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This staff working paper was discussed at the Council's July 2003 meeting. It was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.


U.S. Public Policy and the Biotechnologies That Touch the Beginnings of Human Life:
Some Policy Options

The purpose of this Staff Working Paper is two-fold: First, responding to Council Members’ request, it aims to describe a range of general and specific public policy options in areas of biotechnology that touch on the beginnings of human life. In doing so, it builds directly on the diagnosis and findings of the Council’s inquiry into these matters. It begins, in a general way, by considering the different possibilities for institutional reform, examining the strengths and weaknesses of each major approach. It then considers, more specifically, several substantive areas of concern and the range of specific actions the country might take. In presenting this overview, it tries to keep in mind both the costs of action and the costs of inaction; the realities and particularities of our political system; the different human goods at stake and the different stakeholders in the debate; and the fact that this inquiry is just beginning, and that there is much important information we do not yet have. The purpose here is to provide a lay of the land, so that the Council, and through it the nation, might consider these complex matters more carefully and more clearly, by presenting a wide range of policy options and the rationale for each of them.

The second purpose of the document is to begin a discussion about what specific actions or policies, if any, the Council might recommend in these areas. It is clear that on some of the matters here under consideration, both substantive and institutional, there are major disagreements on the Council, as there are in the country as a whole. But there are or may be matters where nearly everyone is in agreement about the need for more information, for improved oversight, or for specific reforms and actions. Using this document as a point of departure, we would like to discover any such areas of common concern and agreement. And we would like further to discover whether there might be certain actions or policies that the Council might wish to recommend as interim steps, while we continue to seek a sound national policy in these areas of clinical practice and research that are at once novel and profound.

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The findings drawn from our survey of the status quo, and presented in the previous Working Paper, suggest that a number of serious problems may accompany the present and future uses of biotechnologies that touch on the beginnings of human life. But the existence of problems with the present arrangement does not, in itself, mean that new policies are called for. Any new policy, or form of regulation, would surely come with costs, and in assessing potential policies we must be sure that their costs do not outweigh their benefits or, in other words, that they are not worse than doing nothing.

The appeal of doing nothing in this arena is, frankly, rather great, not only because the costs of regulation may be high (and, in their full proportions, unknowable in advance) but also because the areas of assisted reproduction, new genomic knowledge, and embryo research are socially and politically quite sensitive. Some prospective policies might touch on highly private and often vexing matters of procreation, family life, and infertility, and we Americans are loath to intrude in these areas, even if our aim is to help and to protect those involved. Some potential policies may also involve questions of the character and status of early human life—a crucial but delicate subject in our politics. Parties on all sides have interests to defend that reach well beyond the immediate area under discussion, and the abortion debate casts its giant shadow on this matter as on so many others. On questions involving nascent human life, we often have no avenue to straightforward policies or comfortable compromises, and perhaps it is right that this is so.

But if action, any action, in this field has its bureaucratic, financial, social, and political costs, inaction would surely be costly as well. The most obvious costs of leaving the status quo untouched are reflected in the findings that emerged from our survey of the field. These problems are real, and will not go away unless they are addressed.

Moreover, knowing these problems, and detailing them as we have, places a burden upon us. While much remains unknown about the present state of technologies that touch on the beginnings of human life, we can no longer claim to have no sense of the circumstances surrounding their use. We know a fair amount about what is good and bad regarding ART and embryo research, and we have a sense of what sorts of benefits and difficulties are approaching as ART and new genomic knowledge and technologies intersect. We also have a reasonably well-developed understanding of what sort of information we still lack. Recommending that nothing further needs to be done after having put together this picture of the status quo is akin to a positive statement that the status quo, in all respects, is better than any alternative anyone can reasonably envision.

