The Need to Revise the Declaration of Helsinki

The Declaration of Helsinki requires revision because it is defective in two important respects; it relies on a distinction between therapeutic and nontherapeutic research; all documents that rely on this spurious distinction contain errors not intended by their authors.

Abstract

The Declaration of Helsinki requires revision because it is defective in two important respects. First, it relies on a distinction between therapeutic and nontherapeutic research; all documents that rely on this spurious distinction contain errors not intended by their authors.1 Second, it includes several provisions that are seriously out of touch with contemporary ethical thinking. As a consequence, many researchers routinely violate its requirements. Such routine violations and their associated attitudes rob the declaration of its credibility.Therapeutic and Nontherapeutic ResearchThe nature of the errors that arise from a reliance on the distinction between therapeutic and nontherapeutic research is . . .