Proposed Revisions to the Declaration of Helsinki — Will They Weaken the Ethical Principles Underlying Human Research?

• Published in: The New England journal of medicine Vol. 341; no. 7; pp. 527 - 531
• Main Author: Brennan, Troyen A
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 12.08.1999
• Subjects: Committees; Developing countries; Disease transmission; Editorial Policies; Ethical Theory; Ethics; Ethics Committees, Research; Ethics, Medical - history; Ethics, Research; Federal Government; Government Regulation; Helsinki Declaration; History, 20th Century; HIV; Human Experimentation - legislation & jurisprudence; Human immunodeficiency virus; Human subjects; Humans; Infections; Internationality; LDCs; Medical research; Moral Obligations; Pregnant Women; Research Subjects; Researcher-Subject Relations; Resource Allocation; Risk Assessment; Rural areas; Social Change; Social Control, Formal; Social Justice; United States > US; Declaration of Helsinki; Genetics and Reproduction
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJM199908123410712

At a recent meeting of the human subjects committee of which I am a member, we discussed a proposed protocol involving an analysis of human immunodeficiency virus (HIV) infection in pregnant women and subsequent follow-up of their offspring in rural areas of a country in sub-Saharan Africa. Recalling the recent controversy over the use of placebo in trials of zidovudine treatment to halt perinatal transmission of HIV infection in Third World countries 1 – 4 and the decision by U.S. agencies to stop funding such trials, 5 some members of our committee thought that the proposed protocol was ethically suspect because it did . . .