The concerns described in our survey of the field make it difficult for us to make such a statement, or to allow the difficulties that might accompany new policies to foreclose in advance any discussion of reform. At the same time, we are in no position at this stage of our inquiry to offer any comprehensive suggestions regarding what, if anything, should be done regarding this field as a whole. Before any such suggestions could be made, extensive further investigations and consultations would be needed. Further testimony and advice would need to be taken from the various identifiable stakeholders—including research scientists and biotechnologists, ART practitioners and their professional societies, representatives of disease and disability organizations and advocates, religious organizations, representatives of bioethics and “watchdog” organizations, and the various governmental institutions already charged with some regulatory responsibility in this field—as well as from ordinary citizens. We would also need a thorough exploration of what could be done within the existing regulatory framework, limited though it may at present be. To offer suggestions that would have any hope of gaining an audience, due attention would also need to be paid to the constraints placed on any new recommendations by the special features of American political and economic life, medical and research practices, personal privacy protections, and the realities of public attitudes and domestic political struggles. To do this properly would take at least several years.

In the absence of such ongoing inquiry, we can however present in outline some of the institutional options that might be considered for the field as a whole, indicating in general terms some of their strengths and weaknesses. And, more modestly, we can visit piecemeal some of the findings of our diagnostic assessment and consider some more specific policy options that might command some attention, even as people try to think through the desirability and feasibility of anything more thorough. The remainder of this working paper takes up these matters in turn.


1. Institutional Options
What, then, might be done institutionally regarding this field as a whole? We begin by briefly offering a sense of what sorts of policy may be available to us. There is certainly something counter-intuitive about discussing institutional arrangements in the abstract, without first articulating the substantive principles that should guide their design and operation, but it is nonetheless useful to approach the subject with a sense of the contents of our toolbox, so that we may be able to organize our thinking about which particular substantive options may be plausible. The actual design of oversight and regulatory mechanisms must begin from the substantive aims motivating the policy; but such design is not our purpose at this stage, and a review of possibilities should perhaps begin at the more general level of institutional forms.1

The array of national-level policy options that present themselves, and that have been presented by observers and critics in the past, may be divided into roughly four categories of institutional reform, from most ambitious to most modest: 1) a new regulatory agency, 2) new authority granted to existing regulatory agencies, 3) specific legislative action, and 4) the use of government funding as a regulatory lever. There are of course other options for action in this arena, including state laws, tort litigation, and professional societies. But as our focus here is largely on the question of whether there is a need for federal action, we shall target our discussions at the above four possibilities. Let us briefly describe each of these in institutional terms.

(A) A new regulatory agency
One possibility, suggested by a number of observers and evident in the policies of several foreign countries, is the creation of a new administrative agency of the Executive Branch that would be charged with monitoring and administering the uses of biotechnologies discussed in this report. Such an agency would be charged by Congress with a number of specific tasks, but would be given some leeway in applying its charge to particular circumstances that might arise. Its creation would therefore involve a delegation of regulatory authority. This, for instance, is the idea behind the HFEA in Britain, and also appears to be the direction of policy in Canada.

The logic of this approach is fairly straightforward: by creating a body whose business it is to oversee this arena of research and practice, we might ensure that the problems that worry us are at least noticed and at best addressed. Many issues involved in assisted reproduction, embryo research and related fields are new and largely unique, and might not fall naturally into the purview of any existing government body or agency. Existing agencies, like the FDA, the NIH, the CDC and others, were designed and have evolved to serve different purposes, and authorizing them to oversee this field could well do a disservice to the important concerns that emerge from our review of the present state of affairs.

Such an agency would be granted some degree of latitude in making judgments in particular cases, so that each controversy in this emerging field did not become a legislative question, or result in prolonged Congressional debate.

A new agency dedicated exclusively to the monitoring or regulation of this arena might ensure that the proper concerns are addressed. But the costs of such an agency, financial and otherwise, could be quite great. It would be very difficult for an institution along the lines of the British HFEA to function in the American system, since our approaches to embryology and genetics, the practice of medicine, private enterprise, reproductive freedoms, government regulation, and scientific progress differ from those of the British.

The potential wisdom or utility of such an agency should be determined in light of the tasks it would need to carry out. In purely institutional terms, designing and establishing it would be an enormously complex undertaking. It therefore marks the most ambitious of the potential institutional options before us.

