Beruflich Dokumente
Kultur Dokumente
Repro
R genetics
eprogenetics
and
and Public Policy
REFLECTIONS AND RECOMMENDATIONS
u E R I K PA R E N S AND L O R I P. K N O W L E S
Reprogenetics
▼
Working Group Members
Lori P. Knowles • The Hastings Center
Erik Parens • The Hastings Center
Thomas Murray • The Hastings Center
Timothy Caulfield • University of Alberta, Edmonton, Canada
Chris Evans • Harvard Medical School
Diane Scott-Jones • Boston College
Diane B. Paul • University of Massachusetts at Boston
Bartha Maria Knoppers • Universite de Montreal, Montreal, Canada
Andrea L. Bonnicksen • Northern Illinois University
Eric Juengst • Case Western Reserve University
Gladys White • Veterans Health Admistration/American Nurses Association
Kathi Hanna • Science and Health Policy Consultant
Robert Cook-Deegan • Duke University
Bonnie Steinbock • University at Albany, State University of New York
Project Consultants
Adrienne Asch • Wellesley College
Patricia Baird • University of British Columbia, Vancouver, Canada
Elizabeth Bartholet • Harvard University
Mark S. Frankel • American Association for the Advancement of Science
Jamie Grifo • New York University Medical Center
Andrew Grubb • Cardiff University, United Kingdom
Ruth Hubbard • Bilogical Laboratories, Harvard University
Itziar Alkorta Idiakez • University of the Basque Country
Philip Noguchi • Food and Drug Administration
John Robertson • Law School, University of Texas
Susan Sherwin • Dalhousie University, Halifax, Canada
Alison Harvison Young • Queens University, Kingston, Canada
Research Assistants
Samantha Stokes
Michael Khair
Marguerite Strobel
Art Director
Nora Porter
by ERIK PA R E N S AND L O R I P. K N O W L E S
A
t the first of the discussions that led eventual- forms of unfairness, or complicity with unjust norms?3 Put
ly to this report, a respected researcher-clini- positively, what can we do to increase the chances that
cian in the world of reprogenetic medicine re- these techniques are used in ways that further the happi-
ferred to his field as “one big embryo experi- ness of children, families—and ultimately the well-being
ment.” The phrase nicely captures what this of our society as a whole?
report is about. It is about the ethical issues and policy The answers to these questions will rest on fundamen-
challenges that arise in the context of researchers and clin- tal beliefs and commitments to such values as liberty,
icians doing new things with embryos. The range of such equality, solidarity, and justice. They will likely be com-
activities is wide and growing: from studying embryos for plex and will sometimes reveal deep disagreements. But
the sake of basic knowledge about developmental biology; such disagreement should not stand in the way of trying
to using them as sources of embryonic stem cells that can to talk together about matters of such great importance.
be coaxed to cure disease; to creating, selecting, and alter- We, the authors of this document, cannot help but
ing them for the sake of producing children. This report have views of our own about some of these contested
focuses on that last set of aims and emphasizes the need questions. But our primary purpose is not to defend those
for improved public oversight—a need that grows more views. Rather, we wish chiefly to establish that our society
urgent as reproductive and genetic medicine converge to needs to find better ways to grapple with—and regulate—
produce the new field of “reprogenetics.” 1 reprogenetic activities. The future of reprogenetic practice
For a variety of reasons, research involving the use, cre- is too important to be decided solely by the market. We
ation, alteration, and storage of gametes and embryos is call for the creation of an oversight structure that will
subject to little regulation in the United States. This situa- make possible a thorough and transparent policy discus-
tion is potentially dangerous. Unlike older in vitro fertil- sion of reprogenetics and effective regulation of those fa-
ization (IVF) techniques, many new reprogenetic tech- cilities involved in reprogenetic research and services.
niques make structural changes to cells,2 and with struc- The report is divided into five parts: In the first, we de-
tural changes arise concerns about the safety of the chil- lineate what we mean by reprogenetics. In the second, we
dren produced by the technology. Further, both older and identify some of the ethical concerns that commentators
newer techniques raise concerns about the safety of the have broached about reprogenetics and argue that ques-
women who donate the eggs and the women in whom the tions about well-being must be part of the policy conver-
fertilized eggs are implanted—the egg donors and the ges- sation. Part three describes the historical roots of our cur-
tating mothers. rent oversight situation. Reproductive medicine and ge-
But concerns about reprogenetics are not only about netics have long been overseen separately—and with very
safety. Just as important are concerns about the well-being different degrees of care. The politics of abortion have
of children produced by these techniques—and about the largely prevented any effective oversight of reproductive
well-being of the families and society that will welcome medicine. But as reproductive medicine and genetics con-
those children. Are we in danger of allowing the market verge, the current state of affairs does not allow us as a so-
mentality to colonize childbearing, as it has already colo- ciety to anticipate and contemplate the emerging reproge-
nized so much of our lives? Could the proliferation of netic picture in all of its complexity.
