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Enrolling pregnant women in biomedical research.

机译:使孕妇参加生物医学研究。

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The long history of excluding pregnant women from biomedical research is beginning to witness some overdue rethinking and possible reversal. Perceptions of what is ethically permissible or necessary often change overtime. We have only to think of the evolution of informed consent in both the clinical and research settings to remind us that past practice can change for ethical reasons. Mere decades ago, it was more common for physicians to withhold a diagnosis of cancer than to reveal it to their patients. Fewer than 20 years ago, the US Food and Drug Administration (FDA) still had a policy of excluding women "of childbearing potential" from enrolling in drug research. To exclude any group or population from participating in medical research results in a lack of knowledge about the risks and potential benefits of products that will be available for their use once on the market. Whether it is respect for the autonomy of patients or justice in the selection of participants for research, an evolution in ethical thinking has undeniably occurred
机译:将孕妇排除在生物医学研究之外的悠久历史开始见证一些逾期的重新思考和可能的逆转。人们对道德上允许或必要的事物的看法通常会随着时间而改变。我们只需要考虑在临床和研究环境中知情同意的演变,就可以提醒我们过去的做法可能会出于道德原因而发生变化。几十年前,对于医生来说,不进行癌症诊断而不是向患者透露是很常见的。不到20年前,美国食品药品监督管理局(FDA)仍然有一项政策,将“有生育能力”的妇女排除在药物研究之外。在缺乏对产品风险和潜在收益的了解的情况下,将任何群体或人群排除在医学研究成果之外,这些产品一旦在市场上就可以使用。在选择研究参与者时,无论是尊重患者的自主权还是公正性,都不可避免地发生了伦理思想的演变。

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  • 来源
    《The Lancet 》 |2010年第9715期| 共2页
  • 作者

    Macklin R;

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