what effect on resulting outcomes.
2. Long-Term Longitudinal Studies.
The federal government might fund long-term longitudinal
studies to track the health and well-being of children conceived
using various ART techniques, as well as of mothers who
undergo the procedures. Some information is currently available
through relatively small-scale studies, mostly carried out
abroad. More and better information is essential before
further steps can be taken. Participation would of course
3. Improved/Expanded Decision-Making.
State and federal government or ART practitioners themselves
might put in place an improved and expanded informed consent
process for prospective parents seeking ART procedures.
Such a process might provide more complete information about
the safety and well-being of children born through ART,
including any and all available data about frequency of
birth defects and other problems, in comparison to children
in the general population. It might also seek to develop
uniform consent procedures regarding the disposition and
fate of any unused embryos generated in the process.
4. Requirements for Higher Standards and
More Substantial Animal Research before Moving Experimental
Procedures into Clinical Practice.
Since ART practices are largely unregulated at present,
techniques can move from the experimental stage to clinical
use quite quickly. One prominent technique, ICSI (intracytoplasmic
sperm injection), was introduced into regular clinical use
with minimal animal experimentation and with no studies
to follow up on anecdotal reports of hazards for the children
produced. More rigorous standards may well be called for,
and these might be developed and enforced by a government
body, by the professional societies (such as the American
Society for Reproductive Medicine [ASRM]), or by some combination.
5. Enforcement Mechanism if Studies Show
That Certain Procedures Are Insufficiently Safe.
Should the data collected by any of the above methods,
or others, demonstrate that a particular ART procedure is
sufficiently unsafe to be restricted only to patients with
particular characteristics or needs, or halted altogether
pending further review, some means should be available to
formulate that judgment and to enforce it. The institutional
layout presented above may provide some sense of the possible
place and character of such an enforcement authority, though
the question of who should be given that authority would
of course be a controversial one. At present, we do not
have sufficient information about whether such an agency
might be required, and what might be required of it, to
proffer more specific suggestions.
6. Expanded/Publicly Funded Research with a
View to Improving ART Procedures.
The safety, reliability, and efficacy of ART procedures would be
improved and better understood if more studies were conducted to test
various methods and techniques of assisted reproduction. More and
better-funded research could help to improve the reliability and
effectiveness of existing techniques and to more thoroughly assess new
ones before they are brought into practice. Such funding would also
facilitate greater public oversight of the research in question. The
extent, character, and funding of such research would likely be
controversial issues, even if the benefits would be substantial.
B. Equal and Improved Access to IVF/ART
Among the concerns we have described are not only problems of practice,
but also problems of access. Assisted reproduction procedures can be
quite expensive, and at this point access seems to be fairly limited.
The present situation varies by state (with some mandating that
insurance companies cover it to various degrees, while most are silent)
and by insurance company and policy. Such a situation may of course be
deemed acceptable, but if policymakers were to see a need for action,
at the state or federal level, several related avenues of recourse may
The most commonly discussed policy option would be to
require insurance companies to treat infertility as a medical
condition like any other and to offer coverage for all assisted
reproductive procedures. In most cases to date, proposed
policies mandate funding only under certain circumstances
(for instance, only for married couples, or for women of
specified ages) or couple the funding with guidelines for
practice (mandates regarding efficiency of the procedure,
number of embryos created and implanted, etc.). As noted
earlier, studies have shown a connection between availability
of insurance coverage and decreases in the number of embryos
transferred per cycle.vi
C. Genetic Screening and Selection
of Embryos for Non-Disease-Related Traits
The use of genetic screening and selection of embryos before
implantation is, at the present time, unregulated and largely
unmonitored. For the moment, to be sure, the options for such use are
limited, since the technical capacity to select for particular traits
is still relatively undeveloped. Today there are in general practice
basically two uses for embryo selection outside the disease context:
sex selection, and selection of embryos that could develop into
genetically suitable organ or tissue donors. Both have already become
quite controversial subjects, and as further techniques for selection
are developed, new controversies are likely to emerge.
Should some oversight or regulation of this area prove
necessary, it could take some or all of the following forms:
1. Increased Monitoring.
Regulation might begin with increased monitoring, to develop
a clearer sense of the uses to which genetic screening and
selection are being put and the degree and frequency of
use. Such basic information is for the moment difficult
to come by, and we may not have the kind of understanding
of the status quo that would be required to make further
judgments regarding regulation.
2. Review Mechanisms.
Beyond monitoring, Congress may establish new or improved
mechanisms for reviewing non-disease-related uses of genetic
screening and selection, setting a higher than usual bar
for such techniques to pass before they are made generally
available for clinical use or before they may be used in
individual cases. Since very little information is available
on the effects of screening and selection on the well-being
of the child that results from the process, there may be
a powerful case for such increased standards of scrutiny
3. Limits on Non-Disease Uses.
Finally, Congress might consider placing limits or a moratorium on
non-disease-related uses of screening and selection, whether in general
or in relation to specific uses, such as non-disease-related sex
selection. This would of course be quite challenging to implement,
since it would require a fairly clear delineation of what are and what
are not disease characteristics. It might also have certain unintended
consequences, such as increasing the use of abortions (rather than
preimplantation genetic diagnosis [PGD]) for elective sex selection.