techniques that increasingly enable us not just to have To shed light on what a better approach to reprogenet-
children, but to choose characteristics unrelated to their ics policy in this country might look like, part four briefly
health, exacerbate our tendency to think of children as the explores the weaknesses and strengths of the regulatory ap-
objects of our making? Could these techniques lead us to proaches adopted by the United Kingdom and Canada.
think of ourselves as mechanisms that are valued for our The final part sketches a proposal for an oversight body
individual parts or traits rather than as individuals who are that can respond to the technological and ethical realities
valued for being unique wholes? Could it aggravate some of reprogenetics in this country.
What Is “Reprogenetics”?
transfer of genetic material from one egg to the other. In- in the genetic lottery. The newer techniques go one step
deed, the researchers announced that they had achieved further: they promise to help prospective parents choose
the first successful “germ-line modification” and that it what kind of child they get—or at least to increase the
had resulted in apparently healthy babies.11 chances that their children will have some traits rather than
others. Some of those traits will be related to the health of
n To date, much of the public and policy conversation someone other than the child—like Molly Nash’s brother,
about research on embryonic stem cells (ES cells) has fo- Adam. Other traits, someday, may be related not to any-
cused rather narrowly on the moral status of embryos and one’s health, but to some perceived advantage. 13
the potential of ES cells to be put to the therapeutic pur- It is altogether too early in our understanding of the ge-
pose of creating transplantable tissue. If the ES cells were netics of complex traits to know how far the project of
created through SCNT techniques, they could be used to “enhancing” children can go, in good part because com-
generate transplantable tissue that was fully histocompati- plex traits appear to involve extremely complex interac-
ble with the person who received it. Largely missing from tions among many genes and environmental factors.14 But
this discussion has been a recognition that, in theory, ES even if adding genetic material (whether genes or artificial
cell research could be combined with both SCNT and chromosomes) to embryos to enhance human traits does
gene transfer techniques for the reproductive purpose of not prove feasible, we are likely to learn enough about
creating either healthy or “enhanced” embryos—and chil- genotype-phenotype relationships that some entrepre-
dren.12 neurial individuals will promise that they can at least in-
crease the chances of having a child with some desired
These four examples suggest some of the ways in which trait, even if the child is created merely through IVF and
reproductive and genetic technologies are coming together preimplantation genetic diagnosis rather than through
to increase our capacity to prevent or cure disease—and to SCNT and gene transfer. We are just beginning to explore
create children with traits we desire, some of which are re- what that new power may mean for the well-being of chil-
lated to health, others of which may not be. IVF can help dren, parents, and society as a whole.15
prospective parents have a child—whatever child they get
What’s at Stake?
T
he current public policy stance regarding Converging Lines of Research
reprogenetic technologies is a compro-
mise and a patchwork, derived from deep
divides in American politics and the acci-
dents of scientific progress. It is riddled with redundan-
I n the mid-1970s, when research into reproduction and
genetics was getting off the ground in earnest, the two
fields appeared largely unrelated. Reproductive medicine
cies, inconsistencies, gaps, and inefficiencies. The political had begun to promise that IVF could help infertile cou-
division that has hampered public policy on reprogenetics ples have children. There really was no genetic medicine,
is rooted in the vitriolic U.S. debate over abortion. Given just genetic researchers dreaming of curing terrible dis-
the polarizing dynamics of this debate, much of the pub- eases. The possibility of genetically modifying gametes
lic policy conversation about embryo research and repro- and embryos was quickly dismissed, citing a consensus
ductive policy has consisted of pro-choice and anti-abor- that our society would never embark upon making such
tion activists shouting past each other. Unsurprisingly, changes. The ethical and technical barriers, it was regular-
many policymakers have chosen to avoid entering that ly asserted, were simply too high.56
fray, and they have therefore not been able to agree that At that time, the two fields were overseen in quite dif-
some embryo research is acceptable for some purposes, ferent ways. Gene transfer research underwent intense reg-
but not for others. As a result, almost all embryo research ulatory oversight and became the subject of a well-devel-
has been driven into the private sector. The natural secre- oped policy conversation about its purposes; reproductive
cy of the private sector can have two results: it can impede medicine has received much less careful attention.
