Reproduction and Responsibility:
The Regulation of New Biotechnologies
The President's Council on Bioethics
Washington, D.C.
March 2004 www.bioethics.gov
Chapter Ten Recommendations
Over the past two years, the Council has devoted much time
and energy to examining the current oversight and regulation
of the uses of biotechnologies that touch the beginnings of
human life-practices arising at the intersection of assisted
reproduction, genetic screening, and human embryo research.
The Council has heard from various experts and stakeholders,
engaged in its own diagnostic review of current regulatory
mechanisms and institutions, outlined the key findings emerging
from that review, and surveyed various general and specific
policy options. As the previous chapters indicate, the Council
now understands a great deal about today's regulatory landscape
and has identified concerns that suggest the need for improved
monitoring and oversight and, perhaps, new forms of governmental
regulation. Yet we are very far from being able to offer clear
and well-considered recommendations regarding major institutional
reforms. We do not know the precise costs and benefits of
overhauling existing regulatory institutions and practices
or of creating new regulatory authorities. We do not even
know enough about the incidence and severity of some of the
possible risks and harms that we have identified as causes
of concern to decide whether they are serious enough to justify
changing the present arrangements. We do not accurately know,
for example, how the technologies and practices at the heart
of our inquiry affect the health of those whose lives are
touched by them-most notably, the children conceived with
their aid. Similarly, we do not know how widely preimplantation
genetic diagnosis or preconception (and preimplantation) sex
selection will be practiced, and for which purposes. Without
the answers to such questions, it would be premature at best
to recommend dramatic legal or institutional changes. Further
research and inquiry, and additional consultations with all
those affected, are clearly needed.
Yet even as such inquiry and consultation proceed, the Council
believes that some modifications can and should now be implemented
to address some of the concerns identified by the present
inquiry. The recommendations we offer fall into three general
categories: studies and data collection, oversight and self-regulation
by professional societies, and targeted legislative measures.
In Sections I and II of this chapter, the Council proposes
several measures it believes the federal government and the
various relevant professional societies should adopt immediately.
Most of these suggestions are aimed precisely at addressing
the remaining empirical questions described above. These include
a call for comprehensive information gathering, data collection,
monitoring, and reporting of the uses and effects of these
technologies. They also address the needs for increased consumer
protection, improved informed decision-making, and more conscientious
enforcement of existing guidelines for practitioners of assisted
reproductive technologies (ARTs).
In Section III of this chapter, we identify several matters
that may warrant prudent interim legislative action, especially
in light of rapidly emerging innovations that signal new departures
in human reproduction. Familiar disquiet regarding human cloning
or commerce in human embryos and gametes is augmented by recent
reports of, for example, fusion of male and female embryos
into one chimeric organism and of the derivation of gametes
(in animals) from embryonic stem cells (in principle enabling
embryos to become biological parents). Accordingly, while
policymakers monitor and gather information and while deliberation
continues about the need for better and more permanent monitoring
and oversight arrangements, it may be necessary and desirable
to enact a legislative moratorium on a few boundary-crossing
practices, thereby providing interim prophylactic limitations.
Such limitations would prevent the introduction of certain
significant innovations into human procreation in the absence
of full public discussion and deliberation about their ethical
and social implications and consequences.
In offering these interim recommendations for improvements
in data collection, monitoring, and professional self-regulation
and in proposing limits and restraints on some potential applications
of ARTs, the Council does not intend to challenge the current
practices or impugn the ethical standards of most practitioners
of assisted reproduction. The Council recognizes the efforts
of professionals and patient groups working in this field
to devise and implement appropriate ethical guidelines and
standards of care. Yet we have identified areas of concern
that have not been sufficiently studied or addressed. And
there are at present no effective mechanisms for monitoring
or regulating some of the more problematic practices or for
preventing unwelcome innovations introduced by irresponsible
practitioners. Indeed, it is our belief that responsible professional
participants, patients, policymakers, and interested citizens
should be able to recognize the merit of our proposals and
work to see them implemented.
