College of Health Sciences, Department of Obstetrics and Gynecology, Makerere University, P.O. Box 7072, Kampala, Uganda.
Johns Hopkins University, Berman Institute of Bioethics, Deering Hall, 1809 Ashland Avenue, Baltimore, MD, 21205, USA.
BMC Med Ethics. 2021 Jul 28;22(1):104. doi: 10.1186/s12910-021-00672-w.
Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical trials (RCTs).
This was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process.
Respondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research.
Respondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation.
知情同意旨在确保参与者在披露潜在风险和收益后自愿参与研究，但在紧急情况下的研究中，知情同意可能是不可能或不切实际的。在资源有限的环境下，关于在紧急护理背景下进行随机临床试验的知情同意过程的经验的信息有限。本研究的目的是探讨参与两项产科和新生儿护理随机临床试验（RCT）的知情同意过程的经验和促成参与的因素。
这是一项在乌干达 Kawempe 国家转诊医院进行的紧急产科护理环境中的 RCT 前参与者中进行的定性研究。该研究采用了 2019 年 6 月 1 日至 2019 年 8 月 30 日进行的 30 次深入访谈。探讨的问题包括对研究的态度、他们参与的研究目的、参与研究的动机、影响入组决定的因素以及知情同意过程的经验。
受访者认为研究对于调查疾病的原因、预防或并发症是必要的。参与决策受到物质或治疗益处的希望、对医疗保健系统的信任以及朋友和家人的影响的影响。许多人对知情同意过程感到满意，尽管他们不理解研究的某些方面。
受访者重视参与紧急产科和新生儿护理的 RCT。对获益的希望、利他主义、对进一步科学知识的渴望以及对研究者的信任在参与动机中占据重要地位。内在和外在因素都是参与 RCT 的动机。
