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将孕妇、有怀孕可能的人以及曾经怀孕过的人(即女性)排除在生物医学研究之外。

The exclusion of pregnant, pregnable, and once-pregnable people (a.k.a. women) from biomedical research.

作者信息

Merton V

机构信息

Pace University School of Law.

出版信息

Am J Law Med. 1993;19(4):369-451.

PMID:7942864
Abstract

The barriers to women's participation as subjects in biomedical research are currently being challenged as a matter of legislative policy, medicine, and law. This Article catalogs the ways in which women have been disadvantaged by their exclusion and recent developments to redress them, and goes on to dissect the underlying rationales for excluding women from clinical trials. The author reveals the 'fundamental misconception' behind exclusionary rationales, and argues that research sponsors in fact have more to fear in the way of potential liability from the exclusion of women, even pregnant women and women of child-bearing capacity, than from their inclusion. Finally, the Article suggests strategies for achieving reform of these exclusionary practices.

摘要

目前,作为生物医学研究受试者的女性参与面临的障碍正受到立法政策、医学和法律方面的挑战。本文梳理了女性因被排除在外而处于不利地位的方式以及最近为纠正这些情况所取得的进展,并进而剖析了将女性排除在临床试验之外的潜在理由。作者揭示了这些排除理由背后的“根本误解”,并认为研究资助者实际上更应担心排除女性(甚至是孕妇和具有生育能力的女性)可能带来的潜在责任,而非纳入她们所带来的潜在责任。最后,本文提出了改革这些排除性做法的策略。

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