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This staff working paper was discussed at the Council's September 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:
Draft Recommendations

Over the past twenty months, the Council has devoted much time and energy to examining the current governance of the uses of biotechnologies that touch the beginnings of human life, practices arising at the intersection of assisted reproduction, genetic screening, and human embryo research. The Council has heard from various experts and stakeholders, engaged its own comprehensive diagnosis of current regulatory mechanisms and institutions, outlined the key findings emerging from that diagnosis, and surveyed various general and specific policy options. The Council now understands a great deal about the current regulatory landscape and has identified concerns that suggest the need for improved monitoring, oversight, and, perhaps, new forms of governmental regulation. Yet we are very far from being able to offer clear and well considered recommendations regarding major institutional reforms. We do not know the precise costs and benefits of overhauling existing regulatory institutions and practices or of creating new regulatory authorities. We do not even know enough about the incidence and severity of some of the possible risks and harms we have identified as causes of concern to judge whether they are serious enough to justify changing the present arrangements. We do not accurately know, for example, how the technologies and practices at the heart of our inquiry affect the health of those whose lives are touched by them — most notably, the children conceived with their aid. Similarly, we do not know how widely preimplantation genetic diagnosis or preconception (and preimplantation) sex selection will be practiced, and for which purposes. Without the answers to such questions, it would be premature at best to recommend dramatic legal or institutional changes. Further research and inquiry, and additional consultations with all the relevant actors, are clearly needed.

Yet even as such inquiry and consultation proceeds, the Council believes that some improvements can and should now be implemented to address some of the concerns identified as a result of our present inquiry. There are a number of measures, described in Sections I and II below, that the Council believes the federal government and the various relevant professional societies should adopt immediately. Most of these suggestions are aimed precisely at the remaining empirical questions described above. These include a call for comprehensive information gathering, data collection, monitoring, and reporting of the uses and effects of these technologies. They also address the need for improving informed decision-making, consumer protection, and enforcement of existing guidelines for practitioners of assisted reproductive technologies (ART). In addition, in Section III, we identify for Council discussion several aspects of the dignity of human procreation that may warrant interim prudent legislative action, especially in light of rapidly arriving innovations that signal new departures in human reproduction. Familiar disquiet regarding human cloning or commerce in human embryos and gametes is augmented by recent reports of fusion of male and female embryos into one chimerical organism, and of the derivation of gametes from embryonic stem cells (in principle enabling embryos to become biological parents). Accordingly, while policymakers monitor and gather information and while deliberation continues in search of better and more permanent monitoring and oversight arrangements, it may be necessary and desirable to enact interim prophylactic limitations. Such limitations would prevent individuals, acting on their own, from introducing major innovations into human procreation in the absence of full public discussion and deliberation about their ethical and social implications and consequences.

The recommendations we offer here are consensus recommendations of the Council. Though we differ about certain fundamental ethical questions in this field, and especially about the moral status of the human embryo, we have nevertheless been able to agree on several policy suggestions that we believe should command not only the respect but also the assent of most people of common sense, good will, and a public-spirited concern for human freedom and dignity. We have sought to frame these recommendations with sufficient specificity that they might be adopted by the relevant target audiences.


I. Federal Studies, Data Collection, Reporting, and Monitoring
regarding the Uses and Effects of These Technologies

A. Undertake a federally funded longitudinal study on the health and development impacts of ARTs on children born with their aid. A most important unanswered question before the Council concerns the precise effects of ART and adjunct technologies on the health and normal development of children born with their aid. There have been a few studies, mostly undertaken abroad, reaching variable and sometimes contrary results. An effort has been undertaken, by the Genetics and Public Policy Center in collaboration with the American Academy of Pediatrics and the American Society for Reproductive Medicine, to review all of the existing literature on this question. This is a laudable start, capable of identifying harmful health and development outcomes that should be monitored in the future. The Council strongly believes that what is needed now is a prospective longitudinal study that is national, comprehensive, and federally funded, and which looks at both the short-term and long-term effects of these technologies and practices on the health of children produced with their assistance, including any cognitive, developmental, or physical impairments. An ideal vehicle for this study is the National Children's Study now being planned by a consortium of federal agencies led by the National Institute of Child Health and Human Development (NICHD), which, beginning in 2005, will track the health and development of 100,000 children across the United States from before birth until age 21.