(B) Augmentation of existing agencies
Rather than establish a new agency, Congress might expand the scope and jurisdiction of one or more existing federal agencies to authorize them to exercise oversight over this field.

A number of potential candidates seem apparent. The Food and Drug Administration, as discussed in our overview of the status quo, already exercises some limited oversight over some elements of biotechnology that involve the beginnings of human life, and its reach in this arena might reasonably be expanded somewhat. In addition, the National Institutes of Health, and several of its subsidiary institutions (for example, the Recombinant DNA Advisory Committee), might also be delegated some authority to monitor or even regulate some areas of research and, to a limited extent, of clinical applications. The Centers for Disease Control is already charged by statute with the task of gathering and publishing data on Assisted Reproductive Technologies, and its authority in this regard, and perhaps other related ones, could be increased.

It may in principle be possible to delegate all or nearly all the regulatory and oversight authority deemed appropriate in this field to one of these (or other) federal agencies, or such authority might be divided among several existing agencies.

There could be several advantages of delegating any new authority to existing institutions. For one thing, it would circumvent the need to create a new federal regulatory body, with its incumbent costs, inefficiencies, and potential for future expansion. It is, as a general rule of thumb, preferable to keep the bureaucracy as small as is reasonably possible. A delegation of authority to an existing agency could also be put into effect more quickly, as the basic mechanisms for oversight and enforcement would probably already exist, and the institutional resources for actions would not need to be created from scratch. In addition, such a delegation might integrate these areas of oversight and regulation into existing patterns of regulatory activity, rather than, again, beginning with a blank slate.

On the other hand, the delegation of oversight authority over biotechnology that touches on the beginnings of human life to an existing federal agency would mean that no institution would have this arena as its prime or exclusive portfolio, and therefore that the questions and concerns we have raised would not be quite anyone’s principal business. In addition, the structure, authority, experience, and expertise of existing federal agencies might not be quite appropriate for regulating in this area. Each existing federal agency was created, and has evolved, to oversee a particular sort of activity, and the issues that concern us may not fall neatly into any of them. The questions before us do not, for the most part, involve food or drugs, the control of disease, or the funding of scientific research, for instance. They touch on these subjects, but should not be understood primarily through lenses developed for viewing these subjects. There is also the further difficulty, intrinsic to all attempts at regulation, that the regulators may be co-opted by the interests they seek to regulate.

If the Congress deems it necessary to delegate some new regulatory authority over the technologies we have discussed, the choice between delegating such power to a new federal agency or to an existing agency or agencies should come down to the question of whether this arena of technology and activity raises (or stands to raise) fundamentally new and different sorts of questions and challenges from those that have been dealt with by existing federal agencies in the past. This is a complex question that certainly cannot be answered in the abstract, and which must be considered with regard to each particular target of potential oversight and regulation.

(C) Particular legislative action
The above two options assume some degree of delegation of authority for the regulation of these technologies in particular instances. Congress, however, may also decide to address particular issues directly and specifically through legislation. Acts of Congress are necessarily more broad and blunt instruments than the particular case-by-case decisions of a regulatory agency, but they can also speak with greater force, clarity, and legitimacy.

Of course, the delegation of power to a regulatory agency would itself be an act of Congress, but what we have in mind in this category of potential institutional reform is the passage of laws that lay down distinct and precise policy that does not require a great deal of complex regulation, or much case-by-case judgment to enforce it. The issues would be dealt with legislatively more than administratively. Such policies might involve limitations or prohibitions, but they might also involve means of support for certain technologies and practices, or offers of funding that might then be made available through existing funding agencies.

Several advantages may be gained by proceeding through acts of Congress, rather than delegating judgment to an administrative agency. Such a process would be more democratic and more directly answerable to public wishes and concerns. Its results might also be clearer and starker, and thus easier to respect and enforce.

