Three months following the release of that report, the Council decided
to undertake a thoroughgoing inquiry into the current regulation
of those biotechnologies that touch human reproduction.
This report is the fruit of that inquiry. Its principal
aim is to describe and critically assess the various oversight
and regulatory measures that now govern the biotechnologies
and practices at the intersection of assisted reproduction,
human genetics, and human embryo research.
II. The Domain of Inquiry
The reason for and focus of this inquiry is the growing capacity
to influence and control the beginnings of human life, especially
as exercised ex vivo (outside the body), in the clinic and
the laboratory. These capacities emerge from a confluence
of work in reproductive biology, developmental biology, and
human genetics. The well-established practices of assisted
reproduction are today being augmented by techniques of genetic
screening and selection of embryos; some day, gametes or embryos
may be modifiable by directed genetic manipulation. Our focus
here is not assisted reproduction as such, nor is it the fate
of human embryos or the evolving understanding of human genetics
and the novel capacities for genetic diagnosis and manipulation.
Rather, we are concerned with the unique interactions among
these elements and the new possibilities these interactions
create for controlling and perhaps someday altering the character
of human procreation and human life.
Our point of departure will be the practice of assisted
reproduction. We are well aware that assisted reproduction
is not new—indeed, it has over the past quarter-century
become firmly established within the practice of medicine,
and it is thus subject to the usual formal and informal
mechanisms that regulate medical practice. With great success,
assisted reproductive technologies (ART) have enabled over
one million otherwise infertile couples and individuals
to have biologically related children and to participate
in the joys of family life. Our purpose here is not to second-guess
how this novel and profoundly important practice grew and
came to be regulated in the way it has. Neither are we interested
in interfering with that practice. However, three reasons,
taken together, recommend assisted reproduction as our point
of departure. First, all the other activities of interest—preimplantation
genetic diagnosis, sex selection, germ-line genetic modification,
human embryo research, and a range of potential new modes
of human conception—presuppose the creation and existence
of human embryos in vitro. The ability to screen and select
genetic traits in vitro depends on the prior ability to
initiate and sustain embryonic life in the laboratory. Thus,
in vitro fertilization and related techniques are the starting
point for all the others, both in practice and, hence, in
our inquiry. Second, as a consequence, any oversight or
regulation of the use of genetic technologies in the context
of human procreation will necessarily depend on the systems
that oversee and regulate assisted reproduction itself:
what they are and how well they work. Third, the addition
of genetic technologies to existing techniques of assisted
reproduction has made it clear—if it had not been clear
before—that we are dealing here with a most unusual branch
of medicine. In no other area of medicine does the treatment
of an ailment—in this case, infertility—call for the creation
of another human being. Here, the therapeutic intervention,
addressing the needs and desires of the procreating adults,
aims at and consists in the production of a new human child,
who may be at risk of harm from the very procedures used
to conceive or produce him. It is our concern for the safety
and well-being of children that suggests to us the need
for special attention—especially now that genetic screening
and selection are being added to the practices of assisted
reproduction.
III. The Human Goods
at Stake
All regulatory institutions and practices operate, either explicitly or
tacitly, in order to promote or protect one or more important human
goods. Identifying those goods and the things that challenge them is
indispensable for any analysis and evaluation of how—and how
well—regulatory activities are conducted. It is therefore useful, at
the start of this document, to identify the major goods, values, and
ethical concerns that the Council finds pertinent to the subject area,
and hence to our assessment. First among these, as already indicated,
is the health and well-being of the human subjects directly affected by
the biotechnologies, not only the individuals or couples seeking their
use but also and especially the children who may be born with their
aid. Concern for the bodily health, safety, and well-being of those
children is of prime importance, especially in an age in which more and
more features of their genetic make-up could be shaped by technical
intervention and deliberate human decision.
