Rid Annette, Schmidt Harald
Department of Bioethics, National Institutes of Health, University of Zurich, Switzerland.
J Law Med Ethics. 2010 Spring;38(1):143-8. doi: 10.1111/j.1748-720X.2010.00474.x.
The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Its most recent 2008 version declares unprecedented universal primacy over all existing national or international ethical, legal, or regulatory requirements. This self-proclaimed status as a set of minimal ethical standards raises important questions about the Declaration's appropriate normative status. The present paper argues that the new claim of ethical primacy is problematic and makes the Declaration unnecessarily vulnerable to criticism. Future revisions of the Declaration should therefore remove this claim and strengthen the document, first, by clarifying its normative status as a set of strong default recommendations, to be followed unless there is compelling ethical reason to do otherwise; and second, by improving the substance of the Declaration through further precision, specification, and argument.
世界医学协会（WMA）的《赫尔辛基宣言》是最重要且最具影响力的国际研究伦理文件之一。其2008年的最新版本宣称，相对于所有现行的国家或国际伦理、法律或监管要求，具有前所未有的普遍首要地位。这种将自身标榜为一套最低限度伦理标准的地位，引发了关于该宣言适当规范地位的重要问题。本文认为，这种新的伦理首要地位主张存在问题，且使该宣言不必要地容易受到批评。因此，该宣言未来的修订应消除这一主张，并通过以下方式强化该文件：首先，明确其作为一套强有力的默认建议的规范地位，除非有令人信服的伦理理由否则应予以遵循；其次，通过进一步精确、细化和论证来改进宣言的实质内容。
