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Previous Volume 329:1815-1816 December 9, 1993 Number 24 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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To the Editor: We support the general direction in which the Food and Drug Administration (FDA) is moving regarding the inclusion of fertile women in clinical trials, as outlined by Merkatz et al. (July 22 issue).¹ The previous policy prohibiting women with childbearing capacity from participating in the early phases of research lacked a coherent scientific foundation. Unfortunately, no consistent, logical approach has yet been developed that adequately addresses such important matters as fetal exposure and fully informed consent. We reviewed the informed-consent documents used in 36 clinical trials focusing on AIDS. Pregnant women were generally excluded but on inconsistent . . . [Full Text of this Article]

References

This article has been cited by other articles:

• Kass, N. E., Taylor, H. A., King, P. A. (1996). Harms of Excluding Pregnant Women from Clinical Research: The Case of HIV-Infected Pregnant Women. J Law Med Ethics 24: 36-46