The Need to Revise the Declaration of Helsinki

• Published in: The New England journal of medicine Vol. 341; no. 7; pp. 531 - 534
• Main Author: Levine, Robert J
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 12.08.1999
• Subjects: Anti-HIV Agents - therapeutic use; Clinical trials; Control Groups; Editorial Policies; Ethics; Ethics, Medical; Ethics, Research; Federal Government; Government Regulation; Helsinki Declaration; HIV Infections - drug therapy; Human Experimentation - legislation & jurisprudence; Human subjects; Humans; Internationality; Nontherapeutic Human Experimentation; Pathogenesis; Patients; Placebos; Pregnant Women; Randomized Controlled Trials as Topic - standards; Risk Assessment; Therapeutic Human Experimentation; Therapeutics; Zidovudine - therapeutic use; Council for International Organizations of Medical Sciences; Declaration of Helsinki; Biomedical and Behavioral Research
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJM199908123410713

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 Research The nature of the errors that arise from a reliance on the distinction between therapeutic and nontherapeutic research is . . .