B. Undertake federally funded studies on the impacts of ARTs on women. Another area where better information would be helpful regards the health and well-being of women who use ARTs. One or more studies, either in conjunction with or separate from the above-mentioned longitudinal study should be conducted to discover the effects, if any, of the use of ARTs on women’s health, including any short-term or long-term hormonal, emotional, or physical impairments.

C. Undertake federally funded comprehensive studies on the uses and effects of reproductive genetic technologies. As noted above, assisted reproduction and genomic knowledge are increasingly converging. Practices such as preimplantation genetic diagnosis and gamete sorting represent the first fusion of these disciplines. Before these practices become routine, it is necessary for policymakers and the public to understand their present and projected uses and effects. To this end, there should be a federally funded comprehensive study, undertaken with the full participation of the ART industry, on how and to what extent such practices are currently and may soon be employed, and their health effects on children born with their aid. Mechanisms need to be developed for ongoing monitoring of the outcomes of these practices and others to which they may lead.

D. Strengthen and augment the Fertility Clinic Success Rate and Certification Act. As currently written, the FCSRCA is aimed at providing consumers with key information about the pregnancy and live-birth success rates of assisted reproduction clinics in the United States. We believe that the Act should be augmented and strengthened, both to improve this original function of consumer protection and to enable the federal government (through the already existing Centers for Disease Control ART surveillance program) to gather information and to monitor the development, uses, and effects of all technologies and practices that touch the beginnings of human life. Toward these ends, the Act should be improved and strengthened in the following ways.

1. Enhance Reporting Requirements.

(a) Efficacy: Provide more user-friendly reporting of data, including adding “patients” as an additional unit of measure. Currently, data are reported only in terms of “cycles” of treatment (beginning when a woman starts ovarian stimulation or monitoring), rather than in terms of individual patients treated. Thus, it is impossible to know how many individuals undergo assisted reproduction procedures in a given year, how many patients achieve success in the first (or second or third) cycle, how many women fail to conceive, and the like. Presenting results in terms of numbers of individuals would be more meaningful to prospective patients and would yield more precise information for policymakers.

(b) Risks and Side Effects: Require reporting of all adverse health effects. There is today no mechanism for reporting adverse health effects of assisted reproductive technologies, either for the adult patients or for the children produced. Such adverse effects are of paramount concern for prospective patients, policymakers, and the public at large. ART clinics should be asked to provide data on the incidence of adverse effects on women undergoing treatment, as well as on the health and development of children born using ART, at least through the first year of life.

(c) Costs: Require the reporting of the average costs of the procedures and successful pregnancy. There is currently no comprehensive source of information regarding these costs. Not surprisingly, prospective patients are keenly interested in this information. Moreover, policymakers interested in questions regarding equality of access and related matters would greatly benefit from such information. It would shed light on the incentives currently at work that may induce patients and clinicians to engage in risky behavior, such as the transfer of multiple embryos in each cycle, in an effort to reduce costs.

(d) Untransferred Embryos: Require reporting of creation, use, and disposition of embryos. There is at present no means of reporting or monitoring the creation, use, and disposition of embryos produced in the context of assisted reproduction. By requiring such reporting, the federal government would signal a measure of respect for nascent human life and would allow prospective patients, policy makers, and the public to better understand the actual practice of assisted reproduction. Specifically, it would yield information regarding the number of embryos typically required to achieve a successful pregnancy, the ultimate disposition of untransferred embryos, and present and projected numbers of embryos in cryopreservation, as well as the rules and practices regarding the fate of the stored embryos.