Other human goods of crucial relevance to this discussion
include:i
(1) Relief of the suffering and sorrow of those afflicted
with infertility, for whom assisted reproductive technologies
are an avenue of hope and possibility and offer the chance
to enjoy the blessings of rearing (biologically related)
children. (2) Compassion for children with serious genetic
diseases, and relief of the sorrows and burdens that they
and those who love and care for them must bear. (3) The
intrinsic value of new knowledge of human development and
genetic function in addition to the inestimable practical
value of new treatments for diseases and disabilities—the
main goals of some of the associated genetic and reproductive
technologies under consideration and of research using embryonic
stem cells. (4) Privacy of genetic information and reproductive
practice. (5) The foundational value of human life and the
respect owed to it in its various stages. (6) Several expressions
and avenues of human freedom, including the freedom of parents
to make their own reproductive decisions or to use or refuse
genetic screening, and the freedom of scientists to conduct
research. As important, as well, is the necessity to protect
the freedom of children from improper attempts to manipulate
their lives through control of their genetic make-up or
from unreasonable expectations that could accompany such
manipulations. (7) The promotion of justice and equality,
including equitable access to the use and benefits of new
technologies, equal respect and opportunity in a world that
places great emphasis on genetic distinctions, and the prevention
of discrimination and contempt for genetic “defectiveness”
or “inferiority.” (8) The protection of human dignity, including
the dignity of the human body and its parts, the dignity
of important human relationships (parent and child, one
generation and the next), and the humanity of human procreation.
IV. Some Specific
Issues
Some of the aforementioned human goods—for example, relieving the
sorrows of the infertile or preventing and treating heritable
diseases—are, of course, among the primary goals of the practice of ART
or the study of human genetics and development. Although many have
reaped the benefits of these technologies, many others who seek these
benefits still wait in sadness and hope. Other goods—for example,
protecting the freedom and privacy of reproductive choice or preventing
genetic discrimination—have been the focus of professional
self-regulation and legislative enactments. Nevertheless, other
relevant human goods appear not to be receiving comparable attention.
And, while ethical issues connected with these various goods are
identifiable, there appears to be no existing oversight body or
significant regulatory activity directly concerned with those issues.
Accordingly, throughout our analysis we shall be especially mindful of
how various existing regulatory practices address these ethical issues.
Some issues are raised by the practice of ART as such, others by the
practices of genetic screening and selection, and still others by
potential new techniques of human conception. In addition, there are
concerns raised by the commercialization of human reproductive services
and the advent of commerce in eggs, sperm, and embryos.
Beyond the obvious and important issues of health and safety, there are
a number of broader ethical and social concerns that have been called
to our attention—some already here, others perhaps on the way. These
concerns include the following: (1) The daunting complexity of options
confronting would-be ART patients, and the need for full and candid
reporting of the successes and failures of different ART treatments and
techniques. (2) The adequacy or inadequacy of procedures for informed
decision-making by patients. (3) The potential aggravation of existing
social inequalities, should such technologies become available only to
the wealthy or the privileged. (4) The possible emergence of new
grounds for inequality and discrimination based on genetic
characteristics. (5) The prospect of making entrance into human life
contingent on passing certain genetic tests. (6) The concern that the
state, insurance providers, or others may attempt to impose prenatal or
preconception testing on prospective parents. (7) The use,
cryopreservation, and destruction of embryonic human life. (8)
Questions about the boundary between disease-prevention and so-called
“enhancement” uses of these technologies—how to define that boundary
and what to do about it. (9) The effects of commercialization of
aspects of human procreation (such as the sale or patenting of gametes
and embryos). (10) The consequences of moving procreation more and more
into the laboratory and possibly turning it in the direction of
manufacture. (11) The changing expectations of parents regarding
children born using—or not using—genetic screening and
selection. (12) The concern that children born through certain assisted
reproductive technologies (for example, cloning) will be denied a share
in our common human heritage (such as a biological connection to two
adult parents and two clear lineages). (13) A blurring of the line
between the human and the animal in certain laboratory research
techniques. (14) The fear that a growing emphasis on genetic
determinants of human life will exaggerate the primacy of genetic
causation over environment, free will, agency, and choice.