the progression of the science given the need for confiden-
tiality, 54 and it can reduce the public’s role in deliberating GENETICS . The National Institute of Health’s Recom-
about the direction of the science. For the bulk of such binant DNA Advisory Committee (the RAC) was created
work to go on in the “shadowlands” of the private sector55 in 1974 in part to be a forum for better public conversa-
can be both dangerous for participants and incompatible tion about genetics research. In the beginning, RAC was a
with the ideal of conducting such work in the light of forum to discuss concerns about the safety of splicing for-
forthright public deliberation. eign genes into microorganisms. In 1982, the report Splic-
The second reason we lack a productive public conver- ing Life, produced by the President’s Commission for the
sation about reprogenetics has to do with the historical Study of Ethical Problems in Medicine and Biomedical
fact that until very recently, reproductive medicine and ge- and Behavioral Research, argued that RAC’s purview
netic medicine have been separate lines of inquiry, pur- should be expanded to include gene transfer protocols in
sued by professionals with training in quite independent humans and that its membership should be expanded to
scientific and medical fields. Even if genetic and reproduc- include, among others, lay public participants, and ethi-
tive technologies were not in the midst of converging, the cists.57 In 1985, when RAC adopted guidelines for re-
redundancies, inconsistencies, gaps, and inefficiencies in searchers proposing to embark upon gene transfer experi-
the current systems of oversight for genetic and, especially, ments in humans, it was responsible for making recom-
for reproductive medicine would call out for reform. But mendations to the NIH director about protocol approval
genetic and reproductive technologies are converging. A and for promoting a public conversation about the pur-
new system to oversee reprogenetic research and services is poses of such research. It became, therefore, a place to dis-
needed, therefore, for functional reasons, since the old cat- cuss questions about both safety and well-being. Even
egories of “genetics” and “reproductive” research do not though researchers in the private sector were not required
reflect the new technological realities. The ooplasm trans- by law to put their protocols before RAC, they did so vol-
plantation protocol (see page S4) is a prime example of an untarily—at least until 1996.
intervention that does not fit cleanly into either of the old In 1996, NIH director Harold Varmus announced that
categories: the purpose is reproductive, but achieving it he would eliminate RAC. He argued that because the
entails a genetic change. basic issues surrounding gene transfer research had been
resolved, RAC oversight was redundant.58 When observers
responded that RAC was needed more than ever because
of the prospect of germ-line modification and genetic en-
hancement, Varmus revised his recommendation to elimi-
SPECIAL SUPPLEMENT / Reprogenetics and Pulic Policy: Reflections and Recommendations S11
created guidelines for gamete
and embryo donation in 1998,
and revised them in 2002.78
Members of ASRM’s Society
for Assisted Reproductive Tech-
nologies (SART), who account
for as many as 90 percent of the
providers of reproductive ser-
vices, comply with FCSRCA,
allow inspections, run accredit-
ed embryology laboratories,
and follow the ethical guide-
lines of ASRM.
Finally, the FDA has assert-
ed its jurisdiction over cloning
and ooplasm transplantation
on grounds that such interven-
tions create “products” analo-
gous to the biologic products
already within its mandate
(gene-therapy products, for ex-
ample).79 Given that the FDA’s
mandate is limited to the con-
than as research, oversight of them is left to the discretion sideration of issues related to safety and efficacy, therefore
of the individuals or institutions offering them. leaving out concerns about well-being, it would be best if
Moreover, because most insurance companies still do technologies like cloning and ooplasm transplantation did
not pay for infertility services, they have not insisted on not fall exclusively within FDA’s mandate.
scrutinizing the results of reproductive research in the way Presidential bioethics advisory commissions have taken
they scrutinize other forms of medical research. And be- up both the safety and well-being issues raised by certain
cause patients often accept that the failure rate of repro- technologies involving embryos—cloning and stem cell
ductive interventions is high, malpractice litigation has research—but only on an ad hoc basis. The modus
not effectively brought legal scrutiny to the field. 73 operandi of President Clinton’s National Bioethics Adviso-
None of this is to say that reproductive research and ry Commission (NBAC) was to respond to the president’s
services go on without any oversight or regulation. Vir- specific requests, which made it difficult to consider the
ginia and New Hampshire have comprehensive legislation full reprogenetic picture. President Bush’s President’s
regarding assisted reproduction,74 and many states have Council on Bioethics (PCB) recently issued an advisory
laws regulating some aspects of, or techniques used in, em- report on the use of cloning technology, 80 but like NBAC,
bryo research.75 At the federal level, the 1992 Congres- its resources and mandate are limited, it will likely be re-
sional Fertility Clinic Success Rate and Certification Act placed by a change in presidents, and its role is purely ad-
(FCSRCA) requires clinics offering assisted reproduction visory. Consequently, the NBAC and PCB reports will
technologies to disclose pregnancy success rates to the likely join the thoughtful, articulate advisory reports that
Centers for Disease Control. And laboratories that per- form part of this country’s academic bioethics work, but
form the diagnostic tests related to assisted reproduction, not part of its public policy.
such as semen or hormonal analysis, must be certified In sum, many groups, commissions, and federal agen-
under the federal Clinical Laboratories Improvement Act cies have commented on or asserted authority over various
(CLIA).76 aspects of reproductive services and research, yet there is,
Professional organizations in reproductive medicine at best, a patchwork system of oversight. There is no
have also set practice standards. The American Society for standing body to promote public conversation about both
Reproductive Medicine (ASRM) set practice standards for the safety and well-being issues that arise in the context of
IVF, GIFT, and related procedures in 1998.77 ASRM also new reproductive technologies.