(e) Innovative Techniques: Include information on novel and experimental procedures. A key area of concern for the Council is the ease and speed with which experimental technologies and procedures (such as intracytoplasmic sperm injection [ICSI] or preimplantation genetic diagnosis [PGD]) move into clinical practice, even in the absence of careful clinical trials regarding the efficacy and long-term consequences. It would be useful for consumers and policymakers to understand more fully how each clinic manages this process and what safeguards are in place. Such information would include human subjects protections, the extent to which technologies are tested in animals, the standards that must be satisfied before a given procedure is deemed fit for clinical use, and the measures taken to evaluate safety and efficacy.

(f) Adjunct Technologies: Require more specific reporting on the frequency of, and reasons for, uses of specialized techniques (such as ICSI), genetic diagnosis, sperm sorting for sex-selection, etc. Little is understood about the frequency and uses of the various adjunct technologies and practices complementing standard IVF. While the current version of the Act provides some raw data on the number of cycles in which certain techniques are used, this information is inadequate for policymakers and the public to understand fully the contours of present practice. For example, the present system of reporting sheds no light on why patients chose ICSI as their preferred method of fertilization. The CDC reported that in 2000, ICSI was used in 46 percent of all IVF cycles, yet in nearly 40 percent of these instances the prospective patients did not suffer from male factor infertility. Also, because results are reported in terms of cycles rather than patients (as discussed above), it is impossible to know how many individuals used ICSI in 2000. Other techniques, particularly those fusing reproductive technology and genomic knowledge, are not reported at all under the present version of the Act. For example, there is no requirement to report the number of cycles using PGD, much less the reasons for using PGD. For example, how many patients using PGD are infertile? How many have family histories of genetic disorders? What sort of screening is being done? For aneuploidy and single-gene mutations? For donor siblings? For non-medical traits? There is also no reporting of any practices in which sex selection occurs, and the reasons for undertaking them. Consumer protection and public policy would be enhanced if this information were included. Consumers would benefit from knowing how much experience a given clinic has in performing such procedures. Policymakers and the public would benefit from knowing how, why, and to what extent genomic knowledge is being used to enhance control over procreation.

2. Enhance Patient Protections.

(a) Improved Measures of Reporting: De-emphasize per cycle “success rates” as chief benchmark. By narrowly focusing on pregnancy and birth rates per cycle, the Act may unintentionally be creating incentives for clinicians and patients to adopt practices that carry extra risks to health and safety. For example, it might encourage the transfer of an increased number of embryos, leading to more multiple gestations that threaten both mother and children, or it might encourage additional use of ICSI to increase the success rate, even in the absence of male-factor infertility. Also, the present emphasis on a clinic’s success rate might induce clinicians to reject patients whose chance of pregnancy is low. 1 Finally, success rates are highly manipulable. For example, clinicians can reclassify unsuccessful cycles in an effort to improve their overall statistics. For example, such clinics might classify their most difficult cases as “research” rather than as cycles of treatment that must be reported to the CDC.

(b) Informed decision-making: Provide model decision-making form. The present Act would be greatly improved by providing for the promulgation of an easy-to-read model consent form that includes information on the possible health risks to mother and child, the novelty of the various procedures used, the number of procedures performed to date, the outcomes, and the various safeguards in place to ensure that such procedures are safe and effective.
3. Improve Implementation.
(a) Enforcement: Provide stronger penalties to enhance compliance. Under the Act as currently written the only penalty for noncompliance is publication of the names of non-reporting clinics. This is insufficient, given the importance of clinic compliance to ART customers and the greater public. The penalties should reflect the magnitude of harms to be avoided. We leave to legislators the question of what precisely these should be.

(b) ?Funding: Increase funding for CDC’s ART surveillance project. CDC’s budget should be augmented sufficiently to enable it to undertake the additional measures suggested above. We leave to legislators the question of how much additional funding would be required.