Not all of these ethical issues are equally susceptible to regulatory
activity, and few of them are likely to be the subject of anything so
far-reaching as restrictive legislation. Not all of these concerns are
shared or shared equally by every member of this Council. But most, if
not all, of these issues are sufficiently serious as to suggest the
desirability of monitoring what is going on, with a view at the very
least to informing patients and policymakers how well we are handling
any possible untoward consequences.
Also animating the following inquiry are concerns about
the chilling effect that overbroad or excessive regulation
might have on the development and practice of promising
and worthwhile technologies. Just as the absence of fitting
and effective regulation is ethically problematic, so too
is overly burdensome or unjustifiable regulation of practices
that alleviate human suffering and bring great joy. The
possible costs and drawbacks of potential regulation must
themselves be counted among the concerns that drive our
interest in this field. However, while this report will
touch on a wide range of subjects, our main focus is on
the well-being of children who might be conceived and born
with the aid of new reproductive and genetic technologies,
and on the possible implications of these biotechnologies
for human reproduction considered more broadly.
V. The American Legal Landscape
Before moving to the substantive analysis of the present regulatory
landscape, it is worth noticing briefly some unique aspects of
American law that create the backdrop against which the current
regulatory mechanisms exist.
First, because practices touching reproduction and developing human
life raise questions related to the central themes of the abortion
debate, any efforts at regulation are likely to be fraught with
political difficulty. Proposed efforts to regulate or monitor assisted
reproduction are viewed by many people through the prism of Roe v.
Wade and the legal-political context it has created, arousing
suspicion and concern among individuals on both sides of the abortion
conflict. Defenders of reproductive freedom want no infringement of the
right to make personal reproductive decisions, and they fear that the
regulation of ART might undermine the right to privacy. Pro-life
opponents of embryo destruction fear that the federal regulation of
assisted reproduction or embryo research might give tacit or explicit
public approval to practices that they find morally objectionable. This
situation creates a powerful disincentive for any regulation of the
uses of reproductive technologies. More generally, there is deep
disagreement in our society about the degree of respect owed to in
vitro embryonic human life and the weight that respect should carry in
relation to other moral considerations, such as helping infertile
couples to have children, helping couples to have healthy children, and
advancing biomedical knowledge that could well lead to cures for dread
diseases. This disagreement is one of the main reasons for the current
relatively laissez-faire approach to regulation. While some observers
urge that the standoff over the moral status of embryonic human life
should not be permitted to hold up appropriate and useful regulation of
ART and related practices, others respond that resolution of this
dispute is the sine qua non of any responsible approach to
regulation.
Second, the practice of medicine (now embracing ART) occupies a special
place in the American legislative and legal system. The practice of
medicine is principally regulated through state licensure and
certification of physicians rather than by reference to specific
legislative proscriptions or prescriptions of conduct. Legislatures
defer to the profession not only because medicine is highly esteemed,
but also because of the special expertise of physicians in their
various specialties and the relative lack of medical expertise on the
part of legislatures or other governmental authorities. Medicine is a
profession where crucial judgments must be made on a case-by-case basis
by a practitioner familiar with the details and circumstances involved.
The law tends to give physicians ample latitude to make such judgments.
