This staff working paper was discussed at the Council's
July 2003 meeting.
It was prepared by staff solely to aid discussion, and does not represent
the official views of the Council or of the United States Government.
U.S. Public Policy and the Biotechnologies
That Touch the Beginnings of Human Life:
Some Policy Options
The purpose of this Staff Working Paper is two-fold: First, responding
to Council Members’ request, it aims to describe a range of
general and specific public policy options in areas of biotechnology
that touch on the beginnings of human life. In doing so, it builds
directly on the diagnosis and findings of the Council’s inquiry
into these matters. It begins, in a general way, by considering
the different possibilities for institutional reform, examining
the strengths and weaknesses of each major approach. It then considers,
more specifically, several substantive areas of concern and the
range of specific actions the country might take. In presenting
this overview, it tries to keep in mind both the costs of action
and the costs of inaction; the realities and particularities of
our political system; the different human goods at stake and the
different stakeholders in the debate; and the fact that this inquiry
is just beginning, and that there is much important information
we do not yet have. The purpose here is to provide a lay of the
land, so that the Council, and through it the nation, might consider
these complex matters more carefully and more clearly, by presenting
a wide range of policy options and the rationale for each of them.
The second purpose of the document is to begin a discussion about
what specific actions or policies, if any, the Council might recommend
in these areas. It is clear that on some of the matters here under
consideration, both substantive and institutional, there are major
disagreements on the Council, as there are in the country as a whole.
But there are or may be matters where nearly everyone is in agreement
about the need for more information, for improved oversight, or
for specific reforms and actions. Using this document as a point
of departure, we would like to discover any such areas of common
concern and agreement. And we would like further to discover whether
there might be certain actions or policies that the Council might
wish to recommend as interim steps, while we continue to seek a
sound national policy in these areas of clinical practice and research
that are at once novel and profound.
The findings drawn from our survey of the status quo, and presented
in the previous Working Paper, suggest that a number of serious
problems may accompany the present and future uses of biotechnologies
that touch on the beginnings of human life. But the existence of
problems with the present arrangement does not, in itself, mean
that new policies are called for. Any new policy, or form of regulation,
would surely come with costs, and in assessing potential policies
we must be sure that their costs do not outweigh their benefits
or, in other words, that they 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, unknowable 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 and often vexing 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 early human life—a crucial but
delicate subject in our politics. Parties on all sides have interests
to defend that reach well beyond the immediate area under discussion,
and the abortion debate casts its giant shadow on this matter as
on so many others. On questions involving nascent human life, we
often have no avenue to straightforward policies or comfortable
compromises, and perhaps it is right that this is so.
But if action, any action, in this field has its bureaucratic,
financial, social, and political costs, inaction would surely be
costly as well. The most obvious costs of leaving the status quo
untouched are reflected in the findings that emerged from our survey
of the field. These problems are real, and will not go away unless
they are addressed.
Moreover, knowing these problems, and detailing them as we have,
places a burden upon us. While much remains unknown about the present
state of technologies that touch on the beginnings of human life,
we can no longer claim to have no sense of the circumstances surrounding
their use. We know a fair amount about what is good and bad regarding
ART and embryo research, and we have a sense of what sorts of benefits
and difficulties are approaching as ART and new genomic knowledge
and technologies intersect. We also have a reasonably well-developed
understanding of what sort of information we still lack. Recommending
that nothing further needs to be done after having put together
this picture of the status quo is akin to a positive statement that
the status quo, in all respects, is better than any alternative
anyone can reasonably envision.
The concerns described in our survey of the field make it difficult
for us to make such a statement, or to allow the difficulties that
might accompany new policies to foreclose in advance any discussion
of reform. 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 investigations
and consultations would be needed. Further testimony and advice
would need to be taken from the various identifiable stakeholders—including
research scientists and biotechnologists, ART practitioners and
their professional societies, representatives of disease and disability
organizations and advocates, religious organizations, representatives
of 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 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 have any hope of gaining an
audience, due attention would also need to be paid to the constraints
placed on any new recommendations 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
In the absence of such ongoing inquiry, we can however present
in outline some of the 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 visit piecemeal
some of the findings of our diagnostic assessment and consider some
more specific policy options that might command some attention,
even as people try to think through the desirability and feasibility
of anything more thorough. The remainder of this working paper takes
up these matters in turn.
