Hurwitz B
Department of General Practice, St. Mary's Hospital Medical School, London, UK.
J Eval Clin Pract. 1995 Sep;1(1):49-60. doi: 10.1111/j.1365-2753.1995.tb00007.x.
Proliferation of clinical guidelines has given rise to a number of concerns about the status of clinical advisory statements. Are guidelines advisory or mandatory? What regulatory functions do guidelines serve; do they allow clinical discretion a large enough role? Relationships between legislation and guidelines, and the way courts go about determining the legal status of guidelines, are explained. The following questions in the context of the law of negligence are addressed. Do doctors who deviate from guidelines place themselves at increased risk of being found liable in negligence if patients suffer injury as a result? Could compliance with guidelines protect health care workers from liability in such circumstances? What legal responsibility do the developers and issuers of guidelines have if their guidance is found to be faulty? Common law cases featuring clinical guidelines or protocols have been identified from the database Lexis, which searches the full text of the transcripts and reports of court cases in UK, Commonwealth and United States jurisdictions. Secondary literature, identified from the bibliography of clinical guidelines maintained by the Department of Health Services Research at the University of Aberdeen (assembled from DHSS-DATA, Embase, Grateful Med, Medline and SIGLE) has also been consulted. The legal status of a guideline turns on whether its development and application have statutory backing, and whether the guideline embodies clinical practices accepted as proper by a responsible body of doctors. The mandatory effects of guidelines can be gauged, to some extent, by the sanctions that apply in the event of non-compliance. US courts have ruled that guideline developers can be held liable for faulty guidelines, and that doctors cannot pass off their liability by claiming that adherence to guidelines has corrupted clinical judgement. Protocols and guidelines provide the courts with examples of clinical standards across a wide range of medical practice. As guidelines proliferate, so they will increasingly be used in court. However, adherence to guidelines has not automatically been equated with reasonable practice, and the courts seem unlikely to follow the standards enunciated in clinical guidelines without critically evaluating their authority, flexibility and scope of application.
临床指南的激增引发了人们对临床咨询声明地位的诸多担忧。指南是具有咨询性还是强制性？指南发挥着哪些监管功能；它们是否给予临床自由裁量权足够大的空间？文中解释了立法与指南之间的关系，以及法院确定指南法律地位的方式。本文探讨了过失法背景下的以下问题。如果患者因医生偏离指南而受伤，那么这些医生是否更有可能被判定存在过失责任？在这种情况下，遵守指南能否使医护人员免于承担责任？如果指南的制定者和发布者的指导意见被发现存在缺陷，他们应承担何种法律责任？已从Lexis数据库中找出涉及临床指南或方案的普通法案例，该数据库可搜索英国、英联邦和美国司法管辖区法院案例的庭审记录和报告全文。还查阅了阿伯丁大学卫生服务研究部维护的临床指南参考文献（由卫生与社会保障部数据、Embase、Grateful Med、Medline和SIGLE汇编而成）中的二手文献。指南的法律地位取决于其制定和应用是否有法定依据，以及该指南是否体现了负责任的医生群体认可为恰当的临床实践。在某种程度上，可通过对不遵守指南时适用的制裁措施来衡量指南的强制效力。美国法院裁定，指南制定者可能会因有缺陷的指南而承担责任，并且医生不能以遵循指南已损害临床判断为由推卸自己的责任。方案和指南为法院提供了广泛医疗实践中临床标准的示例。随着指南的不断增多，它们在法庭上的使用也会越来越频繁。然而，遵循指南并不自动等同于合理的医疗行为，而且法院在没有严格评估其权威性、灵活性和适用范围的情况下，似乎不太可能遵循临床指南中阐明的标准。
