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Chapter 29 Formation of policy for emerging reproductive technologies
Chapter 29 Formation of policy for emerging reproductive technologies Rapid advance in ART, addressed in other chapters of this report, has contributed to a wave of questions about traditional attitudes and policies concerning reproduction. It is clear that the use of ART touches key issues, beyond general medical ones, not only for individuals but also for families and for society as a whole. These issues include hereditary lineage, the status of marriage, and the family. In turn, the fundamental nature of these issues and questions has generated more searching analyses of attitudes and policies concerning reproduction, and a recognition that existing ones may not adequately deal with present or prospective innovations. A legitimate question is raised whether ART should be treated differently from medical practice in general. Accordingly, this chapter focuses on the process of policy formation in the United States and provides recommendations for the application of these processes to the special and always controversial area of human reproduction. GENERAL OPTIONS PROVIDED BY THE U.S. POLICY PROCESS
Policy consists of general statements that are intended to be applied as standards or guides for specific actions. Policy may be made in both private and public sectors, by professional or lay groups, at any level of society, from individuals to international communities. It should be clear that reproductive policy need not be exclusively public or private; indeed, it is precisely on the question of the division between these two sectors that much controversy arises. For example, people may fully agree that the objective of a proposed policy is sound but may totally disagree on the respective roles of the public and private sectors. Implementation of policy varies in the degree and kind of intervention required. So-called laissezfaire policy carries no restrictions and requires no intervention; some predictable uncertainty and other possible unfavorable consequences are the prices to be paid. Such policy is sometimes resorted 868
Supplement 1
to as a matter of principle and sometimes as the easiest way to avoid hard decisions. Policy that emphasizes dissemination of information intervenes minimally, with reliance on informed choices to achieve policy objectives. An educational campaign calculated to change behavior in particular ways clearly intervenes more; introduction of incentives and penalties into such a campaign intervenes still more. Prescriptive regulation can be carried out in a number of ways and constitutes still stronger intervention. Policies differ in response to the degree of urgency. A single, slowly developing, noncrisis issue may invoke a laissez-faire response, if only to permit better evaluation of the nature and magnitude of the problem. A perceived set of slowly rising issues may be approached on a case-by-case basis because their interconnection, if any, may not yet be clear. On the other hand, a rapidly rising set of clearly connected issues invites a comprehensive policy based on some encompassing principle, although the comprehensiveness of the policy may generate broader consequences than originally perceived. It should be noted that disagreement on the degree of urgency often complicates appraisal of the issue itself. This complication may divert the debate from substance to procedural conflict between those who press for immediate policy decision and those who would go slowly to allow for further factfinding and deliberation. Policies also vary in the degree of their direction toward individual or institutional action in the private sector or toward public action by local, state, or federal government. Policy regarding reproduction is especially controversial in this dimension. Finally, if some kind of intervention is required by a given policy, there is a wide range of possible mechanisms. In reproduction, these mechanisms include licensure, certification, advisory bodies such as the Institutional Review Boards, quasigovernmental groups such as the National Research Council, and a plethora of existing or imaginable state and federal regulatory agencies. It is with this background of diversity in our Fertility and Sterility
national policy process that the Committee has confronted the issues and opportunities presented by ART. What policy structure currently exists to deal with reproductive issues and in what ways is it adequate or inadequate to cope with present problems and future contingencies?
CURRENT STATUS OF REPRODUCTIVE POLICY
United States policy regards human reproduction as constitutionally private and privileged, not to be interfered with by government at any level without a demonstrable compelling interest. The policy trend has been to reaffirm the privacy doctrine in all areas. In the last decade, because of the sharply polarized opinion over abortion, other reproductive issues have often been avoided in the interest of not becoming involved in a complex and seemingly no-win conflict area. This tendency has largely delayed consideration of appropriate policy for ART, such as in IVF. For example, there is no prescribed, uniform procedure for accurate recording and disclosure of pregnancy rates, no means of certification for professional competence, and no specific address to the unique issues raised by preembryo freezing. Nor is there any official government encouragement for research to improve the IVF procedure. In the 1970s, policy regarding embryo and fetal research became a focus of concern. From 1973 to 1975, the then U.S. Department of Health, Education, and Welfare (HEW) developed and promulgated a set of regulations dealing with IVF and embryo transfer, as well as research on fetuses, pregnant women, and children (U.S. Dept. of HEW, 1975). These regulations included the following provision: No application or proposal involving human in vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethics Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint.