1. 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 sense of the contents of our toolbox, so that
we may be able to organize our thinking about which particular substantive
options may be plausible. The actual design of oversight and regulatory
mechanisms must begin from the substantive aims motivating the policy;
but such design is not our purpose at this stage, and a review of
possibilities should perhaps begin at the more general level of
The array of national-level policy options that present themselves,
and that have been presented by observers and critics in the past,
may be divided into roughly four categories of institutional reform,
from most ambitious to most modest: 1) a new regulatory agency,
2) new authority granted to existing regulatory agencies, 3) specific
legislative action, and 4) the use of government funding as a regulatory
lever. There are of course other options for action in this arena,
including state laws, tort litigation, and professional societies.
But as our focus here is largely on the question of whether there
is a need for federal action, we shall target our discussions at
the above four possibilities. Let us briefly describe each of these
in institutional terms.
(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
charged with monitoring and administering 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 given some leeway
in applying its charge to particular circumstances that might arise.
Its creation would therefore involve a delegation of regulatory
authority. This, for instance, is the idea behind the HFEA in Britain,
and also appears to be the direction of policy 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. Many issues involved in assisted
reproduction, embryo research and related fields are new and largely
unique, and might not fall naturally into the purview of any existing
government body or agency. Existing agencies, like the FDA, the
NIH, the CDC and others, were designed and have evolved to serve
different purposes, and authorizing them to oversee this field could
well do a disservice to the important concerns that emerge from
our review of the present state of affairs.
Such an agency would be granted some degree of latitude in making
judgments in particular cases, so that each controversy in this
emerging field did not become a legislative question, or result
in prolonged Congressional debate.
A new agency dedicated exclusively to the monitoring or regulation
of this arena might ensure that the proper concerns are addressed.
But the costs of such an agency, financial and otherwise, could
be quite great. 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 genetics, the practice of
medicine, private enterprise, reproductive freedoms, government
regulation, and scientific progress differ from those of the British.
The potential wisdom or utility of such an agency should be determined
in light of the tasks it would need to carry out. In purely institutional
terms, designing and establishing it would be an enormously 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 seem apparent. The Food and Drug
Administration, as discussed in our overview of the status quo,
already exercises some limited oversight over some elements of biotechnology
that involve the beginnings of human life, and its reach in this
arena might reasonably be expanded somewhat. In addition, the National
Institutes of Health, and several of its subsidiary institutions
(for example, the Recombinant DNA Advisory Committee), might also
be delegated some authority to monitor or even regulate some areas
of research and, to a limited extent, of clinical applications.
The Centers for Disease Control is already charged by statute with
the task of gathering and publishing data on Assisted Reproductive
Technologies, and its authority in this regard, and perhaps other
related ones, could be increased.
It may in principle be possible to delegate all or nearly all the
regulatory and oversight authority deemed appropriate in this field
to one of these (or other) federal agencies, or such authority might
be divided among several existing agencies.
There could be several advantages of delegating any new authority
to existing institutions. For one thing, it would circumvent the
need to create a new federal regulatory body, with its incumbent
costs, inefficiencies, and potential for future expansion. It is,
as a general rule of thumb, preferable to keep the bureaucracy as
small as is reasonably possible. A delegation of authority to an
existing agency could also be put into effect more quickly, as the
basic mechanisms for oversight and enforcement would probably already
exist, and the institutional resources for actions would not need
to be created from scratch. In addition, such a delegation might
integrate these areas of oversight and regulation into existing
patterns of regulatory activity, rather than, again, beginning with
a blank slate.
On the other hand, the delegation of oversight authority over biotechnology
that touches on the beginnings of human life to an existing federal
agency would mean that no institution would have this arena as its
prime or exclusive portfolio, and therefore that the questions and
concerns we have raised would not be quite anyone’s principal
business. In addition, the structure, authority, experience, and
expertise of existing federal agencies might not be quite appropriate
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 fall neatly into 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. They touch on these subjects, but should not be understood
primarily through lenses developed for viewing these subjects. 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
If the 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 stands 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,
and which must be considered with regard to each particular target
of potential oversight and regulation.
