Designing Our Descendants: The Promises and Perils of Genetic Modifications

20 Recommendations for Policy

c h a p t e r t w e n t  Recommendations for Policy Mark S. Frankel, Ph.D., and Audrey R. Chapman, Ph.D. The technologies of inheritable genetic modifications (IGM) will be highly seductive to those who welcome them as a positive step toward shaping our genetic future. Their appeal, however, must be weighed against the uncertainty associated with their safety and the profound ethical and religious questions raised by conscious efforts to design our descendants. As advances in genetics move us ever more closely to a threshold decision on IGM, the AAAS study proposed a number of policy recommendations (see Appendix B), some of which have become even more compelling in the light of events occurring since it was published. This chapter considers those new developments in reviewing both the context and substance of policy recommendations . Balancing Scientific Freedom and Responsibility Inheritable genetic modifications (IGMs) are likely to generate both high hopes and uneasiness. Currently, it is the policy of the federal government not to “entertain proposals for germ line alterations.”1 This is not a policy of pro- scription; there is no explicit ban on such research. Rather, it is a policy that takes the view that it is premature on scientific and ethical grounds to proceed with IGM.Presumably,if these conditions were to change appreciably,the government would reconsider the policy. Certainly, change will not occur without allowing research to proceed at some level, concurrent with appropriate oversight and a societywide dialogue on the moral questions surrounding IGM. This policy imposes a heavy responsibility on scientists and their institutions, whether academic or commercial. Society expects scientists to pursue research within the constraints of established social controls, such as those to protect the rights and welfare of human subjects, and according to the norms and ethical traditions of the scientific community. To act responsibly, therefore, with respect to IGM means not engaging in such research until public oversight mechanisms are in place to review proposals,while also supporting educational efforts to help scientists and the public consider the broader implications of the research. Yet, in 2001 researchers reported “the first case of human germline genetic modification resulting in normal healthy children.”2 The research involved the transfer of ooplasm from donor eggs into the eggs of women with recurring failure of embryos to implant in their uteruses. An inadvertent consequence of this procedure, which the clinic reported had “led to the birth of 30 babies worldwide,”3 was that the donated mitochondrial DNA, as well as that of the birth mother, was found in the cells of those babies born by this method. The report was met with ethical disapproval in some quarters of the United States4 and British commentators reminded us that the procedure would be illegal in the United Kingdom.5 In light of the uncertainties regarding the safety of mitochondrial manipulation in the germ line,6 and the lack of informed discussion of the ethical and social implications of the work, it is imperative that we move quickly to implement a system of oversight that will enable us to make informed and reasoned choices about what place this and other IGM technologies should have in our society. The remainder of this chapter outlines the rationale and thrust of what we believe is the needed system of oversight. Effective Public Oversight There are basically four reasons for instituting a system of public oversight for IGM. Recommendations for Policy 327 Public Safety We must be vigilant to protect the safety of those participating in experimentalstudies ,amoralimperativeevenmorecriticalwithIGMresearchsincethewellbeing of future children will be affected. Concern for public safety is heightened by the intense commercial interest in genetics research and potential applications, where pressures for quick results—and profits—have led to claims that a rush to clinical trials has outstripped our understanding of the basic science involved.7 Social Values While the private sector can contribute valuable resources in developing IGM, the public interest requires the promotion of broad social values, such as freedom of scientific inquiry, assurances that people in need will have access to benefits derived from research, and that decisions on the uses of IGM will be openly vetted in the arena of public discourse.Effective public involvement will help to ensure that the scope and direction of IGM research reflect adequate attention to public...