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Volume 341:527-531 August 12, 1999 Number 7
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Proposed Revisions to the Declaration of Helsinki — Will They Weaken the Ethical Principles Underlying Human Research?

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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 countries1,2,3,4 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 not . . . [Full Text of this Article]

Foundations of Research Involving Human Subjects

Revising the Declaration of Helsinki

Should We Generalize from the Experience with the HIV Trials?

Conclusions

References


Related Letters:

Should the Declaration of Helsinki Be Revised?
Morens D. M., Kopp V. J., Senn S., Macpherson C. C., O'Ryan M., Misbin R. I., Levine R. J.
Extract | Full Text  
N Engl J Med 1999; 341:1851-1853, Dec 9, 1999. Correspondence

The Ethics of Research in Developing Countries
Gray R. H., Quinn T. C., Serwadda D., Sewankambo N. K., Wabwire-Mangen F., Wawer M. J., Mullings A. M.A., Greco D. B., Hearst N., Cates W., Coates T. J., Handsfield H. H., Angell M.
Extract | Full Text  
N Engl J Med 2000; 343:361-363, Aug 3, 2000. Correspondence

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