The recommendations we offer here are recommendations of
the Council as a whole. Though we differ about certain fundamental
ethical questions in this field, and especially about the
moral standing of human embryos, we have nevertheless been
able to agree on several policy suggestions that we believe
should command not only the respect but also the assent of
most people of common sense, good will, and a public-spirited
concern for human freedom and dignity. These recommendations
emerge quite naturally from the diagnostic survey and analysis
presented in the previous chapters, and they are best understood
only when read in that context. We have sought to frame the
recommendations with sufficient specificity that they might
be adopted by the relevant target audiences.
I. FEDERAL STUDIES, DATA
COLLECTION, REPORTING, AND MONITORING REGARDING THE USES AND
EFFECTS OF THESE TECHNOLOGIES
A. Undertake a Federally Funded Longitudinal
Study of the Impact of ARTs on the Health and Development
of Children Born with Their Aid
A most important unanswered question before the Council
concerns the precise effects of ART and adjunct technologies
on the health and normal development of children who are now
being born or who will in the future be born with their aid.
There have been a few studies, mostly undertaken abroad, reaching
different and sometimes contradictory results. An effort has
been undertaken, by the Genetics and Public Policy Center
at the Johns Hopkins University, in collaboration with the
American Academy of Pediatrics (AAP) and the American Society
for Reproductive Medicine (ASRM), to review all of the existing
literature on this question. This retrospective study is a
laudable start, capable of identifying harmful health and
development outcomes that should be monitored in the future.
The Council strongly believes, however, that what is needed
now is a prospective longitudinal study-national, comprehensive,
and federally funded-that looks at both the short-term and
the long-term effects of these technologies and practices
on the health of children produced with their assistance,
including any cognitive, developmental, or physical impairments.
Such a study would require an adequate control sample, and
a sufficiently large population of subjects to yield meaningful
statistical results. Participation in such a study would,
of course, be voluntary.
A seemingly ideal vehicle for this study is the National
Children's Study (NCS) now being planned by a consortium of
federal agencies led by the National Institute of Child Health
and Human Development (NICHD). This study, which (if funded)
is scheduled to begin in 2005, would track the health and
development of 100,000 children across the United States from
before birth until age 21. Given its great demographic, temporal,
and substantive scope, the NCS would be uniquely suited to
studying the health of children conceived with the aid of
ART. It would be national in scope, it would not require the
special recruitment of a population of children conceived
with the aid of ART, and all participation would be voluntary.
Correcting a major defect in other studies of the impact of
ART, the NCS would have a built-in control sample, namely,
children conceived without the aid of ART. It would allow
researchers to observe and consider health impacts that reveal
themselves only years after birth. It would analyze an exceptionally
wide range of biological, physical, social, cultural, and
other factors that may significantly influence a child's health
and development. The NCS would have enormous resources at
its disposal, as it would be undertaken by a partnership of
federal, state, and local agencies; universities; academic
and professional societies; medical centers; communities;
industries; companies; and other private groups. Finally,
the NCS would release its results as the study progresses;
thus, it would not be necessary to wait until 2025 to review
the information gathered. The study would publicize results
as the children reached certain developmental milestones.
In short, the NCS would offer an unprecedented and perhaps
unrepeatable opportunity to answer questions relating to the
well-being of children conceived with the aid of ART.
Should the planned NCS not go forward for any reason (or
should it not include a suitable or statistically significant
study of children conceived using ARTs), the Council recommends
that an independent federally funded longitudinal study be
undertaken on the health and development of children who are
born with the aid of ARTs.
B. Undertake Federally Funded Studies
on the Impact of ARTs on the Health and Well-Being of Women
Another area where better information is needed regards
the health and well-being of women who use ARTs and of women
who donate their eggs for the use of others. One or more studies,
either in conjunction with or separate from the above-mentioned
longitudinal study, should be conducted to discover the effects,
if any, of the use of ARTs on women's health, including any
short-term or long-term hormonal, physical, or psychological
impairments. Participation in such a study would, of course,
be voluntary.