SPECIAL SUPPLEMENT / Reprogenetics and Pulic Policy: Reflections and Recommendations S13
promoting some forms of research and constraining oth- tions of providing for individual security and the preven-
ers, they must receive some institutional support. We must tion of harm, as important as these are. The function of
create a governmental body that will, among other things, public policy even in a democratic, pluralistic society is
facilitate systematic and nuanced policy deliberation about also positive; it is to promote the enjoyment of liberty and
the wide variety of health and non-heath-related things we rights, to promote social justice, and to promote the well-
can do with embryos. being of its citizens.
Liberty itself is an aspect of human well-being. Liberty
The Role of Government in Reprogenetics and autonomy cannot flourish in a society in which the
individual is merely protected from harm; they can flour-
T here will be little disagreement about the claim that
safety concerns warrant government oversight. Many
people from within infertility medicine believe that we
ish only where the individual also is supported in her
human dignity and worth—where she is educated and is
provided with equal opportunities to develop personal tal-
need improved government oversight to protect partici- ents and abilities. It would be supremely ironic if, out of
pants/consumers. 89 Many of those same people would concern for the protection of individual liberty and diver-
probably also agree that there ought to be some form of sity of opinion, we hobbled the primary democratic vehi-
public discussion about how this new research and prac- cle we have that creates a context within which liberty it-
tice will affect the well-being of us all. self can prosper and be most meaningful. That vehicle is
Two objections, however, can be raised against at- the process of fair and open public deliberation about the
tempting to promote broad-based public deliberation conditions of justice and liberty in our polity, and the con-
about questions of well-being and against attempting, ditions of human well-being in our society. Contrasting
through political and moral deliberation, to develop a visions of human well-being are the lifeblood of politics
common framework of values within which public policy and are always at work, even though sometimes they are so
on reprogenetics could be formulated.90 First, questions “self-evident” to so many that we do not notice them at
about possible future consequences are necessarily based all. We should not fear this aspect of political discourse
on claims that are more tentative than the scientific and deliberation, we should embrace it and put it to good
knowledge and empirical data that policymakers often use.
wish to have on hand before making decisions. But in fact, One of the government’s responsibilities is to promote
making public policy decisions under conditions of uncer- the public welfare, and how reprogenetic technologies are
tainty and incomplete knowledge is a familiar problem, developed and disseminated will affect the public welfare.
and the remedy is not policy inaction. What are required Some of those effects will be relatively narrow: among
are open and reasonable deliberation, a sense of humility these more contained consequences might be legal dilem-
in the face of very complex questions, a willingness to lis- mas regarding the identities of children and responsibili-
ten and learn, and the flexibility and honesty to make cor- ties of parents; questions regarding the care and support of
rections to policy when initial assumptions or beliefs turn children, and issues surrounding the medical treatment
out to be mistaken. decisions of children produced by these new techniques. 92
Second, some have argued that public deliberation and Other effects will be broader: reprogenetics might trans-
public policy should be limited to procedural and techni- form the meaning of having a child, being a member of a
cal questions. This is primarily because, they believe, family, and being a member of a community.
opening the public sphere up to issues as difficult and con- Our government has an interest in influencing the de-
troversial as what constitutes human well-being would be velopment and dissemination of technologies with this
dangerous in a pluralistic democracy. 91 It would be dan- kind of power. Given that the current system of reproge-
gerous partly because it would be a source of conflict, and netics oversight is potentially dangerous, out of step with
partly because policies or laws informed by a particular the reality of the convergence of reproductive and genetic
conception of human well-being could threaten the liber- medicine, and sometimes subverts genuine public conver-
ty of those who hold different beliefs about human well- sation, it is time to contemplate new reprogenetic policy
being. mechanisms. It is, of course, ambitious to try to describe
This second viewpoint is important as a caution against mechanisms that are less dangerous, that reflect current
the possible misuse of public deliberation, but it does not technological developments, and are capable of facilitating
provide a compelling reason to forgo the process of delib- a conversation about the bigger picture. Such a task could
eration altogether. Even in so contentious and sensitive an not possibly be accomplished in one fell swoop by any sin-
area as human reproduction and family life, public policy gle group. We are at the beginning of a long process, and
cannot and should not be limited to procedural issues this report merely points in one direction we might go to
alone. Doing so suggests that all human relationships are create safer and better-informed oversight of reprogenetic
characterized only by rational, voluntary contract and self- research and practice.
