Kaye Dan Kabonge
College of Health Sciences, Department of Obstetrics and Gynecology, Makerere University, P.O. Box 7072, Kampala, Uganda.
Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, 21205, USA.
Philos Ethics Humanit Med. 2019 Sep 6;14(1):11. doi: 10.1186/s13010-019-0081-8.
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.
Conceptual analysis.
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.
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).
将孕妇纳入研究的必要性已达成长期共识。临床研究的目标是找到高度规范、严格控制且符合道德责任的方法，以生成关于如何有效且安全地预防疾病或治疗患者的证据。本文对三种情况下临床试验的伦理问题进行了概念分析：孕妇在孕期作为参与者参与临床试验以获取解决妊娠并发症的数据；孕妇为患有并发症的未出生婴儿同意参与临床试验，以生成该生命阶段并发症的数据；母亲可能同意其新生儿参与临床试验。
概念分析。
研究人员通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、药物代谢动力学改变和不良反应风险，需要平衡研究参与对母亲和胎儿的潜在风险与益处。虽然这些反对意见可能有道理，但不进行研究却放大了研究中本应严格控制的风险，将这种风险推至临床环境中，进而给面临为疗效和安全性证据有限的孕妇做出治疗决策的临床医生带来挑战。公平纳入临床试验的潜在益处超过潜在风险。
涉及孕妇的研究对于在孕期为女性提供有效治疗、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）、减少因护理不佳（如剂量不足）导致的可避免伤害以及为孕妇、其胎儿和新生儿提供参与研究的潜在益处而言是必要的。