II. Increased Oversight by Professional Societies and Industry

Professional oversight has traditionally been the principal mechanism of regulation for the practice of medicine. While there is a well developed body of professional guidelines and standards for the clinical practice of assisted reproduction, the Council has identified the following substantive areas that require attention and improvement:

A. Improve informed decision-making. Clinicians and their professional societies should make efforts to improve the current system of informed decision-making to conform to the concerns and suggestions described above. ASRM and SART (Society for Assisted Reproductive Technology) should pay attention not only to helping devise an improved and standardized consent form, but also to recommending procedures to their members for discussing it properly with patients and securing their meaningful consent. For this purpose, they should consider making training sessions on this subject a requirement of membership.

B. Treat children-to-be as patients. ART clinicians should take measures to ensure the health and safety of all participants in the ART process, including the children who are born as a result. To this end, ART clinicians should collaborate with pediatricians in making decisions that might affect the health and safety of these children. Moreover, they should not view their responsibility as ending once a pregnancy has been initiated. Clinicians and professional societies should also cooperate fully and vigorously with any efforts (such as the studies described in part I above) to study the effects of ART and related practices on the health and development of such children. As a substantive matter, clinicians and professional societies should take concrete steps to reduce the incidence of multiple embryo transfers and resulting multiple births.

C. Improve enforcement of existing guidelines. There are today a host of meaningful guidelines in place for clinicians and practitioners engaged in ART. However, the relevant professional societies need to take stronger steps to ensure that these guidelines are followed. For example, one such society “actively discourages” the use of PGD for sex selection for non-medical purpose, yet several prominent members of the society openly advertise the practice. Professional societies must clarify the contours of appropriate conduct and adopt reasonable mechanisms of enforcement.

D. Improve procedures for movement of experimental procedures into practice. Professional societies and clinicians should develop a more systematic mechanism for reviewing experimental procedures before they become part of standard clinical practice. Such a system might include requirements for animal studies, IRB oversight, and formal discussion of the significance and results of novel procedures.

E. Create and enforce minimum, uniform standards for human subjects protection. At present there is no systematic, mandatory mechanism for protecting human subjects who are engaged in experimental ART protocols not affiliated with institutions receiving federal funds. This problem is compounded by the fact that there is not a clear distinction between research and innovative clinical practice in the context of ART. Investigational interventions that could affect the health and well-being of a future child should be subjected to at least as much ethical scrutiny and regulatory oversight as investigational interventions affecting humans after birth. A higher degree of scrutiny and oversight is justified in this context, because those affected by the interventions cannot protect their interests and prospective parents may have interests that conflict with those of the future child. Clinicians and their professional societies should adopt measures (such as IRB-like oversight) to provide safeguards to protect the health and well-being of human subjects.

F. Develop self-imposed ethical boundaries. Clinicians and professional societies would be well advised to establish for themselves clear boundaries defining what is and what is not ethically appropriate conduct, in the context of both research and clinical practice. Recent events have shown that without such guidance rogue clinicians and scientists may engage in practices that will, fairly or unfairly, bring opprobrium on the discipline as a whole. Practices such as the fusion of male and female embryos, use of gametes harvested from fetuses (or produced from stem cells) to create embryos, and transfer of embryos to non-human uteri for purposes of research fall squarely into this category. The relevant professional societies should preemptively take a firm stand against such practices and back it up with meaningful enforcement.


III. Possible Targeted Measures to Defend the Dignity of Human Procreation

Several particular practices and techniques (some present, some likely forthcoming) that touch the beginnings of human life raise new and distinctive challenges to the special character and dignity of human procreation. For that reason they require special attention, not only from professional societies but also from the people’s representatives. Especially because technological innovations are coming quickly and because there are today no other institutions capable of setting appropriate limits, we believe the Congress should consider some targeted measures that might give expression to and provide protection for the dignity of human procreation, by limiting the practice of a number of carefully defined activities. These measures would remain operative at least until policy makers and the public can discuss the possible impact and human significance of these new possibilities and deliberate about how they should be governed or regulated.