Third, the U. S. Constitution has several distinctive features that
bear on the present discussion. The American system of federalism has
tended to vest principal authority for safeguarding the health, safety,
and general welfare of citizens in their respective states. This broad
mandate of the states leads to a lack of uniformity across local
jurisdictions, but also permits states to serve as “laboratories” for
regulatory experimentation. In addition, the enumeration of federal
powers in the Constitution sets limits on what the national government
may legislate. Only conduct that meets a specific jurisdictional
threshold (for example, activities that involve interstate commerce) is
reachable by federal mechanisms of regulation. (The authority of the
FDA, for example, a key player in the regulation of human
biotechnology, is grounded partly in the constitutional power of the
federal government to regulate interstate commerce.) On the other hand,
the Constitution recognizes certain individual rights inhering in all
citizens (or, depending on the right, in all persons), as well as
liberties that may be vindicated against both state and federal
governments. The assertion of such rights can be controversial,
especially in cases in which the rights in question are not explicitly
enumerated in the Constitution itself. One such controversial right is,
of course, the right to privacy in intimate matters relating to
procreation. The relevance of the right to privacy to the regulation of
assisted reproduction is easily recognized, while its likely
application in actual cases is difficult to predict.
A fourth principal concept in American law, directly relevant to the
present inquiry, is that the public and private realms of conduct are
legally and ethically distinct. The reach of law is in many ways driven
by this distinction: public action may properly be regulated by the
government, especially to protect public health, safety, and welfare,
and to vindicate individual rights; by contrast, the realm of private
conduct (that is, actions undertaken in private, affecting only the
particular individuals involved) is the zone of maximum individual
liberty. To be sure, this distinction, while simple in theory, proves
complicated in practice. The new biotechnologies and practices treated
in this report involve human life in its most intimate and private
aspects: procreation, child rearing, human suffering, and individual
conscience. In such matters, there is a strong legal and cultural
presumption in favor of personal liberty. This presumption is only
overcome by an equally compelling governmental and societal interest,
typically the protection of life and limb. The tension between these
concepts—public and private, liberty and the public good—should be
borne in mind when considering these technologies and practices.
A fifth concept, related but different, is the distinction
often drawn between publicly funded and privately funded
activities. Some activities the law chooses silently to
tolerate while withholding its official sanction or endorsement
through public support; other activities are actively promoted
and funded by the government; and still others are regulated
or prohibited entirely. This distinction between prohibition,
silence, and active endorsement is especially significant
in some arenas touched on in this discussion.ii
A sixth crucial principle is the special role of parents in American
law. They are considered the principal protectors of the well-being of
their children, including their as-yet-unborn children. As such, they
are granted wide latitude by the law to make decisions that directly
affect their children’s well-being, and this is especially true in the
context of assisted reproduction. At the same time, however, the law
recognizes certain circumstances in which the state may intervene to
protect the welfare of children.
A seventh feature of American law relevant to the present inquiry is
the presumption in favor of commerce and free enterprise. The values of
freedom to contract, to participate in the free market, and to profit
from the fruits of one’s labors are embodied in the Constitution,
statutes, and decisional authorities that constitute U.S. law. Any
governmental efforts to regulate biotechnology and related activities
would take place against this legal backdrop. Similarly, unlike many
other nations, our health care system is not run by the government, and
physicians enjoy a large measure of autonomy in their own economic
activity. The largely private funding of medical care also places
additional obstacles in the way of attempts at government regulation.
An eighth element that informs the present inquiry is the absence of
human dignity as an explicit concept in American law. Much of the legal
discourse in this country employs operative terms such as liberty,
equality, justice, and rights. Unlike some of our European
counterparts, “human dignity” is not in our legal lexicon. Thus,
legislators and courts lack the language (and therefore the explicit
authority) to fashion responses and remedies to conduct solely on the
grounds that it threatens the dignity of the human person.
Ninth, it is necessary to bear in mind the range and variety of
activities that may be properly deemed “regulation” for purposes of
this inquiry. Regulation comes in myriad forms, from various sources,
with widely differing results. Regulation can include a variety of
mechanisms, ranging from legal prohibition and statutory obligations to
mere monitoring and data collection. Methods of enforcement range from
criminal prosecution to mere hortatory suggestion. Even
information-gathering can serve as a kind of cautionary regulatory
function. It signals to practitioners in the field that society is
paying attention and has a stake in the underlying activity. In
addition, the source of regulation can be governmental (with the
coercive power of the state as the principal mechanism for
implementation) or nongovernmental (where market forces and peer
evaluation are the chief means of implementation).
