This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies.

本文针对研究伦理学中的一个孤儿话题，即所谓的以人为本原则，即人类主体的利益应始终高于科学和社会的利益。尽管该原则在生物医学研究的大多数国际伦理和法律标准中占据中心地位，但在文献中主要是顺带评论。除了一些值得注意的例外，几乎没有关于该原则的含义和作用的深入讨论。几位作者指出，该原则是流行的、模棱两可的，并且显然与对无法给予同意的个人进行非有益研究的公认做法相冲突。有观点认为，这只是“一种空洞的比喻”，应该放弃。本文认为，首要原则远非“空洞的修辞格”，而应被视为一个三重概念：基本的解释性规则、程序性规则和旨在保护研究对象免受工具性待遇的实体性规则。和不可接受的风险。这种解释可以追溯到 1975 年赫尔辛基宣言中的主要监管和规范起源，但也承认在 20 世纪和 21 世纪之交发生的研究伦理和实践的变化。因此，对原则的建议解读不仅具有原创性，而且具有历史基础和规范性成果。它为广泛辩论的、