Because an Ethics Advisory Board was not appointed until 1977 and ceased to exist in 1980 because its charge and membership were not renewed at the end of its first term, the regulations of 1975 became a de facto moratorium on all research on IVF and embryo transfer supported by the U.S. Department of Health and Human Services (HHS, formerly HEW). This is the case despite the fact Vol. 62, No.5, November 1994
that one of the four major conclusions of the Board was as follows: The Board finds it acceptable from an ethical standpoint for the Department to support or conduct research involving human in vitro fertilization and embryo transfer, provided that the applicable conditions set forth (in other conclusions) are met (Ethics Advisory Board, 1979).
The report and its conclusions were never acted on by successive Department Secretaries. Although this course of events effectively established a policy of federal nonsupport of research in human IVF and embryo transfer, it did not prohibit either research or clinical activity in the area if not federally funded. It may, however, have inhibited nonfederal support as well. Nevertheless, as noted in other chapters, clinical activity has expanded rapidly in the private sector, although levels of efficacy have varied substantially and, in the most experienced centers, have tended to plateau somewhat below the success rate of natural reproduction (20% to 25% per reproductive cycle in which a woman is sexually active). Practitioners believe that overall efficacy might be improved further if knowledge could be expanded through systematic observation and research. Clinical trials have been cautiously attempted with the approval of local Institutional Review Boards or their equivalent, but -in the absence of federal funding and general guidelines-there has been considerable reluctance and uncertainty about how far and in what direction to proceed. In 1993, Congress repealed the regulation that imposed the de facto moratorium on federal funding for research involving human IVF (chapter 6). However, it has not created a mechanism for developing public policy pertaining to ART. There is a continuing need for a comprehensive analysis of current policy and consideration of what new policies may be required to match the rapidly advancing reproductive technologies.
COMMITTEE RECOMMENDATIONS
The initiative taken by The American Fertility Society in launching this study and report should be continued, preferably in concert with other groups involved in ART. Ethically informed policy guidelines, such as those outlined in this report, should be promulgated by these groups for the voluntary compliance of Supplement 1
878
health professionals involved in ART. The guidelines should be directed toward quality assurance in the provision of reproductive health care, which should include both technical excellence and professional ethical responsibility. The latter should include full disclosure of success rates and risks, both overall and at individual health care centers, to permit patients to make choices of centers and alternative procedures (chapter 27). To assess broader implications and requirements of ART, wider participatory deliberation is required, as has been undertaken in Australia, Great Britain, and other countries. This can only be done through one or more mechanisms at a level that assures wide national impact, access, and participation. The objective is to monitor emerging reproductive technologies and issues, to study and deliberate on them, and to formulate, as necessary, general principles for altered or new policies. The Committee recommends that The American Fertility Society actively seek and encourage such anational effort. In 1992, The American Fertility Society and the American College of Obstetricians and Gynecologists took a major positive step in creating the National Advisory Board on Ethics in Reproduction (NABER). It was expected that this Board would identify and publicize constructive policies relative to biomedical and behavioral research associated with reproductive technologies and relative to the use of these technologies in the practice of medicine. However, NABER has neither the authority nor the resources that a public Board would normally have. The Committee recommends, there-
888
Supplement 1
fore, that The American Fertility Society continue to press for creation of one or more public federal forums (see chapter 6). Under such auspices, the actual deliberative group should be constituted to be widely representative in expertise and in moral and social outlook. It should be charged to function with public access, both to the deliberative process itself and also to the rationale for its recommendations. The group should consider the means of implementing its recommendations but should not itself be implementative in function. So that wider public understanding and betterinformed individual choices can be promoted, particularly among the young, public education on ART should be emphasized as fundamental to effective reproductive policy. The nature and implications of ART should be fully addressed, because they affect individuals and families as well associety as a whole. Emphasis should be placed on broad, fundamental moral and social issues, which may not only challenge attitudes and traditions but which must also be compatible with the foreseeable future. The Committee recommends that The American Fertility Society should continue to actively promote its broad educational effort. Within sound policy to protect private, individual procreative choice and informed consent, appropriate research should be undertaken in support of ART. To this end, the U.S. Department of Health and Human Services should encourage funding for research in the area under approved human experimentation guidelines and in light of such additional guidelines as are suggested in this report.