Finally, another distinctive aspect of regulation in the United States
is the nation’s deeply ingrained commitment to pluralism. The potential
need to regulate assisted reproduction runs up against American
individualism and an aversion to “legislating morals.” Americans expect
their governments to give compelling reasons before restricting
individual liberty. Many people also harbor suspicions that
governmental regulations and the bureaucracies needed to manage them
are harmful, ineffective, and threatening to salutary personal freedoms
and economic progress.
All these considerations make thinking about regulating
new reproductive biotechnologies extremely complicated,
in ways largely peculiar to the United States. Although
the Council has heard presentations on regulatory schemes
used in other countries, this document does not deal with
them. We are eager, first of all, to disclose and assess
what is going on in our own country. And, given the noted
peculiarities of American law and political culture, there
is good reason to doubt whether foreign practices can serve
directly as models for what we can and should do here. In
any event, there is no consensus among those nations that
have chosen to regulate in this domain.iii
VI. The Character and
Significances of Human Procreation
While following our inquiry into the regulation of new reproductive
biotechnologies, it will be important to keep in mind the character and
significance of the area of human life we are discussing—namely, human
procreation. Thus, before considering the new technologies and how they
are regulated, we would do well to reflect (however briefly) on the
character of human reproduction itself—especially on the significance
of procreation in shaping fundamental human relationships, both
familial and social.
Human procreation is an activity of deep biological and
anthropological significance. Biologically speaking, as
with other animals, human procreation represents life’s
answer to mortality, perpetuating the human species despite
the perishability of every one of its members. In addition,
through the genetic recombination produced by the lottery
of sexual reproduction, genetic novelty is assured, allowing
for the gradual evolutionary emergence of new biological
capacities and possibilities. Humanly speaking, because
these deep biological facts are lifted up into human self-consciousness,
procreation commonly establishes ties of belonging, rooted
in begetting, richly significant for parents, children,
and the larger society. These last implications deserve
further specification.iv
Through procreation, each parent (mother and father) acquires a share
in a life that transcends his or her own, and thereby also a role in
perpetuating the human species. Both parents together wittingly acquire
an equal share in their offspring; and, supported by social customs and
expectations built on this biological foundation, they also acquire a
shared responsibility to nurture, humanize, and civilize the children
they generate, by caring for and rearing them well. Each child enters
life as a unique, unbidden, and as-yet-mysterious stranger; each child
is endowed with both the universal potential for human activity and his
or her own unique and unprecedented version of it. The former potential
anticipates the common human stage upon which the child now enters; the
latter potential foreshadows the individuated, never-before-enacted
life that he or she will henceforth live. As the parents’ union issues
in their child, so the child correlatively stands in immediate and
dependent relation to its two progenitors, who are the child’s dual and
complementary sources. Viewed more broadly and looking backward,
the child also stands—and can later also understand that he stands—as a
singular intersection of long, venerable, and now converging chains of
descent; viewed more broadly and looking forward, the child
stands—and can later also understand that he stands—as a new sprout on
the ever-branching and ever-widening family tree—a human-family tree.
For any human society, procreation means the renewal of human
possibility and the promise of ever-returning youth and freshness. It
provides new members who can look upon the community and the world
anew, who will be responsible for preserving and transmitting the best
of what is past, and who will have the energy and the hope to try to
improve upon it for the future.