interested exchange. In this realm, public policy cannot
and should not be limited to the negative, protective func-
T
here are several possible regulatory vehi- sure that it is not “overloaded” by scientist and clinician
cles that might allow for better oversight voices, the act stipulates that membership is interdiscipli-
of reprogenetics, and each strategy has nary.
strengths and weaknesses. The overarch- The HFEA is responsible, through various committees,
ing recommendation of this report is for comprehensive for licensing and monitoring clinics and laboratories in-
regulation of reprogenetic techniques in both the private volved in gamete or embryo storage, creation, or use, and
and public sphere. That recommendation is guided, in the act sets out the purposes for which licenses will be re-
part, by an analysis of the regulatory strategies of other quired (falling under the rubric of licenses for treatment,
countries, in particular those of the United Kingdom and storage, or research).95 In addition, the HFEA functions as
Canada. In spite of the close cultural ties between those an information resource for patients, clinics, and clinicians
countries and our own, differences in culture and politi- alike. It achieves this, in part, by establishing and publish-
cal tradition make wholesale importation of either of their ing a code of practice “giving guidance about the proper
regulatory schemes both impossible and inappropriate. conduct of activities carried on in pursuance of a license
Nonetheless, it is informative to consider what in these under the Act.” Through the setting of standards and the
countries has worked and what has failed. provision of licenses, the HFEA provides both quality
control and assurances that ethical conduct in embryo re-
search is maintained.
The United Kingdom The act also details the situations in which consents
must be obtained. 96 Through a series of detailed and
SPECIAL SUPPLEMENT / Reprogenetics and Pulic Policy: Reflections and Recommendations S15
techniques has ensured that the act can incorporate novel guably has one of the most liberal embryo research policies
techniques that were not envisaged when the act was in the world.
drafted. In addition, if new techniques and applications There are a number of lessons to be gleaned from the
emerge that fall outside the HFEA’s statutory authority, experience in the United Kingdom. First, recommenda-
the act allows parliament to expand the range of purposes tions for Congress should be framed in general terms out-
that are placed under the HFEA’s authority, thereby en- lining suggested restrictions, conditions, and limits on the
suring that new purposes do not call for new oversight use, storage, and creation of embryos and gametes. Sec-
agencies and preserving the integrity of the system. The ond, acceptable and unacceptable purposes of embryo re-
act has been drafted in sufficiently general terms, however, search should be articulated rather than specific tech-
that it remains almost unchanged more than a decade after niques. Third, a mechanism for adding to or adapting the
its inception. enabling legislation in the face of new developments or in-
One reprogenetic development that the act could not formation should be incorporated into the legislation.
incorporate, as initially written, was the isolation of ES Fourth, a detailed informed consent procedure should be
cells. The response was a good, if not painless, example of considered as a way of preventing unnecessary litigation
well-informed democratic policymaking in the face of and respecting patient autonomy. Fifth, the oversight au-
rapid scientific advance.99 The government spearheaded a thority should be responsible for developing a code of
public and policy debate about whether and when ES cell practice as a means of educating researchers, clinicians,
research and cloning techniques are valuable enough to be and patients. And, finally, the respect the HFEA enjoys is
permitted for some purposes, and about what those pur- partly the result of its ability to make scientifically in-
poses might be.100 Both the HFEA (together with the formed and coherent decisions. This ability derives from
Human Genetics Advisory Commission) and an indepen- its members’ considerable expertise and the wide discre-
dent expert group formulated policy recommendations. 101 tion accorded them. Similarly, any U.S. oversight authori-
The independent expert group recommended that ES ty will possess an expertise not likely shared by the mem-
cell research be allowed for specific therapeutic purposes bers of Congress and should be granted significant discre-
and that cloning techniques be permitted for the creation tion in making its decisions.
of research embryos that might lead ultimately to autolo-
gous transplantation techniques. 102 In addition, the Canada
group’s report (known as the Donaldson Report) recom-
mended that future review of approved ES cell protocols
be conducted to determine whether the research has
proven fruitful and merits continued use of human em-
T he Canadian policy experience in overseeing human
reprogenetic technologies has followed a slightly
more tortured path than the British. Its different experi-
bryos. The Donaldson report was accepted in its entirety ence is partly the result of Canada’s diversity of opinions
by the government, which drafted additional purposes to about reprogenetics, the depth and effort put into the
add to the Act by way of regulation. These amendments public consultation process, and the constitutional and
were accepted in a free (non-partisan) vote by parliamen- political division of powers between the federal and
tarians.103 Consequently, these new reprogenetic tech- provincial governments.