Fertility and Sterility
Policy consists of general statements that are intended to be applied as standards or guides for specific actions. Policy may be made in both private and public sectors, by professional or lay groups, at any level of society, from individuals to international communities. It should be clear that reproductive policy need not be exclusively public or private; indeed, it is precisely on the question of the division between these two sectors that much controversy arises. For example, people may fully agree that the objective of a proposed policy is sound but may totally disagree on the respective roles of the public and private sectors. Implementation of policy varies in the degree and kind of intervention required. So-called laissezfaire policy carries no restrictions and requires no intervention; some predictable uncertainty and other possible unfavorable consequences are the prices to be paid. Such policy is sometimes resorted 868
Supplement 1
to as a matter of principle and sometimes as the easiest way to avoid hard decisions. Policy that emphasizes dissemination of information intervenes minimally, with reliance on informed choices to achieve policy objectives. An educational campaign calculated to change behavior in particular ways clearly intervenes more; introduction of incentives and penalties into such a campaign intervenes still more. Prescriptive regulation can be carried out in a number of ways and constitutes still stronger intervention. Policies differ in response to the degree of urgency. A single, slowly developing, noncrisis issue may invoke a laissez-faire response, if only to permit better evaluation of the nature and magnitude of the problem. A perceived set of slowly rising issues may be approached on a case-by-case basis because their interconnection, if any, may not yet be clear. On the other hand, a rapidly rising set of clearly connected issues invites a comprehensive policy based on some encompassing principle, although the comprehensiveness of the policy may generate broader consequences than originally perceived. It should be noted that disagreement on the degree of urgency often complicates appraisal of the issue itself. This complication may divert the debate from substance to procedural conflict between those who press for immediate policy decision and those who would go slowly to allow for further factfinding and deliberation. Policies also vary in the degree of their direction toward individual or institutional action in the private sector or toward public action by local, state, or federal government. Policy regarding reproduction is especially controversial in this dimension. Finally, if some kind of intervention is required by a given policy, there is a wide range of possible mechanisms. In reproduction, these mechanisms include licensure, certification, advisory bodies such as the Institutional Review Boards, quasigovernmental groups such as the National Research Council, and a plethora of existing or imaginable state and federal regulatory agencies. It is with this background of diversity in our Fertility and Sterility
national policy process that the Committee has confronted the issues and opportunities presented by ART. What policy structure currently exists to deal with reproductive issues and in what ways is it adequate or inadequate to cope with present problems and future contingencies?
CURRENT STATUS OF REPRODUCTIVE POLICY
United States policy regards human reproduction as constitutionally private and privileged, not to be interfered with by government at any level without a demonstrable compelling interest. The policy trend has been to reaffirm the privacy doctrine in all areas. In the last decade, because of the sharply polarized opinion over abortion, other reproductive issues have often been avoided in the interest of not becoming involved in a complex and seemingly no-win conflict area. This tendency has largely delayed consideration of appropriate policy for ART, such as in IVF. For example, there is no prescribed, uniform procedure for accurate recording and disclosure of pregnancy rates, no means of certification for professional competence, and no specific address to the unique issues raised by preembryo freezing. Nor is there any official government encouragement for research to improve the IVF procedure. In the 1970s, policy regarding embryo and fetal research became a focus of concern. From 1973 to 1975, the then U.S. Department of Health, Education, and Welfare (HEW) developed and promulgated a set of regulations dealing with IVF and embryo transfer, as well as research on fetuses, pregnant women, and children (U.S. Dept. of HEW, 1975). These regulations included the following provision: No application or proposal involving human in vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethics Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint.