A concern for the integrity and dignity of human procreation might give rise to a fairly wide range of specific provisions, and the Congress should consider these in their full array. But the concerns we have taken up in this report, and which emerge from our findings, suggest to us a few that are especially crucial, and also especially likely to command fairly broad assent. They may be usefully grouped around the following four principles and desiderata:

1. Respect for the humanity of human procreation, preserving a clear boundary between the human and the non-human (or, between the human and the animal).

2. Respect for women and human pregnancy, protecting them against certain exploitative and degrading practices.

3. Respect for children born with assisted reproductive technologies, securing for them the same rights and human attachments naturally available to children conceived in vivo.

4. Respect for early stages of nascent human life, setting some agreed upon boundaries on why embryos may be made and how they may be used and treated.

The following suggestions indicate the kinds of specific measures that could give concrete expression to these goals and that might serve as safe interim boundaries, as public deliberation tries to catch up with rapidly changing technologies.

For instance, in an effort to guard the humanity of human procreation, Congress might consider a ban (or moratorium) on the production of human-animal chimeras, produced either by combining a human gamete with a gamete from any non-human species or by combining blastomeres from human and non-human embryos to produce a hybrid human-animal embryo. Legislators might also proscribe the transfer, for any purpose, of any human embryo into the body of any member of a non-human species.

To guard the dignity of women and of human pregnancy, legislators might institute measures to carefully limit the purposes for which a pregnancy may be initiated artificially. Congress might, for instance, prohibit the initiation of a human pregnancy (using embryos produced ex vivo) for purposes of research, for purposes of securing fetal tissues or organs for transplant, or for any purpose other than to attempt to produce a live-born child. It might also consider restrictions on so-called “surrogate pregnancy,” at least for pay.

To guarantee that all children conceived through assisted reproduction techniques receive a full and equal share in our common human origins, legislators might act to make certain that no child conceived by means of artificial reproductive technologies be denied two (adult, not fetal or embryonic) human biological parents. This, for instance, might lead to a prohibition on attempts to conceive a child using gametes from more than two or less than two human parents, or by any means other than the union of egg and sperm obtained directly from such parents. It might also lead to specific prohibitions on creating a human embryo from the fusion of blastomeres from two or more other embryos, or by fertilization using gametes obtained from a human fetus or derived from human embryonic stem cells.

In addition, some measures may be taken to show a decent respect for the early stages of nascent human life, and therefore set some general boundaries on how human embryos may be used and treated. This subject can of course arouse great controversy, but we believe some measures may be agreeable to all parties to the significant ongoing dispute over the moral status of the embryo, whether as modest steps toward the protection of nascent life, or as demonstrations of a limited but nonetheless genuine respect for the human embryo. These may include a prohibition on the use in research, or the preservation for the purpose of conducting research, of any human embryo past the tenth day of development (not counting any time during which it is stored in a frozen state); and a prohibition on the buying and selling of any human organism, at any stage of development. They may also include a moratorium on creating human embryos solely for the purpose of research.

Moreover, these concerns, combined with a certain ambiguity in the patent laws, also suggest the need for a provision instructing the United States Patent and Trademark Office not to issue patents on claims directed to or encompassing a human organism at any stage of development; and amending Title 35, United States Code, section 271(g) (which extends patent protections to products resulting from a patented process) to exclude any product which is a human organism at any stage of development. Such a law should, however, be quite careful to clarify that human genes, human stem cell lines, and processes that result in human organisms will still be eligible for patents.

Of course, these are by no means the only possible legislative measures Congress might take to limit practices that put at risk the dignity of human procreation. We believe, however, that some provisions along these lines are at present among the most needful and most likely to win agreement.

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Endnotes

1. There are, of course, defensible reasons to reject such patients, and it is arguably unethical to encourage hopes in couples whose chances of pregnancy are extremely low, or to take their money for a service that is unlikely to do them any good.


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