Mtande Tiwonge K, Lombard Carl, Nair Gonasagrie, Rennie Stuart
Stellenbosch University, South Africa, Kamuzu University of Health Sciences, Malawi.
Stellenbosch University, South Africa, South African Medical Research Council, South Africa.
Res Ethics. 2024 Jan;20(1):64-78. doi: 10.1177/17470161231191247. Epub 2023 Aug 15.
Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.
尽管采用整群随机试验（CRT）设计来评估疫苗、公共卫生干预措施或卫生系统的情况日益增多，但该设计所带来的伦理问题却未得到充分解决，尤其是在低收入和中等收入国家（LMICs）的背景下。为了帮助揭示伦理挑战，我们对在马拉维设计和开展两项选定的整群随机试验方面经验丰富的关键利益相关者进行了定性访谈。接受访谈的18位利益相关者包括研究人员、临床医生、护士、数据管理人员和社区工作者，他们受邀分享了与整群随机试验实施相关的经验。数据分析揭示了五个具有伦理意义的主要主题：（1）医疗保健提供者参与健康研究的道德义务及其补偿；（2）次优护理服务损害了整群随机试验的完整性；（3）确保科学有效性与 withholding care service；（4）获得有效同意以及同意豁免的许可；（5）对试验参与的风险评估不足。了解马拉维整群随机试验所带来的关键伦理问题，有助于改进对这一特定研究设计的伦理审查和研究监督。 （注：原文中“withholding care service”表述不太准确，可能存在信息缺失，这里按原文翻译）