Because an Ethics Advisory Board was not appointed until 1977 and ceased to exist in 1980 because its charge and membership were not renewed at the end of its first term, the regulations of 1975 became a de facto moratorium on all research on IVF and embryo transfer supported by the U.S. Department of Health and Human Services (HHS, formerly HEW). This is the case despite the fact Vol. 62, No.5, November 1994
that one of the four major conclusions of the Board was as follows: The Board finds it acceptable from an ethical standpoint for the Department to support or conduct research involving human in vitro fertilization and embryo transfer, provided that the applicable conditions set forth (in other conclusions) are met (Ethics Advisory Board, 1979).
The report and its conclusions were never acted on by successive Department Secretaries. Although this course of events effectively established a policy of federal nonsupport of research in human IVF and embryo transfer, it did not prohibit either research or clinical activity in the area if not federally funded. It may, however, have inhibited nonfederal support as well. Nevertheless, as noted in other chapters, clinical activity has expanded rapidly in the private sector, although levels of efficacy have varied substantially and, in the most experienced centers, have tended to plateau somewhat below the success rate of natural reproduction (20% to 25% per reproductive cycle in which a woman is sexually active). Practitioners believe that overall efficacy might be improved further if knowledge could be expanded through systematic observation and research. Clinical trials have been cautiously attempted with the approval of local Institutional Review Boards or their equivalent, but -in the absence of federal funding and general guidelines-there has been considerable reluctance and uncertainty about how far and in what direction to proceed. In 1993, Congress repealed the regulation that imposed the de facto moratorium on federal funding for research involving human IVF (chapter 6). However, it has not created a mechanism for developing public policy pertaining to ART. There is a continuing need for a comprehensive analysis of current policy and consideration of what new policies may be required to match the rapidly advancing reproductive technologies.
COMMITTEE RECOMMENDATIONS
The initiative taken by The American Fertility Society in launching this study and report should be continued, preferably in concert with other groups involved in ART. Ethically informed policy guidelines, such as those outlined in this report, should be promulgated by these groups for the voluntary compliance of Supplement 1
878
health professionals involved in ART. The guidelines should be directed toward quality assurance in the provision of reproductive health care, which should include both technical excellence and professional ethical responsibility. The latter should include full disclosure of success rates and risks, both overall and at individual health care centers, to permit patients to make choices of centers and alternative procedures (chapter 27). To assess broader implications and requirements of ART, wider participatory deliberation is required, as has been undertaken in Australia, Great Britain, and other countries. This can only be done through one or more mechanisms at a level that assures wide national impact, access, and participation. The objective is to monitor emerging reproductive technologies and issues, to study and deliberate on them, and to formulate, as necessary, general principles for altered or new policies. The Committee recommends that The American Fertility Society actively seek and encourage such anational effort. In 1992, The American Fertility Society and the American College of Obstetricians and Gynecologists took a major positive step in creating the National Advisory Board on Ethics in Reproduction (NABER). It was expected that this Board would identify and publicize constructive policies relative to biomedical and behavioral research associated with reproductive technologies and relative to the use of these technologies in the practice of medicine. However, NABER has neither the authority nor the resources that a public Board would normally have. The Committee recommends, there-
888
Supplement 1
fore, that The American Fertility Society continue to press for creation of one or more public federal forums (see chapter 6). Under such auspices, the actual deliberative group should be constituted to be widely representative in expertise and in moral and social outlook. It should be charged to function with public access, both to the deliberative process itself and also to the rationale for its recommendations. The group should consider the means of implementing its recommendations but should not itself be implementative in function. So that wider public understanding and betterinformed individual choices can be promoted, particularly among the young, public education on ART should be emphasized as fundamental to effective reproductive policy. The nature and implications of ART should be fully addressed, because they affect individuals and families as well associety as a whole. Emphasis should be placed on broad, fundamental moral and social issues, which may not only challenge attitudes and traditions but which must also be compatible with the foreseeable future. The Committee recommends that The American Fertility Society should continue to actively promote its broad educational effort. Within sound policy to protect private, individual procreative choice and informed consent, appropriate research should be undertaken in support of ART. To this end, the U.S. Department of Health and Human Services should encourage funding for research in the area under approved human experimentation guidelines and in light of such additional guidelines as are suggested in this report.
Fertility and Sterility