C. Undertake Federally Funded Comprehensive
Studies on the Uses of Reproductive Genetic Technologies,
and on Their Effects on Children Born with Their Aid
As noted above, assisted reproduction and genomic knowledge
are increasingly converging with one another. Practices such
as preimplantation genetic diagnosis (PGD) and gamete sorting
represent the first fusion of these disciplines. Before these
practices become routine, it is desirable that policymakers
and the public understand their present and projected uses
and effects. To this end, there should be federally funded
comprehensive studies, undertaken ideally with the full participation
of ART practitioners and their professional associations,
on how and to what extent such practices are currently and
may soon be employed, and their effects on the health of children
born with their aid. Mechanisms need to be developed for ongoing
monitoring of the outcomes of these practices and other practices
to which they may lead. Participation in any such studies
would, of course, be voluntary.
D. Strengthen and Augment the Fertility
Clinic Success Rate and Certification Act
As currently written, the Fertility Clinic Success Rate
and Certification Act (FCSRCA) is aimed at providing consumers
with key information about the pregnancy and live-birth success
rates of assisted reproduction clinics in the United States.
We believe that the Act should be augmented and strengthened,
both to improve this original function of consumer protection
and to allow for better public oversight (through the already
existing ART surveillance program at the Centers for Disease
Control [CDC]) of the development, uses, and effects of reproductive
technologies and practices. Toward these ends, the Act, or
the regulations propounded pursuant to it, or both, should
be improved and strengthened in the following ways.
1. Enhance Reporting Requirements.
a. Efficacy. Provide more user-friendly reporting of
data, including adding "patients" as an additional unit of
measure. Currently, data are reported only in terms of
"cycles" of treatment (beginning when a woman starts ovarian
stimulation or monitoring), rather than in terms of individual
patients treated. Thus, it is impossible to know how many
individuals undergo assisted reproduction procedures in a
given year, how many patients achieve success in the first
(or second or third) cycle, how many women fail to conceive,
and the like. Presenting results in terms of "numbers of individuals"
(in addition to "numbers of cycles") would be very helpful
to prospective patients and would yield more precise information
for policymakers.i
Also, this information should be presented with any qualifying
language or additional information that would help to avoid
confusion for prospective patients or the public.ii
b. Risks and side effects. Require the publication of
all reported adverse health effects. Adequate consumer
protection requires informing prospective users of the known
hazards connected with the services or products they are using.
Yet there is today no mechanism for the publication of information
regarding adverse effects of ARTs, either on the health of
adult patients or on that of their children. At the present
time, the CDC does collect data on complications and adverse
outcomes of pregnancy, including low birthweight and birth
defects for each live born and stillborn infant, but this
information is not made public. Knowledge of such adverse
effects is of paramount concern for prospective patients,
policymakers, and the public at large. The CDC should publish
its data on the incidence of adverse effects on women undergoing
treatment, as well as on the health and development of children
born with the aid of ART. In order not to confuse or unduly
alarm prospective patients or the public, the CDC should include
in its publication comparative data on the incidence of such
effects in unassisted births, as well as any other relevant
information that could help prevent misimpressions regarding
the nature and magnitude of the hazards associated with ART.
c. Costs to the patients. Require the reporting
and publication of the average prices of the procedures and
the average cost (to patients) of a successful assisted pregnancy.
There is currently no comprehensive source of information
regarding the costs borne by the patients seeking treatment
involving assisted reproductive technologies. Not surprisingly,
prospective patients are keenly interested in this information.
Moreover, policymakers interested in questions regarding equality
of access, insurance coverage, and related matters would greatly
benefit from such information. It would also shed light on
whether incentives currently exist that may induce patients
and clinicians to engage in potentially risky behavior, such
as the transfer of multiple embryos in each cycle, in an effort
to reduce costs (especially in those places where in vitro
fertilization (IVF) is not covered by insurance). While the
publication of such information may cause some confusion or,
worse, may create a perverse incentive to cut costs at the
expense of health and safety, the Council believes that the
consumer benefits of providing such information outweigh such
speculative harms. This is especially true if this information
about costs to the patient is published alongside the information,
recommended above, regarding patient health and safety.
