College of Health Sciences, Department of Obstetrics and Gynecology, Makerere University, P.O. Box 7072, Kampala, Uganda.
Johns Hopkins University, Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, 21205, USA.
BMC Med Ethics. 2019 Apr 27;20(1):27. doi: 10.1186/s12910-019-0363-0.
There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated.
A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants.
Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits.
人们一致认为，有必要在伦理上开展研究，以改善对因急性病入院的患者（包括在产科急症护理中）的治疗。我们对产科急症护理中随机临床试验的知情同意过程中固有的伦理紧张关系进行了概念分析，并提出了缓解这些紧张关系的方法。
有效的同意过程，即知情同意，是维护和尊重自主权和尊严的必要方面的基石。在产科急症护理研究中，获得知情同意可能存在问题，从而导致不同道德考虑之间存在伦理紧张关系。由于疾病的严重程度、无力或决策能力受损，潜在参与者可能处于弱势地位。同意过程的时间有限，并且某些干预措施的治疗窗口期较窄。这些因素在允许潜在有益的研究的同时，避免潜在危害并维护参与者的尊严、人权、公正和自主权方面，造成了伦理上的紧张关系。
在中低收入国家的产科急症护理中，知情同意提出了许多伦理挑战。在尊重参与者尊严和自主权的同时，允许对弱势群体进行研究，保护参与者免受潜在危害，并促进公平，这些都构成了产科急症和新生儿护理研究中的伦理紧张关系。那些参与研究实施或监督的人有公平包容的责任，避免剥夺参与者参与的权利和任何潜在的研究收益。