(C) Particular legislative action
The above two options assume some degree of delegation of authority
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 more broad and blunt instruments than the particular
case-by-case decisions of a regulatory agency, but they can also
speak with greater force, clarity, and legitimacy.
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 reform is the passage of laws that lay
down distinct and precise policy that does not require a great deal
of complex regulation, or much case-by-case judgment to enforce
it. The issues would be dealt with legislatively more than administratively.
Such policies might involve limitations or prohibitions, but they
might also involve means of support for certain technologies and
practices, or offers of funding that might then be made available
through existing funding agencies.
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. Its results might also be clearer
and starker, and thus easier to respect and enforce.
But proceeding by acts of Congress would also limit the potential
flexibility of oversight and legislation in this arena. It would
make black and white prohibitions more likely, and case-by-case
judgment more difficult. It would also, of course, be slow and arduous,
as efforts to legislate policy regarding human cloning and similar
subjects that touch on biotechnology have already demonstrated.
It may well be the appropriate means to achieve some potentially
desirable reforms, but its limits must be appreciated.
(D) Federal funding as a regulatory lever
A fourth institutional means for reform 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 the Congress can attach
requirements to funding, and compel all recipients to abide by certain
rules. Indeed, this is perhaps the primary 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, consent, and other issues.
The question of funding is, however, quite complex and controversial.
By offering funding for a practice, the government at least implicitly
expresses a note of support for the work, in deeming it worthy of
a share of taxpayer money. This becomes a problem when the work
in question is controversial, or 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. For
this reason, for instance, much of the work in the fields taken
up in this report—research that involves human embryos—has
never been supported with federal funds.
Of course, to refrain from offering funds is also a kind of policy
decision, and indeed an act of Congress that expressly forbids federal
funding of certain sorts of 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 reach and regulate
those activities it does not fund directly.
Federal funds, in one way or another, may therefore be used as
means of encouraging or opposing certain practices that are deemed
to call for some government policy, though of course there is no
necessary relationship between funding and regulation: the government
can and does regulate activities it does not fund.
2. Substantive Options
As we have already indicated, we are not now prepared to reach judgments
on the best form of general regulation, not only because much remains
unknown about the field, but also (and especially) because we must
decide what problems, if any, call out for government action, and
what sorts of actions, if any, may be best. Nevertheless, the findings
of our diagnostic inquiry identify several substantive areas of
ethical and social concern that may be of sufficient magnitude to
warrant a consideration of policy options currently available that
might address them. Once again, we present these options, and their
perceived strengths and weaknesses, without endorsing any of them.
The following, then, are some concerns that emerge from the findings
laid out in the accompanying staff working paper, and some suggestions
for possible ways of dealing with them. As will become apparent,
in some instances we have proposed a variety of possible options,
some of which may be contradictory. In many cases, we do not yet
have enough information to make a choice among the options (and
so the options include the gathering of information). In other cases,
there remain deep disagreements over matters of principle. 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:
The safety and well-being of children conceived through assisted
reproductive technologies seems to be the segment of this field
most urgently 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, mentioned in the diagnostic Discussion Document, it appears
to us that it has not received sufficient attention.
It would of course be unfair to say that no care at all is presently
taken for the well-being of children to be. But those steps that
are taken are very small indeed, and those rules that have been
set by professional societies tend to be vague and all too often
Several options for policy seem plausible in this arena:
(a) Improved annual monitoring of ART techniques and outcomes:
The federal government could gather and compile more copious
and specific data regarding techniques and outcomes in assisted
reproduction procedures. The mechanism for collecting such information
is already in place, through the Centers for Disease Control,
and could fairly easily be expanded or relocated as deemed necessary.
This information would provide more detailed data about what methods
and materials are used in assisted reproduction procedures, and
what effect these have on resulting outcomes.
(b) 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,
and of mothers who undergo the procedures. Such information is
presently available through relatively small-scale studies, mostly
carried out abroad. More and better information is essential before
further steps are decided upon.
(c) Improved/expanded informed consent: Among such further
steps, should they be deemed necessary, might be 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 occurrences of birth
defects and other problems, in proportion to the general population.
It might also seek to develop uniform consent procedures regarding
the disposition and fate of any unused embryos generated in the
(d) 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—was
introduced into regular clinical use with minimal animal experimentation
and 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, an industry group, or some combination.