niques now fall under the oversight of the HFEA, main- In 1989, a Royal Commission on New Reproductive
taining a comprehensive, coherent oversight of reproduc- Technologies was established by the Federal Government
tive genetics. to consult the public on issues related to “new reproduc-
The HFEA has been a model law for many countries tive technologies.” The commission was charged with de-
attempting to craft regulation in this area, including veloping a substantive analysis of the technologies’ impli-
Canada, Australia, and France. It is important to note, cations for Canadian citizens and society, and with mak-
however, that the United Kingdom is not mired in a divi- ing recommendations to the government for public over-
sive abortion debate, and that fact probably helps explain sight. Over 40,000 Canadians were directly involved in
the public acceptance (for the most part104) of the over- the commission’s public consultation process.105
sight system’s decisions. In 1993, the commission released its findings in a two-
The support in the United Kingdom for the HFEA ex- volume report, with fifteen volumes of supporting mater-
tends to the scientific and regulatory communities, which ial and discussion. 106 The report articulated an “ethic of
appear to have worked out a nonadversarial relationship. care” that should govern this area of research and practice
When a clinic cannot be licensed due to insufficiencies in and eight detailed principles that informed its recommen-
its standards or its protocols, the HFEA works with that dations. The commission made specific recommendations
clinic to ensure that it understands what is required for it with respect to prohibitions and restrictions that should
to successfully apply for a license. Despite the comprehen- apply to embryo research. In addition, it recommended
sive and highly centralized regulation, the United King- the establishment of a national regulatory body responsi-
dom remains committed to scientific freedom, and ar- ble for mandatory licensing of treatment and research in-
volving gametes and embryos. Like the HFEA, the com-
SPECIAL SUPPLEMENT / Reprogenetics and Pulic Policy: Reflections and Recommendations S17
PART FIVE
A Policy Proposal
T
here are many obstacles to any serious po- would, in part, engage the public, stakeholder, and expert
litical initiative to regulate reprogenetics constituencies in consultation; articulate the ethical com-
research—and human embryo research in mitments that must guide such a regulatory effort; and
general. Surely one of the greatest obsta- draft the terms of reference for embryo research, including
cles is the fear each side in the abortion war will have of the limits, restrictions, and prohibitions to be written into
losing any ground. Many people would prefer the status legislation. That commission would then report its find-
quo to any risk of a setback. ings in the form of recommendations to Congress for a
But some people have begun to take such risks. And if legislative initiative.
our society is to submit reprogenetic innovations to public
oversight, others must take such risks as well. Develop- n Third, in formulating its recommendations, the com-
ments in, for example, preimplantation genetic diagnosis, mission should carefully consider the possibility of creat-
ooplasm transfer, cloning, and ES cell research invite us to ing a standing federal entity, a Reprogenetics Technologies
step back and contemplate the bigger reprogenetic picture. Board (RTB), to facilitate reasoned and systematic public
Thoughtful people should accept that invitation and and policy deliberation about the purposes of reprogenet-
begin to think broadly and boldly: they should design a ic research and practice. The board’s authority would ex-
system that can foster the discussion of safety and well- tend to the public and private sectors, and it would factor
being concerns—and can ensure that new reprogenetic concerns about safety and well-being into policy-making
techniques that raise those concerns do not slip through and license-granting decisions. The board would, in im-
the regulatory cracks. portant respects, resemble the United Kingdom’s Human
Fertilisation and Embryology Authority (HFEA).
First Steps toward Public Discussion
Drawing from the lessons learned in the United King-
We make three recommendations. dom and Canadian experience, it will be important, first,
that the Reprogenetics Technologies Advisory Commis-
n First, to bring embryo research into the light of public sion’s recommendations for Congress be framed in gener-
deliberation, Congress should lift the current ban on fed- al terms; it should only outline its suggested restrictions,
erally funded embryo research. We cannot have responsi- conditions, and limits on the use, storage, and creation of
ble oversight of reprogenetics research and practice, nor of embryos and gametes. Second, in defining the Reproge-
embryo research generally, if we do not first acknowledge netics Technologies Board’s purview, the recommenda-
that we already support those activities in a wide variety of tions (and the eventual legislation) should articulate ac-
ways. Our country has already embarked upon “one big ceptable and unacceptable purposes of embryo research
embryo experiment.” If we do not forthrightly accept that rather than specific techniques. Third, recognizing that it
fact by allowing the federal government to oversee research is impossible to keep pace with scientific and technologi-
and practice involving embryos, then the market will be cal developments, the legislative initiative should incorpo-
the only mechanism that will distinguish between the ac- rate a mechanism for adding to or adapting the enabling
ceptable and unacceptable purposes of those activities. legislation in the face of new developments or informa-
tion. Fourth, the RTB should be granted significant dis-
n Second, to take action toward regulatory oversight in cretion, since its members will need to develop an exper-
the United States, a commission must consolidate and tise not likely shared by the members of Congress. Fifth, a
translate the many documents that have already been writ- detailed informed consent procedure should be considered
ten on this topic, solicit views from the diverse U.S. con- to enable patients to contemplate what they want done
stituencies that are or should be engaged with this topic, with their embryos and gametes in unexpected circum-
and synthesize this material to make legislative recommen- stances like death and divorce; such procedures would be
dations about statutory authority for an oversight body. aimed both at preventing unnecessary litigation and re-
The work of the commission, referred to in this report as specting patient autonomy. And, finally, the RTB should
the Reprogenetics Technologies Advisory Commission be responsible for developing a code of practice as a means
(RTAC), would be similar in some respects to that of the of educating researchers, clinicians, and patients.
