MANAGING ENHANCEMENT--ETHICAL AND PUBLIC POLICY ISSUES

在过去的一年里，我们一直在研究将人类基因组研究产品用于增强目的的前景所引发的伦理和法律问题。该项目将分为两个阶段：试图从一系列生物医学先例中收集有关问题的教训，并从这些分析中得出一套基本的伦理考虑，为社会政策提供参考。这项工作的第一阶段已接近完成，并产生了附录1所列的文件。在1998年期间，我们正在共同编写一本专著，试图阐明在个人决策、职业道德和公共决策层面上加强道德操守的问题，从而推进第二阶段的工作。与此同时，我们第一年的工作已经确定了将我们的分析应用于制定这一领域有效的社会政策方面的三个关键挑战。首先，大多数可用于增强的干预措施很可能是最初开发并批准用于治疗的。然而，一旦获得批准，目前的监管结构就没有提供足够的手段来管理临床医生及其客户出于增强目的而“非标签”地使用此类干预措施。其次，对植入前胚胎进行的任何增强干预都可能是在临床生殖生物学和不孕不育医学的很大程度上不受监管的背景下进行的。虽然我们目前的项目将使我们能够概述与这一领域的职业道德有关的考虑因素，但仍不清楚如何最好地执行这些标准。最后，植入前或植入后基因增强干预措施的可用性还将取决于我们在美国境外获得这些干预措施的政策。在我们的下一个项目中，我们建议对这三个问题进行细致的分析，因为它们将挑战基因增强技术的管理，并为公共政策制定者制定具体的政策建议，使这些问题能够在我们已经提出的考虑框架内得到解决。该项目的方法将主要是分析和论述的：我们将根据关于每个问题最接近的先例的文献，通过继续定期研究会议和合作写作的养生法来批评、构建和提出政策立场，这些会议和合作写作推动了我们迄今的工作。

For the past year we have been examining the ethical and legal issues raised by the prospect of using the products of human genome research for enhancement purposes. That project was to have two phases: attempting to glean lessons about the issues to anticipate from a range of biomedical precedents and, drawing from those analyses a set of basic ethical considerations to inform social policy. The first phase of this work is nearly complete and has produced the papers listed in Appendix 1. During 1998 we are pursuing the second phase by jointly authoring a monograph that attempts to articulate an ethics of enhancement at the levels of personal decision-making, professional ethics, and public policymaking. Meanwhile, our first year's work has already identified three critical challenges in applying our analysis to the development of effective social policy in this area. First, most interventions that can be used for enhancement are likely to be initially developed and approved for therapeutic use. However, once so approved, the current regulatory structure provides no adequate means of managing the "off-label" use of such interventions for enhancement purposes by clinicians and their clients. Second, any enhancement interventions performed on pre-implantation embryos are likely to be undertaken in the largely unregulated context of clinical reproductive biology and infertility medicine. While our current project will allow us to outline the considerations relevant to professional ethics in this area, it is still not clear how those standards would be best enforced. Finally, the availability of either pre-implantation or post-implantation genetic enhancement interventions will also depend on our policies regarding access to these interventions outside the boundaries of the U.S. In our next project we propose to undertake a close-grained analysis of these three problems as they will challenge the management of genetic enhancement technologies, and to develop specific policy recommendations for public policy makers that would allow the issues to be addressed within the framework of considerations we will have already set out. The project's methods will be primarily analytic and discursive: we will be critiquing, constructing, and proposing policy positions on the basis of the literature about the closest precedents for each of these problems by continuing the regimen of regular research meetings and collaborative writing that has propelled our work to date.