(e) 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 make
that judgment and to enforce it. The institutional layout presented
above may provide some sense of the possible place and character
of that enforcement body, though the question would of course
be a controversial one. At present, we do not have sufficient
information about whether such a body might be required, and what
might be required of it, to proffer more specific suggestions.
(f) Expanded/publicly funded research with a view to improving
ART procedures: The safety, reliability, and efficacy of
ART procedures might 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
improve the reliability and effectiveness of existing techniques,
and more thoroughly assess new ones before they are brought into
practice, though of course the extent and the nature of research
that might be conducted or funded would likely be an issue of
(B) Implantation of Human Embryos into Human or Non-Human Wombs/Uteruses
for Biomedical Research:
At present, there are no laws or rules restricting or prohibiting
the transfer of human embryos into a womb for the purpose of developing
it purely for research. It is, in principle, possible to transfer
an embryo, allow it to develop for a certain time, and then abort
it for research purposes. It is also permissible, in principle,
to implant a human embryo into an animal uterus.
If this concern is deemed serious enough to require action, two
general options present themselves:
(a) Restrictions on embryo transfer for research: The
Congress might put into effect a ban or moratorium on the transfer
of human embryos to a womb 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.
(b) Time limit on embryo preservation: This concern
might also be addressed, as it is in the United Kingdom and elsewhere,
by prohibiting research on embryos older than a certain age.
(C) Equal/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 circumstance
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 be available.
The most commonly discussed are policies requiring insurance companies
to treat infertility as a medical condition like any other, and
to offer coverage for procedures. In most cases, proposed policies
suggest that funding might be afforded only under certain circumstances
(for instance, only for married couples, or for women of specified
ages) or that they be coupled with guidelines for practice (mandates
regarding efficiency of the procedure, number of embryos created
and implanted, etc.).
(D) Non-Disease Related Genetic Screening and Selection of Embryos:
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 fairly limited,
since the technical capacity to select for particular traits is
mostly undeveloped. Sex is essentially the only trait for which
routine selection is possible, along with histocompatibility for
subsequent tissue or organ donation. Selection for a prospective
child’s sex has already become quite a controversial subject,
and as further techniques for selection are developed, new controversies
are sure to emerge.
If some oversight or regulation of this area is needed, it may
take some or all of the following forms:
(a) Increased monitoring: Regulation might begin with
increased monitoring, to develop a clearer sense of the uses to
which embryo screening and selection is being put, and the degree
and frequency of use. These basic data are for the moment difficult
to come by, and we may not have the kind of understanding of the
status quo that might be required to make further judgments regarding
(b) Review mechanisms: Beyond monitoring, the Congress
may establish new or improved mechanisms for reviewing non-disease
related uses of screening and selection, setting a higher than
usual bar for such techniques to pass before they may be 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 child that results from the process, there
may be a powerful case for such increased standards of scrutiny
(c) 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 complicated, since it would require a
fairly clear delineation of what are and are not disease characteristics,
and it would also carry great costs (including potentially increasing
the number of abortions). But policymakers may deem it sufficiently
The various options along this continuum are not mutually exclusive,
though given our fundamental lack of data regarding the volume and
popularity of such practices, and given the fact that most such
practices are projected and not present, it may be wise to begin
with monitoring and data collection, to inform further decision
making in the future.
(E) Intentional Germ-line Modification of Embryos/Gametes:
Presently, 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
Given the fairly broad agreement in the country and the Congress
that germ-line modification should not now be attempted, it may
be advisable to institute, by statute, a national moratorium on
germ-line modification to produce children, potentially including
particular sorts of:
(a) Ooplasm transfer
(b) Insertion of foreign human genetic material to gametes or
embryos with a view to fertilization or implantation to produce
(c) Insertion of animal genes or genetic material into gametes
or embryos with a view to fertilization or implantation to produce
(d) Insertion of artificial genes or genetic material with a view
to fertilization or implantation to produce children.
(F) Commodification of Nascent Human Life/Human Procreation:
The commodification of human procreation 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.
The potential patenting of human embryos is also a concern: the
U.S. Patent and Trademark Office refuses to grant such patents as
a matter of institutional policy, but the policy would likely not
hold up in court without specific statutory backing.