Royal Commission in Canada, although the audience for There are many possible obstacles to the creation of a
this body would be Congress. The advisory commission new federal oversight board for reprogenetics. First, there
SPECIAL SUPPLEMENT / Reprogenetics and Pulic Policy: Reflections and Recommendations S19
late those purposes, related to both treatment and re- with gametes and embryos, from basic embryo research to
search, involving the creation, use, manipulation, and reprogenetics services, by applying and interpreting the
storage of gametes and embryos for which licenses may be purposes, principles, and strictures of the enabling legisla-
granted by the RTB. The RTB would be empowered to tion. This policymaking function would be accomplished
make licensing decisions in light of concerns about both by granting (or denying) licenses for laboratories and clin-
safety and well-being. ics to carry out the research and clinical activities described
In addition, an important function of the legislation is in the legislation. The enabling legislation will probably
to articulate those practices that are unacceptable and flatly prohibit some activities, but other activities will like-
therefore may not be the subject of a license. Both the ly be left partly to the RTB’s discretion. Thus the licensing
British and Canadian acts forbid, for example, reproduc- might, for example, make it possible to sell pre-implanta-
tive cloning and use of an embryo past fourteen days of tion genetic diagnosis to prospective parents seeking to
development. Which practices should be identified as un- test for disease-related traits but not to test for traits unre-
acceptable would be part of the deliberations of the advi- lated to disease (such as height, if testing for such traits be-
sory commission. came technically feasible). The licensing would be analo-
The RTB’s authority would extend to both the public gous to that performed by the HFEA in the United King-
and private sectors. At least with respect to safety con- dom.123 Also like the HFEA, the RTB would monitor and
cerns, a system of regulatory separation is arbitrary. It de- inspect premises and activities carried out under a license
fies commonsense to protect participants in federally and maintain a register of information about donors,
funded research from bodily harm, but not to protect treatments, and children born from those treatments.
those in privately funded research from the same. Respect The second function of the RTB is to set standards for
for the safety and dignity of persons does not change with those activities by creating a Code of Practice. Such a code
their location. In accordance with this line of reasoning, might detail informed consent procedures, for example, or
NBAC recently recommended the creation of a new fed- delineate the proper handling of embryos that are to be
eral-level body to oversee all human subjects research.121 transferred to a woman’s uterus in the course of IVF. The
code would necessarily change over time, of course, but at
MEMBERSHIP. The RTB should be composed of per- any given time it would establish a uniform standard for
sons from inside and outside the scientific community. everyone offering reproductive services covered under the
The United Kingdom’s HFEA has seventeen members legislation. The code would also articulate the general
and a staff of approximately forty-five. The proposed guiding principles, which might build on the established
Canadian Agency would seat thirteen members, at least U.S. principles of justice, beneficence, and autonomy.
half of which must be women. Given the volume of work A third and fundamentally important function of the
required to oversee reprogenetics in the United States, the RTB would be to engage in public consultation and promote
RTB should have approximately seventeen members, and public conversation about emerging issues in embryo re-
be well staffed and funded. According to the act establish- search generally and reprogenetics more particularly. This
ing the HFEA, at least half of the HFEA’s members must responsibility to promote public conversation—indeed to
not be involved in medicine or science; neither the chair create new constituencies committed to exploring this fas-
nor deputy chair is allowed to be a physician or scientist; cinating and important new arena of endeavor—is essen-
the chair represents the “lay non-scientific opinion on tial. In effect, we are calling not merely for the creation of
these matters.”122 This seems an appropriate balance of ex- a regulatory body, but for richer and more nuanced dem-
pertise for the RTB as well. In addition, a minimum of 50 ocratic deliberation about these vital issues. But one note
percent of the RTB members should be women. of caution must be sounded here. Public consultation and
Such a body should be as independent and insulated as transparency of political process are both important, and
possible from the undue influence of election politics, public consultation must not stand in the way of action.
consumer or business advocates, and pro- or anti-abortion Public consultation should be immediate and ongoing,
activists. For it to have moral authority, it must represent a but so too must be the creation of policy.