But proceeding by acts of Congress would also limit the potential flexibility of oversight and legislation in this arena. It would make black and white prohibitions more likely, and case-by-case judgment more difficult. It would also, of course, be slow and arduous, as efforts to legislate policy regarding human cloning and similar subjects that touch on biotechnology have already demonstrated. It may well be the appropriate means to achieve some potentially desirable reforms, but its limits must be appreciated.

(D) Federal funding as a regulatory lever
A fourth institutional means for reform involves the use of federal funding to encourage desirable practices and (by withholding funding) to discourage troubling ones. Federal funding can also be used as a more nuanced regulatory mechanism, since the Congress can attach requirements to funding, and compel all recipients to abide by certain rules. Indeed, this is perhaps the primary way in which scientific research is currently regulated by the federal government. Researchers who receive federal funds, or whose institutions do, are required to abide by certain basic guidelines regarding clinical standards, human subject protections, consent, and other issues.

The question of funding is, however, quite complex and controversial. By offering funding for a practice, the government at least implicitly expresses a note of support for the work, in deeming it worthy of a share of taxpayer money. This becomes a problem when the work in question is controversial, or is deemed unethical or otherwise unacceptable by some significant portion of the public. Those who oppose the practice neither want their own tax money used to support it, nor wish to have their government express approval of it. For this reason, for instance, much of the work in the fields taken up in this report—research that involves human embryos—has never been supported with federal funds.

Of course, to refrain from offering funds is also a kind of policy decision, and indeed an act of Congress that expressly forbids federal funding of certain sorts of practices (as is the case with embryo research, for instance) is an explicit policy, and a form of regulation.

Moreover, institutions that receive federal funds may sometimes be required to submit to government regulations even in their privately funded activities, so that the government can reach and regulate those activities it does not fund directly.

Federal funds, in one way or another, may therefore be used as means of encouraging or opposing certain practices that are deemed to call for some government policy, though of course there is no necessary relationship between funding and regulation: the government can and does regulate activities it does not fund.


2. Substantive Options
As we have already indicated, we are not now prepared to reach judgments on the best form of general regulation, not only because much remains unknown about the field, but also (and especially) because we must decide what problems, if any, call out for government action, and what sorts of actions, if any, may be best. Nevertheless, the findings of our diagnostic inquiry identify several substantive areas of ethical and social concern that may be of sufficient magnitude to warrant a consideration of policy options currently available that might address them. Once again, we present these options, and their perceived strengths and weaknesses, without endorsing any of them.

The following, then, are some concerns that emerge from the findings laid out in the accompanying staff working paper, and some suggestions for possible ways of dealing with them. As will become apparent, in some instances we have proposed a variety of possible options, some of which may be contradictory. In many cases, we do not yet have enough information to make a choice among the options (and so the options include the gathering of information). In other cases, there remain deep disagreements over matters of principle. Our aim in presenting the following policy options is to map the landscape so that public discussion on these matters might proceed in a more informed manner, and to see whether some limited, specific, but perhaps much-needed action might be recommended by the Council.

(A) Safety and Well-Being of Children Born Using ART:
The safety and well-being of children conceived through assisted reproductive technologies seems to be the segment of this field most urgently in need of greater attention. Together with the safety of the women involved, it ought to be the first consideration (though surely not the only one) guiding the use of ART. But for various reasons, mentioned in the diagnostic Discussion Document, it appears to us that it has not received sufficient attention.

It would of course be unfair to say that no care at all is presently taken for the well-being of children to be. But those steps that are taken are very small indeed, and those rules that have been set by professional societies tend to be vague and all too often ignored.

Several options for policy seem plausible in this arena:

(a) Improved annual monitoring of ART techniques and outcomes: The federal government could gather and compile more copious and specific data regarding techniques and outcomes in assisted reproduction procedures. The mechanism for collecting such information is already in place, through the Centers for Disease Control, and could fairly easily be expanded or relocated as deemed necessary. This information would provide more detailed data about what methods and materials are used in assisted reproduction procedures, and what effect these have on resulting outcomes.

(b) Long-term longitudinal studies: The federal government might fund long-term longitudinal studies to track the health and well-being of children conceived using various ART techniques, and of mothers who undergo the procedures. Such information is presently available through relatively small-scale studies, mostly carried out abroad. More and better information is essential before further steps are decided upon.

