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全球研究中的生物伦理学论坛会议,“妊娠研究的伦理学”:新兴共识主题和成果。

The global forum on bioethics in research meeting, "ethics of research in pregnancy": emerging consensus themes and outputs.

机构信息

Policy Department, The Wellcome Trust, London, UK.

出版信息

Reprod Health. 2017 Dec 14;14(Suppl 3):158. doi: 10.1186/s12978-017-0431-1.

Abstract

Research during pregnancy is affected by multiple ethical challenges which have not received sufficient international attention and consideration from the bioethics, clinical, and policymaking communities working together. Unresolved ethical questions about research in pregnancy have significant detrimental impacts on maternal and newborn health, in part because they inhibit an evidence base being developed on the efficacy and safety of medicines and health interventions for pregnant women. These problems are compounded in low- and middle-income country (LMIC) settings due to variability in regulatory provisions, the burden of maternal morbidity and mortality, and many social and cultural conventions that impact on pregnant women's ability to participate in research. Research in pregnancy was chosen as a topic for the 2016 Global Forum on Bioethics in Research (GFBR) meeting, and its timeliness was all the more apparent given the 2016 Zika outbreak, which has deeply affected the Latin American region. The meeting's emerging consensus themes and outputs epitomized the core aims of the GFBR-to give voice to LMIC perspectives as a priority in dialogue about global health research ethics and to promote collaboration. In this instance, the GFBR meeting catalyzed a strong, unified drive to push researchers and policymakers to include pregnant women in research by default: given the complex nature of the topic, this is a significant achievement in addressing an important question of social justice.

摘要

妊娠期研究受到多种伦理挑战的影响,而这些挑战尚未得到从事生物伦理、临床和决策制定工作的国际社会的充分关注和考虑。关于妊娠期研究的未解决的伦理问题对母婴健康产生了重大的不利影响,部分原因是它们阻碍了针对孕妇用药和卫生干预措施的疗效和安全性的证据基础的发展。在中低收入国家(LMIC),由于监管规定的差异、孕产妇发病率和死亡率的负担以及许多影响孕妇参与研究能力的社会和文化习俗,这些问题更加复杂。妊娠期研究被选为 2016 年全球研究生物伦理学论坛(GFBR)会议的主题,鉴于 2016 年寨卡病毒爆发对拉丁美洲地区产生了深远影响,该主题的及时性更加明显。会议形成的共识主题和成果体现了 GFBR 的核心目标——优先考虑中低收入国家的观点,以此作为全球卫生研究伦理对话的重点,并促进合作。在这种情况下,GFBR 会议有力地推动了研究人员和政策制定者默认将孕妇纳入研究:考虑到该主题的复杂性,这是在解决一个重要的社会公正问题方面的一项重大成就。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ab4/5751090/d6f4c548700b/12978_2017_431_Fig1_HTML.jpg

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