wide range of perspectives and interests. Its membership
would need to draw upon researchers, clinicians, con- The Bigger Picture
sumers, lawyers, ethicists, and others. Yet every effort must
be made to enable members to speak as individuals, with
particular views, rather than as defenders of a given group’s
agenda. Striking this balance will be crucial and very diffi-
T he convergence of reproductive and genetic medicine
will lead to a vast increase in our capacity to relieve
suffering and distress. It may also eventually increase our
cult, but not impossible. capacity to shape our children. Thus that convergence
raises questions not only about the safety of children, but
FUNCTIONS. A body such as the RTB can be thought also about the well-being of those children and of the so-
of as fulfilling three intimately related functions. The first ciety they will join. Asking questions about the well-being
would be to make policy regarding the things people do of the participants in this endeavor is as important as ask-
SPECIAL SUPPLEMENT / Reprogenetics and Pulic Policy: Reflections and Recommendations S21
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81. A. Regalado, “The Troubled Hunt http://www.doh.gov.uk/hgac/papers/pa- 114. Jones, Jr., “The Time Has Come,”
for the Ultimate Cell,” Technology Review perd1.htm. at 1092.
101 (1998): 4-41. 102. Chief Medical Office’s expert 115. Ibid.
82. J.W. Gordon, “Genetic Enhance- group, Stem Cell Research: Medical 116. D.D. Aronson and K.M. Ziesel-
ment in Humans,” Science 283 (1999): Progress with Responsibility: A Report man, “A Consensus for Regulation?” Fertil-
2023-24. from the Chief Medical Officer’s Expert ity and Sterility 66, no. 5 (November 1996):
83. Regalado, “The Troubled Hunt for Group Reviewing the Potential of Develop- 862-63, at 863.
the Ultimate Cell.” ments in Stem Cell Research and Cell Nu- 117. Frankel and Chapman, Human In-
84. National Bioethics Advisory Com- clear Replacement to Benefit Human heritable Genetic Modifications. The scope of
mission, Ethical Issues in Human Stem Cell Health (Department of Health, 16 August the AAAS recommendations is narrower
Research. 2000). than ours, however, since it speaks only to
85. Memo from Harriet Rabb to Harold 103. Statutory Instrument 2001 No. the alteration of gametes and embryos,
Varmus, 15 January 1999, cited in “State- 188. The Human Fertilisation and Embry- whereas we seek to address the creation, use,
ment of Harold Varmus, M.D., Director, ology (Research Purposes) Regulations and storage of gametes and embryos. Our
Hational Institutes of Health, Before the 2001. recommendations are also more expansive
Senate Appropriations Subcommittee on 104. “Designer Baby Ruling Con- in that they suggest the creation of a feder-
Labor, Health and Human Services, Educa- demned,” BBC News, 18 July 2002, al-level body that both makes policy and
tion and Related Agencies 26 Jan 1999.” http://news.bbc.co.uk/1/hi/health/213431 grants licenses. Whereas the AAAS report
http://freedom.house.gov/library/technolo- 4.stm. looks primarily to the RAC as a model
gy/stemcell.asp 105. Royal Commission on New Repro- body, our report looks first to HFEA.
86. G.W. Bush, “Remarks by the Presi- ductive Technologies, Proceed with Care: 118. New York State Task Force on Life
dent on Stem Cell Research,” 9 August The Final Report of the Royal Commission on and the Law, Assisted Reproductive Technolo-
2001, http://www.whitehouse.gov/news/re- New Reproductive Technologies (Ottawa: gies, p. 31.
leases/2001/08/20010809-2.html. Canadian Government Publishing,1993). 119. Statewide Advisory Committee.
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90. We thank Bruce Jennings for his in- Human Reproductive Technologies and Re- mission, Ethical and Policy Issues in Research
sights on this question. lated Research,” Bill C-13, Second reading involving Human Participants, vol.1 (
October 9 2002, reprinted as amended by Bethesda, Md.: National Bioethics Advisory
91. Cf. G. Calabresi and P. Bobbitt, Trag- Commission, 2001).
ic Choices (New York: W.W. Norton & Co, the Standing Committee on Health as a
1978). working copy for the use of the House of 122. R. Deech, “Assisted Reproductive
Commons at Report Stage and as reported Techniques and the Law,” Medico-Legal
92. Annas, “The Shadowlands.” to the House on 12 December 2002; Journal 69, part 1 (2000): 13-24, at 17.
93. Report of the Committee of Inquiry http://www.parl.gc.ca/37/21parlbus/cham- 123. Human Fertilisation and Embryol-
into Human Fertilisation and Embryology, bus/house/bills/government/c-13/c- ogy Act 1990, Schedule 2.
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99. E. Masood, “Expert Group to Look Genetic Modifications Research,” in De-
at UK Cloning Law,” Nature 400 (1999): 4; signing Our Descendants: The Promises and
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UK Cloning Law,” 4. Board on Ethics in Reproduction
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