(c) Improved/expanded informed consent: Among such further steps, should they be deemed necessary, might be an improved and expanded informed consent process for prospective parents seeking ART procedures. Such a process might provide more complete information about the safety and well-being of children born through ART, including any and all available data about occurrences of birth defects and other problems, in proportion to the general population. It might also seek to develop uniform consent procedures regarding the disposition and fate of any unused embryos generated in the process.

(d) Requirements for higher standards and more substantial animal research before moving experimental procedures into clinical practice: Since ART practices are largely unregulated at present, techniques can move from the experimental stage to clinical use quite quickly. One prominent technique—ICSI—was introduced into regular clinical use with minimal animal experimentation and no studies to follow-up on anecdotal reports of hazards for the children produced. More rigorous standards may well be called for, and these might be developed and enforced by a government body, an industry group, or some combination.

(e) Enforcement mechanism if studies show that certain procedures are insufficiently safe: Should the data collected by any of the above methods, or others, demonstrate that a particular ART procedure is sufficiently unsafe to be restricted only to patients with particular characteristics or needs, or halted altogether pending further review, some means should be available to make that judgment and to enforce it. The institutional layout presented above may provide some sense of the possible place and character of that enforcement body, though the question would of course be a controversial one. At present, we do not have sufficient information about whether such a body might be required, and what might be required of it, to proffer more specific suggestions.

(f) Expanded/publicly funded research with a view to improving ART procedures: The safety, reliability, and efficacy of ART procedures might be improved and better understood if more studies were conducted to test various methods and techniques of assisted reproduction. More, and better funded, research could improve the reliability and effectiveness of existing techniques, and more thoroughly assess new ones before they are brought into practice, though of course the extent and the nature of research that might be conducted or funded would likely be an issue of contention.


(B) Implantation of Human Embryos into Human or Non-Human Wombs/Uteruses for Biomedical Research:
At present, there are no laws or rules restricting or prohibiting the transfer of human embryos into a womb for the purpose of developing it purely for research. It is, in principle, possible to transfer an embryo, allow it to develop for a certain time, and then abort it for research purposes. It is also permissible, in principle, to implant a human embryo into an animal uterus.

If this concern is deemed serious enough to require action, two general options present themselves:

(a) Restrictions on embryo transfer for research: The Congress might put into effect a ban or moratorium on the transfer of human embryos to a womb purely for research purposes. The law could also be more narrowly tailored, if desired, to restrict specifically the transfer of embryos into animals, human uterine material outside the body, (prospective) artificial wombs, or any combination of these, with the intent to keep such embryos alive purely for purposes of research.

(b) Time limit on embryo preservation: This concern might also be addressed, as it is in the United Kingdom and elsewhere, by prohibiting research on embryos older than a certain age.


(C) Equal/Improved Access to IVF/ART:
Among the concerns we have described are not only problems of practice, but also problems of access. Assisted reproduction procedures can be quite expensive, and at this point access seems to be fairly limited. The present situation varies by state (with some mandating that insurance companies cover it to various degrees, while most are silent) and by insurance company and policy. Such a circumstance may of course be deemed acceptable, but if policymakers were to see a need for action, at the state or federal level, several related avenues of recourse may be available.

The most commonly discussed are policies requiring insurance companies to treat infertility as a medical condition like any other, and to offer coverage for procedures. In most cases, proposed policies suggest that funding might be afforded only under certain circumstances (for instance, only for married couples, or for women of specified ages) or that they be coupled with guidelines for practice (mandates regarding efficiency of the procedure, number of embryos created and implanted, etc.).


(D) Non-Disease Related Genetic Screening and Selection of Embryos:
The use of genetic screening and selection of embryos before implantation is, at the present time, unregulated and largely unmonitored. For the moment, to be sure, the options for such use are fairly limited, since the technical capacity to select for particular traits is mostly undeveloped. Sex is essentially the only trait for which routine selection is possible, along with histocompatibility for subsequent tissue or organ donation. Selection for a prospective child’s sex has already become quite a controversial subject, and as further techniques for selection are developed, new controversies are sure to emerge.