d. Innovative techniques. Include information on novel
and experimental procedures. A key area of concern for
the Council is the ease and speed with which experimental
technologies and procedures (such as intracytoplasmic sperm
injection [ICSI] or PGD) move into clinical practice, even
in the absence of careful clinical trials regarding their
efficacy and their long-term effects on children born with
their use. It would be useful for consumers and policymakers
to understand more fully how each clinic manages the process
of introducing new technologies and practices and what safeguards
are employed. Such information would include the human subjects
protections in place; the extent to which technologies are
first tested in animals; the standards that must be satisfied
before a given procedure is deemed fit for clinical use; and
the measures taken to evaluate safety and efficacy.
e. Adjunct technologies. Require more specific
reporting and publication of the frequency of, and reasons
for, uses of specialized techniques such as ICSI, PGD, and
sperm sorting for sex selection. Little is understood
about the frequency and uses of the various adjunct technologies
and practices complementing standard IVF. Under the present
system, the CDC already collects and reports information relating
to the incidence and uses of some adjunct technologies.iii
The present approach could be greatly improved, however, by
modestly changing the relevant law to require information
on additional adjunct procedures (particularly those that
combine assisted reproduction with human genetic technologies),
as well as to require the reporting and publication of somewhat
more detailed information relating to the reasons patients
elect to use those procedures that are already subject to
reporting requirements. For example, the present system of
reporting sheds little light on precisely why patients
chose ICSI as their preferred method of fertilization. Also,
because results are reported in terms of cycles rather than
patients (as discussed above), it is impossible to know how
many individuals used ICSI.
Other techniques, particularly those fusing reproductive
technology and genomic knowledge, are not reported at all
under the present version of the Act. There is no requirement
to report the number of cycles using PGD, much less the reasons
for using PGD. For example, how many patients using PGD are
infertile? How many have family histories of genetic disorders?
What sort of genetic screening is being done? For aneuploidy
and single-gene mutations? For donor siblings? For non-disease-related
traits? There is also no reporting of any practices in which
sex selection occurs or of the reasons for undertaking them.
Consumer protection and public policy would be enhanced if
this information were available and published. Consumers would
benefit from knowing how much experience a given clinic has
in performing such procedures. The public would benefit from
knowing how, why, and to what effect genomic knowledge is
being used in human reproduction.
2. Enhance Patient Protections: Informed
Decision-Making.
a. Provide model forms for decision-making.
The present Act would be greatly improved by providing for
the promulgation of easy-to-read model consent forms that
include information on the possible health risks to mother
and child, the novelty of the various procedures used, the
number of procedures performed to date, the outcomes, and
the various safeguards in place to ensure that such procedures
are safe and effective.
3. Improve Implementation.
Enforcement. Provide stronger penalties to enhance compliance
with the Act's reporting requirements. Under the Act as
currently written the only penalty for noncompliance is the
publication of the names of nonreporting clinics. This is
insufficient, given the importance of clinic compliance to
ART consumers and the greater public. The penalties should
reflect the magnitude of harms to be avoided. We leave to
legislators the question of what precisely these should be.
b.Funding. Increase funding for implementation
of the Act. CDC's budget should be augmented sufficiently
to enable it to undertake the additional measures suggested
above. In this way, the increased oversight called for will
be borne by the government rather than by the individual patient.
We leave to legislators the question of how much additional
funding would be required.
II. INCREASED OVERSIGHT BY PROFESSIONAL
SOCIETIES AND PRACTITIONERS
Professional oversight has traditionally been the principal
mechanism of regulation for the practice of medicine, and
the practice of reproductive medicine is no exception. There
is a well-developed body of professional guidelines and standards
for the clinical practice of assisted reproduction, and as
far as the Council can determine (in the absence of a more
comprehensive investigation of physicians' actual conduct),
the vast majority of practitioners abide by these guidelines
and standards and are dedicated to the welfare of their patients.
