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The moral imperative to approve pregnant women's participation in randomized clinical trials for pregnancy and newborn complications.
Philosophy, Ethics, and Humanities in Medicine ( IF 1.9 ) Pub Date : 2019-09-06 , DOI: 10.1186/s13010-019-0081-8
Dan Kabonge Kaye 1, 2
Affiliation  

BACKGROUND There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick people. This manuscripts present a conceptual analysis of the ethicality of clinical trials in 3 scenarios: where the pregnant is involved in clinical trials as a participant during pregnancy for data that addresses pregnancy complications, where the pregnant woman consents to clinical trial participation for an unborn baby that has complications, to generate data on complications at this stage of life, and where the mother may consent for participation of their newborn child in clinical trials. METHODS Conceptual analysis. FINDINGS Investigators often choose to exclude pregnant women and newborns from research, even where there is possibility for them to benefit from the study intervention. Objections include vulnerability of pregnant women, altered pharmacokinetics and risk of adverse effects, with a need to balance potential maternal and fetal risks and benefits of research participation. While the objections may be valid, not performing research magnifies what should be a carefully controlled risk during research, pushing this risk into the clinical setting, and subsequently posing a challenge to clinicians who are faced with making treatment decisions for pregnant patients with limited evidence of efficacy and safety. The potential benefits of fair inclusion in clinical trials outweigh the potential risks. CONCLUSION Research involving pregnant women is necessary to provide women with effective treatment during pregnancy, to promote fetal safety (such as by avoiding the clinical use of drugs that may be harmful to the developing fetus), and to reduce avoidable harm from suboptimal care (such as from underdosing) and to provide pregnant women, their fetuses and newborns (with access to potential benefits of research participation).

中文翻译:

批准孕妇参与妊娠和新生儿并发症随机临床试验的道义上的必要性。

背景 人们长期以来就需要将孕妇纳入研究达成共识。临床研究的目标是找到高度监管、仔细控制、道德负责的方法,以产生有关如何有效、安全地预防疾病或治疗病人的证据。本手稿对 3 种情况下的临床试验伦理性进行了概念分析:孕妇在怀孕期间作为参与者参与临床试验,以获取解决妊娠并发症的数据;孕妇同意参与未出生婴儿的临床试验患有并发症,生成有关该生命阶段并发症的数据,并且母亲可能同意其新生儿参与临床试验。方法概念分析。研究结果 研究人员经常选择将孕妇和新生儿排除在研究之外,即使他们有可能从研究干预中受益。反对意见包括孕妇的脆弱性、药代动力学的改变和不良反应的风险,以及需要平衡潜在的母婴风险和参与研究的益处。虽然反对意见可能是正确的,但不进行研究会放大研究期间应仔细控制的风险,将这种风险推入临床环境,并随后对临床医生提出挑战,因为他们面临着在证据有限的情况下为怀孕患者做出治疗决定的情况。功效和安全性。公平参与临床试验的潜在好处超过了潜在风险。结论 涉及孕妇的研究对于为妇女在怀孕期间提供有效的治疗、促进胎儿安全(例如避免临床使用可能对发育中的胎儿有害的药物)以及减少次优护理造成的可避免的伤害(例如以及为孕妇及其胎儿和新生儿提供参与研究的潜在好处)。
更新日期:2019-11-01
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