Enrolling Pregnant Women: Issues in Clinical Research
Enrolling Pregnant Women: Issues in Clinical Research
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DOI：
10.1016/j.whi.2012.10.003
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发表时间：
2013-01-01
影响因子：
3.2
通讯作者：
Clayton, Janine A.
中科院分区：
文献类型：
--
作者：
Blehar, Mary C.;Spong, Catherine;Clayton, Janine A.
背景资料：尽管许多孕妇受到一系列严重健康状况的影响，并服用治疗这些状况的药物，但人们普遍不愿将其纳入临床干预研究。因此，他们的临床护理通常不通知来自怀孕population.Method的证据：在2010年10月，美国国立卫生研究院妇女健康研究办公室召开了一个研讨会，以解决伦理，监管和科学问题所提出的孕妇在临床研究中的招生。这份报告总结了会议提出的三个领域，作为促进妊娠期伦理责任和科学合理的研究的重要下一步措施：1）将孕妇从目前的“弱势”群体重新归类为科学“复杂”群体，并将排除的假设改为纳入的假设; 2）审查机构审查委员会（IRB）在解释妊娠研究法规方面的把关作用，并确定促进IRB批准伦理知情妊娠研究的步骤;以及3）制定一个以妊娠为重点的研究议程，解决紧迫的临床需求，确定从现有资源和研究中收集信息的机会，结论：需要开展研究，以满足孕妇的治疗需求，并研究怀孕，因为这可能有助于了解孕妇日后的健康及其子女的健康。爱思唯尔公司出版
Background: Despite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations.Method: In October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research. This report summarizes three areas that emerged from that meeting as important next steps to be taken to promote ethically responsible and scientifically sound research during pregnancy.Findings: The three areas are: 1) Reclassify pregnant women from their current status in regulations as a "vulnerable" population to a scientifically "complex" population and change the presumption of exclusion to one of inclusion; 2) examine the institutional review boards' (IRB) gatekeeper role in interpreting regulations governing pregnancy research and identify steps to facilitate IRB approval of ethically informed pregnancy research; and 3) develop a pregnancy-focused research agenda that addresses pressing clinical needs, identifies opportunities to gather information from existing resources and studies, and encourages important new research areas.Conclusion: Research is needed to address the therapeutic needs of pregnant women and to study pregnancy as it may shed light on a pregnant woman's later health and the health of her child. Published by Elsevier Inc.