Yet the Council has identified the following substantive areas
that it believes require attention and improvement:
A. Strengthen Informed Patient Decision-Making
Clinicians and their professional societies should make
efforts to improve the current system of informed decision-making
by patients to conform to the concerns and suggestions described
above. ASRM and SART (the Society for Assisted Reproductive
Technology) should pay attention not only to helping devise
improved consent forms, but also to recommending procedures
to their members for discussing the subject properly with
patients and for securing their meaningful consent. For this
purpose, they should consider making training sessions on
this subject a requirement of membership.
B. Treat the Child Born with the
Aid of Assisted Reproductive Procedures as a Patient
ART clinicians should take additional measures to ensure
the health and safety of all participants in the ART process,
including the children who are born as a result. Thus,
in making decisions and undertaking clinical interventions,
such practitioners should carefully consider how these actions
will affect the health and well-being of these children. We
recognize, of course, that health care services tend in general
to be disaggregated among different specialties, and that
collaboration is not always feasible. In the domain of assisted
reproduction, once pregnancy has been achieved, the prenatal
care of the pregnant woman is transferred to her obstetrician.
But the Council urges clinicians and professional societies
to seek out ways to improve the continuity of the services
offered to their patients and their children. ART clinicians
and their professional societies should consult with pediatricians
(and their professional societies) to learn how their practices
may be affecting the health and safety of the children born
as a result. Clinicians and professional societies should
also cooperate fully and vigorously with any efforts (such
as the studies described in Section I of this chapter) to
ascertain the effects of ART and related practices on the
health and development of such children. In addition, the
Council strongly endorses a specific substantive recommendation:
clinicians and professional societies should take additional
concrete steps to reduce the incidence of multiple embryo
transfers and resulting multiple births, a known source
of high risk and discernible harm to the resulting children.
C. Improve Enforcement of Existing
Guidelines
There are today a host of reasonable guidelines in place
for clinicians and practitioners engaged in ART, and, to repeat,
they are apparently followed by most practitioners. However,
the relevant professional societies need to take stronger
steps to ensure that these guidelines are followed. For example,
one such professional society "actively discourages" the use
of PGD for sex selection for nonmedical purposes, yet several
prominent members of that society openly advertise the practice.
Professional societies must clarify the contours of appropriate
conduct and adopt reasonable mechanisms of enforcement.
D. Improve Procedures for Movement
of Experimental Procedures into
Clinical Practice
Professional societies and clinicians should develop a more
systematic mechanism for reviewing experimental procedures
before they become part of standard clinical practice. Such
a system might include requirements for animal studies, institutional
review board (IRB) oversight, and formal discussion and ongoing
(and prospective) monitoring of the significance and results
of novel procedures.
E. Create and Enforce
Minimum Uniform Standards for the Protection of Human Subjects
Affected by Assisted Reproduction
At present there is no systematic, mandatory mechanism for
protecting human subjects who are engaged in experimental
ART protocols not affiliated with institutions receiving federal
funds. This problem is compounded by the fact that in the
practice of assisted reproduction (as in the practice of medicine
more generally), there is not a clear distinction between
research and innovative clinical practice. Investigational
interventions that could affect the health and well-being
of children born with the aid of ART should be subjected to
at least as much ethical scrutiny and regulatory oversight
as investigational interventions affecting other human subjects
of research. Current research policies establish special protections
for children and fetuses in research. For similar reasons,
there is a need for special protections when research involves
interventions in embryos that could later affect the health
and welfare of the resulting live-born children. Clinicians
and their professional societies should adopt measures (such
as IRB-like oversight) to provide necessary safeguards.
F. Develop Additional Self-Imposed
Ethical Boundaries
Clinicians and professional societies would be well-advised
to establish for themselves additional clear boundaries defining
what is and what is not ethically appropriate conduct, regarding
both research and clinical practice. Without such guidance,
irresponsible clinicians and scientists may engage in practices
that will, fairly or unfairly, bring opprobrium on the discipline
as a whole. Practices such as, among others, the fusion of
male and female embryos, the use of gametes harvested from
fetuses (or produced from stem cells) to create embryos, and
the transfer of human embryos to nonhuman uteri for purposes
of research fall squarely into this category. The relevant
professional societies should preemptively take a firm stand
against such practices and back that stand up with meaningful
enforcement.
