a Macquarie University.
Am J Bioeth. 2014;14(11):3-15. doi: 10.1080/15265161.2014.957416.
Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for-and demands on-these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The "balance" between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs.
许多医疗保健系统都包含允许特殊情况下的患者获得尚未经过证实的有益医疗干预的项目。本文我们考虑了这些特殊准入项目（SAP）的伦理理由和要求。SAP 有一个富有同情心的基础：它们为那些选择有限的患者提供了尝试尚未通过标准监管程序批准的干预措施的机会。但是，虽然它们表明医疗保健系统可以并且将对个人的痛苦做出反应，但 SAP 也有几个缺点，包括有可能破坏构成重大公共产品的监管和知识生成结构。这些考虑因素之间的“平衡”部分取决于 SAP 的使用范围有多广，但也取决于 SAP 是否可以为健康干预效果的知识生成做出贡献。我们认为，患者在使用 SAP 时通常应该被要求提供结果数据。