Human procreation, when viewed most fully, is thus a panorama of wide
import and overlapping human meanings. Yet when viewed concretely and
on the smallest scale, the immediate focus is on the leading figures:
individual parents and their children. At the very center of the
picture of human procreation is the newborn child emerging from his or
her mother’s womb. Even as the child arrives, it is a still-developing
new life, derived from the union of “seeds” contributed by the two
adults who were and are the child’s mother and (biological) father and
whose child the newborn baby now becomes. Newly visible to the world
after nine months of hidden growth, the child arrives not as “anyone”
but as a “someone,” with a defined and distinctive (beginning)
identity—human, familial, individual, male or female. Part of any
child’s identity as this child lies in its special relationship
to two particular human “someones” from whom the child descends. All of
the child’s being and identity it owes to a continuous developmental
process that began with union of egg and sperm and that continued
through an unbroken sequence of embryonic and fetal stages enacted
within the womb of the mother. Though father and mother are equal
contributors of seed, the mother alone brings the child to birth: its
developing life absolutely depends on the protection and silent
nurturing of her body, its emerging life depends absolutely on her
labor.
In this brief synopsis of human procreation, several elements
stand out as matters of human worth that are deserving of
our respect: the special human attachments that human reproduction
both manifests and generates; the special procreative power
of women and the special nature of human pregnancy; the
singular relationships of parents to child and of child
to parents, central to the identity of each; and the (at
least) special respect owed to embryonic human lifev—and
perhaps even some regard for egg and sperm, in view of their
standing as the potential seeds of a new child and of a
new human generation.
Until the first extra-corporeal fertilization of human egg by human
sperm in 1969, the processes of human procreation took place entirely
inside a woman’s body, not only immune to human intervention but also
unobserved by human beholders. Since that time, the beginning of many a
human life has been brought outside the body and placed partially in
human hands and under human control. Undertaken to make procreation
possible for infertile couples, in vitro fertilization has been
responsible for over a million births worldwide, to the great joy of
the parents. Yet by bringing the beginnings of human life outside a
woman’s body, in vitro fertilization has already had several other
consequences, unintended yet foreseeable, and still other possibilities
not yet here that are today equally foreseeable. The presence of
developing human life in vitro exposed it for the first time to
possibilities of manipulation and alteration prior to the initiation of
a pregnancy, as well as to utterly novel uses altogether unrelated to
procreation—in both cases raising unprecedented and vexing ethical
issues.
Among these additional possibilities are the following (those that have
already been accomplished or that are today possible are italicized):
(1) The early human embryo can be frozen and stored for later
use. (2) The early human embryo (at around the eight-cell stage)
can be disaggregated into its separate blastomeres (= embryonic cells),
which can then be recombined with blastomeres from other human embryos
(including those of opposite sex) to produce a hybrid human embryo (of
four or more biological parents). (3) Human blastomeres could
potentially be combined with blastomeres from another species
(including primates) to produce a cross-species hybrid embryo (an
embryonic chimera). (4) An ex vivo human embryo, altered or not, can
be introduced into women other than the donor of the egg. (5) An ex
vivo human embryo could also, in principle, be introduced into the
uterus (or other body cavity) of a non-human animal, where it might be
grown to later stages for purposes of research or (in due course) for
the production of human tissues and organs. (6) An ex vivo embryo
can be grown outside the body for a brief period for purposes of
research on early human development or (at the blastocyst stage: five
to six days, 100-200 cells) used as a source of embryonic stem cells,
themselves usable in research and the pursuit of novel therapies.
(7) An ex vivo embryo can be genetically screened prior to
transfer, and, in principle, genetically or otherwise altered by
the addition of cytoplasm (ooplasm), genes, or other materials. (8)
Egg and sperm (or their precursors) may be extractable from fetuses or
derivable from embryonic stem cells (achieved in mice), making it
possible that a child might have a fetus or a five-day old embryo as
its biological mother or father. (9) With the aid of synthetic devices
(now being pursued) that might serve as an artificial placenta, an
embryo could in principle be grown to later stages outside of any
living body, for purposes of research or needed tissue or organs. (10)
An ex vivo embryo (and externalized human eggs, as well as sperm)
can be treated as an article of commerce.