III. TARGETED LEGISLATIVE MEASURES
In the course of our review, discussion, and findings, we
have encountered and highlighted several particular practices
and techniques (some already in use, others likely to be tried
in the foreseeable future) touching human procreation that
raise new and distinctive challenges. Given the importance
of the matter, we believe these practices and techniques require
special attention, not only from professional societies but
also from the people's representatives. Especially because
technological innovations are coming quickly and because there
are today no other public institutions charged with setting
appropriate limits, we believe Congress should consider some
limited targeted measures-bundled together perhaps as a "Reproduction
and Responsibility Act"-that might erect boundaries against
certain particularly questionable practices.iv
These measures, proposed as moratoria, would remain operative
at least until policymakers and the public can discuss the
possible impact and human significance of these new possibilities
and deliberate about how they should be governed or regulated.
The benefits of such congressional legislation, as we see
it, are multiple:
(a) It could help educate the public about the transformative
character of some new reproductive biotechnologies; and
it could enhance public awareness of the need for research
and practice in this area to be guided by respect for the
women using assisted reproduction and for the children born
with its aid (on which see below).
(b) It would institute a temporary moratorium on certain
practices, imposing a few carefully defined boundaries on
what may be done and preventing any individual from committing
acts that could radically alter what the community regards
as acceptable in human reproduction without prior public
discussion and debate.
(c) If carefully drafted, it would not interfere with
important scientific research. On the contrary, it could
serve to protect the reputation of honorable scientists
and practitioners of assisted reproduction against the mischief
done by "rogues," whose misconduct might invite harsh and
crippling legislative responses.
(d) Practically, it would place the burden of persuasion
on those innovators who are inclined to transgress these
important boundaries without adequate prior public discussion
or due regard for social or moral norms.
(e) It would show that there is a way forward for continuing
public oversight in these areas, and it would demonstrate
that scientists and humanists, physicians and laymen, liberals
and conservatives, "pro-lifers" and "pro-choicers," can
find certain shared core values that they are willing to
defend collectively and by deliberate agreement.
Legislative interest in responsible reproductive practices
might give rise to a fairly wide range of specific provisions,
and Congress should consider these in their full array. But
the concerns we have taken up in this report, and which emerge
from our findings, suggest to us a few that are especially
crucial, and also especially likely to command fairly broad
assent. They may be usefully grouped under four principles
or desiderata, each pointing to one or two particular provisions
that we believe to be in order and that we now recommendv:
A. Preserving a Reasonable Boundary
between the Human and the Nonhuman (or, between the Human
and the Animal) in Human Procreation
The question of the human-animal boundary in general can,
in some respects, be quite complex and subtle, and the "mixing"
of human and animal tissues and materials is not, in the Council's
view, by itself objectionable. In the context of therapy
and preventive medicine, we accept the transplantation
of animal organs or their parts to replace defective human
ones; and we welcome the use of vaccines and drugs produced
from animals. Looking to the future, we do not see any overriding
objection to the insertion of animal-derived genes or cells
into a human body-or even into human fetuses-where the aim
would be to treat or prevent a dread disease in the patient
or the developing child (although issues would remain about
indirect genetic modification of egg and sperm that could
adversely affect future generations). Likewise in the context
of biomedical research, we now see nothing objectionable
in the practice of inserting human stem cells into animals-though
we admit that this is a scientifically and morally complicated
matter. But in thecontext of procreation-of actually
mixing human and nonhuman gametes or blastomeres at the very
earliest stages of biological development-we believe that
the ethical concerns raised by violating that boundary are
especially acute, and at the same time that the prospects
for drawing clear lines limiting permissible research are
especially favorable. One bright line should be drawn at the
creation of animal-human hybrid embryos, produced ex vivo
by fertilization of human egg by animal (for example, chimpanzee)
sperm (or the reverse): we do not wish to have to judge the
humanity or moral worth of such an ambiguous hybrid entity
(for example, a "humanzee," the analog of the mule); we do
not want a possibly human being to have other than human progenitors.