If some oversight or regulation of this area is needed, it may take some or all of the following forms:

(a) Increased monitoring: Regulation might begin with increased monitoring, to develop a clearer sense of the uses to which embryo screening and selection is being put, and the degree and frequency of use. These basic data are for the moment difficult to come by, and we may not have the kind of understanding of the status quo that might be required to make further judgments regarding regulation.

(b) Review mechanisms: Beyond monitoring, the Congress may establish new or improved mechanisms for reviewing non-disease related uses of screening and selection, setting a higher than usual bar for such techniques to pass before they may be available for clinical use or before they may be used in individual cases. Since very little information is available on the effects of screening and selection on the child that results from the process, there may be a powerful case for such increased standards of scrutiny and care.

(c) Limits on non-disease uses: Finally, Congress might consider placing limits or a moratorium on non-disease-related uses of screening and selection, whether in general or in relation to specific uses, such as non-disease related sex selection. This would of course be quite complicated, since it would require a fairly clear delineation of what are and are not disease characteristics, and it would also carry great costs (including potentially increasing the number of abortions). But policymakers may deem it sufficiently important nonetheless.

The various options along this continuum are not mutually exclusive, though given our fundamental lack of data regarding the volume and popularity of such practices, and given the fact that most such practices are projected and not present, it may be wise to begin with monitoring and data collection, to inform further decision making in the future.


(E) Intentional Germ-line Modification of Embryos/Gametes:
Presently, germ-line modification of embryos and gametes with the intent to produce modified children is proscribed in practice by a decision of the RAC not to consider proposals for such work. But the Moratorium could be overturned by a simple decision of the RAC, and it is also not clear whether it would apply to all potential modifications.

Given the fairly broad agreement in the country and the Congress that germ-line modification should not now be attempted, it may be advisable to institute, by statute, a national moratorium on germ-line modification to produce children, potentially including particular sorts of:

(a) Ooplasm transfer
(b) Insertion of foreign human genetic material to gametes or embryos with a view to fertilization or implantation to produce children.
(c) Insertion of animal genes or genetic material into gametes or embryos with a view to fertilization or implantation to produce children.
(d) Insertion of artificial genes or genetic material with a view to fertilization or implantation to produce children.


(F) Commodification of Nascent Human Life/Human Procreation:
The commodification of human procreation is, for some, a further cause for concern, and an additional potential target for regulation. At present, the buying and selling of gametes is essentially unrestricted in most states, as is, in principle, the buying and selling of embryos. The potential patenting of human embryos is also a concern: the U.S. Patent and Trademark Office refuses to grant such patents as a matter of institutional policy, but the policy would likely not hold up in court without specific statutory backing.

Possible policies in this arena include:
(a) Limits or restrictions on the buying and selling of gametes: If trade in human gametes is a concern, the government could set certain limits, potentially including a ceiling on the price of eggs, limits on advertising for or by gamete donors, or perhaps even a restriction on the selling of gametes altogether.

(b) Limits or restrictions on the trade in embryos: Similarly, the Congress, or state governments, might set limits on the buying and selling of human embryos, whether for research or implantation.

(c) Prohibition on the patenting of embryos: In addition, Congress could pass a clear restriction on the patenting of human embryos, or human organisms at any stage of development, to support the existing (but uncertainly grounded) PTO policy on the subject.

(G) Biomedical Research Involving the Destruction of Early-Stage Human Embryos/Blastocysts:
Embryo research is certainly among the most controversial of the practices we have discussed, and the most politically sensitive, and therefore difficult to regulate. Those who believe it should be altogether prohibited often oppose regulating it, fearing that by doing so the government might implicitly sanction the practice and assure its continuation. Others, meanwhile, worry that regulations founded in concerns about embryonic human life would set a precedent that might have implications for abortion politics or scientific freedom.