These novel technical possibilities, all of them connected with the
existence of early human embryos outside the human body, are for many
people a source of disquiet. Indeed, whatever one’s opinion regarding
the propriety or morality of any of these additional uses and
practices, one must readily agree that they raise new ethical questions
bearing on the character of human reproduction, well beyond anything
involved in in vitro fertilization for procreative purposes to help an
infertile couple have a child of their own. The ongoing public debate
about the ethics of embryonic stem cell research, centering on the
morality of destroying embryos to obtain stem cells, concerns only one
of the pertinent issues. Other possibilities touch on the respect owed
to women and human pregnancy, the respect owed to children born with
the aid of assisted reproductive technologies, and the boundary between
human and animal life in the context of reproduction.
The enumerated non-procreative operations, present
and projected, that may be performed on or with ex vivo
human embryos not only raise direct ethical questions; they
may also have indirect but important implications for our
thoughts about and attitudes toward human procreation itself.
On the one hand, by gaining new knowledge and understanding
of human development through research on human embryos,
we can acquire an enhanced appreciation of how nature works
in this truly wondrous domain, as well as expanded abilities
to help infertile couples to have a child—and a healthy
child—of their own. On the other hand, and at the same
time, should we adopt a merely technical attitude toward
the beginnings of human life, we risk a diminution of wonder
and awe. The existence of the early embryo in the artificial
setting of the laboratory invites an analytic, reductive,
and partially disembodied view of the procreative process.
It risks isolating and reifying the early stages of human
development—“the embryo,” “the blastocyst”—thus making it
easy to forget their natural place in a continuous, goal-directed,
and humanly significant process of human procreation (for
example, the natural in vivo link between an early embryo
and its mother). And the very fact that the early stages
of human life are now partly subject to human manipulation
and control invites, at least in some people, a diminished
regard for the “naturalness” and awe-inspiring power of
the procreative process. Treating as “normal” all the novel
things we are learning to do with embryonic human life ex
vivo might also desensitize us to still greater departures
from the human way of procreating, putting us at risk of
weakening, in thought as well as in deed, our regard for
the meaning and worth of human procreation. This risk, hard
to measure, is not itself subject to any preventive measures.
Yet it does provide an additional argument for erecting
certain barriers against certain extremely dehumanizing
interventions, placing a burden of justification on those
who would casually break these barriers in the absence of
public debate about the wisdom and propriety of doing so.
Erecting such barriers would also require the public to
consciously confront the novel possibilities as they occur,
rather than complacently acquiescing in the necessity of
every fait accompli.vi
VII. Brief Outline of the Report
The rest of the report is in two major parts: a diagnostic survey of
existing regulatory practices (Chapters 2 through 8) and a discussion
of policy options and recommendations (Chapters 9 and 10).
Chapters 2 through 7 explore precisely which institutions currently
provide oversight and guidance in this context, pursuant to what
authority, according to what principles and values, and with what
ultimate practical effect. Those chapters are strictly diagnostic and
expository in nature. They seek to describe the current state of
affairs, and they are neutral regarding what changes, if any, might be
necessary, desirable, or feasible if one should wish to improve upon
the present arrangements.
Chapter 8 is a distilled account of the specific findings growing out
of the preceding diagnosis.
Chapter 9 is a discussion of the universe of possible public policy
options that might be considered in light of the findings and
diagnosis.
Chapter 10 sets forth a list of recommendations that the Council agrees
should be adopted immediately. These recommendations are not for
structural or institutional changes; we do not propose the wholesale
creation of new regulatory institutions or the reform of existing ones.
Rather, these recommendations are offered as interim measures
with two goals or aims in mind: first, to strengthen existing
legislation and existing regulatory mechanisms in order to gather more
complete and crucial information, information that patients,
policymakers, and the general public do not now have and that is
essential to decision-making in the future; and second, to erect
certain legislative safeguards against a small number of
boundary-crossing practices, at least until there can be further
deliberation and debate about both the human goods at stake and the
best way to protect them.