A second bright line would be at the insertion of ex vivo
human embryos into the bodies of animals: an ex vivo human
embryo entering a uterus belongs only in a human
uterus. If these lines should be crossed, it should only be
after clear public deliberation and assent, not by the private
decision of some adventurous or renegade researchers. We therefore
recommend that Congress should:
- Prohibit the transfer, for any purpose, of any
human embryo into the body of any member of a nonhuman species;
and
- Prohibit the production of a hybrid human-animal embryo
by fertilization of human egg by animal sperm or of animal
egg by human sperm.vi
B. Respect for Women and Human Pregnancy,
Preventing Certain Exploitative and Degrading Practices
Respect for women with regard to assisted reproduction encompasses
many things, including respect for their health, autonomy,
and privacy; these are by and large properly attended to in
current assisted-reproduction practices. But in the face of
some new technological possibilities, we recognize that respect
for women also involves respecting their bodily integrity.
A number of animal experiments using assisted reproductive
technologies have shown the value of initiating pregnancies
solely for the purpose of research on embryonic and fetal
development or for the purpose of securing tissues or organs
for transplantation. We generally do not object to such procedures
being performed on other animals, but we do not believe they
should, under any circumstances, be undertaken with humans,
or that human pregnancy should be initiated using assisted
reproductive technologies for any purpose other than to seek
the birth of a child. A woman and her uterus should not be
regarded or used as a piece of laboratory equipment, as an
"incubator" for growing research materials, or as a "field"
for growing and harvesting body parts. We therefore recommend
that, in an effort to express our society's profound regard
for human pregnancy and pregnant women, Congress should:
- Prohibit the transfer of a human embryo (produced
ex vivo) to a woman's uterus for any purpose other than
to attempt to produce a live-born child.
C. Respect for Children Conceived
with the Aid of Assisted Reproductive Technologies, Securing
for Them the Same Rights and Human Attachments Naturally Available
to Children Conceived In Vivo
We believe that children conceived with the aid of ARTs
deserve to be treated like all other children and to be afforded
the same opportunities, benefits, and human attachments available
to children conceived without such assistance. If some care
is taken, this can surely be accomplished, as it largely has
been for twenty-five years with IVF as ordinarily practiced.
But as we have seen, certain applications of embryo manipulation
and assisted reproductive techniques could deny to children
born with their aid a full and equal share in our common human
origins, for instance by denying them the direct biological
connection to two human genetic parents or by giving
them a fetal or embryonic progenitor. We believe that such
departures and inequities in human origins should not be inflicted
on any child. We therefore recommend that, in an effort to
secure for children who are born with the help of ARTs the
same rights and human attachments naturally available to children
conceived in vivo, Congress should:
- Prohibit attempts to conceive a child by any
means other than the union of egg and sperm.vii
- Prohibit attempts to conceive a child by using
gametes obtained from a human fetus or derived from human
embryonic stem cells.vii
- Prohibit attempts to conceive a child by fusing
blastomeres from two or more embryos.vii
D. Setting Some Agreed-Upon Boundaries
on How Embryos May Be Used and Treated
What degree of respect is owed to early human embryos will
almost certainly continue to arouse great controversy, as
it does among members of this Council. But we all agree that
human embryos deserve, as we have said, "(at least) special
respect." Accordingly, we believe some measures setting upper
age limits on the use of embryos in research and limits on
commerce in human embryos may be agreeable to all parties
to the ongoing dispute over the moral status of human embryos.
Along these lines, we believe that Congress should:
- Prohibit the use of human embryos in research
beyond a designated stage in their development (between
10 and 14 days after fertilization);viii
and
- Prohibit the buying and selling of
human embryos.ix
Furthermore, these concerns about commerce in the domain
of human reproduction suggest to us the need for legislation
instructing the United States Patent and Trademark Office
not to issue patents on claims directed to or encompassing
human embryos or fetuses at any stage of development;
and amending Title 35, United States Code, section 271(g)
(which extends patent protections to products resulting from
a patented process) to exclude these items from patentability.