The result has been essentially no regulation, though also almost no federal funding, of embryo research. All embryo research (including research on embryos left over from IVF procedures, embryos created by IVF solely for research, and potentially also cloned embryos and parthenotes) is legal in the private sector, and if it is regulated at all, it is so only by IRBs, which generally do not have special rules for research involving human embryos used for research purposes. We have only very limited knowledge of the numbers, uses, and commercial applications of embryo research in private sector.

In the public sector, funding of research that involves the destruction of human embryos is prohibited by law, though a certain loophole in the law, combined with a policy decision by the president, has allowed for the funding of research using stem cell lines that meet a series of qualifications: they must have been derived from human embryos originally created solely for reproductive purposes, with the informed consent of the donors, and without any financial inducements to the donors, and destroyed on or before the 9th of August 2001. These funding guidelines, combined with the broader restriction on all other federal funding of embryo research, are essentially the only federal regulations on the subject at present. Some individual states have crafted their own policies, ranging from sharp restrictions on embryo research to encouragement and funding of such work.

Should a national policy be deemed necessary, several options seem plausible:
(a) Expanded Restrictions: The Congress might choose to impose new restrictions on embryo research, perhaps restricting embryo research exclusively to left-over IVF embryos (either all such embryos, present and future, or those left-over embryos that currently exist); banning the production of embryos (or just the cloning of embryos) solely for research purposes; allowing research only on existing stem cell lines, following the logic of the Bush decision; or even banning all future embryo destruction for biomedical research.

(b) Expanded Funding: Conversely, the Congress might choose to relax existing restrictions, and offer more funding for embryo research. Along these lines, the federal government might choose to be open to funding all embryo research, including the creation of embryos (IVF or cloned) solely for research purposes; fund embryo research only on embryos originally created for reproductive purposes through IVF; or fund research on all existing stem cell lines.

(c) Expanded Regulation/Explicit Public Permission Under Certain Guidelines: The Congress might also break the silence on embryo research by explicitly permitting but regulating such work. This policy might involve requiring all embryo researchers to be licensed or registered; requiring embryo experiments to be approved case-by-case on the basis of whether they are deemed “scientifically compelling” by a panel of experts; or requiring each embryo that will be used for research to be registered and the purpose of its use described and recorded. This option might also be combined with the previous ones, so that, for example, the federal government might fund research on all existing embryonic stem cell lines while prohibiting future embryo destruction for research, or fund research on all embryos (IVF or cloned) with extensive regulation, licensing, and approval requirements. It is important to note, however, that there is not a necessary connection between funding and regulation. The government can regulate activities that it does not fund—as is the case with workplace safety regulations, and rules governing air travel, telecommunication, broadcasting, banking, and numerous other industries.

Conclusion
At present, given the limited availability of data, we are not in a position to recommend or to reject most of the options described in these pages, either regarding general institutional reform or specific substantive policies. Some options may be deemed unacceptable on the basis of moral, ethical, or practical considerations independent of any information that might be gathered, while others may turn out to be unwarranted or unwise as the nation learns more about the field, and yet others may prove to be desirable and useful. No overarching policy direction in this arena could or should be set before substantially more and better information is gathered, and before all interested parties are thoroughly consulted as potential policy directions become apparent.

There may, however, be some interim steps that could be advisable while the process of contemplating potential policies progresses. These could involve both essential information gathering and potentially some modest policy reforms that may be deemed appropriate on the basis of the information we already possess and the findings of our preliminary inquiry.


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Endnotes

1. It is worth noting that we take a broad view of the meaning of the term "regulation." In employing that term, we do not refer merely to restrictions or black and white prohibitions, but to a broad range of potential actions that might be undertaken to facilitate, protect, oversee, restrain, or restrict a given activity. A government's regulatory stance may range from promoting (through funding), permitting without restriction, tolerating or permitting within enforceable limits, discouragement (through withholding funding), and prohibition. And particular regulatory policies may range from information gathering and reporting, to monitoring, to oversight, to setting hortatory guidelines, to providing rules and regulations under penalty for violation, among others.


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