But policymakers may deem it sufficiently important nonetheless.
The various options along this continuum are not mutually exclusive;
however, given our fundamental lack of data regarding the volume and
popularity of such practices, and given the fact that most such
practices are projected rather than current, it may be wise to begin
with monitoring and data collection, so as to inform further
decision-making in the future.
D. Intentional Germ-Line Modification of Embryos or
Gametes to Produce Children
At present, germ-line modification of embryos and gametes with the
intent to produce modified children is proscribed in practice by a
decision of the RAC not to consider proposals for such work. But the
moratorium could be overturned by a simple decision of the RAC, and it
is also not clear whether it would apply to all potential
modifications. Should it become technically feasible to safely correct
single mutant genes in embryos or gametes, the RAC might relax its
Given the fairly broad agreement in the country and Congress that
germ-line modification should not now be attempted, Congress might
institute, by statute, a national moratorium on germ-line modification
to produce children, potentially including the following specific
activities: (1) ooplasm transfer; (2) insertion of human genetic
material into gametes or embryos with a view to fertilization and
transfer to produce children; (3) insertion of animal genes or genetic
material into gametes or embryos with a view to fertilization and
transfer to produce children; and (4) insertion of artificial
chromosomes, genes, or genetic material with a view to fertilization
and transfer to produce children. Advances in technology and assurances
of their safe and effective use could lead to a lifting of such a
E. New Reproductive Possibilities That Alter the Biological
Relationships between Children and Parents
A range of potential new reproductive technologies could mark a
significant departure in human procreation, fundamentally
altering the biological relationships between parents and
offspring. In the future, for example, it might be possible
to conceive a child using gametes obtained from an aborted
human fetus or derived from embryonic stem cells. It might
be possible to fuse blastomeres from two or more embryos
to conceive a child with more than two genetic progenitors.
It might be possible to conceive a child by transferring
the nucleus from a person’s somatic cell into an enucleated
egg, producing a child who is virtually genetically identical
to the somatic cell donor (“cloning-to-produce-children”
or “reproductive cloning”). Or it might be possible to “activate”
a human oocyte, producing a child whose genetic heritage
is derived from a single progenitor (“parthenogenesis”).
Under present law, these (and other) reproductive possibilities
would be legal if they were technically feasible. All would
mark a significant crossing of boundaries in human reproduction,
either by denying children the natural connection to two
human genetic parents or by giving children a fetal or embryonic
progenitor. To secure for children born with the aid of
assisted reproduction the same rights and attachments as
children conceived in vivo, Congress could pass a ban or
moratorium on attempts to conceive a child by any means
other than the union of egg and sperm, attempts to conceive
a child using gametes obtained from a human fetus or derived
from embryonic stem cells, or attempts to conceive a child
by fusing the blastomeres from two or more embryos.
F. Commercialization of Elements of Human Reproduction
The commercialization of various elements of human reproduction is, for
some, a further cause for concern and an additional potential target
for regulation. At present, the buying and selling of gametes is
essentially unrestricted in most states, as is, in principle, the
buying and selling of embryos, though there is no evidence to suggest
the existence of any market in embryos. The potential patenting of
human embryos is also a source of concern: the U.S. Patent and
Trademark Office has traditionally refused to grant such patents as a
matter of institutional policy, and an amendment to a recently passed
appropriations bill prevents (through fiscal year 2004) the issuance of
patents on human organisms at any stage of development.
Possible policies in this arena include:
1. Limits or Restrictions on the Buying and Selling
If the buying and selling of human gametes is deemed troubling,
Congress, or state governments, could set certain limits,
potentially including a ceiling on the price of eggs or
sperm, limits on advertising for or by gamete donors, or
perhaps even a restriction on the selling of gametes altogether.
2. Limits or Restrictions on the Buying and Selling
of Human Embryos.
Similarly, Congress, or state governments, might set limits
on the buying and selling of human embryos, whether for
research or for implantation.
3. Prohibition on the Patenting of Human
Embryos or Gametes.
In addition, Congress could permanently amend the
patent laws to specifically forbid the patenting of human
embryos, or of human organisms at any stage of development.
It could also enact restrictions on the patenting of human
G. Biomedical Research Involving
Early-Stage Human Embryos/Blastocysts
Embryo research is certainly among the most controversial and
politically sensitive of the practices we have discussed, and therefore
difficult to regulate. Those who believe it should be altogether
prohibited often oppose regulating it, fearing that by doing so the
government might implicitly sanction the practice and assure its
continuation. Others see no need to regulate such research at all and
fear that new regulations will only slow down or hinder new research.
Still others worry that regulations founded in concerns about embryonic
human life would set a precedent that might have implications for
abortion law or scientific freedom in general.