Possible policies in this arena include:
(a) Limits or restrictions on the buying and selling of gametes:
If trade in human gametes is a concern, the government could set
certain limits, potentially including a ceiling on the price of
eggs, limits on advertising for or by gamete donors, or perhaps
even a restriction on the selling of gametes altogether.
(b) Limits or restrictions on the trade in embryos:
Similarly, the Congress, or state governments, might set limits
on the buying and selling of human embryos, whether for research
(c) Prohibition on the patenting of embryos: In addition,
Congress could pass a clear restriction on the patenting of human
embryos, or human organisms at any stage of development, to support
the existing (but uncertainly grounded) PTO policy on the subject.
(G) Biomedical Research Involving the Destruction of Early-Stage
Embryo research is certainly among the most controversial of the
practices we have discussed, and the most politically sensitive,
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, meanwhile, worry that regulations
founded in concerns about embryonic human life would set a precedent
that might have implications for abortion politics or scientific
The result has been essentially no regulation, though also almost
no federal funding, of embryo research. All embryo research (including
research on embryos left over from IVF procedures, embryos created
by IVF solely for research, and potentially also cloned embryos
and parthenotes) is legal in the private sector, and if it is regulated
at all, it is so only by IRBs, which generally do not have special
rules for research involving human embryos used for research purposes.
We have only very limited knowledge of the numbers, uses, and commercial
applications of embryo research in private sector.
In the public sector, funding of research that involves the destruction
of human embryos is prohibited by law, though a certain loophole
in the law, combined with a policy decision by the president, has
allowed for the funding of research using 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 destroyed on or before the 9th of August 2001.
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 funding of such work.
Should a national policy be deemed necessary, several options
(a) Expanded Restrictions: The Congress might choose
to impose new restrictions on embryo research, perhaps restricting
embryo research exclusively to left-over IVF embryos (either all
such embryos, present and future, or those left-over embryos that
currently exist); banning the production of embryos (or just the
cloning of embryos) solely for research purposes; allowing research
only on existing stem cell lines, following the logic of the Bush
decision; or even banning all future embryo destruction for biomedical
(b) Expanded Funding: Conversely, the Congress might
choose to relax existing restrictions, and offer more funding
for embryo research. Along these lines, the federal government
might choose to be open to funding all embryo research, including
the creation of embryos (IVF or cloned) solely for research purposes;
fund embryo research only on embryos originally created for reproductive
purposes through IVF; or fund research on all existing stem cell
(c) Expanded Regulation/Explicit Public Permission Under
Certain Guidelines: The Congress might also break the silence
on embryo research by explicitly permitting but regulating such
work. 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 that will be used for research to be
registered and the purpose of its use described and recorded.
This option might also be combined with the previous ones, so
that, for example, the federal government might fund research
on all existing embryonic stem cell lines while prohibiting future
embryo destruction for research, or fund research on all embryos
(IVF or cloned) with extensive regulation, licensing, and approval
requirements. It is important to note, however, that there is
not a necessary connection between funding and regulation. The
government can regulate activities that it does not fund—as
is the case with workplace safety regulations, and rules governing
air travel, telecommunication, broadcasting, banking, and numerous
At present, given the limited availability of data, we are not in
a position to recommend or to reject most of the options described
in these pages, either regarding general institutional reform 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, while others may turn
out to be unwarranted or unwise as the nation learns more about
the field, and yet others may prove to be desirable and useful.
No overarching policy direction in this arena could or should be
set before substantially more and better information is gathered,
and before all interested parties are thoroughly consulted as potential
policy directions become apparent.
There may, however, be some interim steps that could be advisable
while the process of contemplating potential policies progresses.
These could involve both essential information gathering and potentially
some modest policy reforms that may be deemed appropriate on the
basis of the information we already possess and the findings of
our preliminary inquiry.
1. It is worth noting 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
black and white prohibitions, but to a broad range of potential
actions that might be undertaken to facilitate, protect, oversee,
restrain, or restrict a given activity. A government's regulatory
stance may range from promoting (through funding), permitting without
restriction, tolerating or permitting within enforceable limits,
discouragement (through withholding funding), and prohibition. And
particular regulatory policies may range from information gathering
and reporting, to monitoring, to oversight, to setting hortatory
guidelines, to providing rules and regulations under penalty for
violation, among others.