The language of any such statute would in our view need to
take some care not to exclude from patentability the processes
that result in these items, but only the products themselves.
Similar language has been included in a component of the federal
budget for fiscal year 2004 (the Consolidated Appropriations
Act of 2004, H.R. 2673, 108th Congress [January
23, 2004], Division B, ยง 634), but we believe this provision
should also be made a clear and permanent element of the patent
law.
These recommendations indicate the kinds of specific measures
that could give concrete expression to widely shared goals
and that might serve as safe interim boundaries, as public
deliberation tries to catch up with rapidly changing technologies.
We do not presume here to make detailed suggestions regarding
specific legislative language or the assignment of penalties,
as Congress, should it choose to take up these recommendations,
would most appropriately determine these in accordance with
its usual procedures. Also, of course, these are by no means
the only possible legislative measures Congress might take
up to limit practices that put at risk important shared public
values. But we offer these recommendations for what in our
view are reasonable and moderate measures, which could do
genuine good and which might command relatively broad assent
across the usual spectrum of opinion on these subjects.
_________________
Footnotes
i.
The Council is not calling for the abandonment of "cycles"
as a unit of measure. Rather, we urge the inclusion of "patients"
as an additional unit of measure.
ii.
The CDC collects but does not publish information regarding
ART patients' prior attempts to conceive using assisted
reproduction. This information might prove useful in helping
the CDC to analyze and present information on a per-patient
basis in a way that does not distort success rates and the
like.
iii.
For example, the CDC publishes information on the percentage
of IVF cycles involving ICSI (49.4 percent in 2001); the
CDC also reports the percentage of the cycles using ICSI
that involve patients with male factor infertility (57.8
percent in 2001).
iv.
The listing (below) of these activities should not be taken
to imply that we believe that the reputable practitioners
of assisted reproduction are interested in engaging in them.
Our goal is rather to establish boundaries and guidelines
for future practice, and barriers against those irresponsible
practitioners who, indifferent to the standards of the profession
and the community, might not only endanger patients and
the public, but also unfairly cast a pall over the entire
field.
v.
The particular provisions that follow below (in boldface
type) have been carefully drafted, with a view to specifying
accurately the Council's concerns. Yet they are to be read
not as precise legislative provisions but as articulations
of possible boundaries that we would like to see erected
and defended.
vi.
It bears noting that, in testing for male-factor infertility,
practitioners of assisted reproduction now use hamster eggs
to test the capacity of human sperm to penetrate an egg;
yet there is no intent to produce a human-animal hybrid
embryo and there is a negligible likelihood that one might
be formed, given the wide gap between the species. Thus,
we do not believe that such procedures run afoul of the
letter or spirit of the above recommendations.
vii.
Operationally, in each of the three cases listed, the prohibited
act comprises the creation ex vivo of any such human embryo
with the intent to transfer it to a woman's body
to initiate a pregnancy.
viii.
Some members of the Council are opposed to any experimentation
that harms or destroys human embryos, but, recognizing that
it is legal and active, they see the value in limiting the
practice. Other members of the Council favor allowing such
experimentation during the early stages of embryonic development,
but nonetheless recognize the need to establish an upper
age limit beyond which such research should not proceed.
Some Council members believe that this upper limit should
be 14 days after the first cell division; others favor 10
(or fewer). This recommendation should not be construed
as silently endorsing (or opposing) embryo research at earlier
stages.
ix.
This provision is not intended to preclude those patients
who receive donated embryos from reimbursing donors for reasonable
expenses, storage costs, and the like. Also, because the compensated
giving of sperm is a long-established practice, and because
payment to egg donors is now also fairly common, efforts to
ban payment to gamete providers would likely prove controversial
and untenable for purposes of actual legislation. Thus,
we decline to recommend such a ban here. That is not to say,
however, that the Council approves of the buying and selling
of gametes. Indeed, many Council members have raised serious
concerns regarding this species of commercialization in the
domain of human reproduction.
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