The result has been essentially no regulation and almost no federal
funding of embryo research, but rather an official policy of silently
allowing such research in the private sector without public endorsement
or support. All embryo research (including research on embryos left
over from IVF procedures undertaken initially for reproductive
purposes, embryos created by IVF solely for research, and cloned
embryos produced solely for research) remains legal in the private
sector. If it is regulated at all, it is regulated only by
institutional review boards (IRBs), which generally do not have special
rules for research involving human embryos used for research purposes,
and whose oversight almost never takes into account the moral questions
relating explicitly to the destruction of developing human life. We
have only very limited knowledge of the numbers, uses, and commercial
applications of embryo research in the private sector.
In the public sector, funding of research that involves
the destruction of human embryos is prohibited by law, though
current policy allows for the funding of research using
certain embryonic stem cell lines that meet a series of
qualifications: they must have been derived from human embryos
originally created solely for reproductive purposes, with
the informed consent of the donors, and without any financial
inducements to the donors, and they must have been derived
on or before August 9, 2001.vii
These funding guidelines, combined with the broader restriction
on all other federal funding of embryo research, are essentially
the only federal regulations on the subject at present.
Some individual states have crafted their own policies,
ranging from sharp restrictions on embryo research to encouragement
and even funding of such work. But most states have no explicit
policy of any kind.
Should a national policy be deemed necessary, several
options seem plausible, at least in theory:
1. Expanded Restrictions.
Congress might choose to impose new restrictions on embryo
research, including restrictions on privately funded embryo
research. For example: It might restrict embryo research
exclusively to left-over IVF embryos. It might ban or pass
a moratorium on the production of embryos solely for research
purposes. It might ban or pass a moratorium on the creation
of cloned embryos solely for research. It might ban or pass
a moratorium on the creation of other “unnatural” embryos,
such as man-animal hybrid embryos or embryos formed using
fetal gametes or gametes derived from embryonic stem cells.
It might allow research only on existing stem cell lines,
and ban all future embryo destruction for biomedical research.
Or it might set an upper limit on the age to which an embryo
used in research may be grown or used for research purposes.
2. Expanded Funding.
Conversely, Congress might choose to relax existing restrictions
and offer increased federal funding for embryo research.
For example: The federal government might choose to fund
all promising embryo research without restriction, including
the creation of IVF or cloned embryos solely for research
purposes. It might fund embryo research on left-over embryos
that were originally created for reproductive purposes.
Or it might fund research on all existing stem cell lines,
including those lines produced since August 9, 2001.
3. Expanded Regulation/Public Licensure
under Certain Guidelines.
Congress might also explicitly permit or endorse embryo
research within the framework of a regulatory system. This
policy might involve requiring all embryo researchers to
be licensed or registered; requiring embryo experiments
to be approved case-by-case on the basis of whether they
are deemed “scientifically compelling” by a panel of experts;
or requiring each embryo used for research to be registered
and the purpose of its use described and recorded. This
regulatory option might be combined with new restrictions,
new funding, or some combination of both. For example, the
federal government might fund research on all existing embryonic
stem cell lines while prohibiting future embryo destruction
for research. Or it might fund research on both IVF and
cloned embryos with extensive regulation, licensing, and
H. Implantation of Human Embryos
into Human or Non-Human Uteri for Biomedical Research
At present, there are no federal laws or rules restricting or
prohibiting the transfer of a human embryo into a human or non-human
uterus for the purpose of developing it solely for research.
If this is deemed sufficiently troubling to require action,
two general options present themselves:
1. Restrictions on Embryo Transfer for Research.
Congress might put into effect a ban or moratorium on
the transfer of human embryos to a woman’s uterus purely
for research purposes. The law could also be more narrowly
tailored, if desired, to restrict specifically the transfer
of embryos into animals, human uterine material outside
the body, (prospective) artificial wombs, or any combination
of these, with the intent to keep such embryos alive purely
for purposes of research.
2. Time Limit on Embryo Use.
Concerns on this score might also be addressed by prohibiting
research on embryos beyond a certain age or stage of development.
At present, given the limited availability of data, we are not in a
position either to recommend or to reject most of the options described
in these pages, be they general institutional reforms or specific
substantive policies. Some options may be deemed unacceptable on the
basis of moral, ethical, or practical considerations independent of any
information that might be gathered; others may turn out to be
unwarranted or unwise as the nation learns more about the field; while
yet others may prove to be desirable and sensible in light of new data
still to be collected. No overarching policy direction in this arena
can or should be set before substantially more and better information
is gathered and before all interested parties are thoroughly consulted
as potential policy options emerge.
There may, however, be some interim steps that would be
advisable while the process of contemplating potential policies
progresses. These involve both essential information gathering
and some modest interim legislative action or policy reforms
that may be deemed appropriate on the basis of the information
we already possess and the findings of our preliminary inquiry.
We offer some recommendations along these lines in the next
(and final) chapter.