Global Health Institute, University of Antwerp, Antwerpen, Belgium
Centre for the Evaluation of Vaccination, University of Antwerp, Antwerpen, Belgium.
BMJ Glob Health. 2021 Jun;6(6). doi: 10.1136/bmjgh-2021-005726.
Implementing an Ebola vaccine trial in a remote area in the Democratic Republic of the Congo (DRC), and being confronted with a dysfunctional health care system and acute unmet health needs of participants, ethical considerations were made regarding the ancillary care obligations of the sponsor and researchers. Spurred by the occurrence of non-related (serious) adverse events (NR-SAEs), the Universities of Antwerp and Kinshasa jointly developed an algorithm, accompanied by an algorithm policy. The algorithm consists of a set of consecutive questions with binary response options, leading to structured, non-arbitrary and consistent support and management for each NR-SAE. It is the result of dialogue and collaboration between the sponsor (University of Antwerp) and the principal investigator (University of Kinshasa), consultation of literature, and input of research ethics and social sciences experts. The characteristics of the project and its budgetary framework were taken into account, as well as the local socioeconomic and healthcare situation. The algorithm and related policy have been approved by the relevant ethics committee (EC), so field implementation will begin when the study activities resume in November 2021. Lessons learnt will be shared with the relevant stakeholders within and outside DRC.If NR-SAEs are not covered by a functioning social welfare system, sponsors and researchers should develop a feasible, standardised and transparent approach to the provision of ancillary care. National legislation and contextualised requirements are therefore needed, particularly in low/middle-income countries, to guide researchers and sponsors in this process. Protocols, particularly of clinical trials conducted in areas with 'access to care' constraints, should include adequate ancillary care arrangements. Furthermore, it is essential that local ECs systematically require ancillary care provisions to enhance the well-being and protection of the rights of research participants. This project was funded by the European Union's Horizon 2020 research and innovation programme, European Federation of Pharmaceutical Industries and Associations, and the Coalition for Epidemic Preparedness Innovations.
在刚果民主共和国（DRC）的一个偏远地区实施埃博拉疫苗试验，并面对功能失调的医疗保健系统和参与者未满足的紧急健康需求，考虑到赞助商和研究人员的辅助护理义务的伦理问题。由于发生非相关（严重）不良事件（NR-SAEs），安特卫普大学和金沙萨大学共同制定了一个算法，并附有算法政策。该算法由一组具有二进制响应选项的连续问题组成，为每个 NR-SAE 提供结构化、非任意和一致的支持和管理。它是赞助商（安特卫普大学）和主要研究者（金沙萨大学）之间的对话与合作、文献咨询以及研究伦理和社会科学专家意见的结果。考虑到项目的特点及其预算框架，以及当地的社会经济和医疗保健状况。该算法和相关政策已经得到了相关伦理委员会（EC）的批准，因此当研究活动于 2021 年 11 月恢复时，将开始现场实施。将与刚果民主共和国内外的相关利益攸关方分享经验教训。如果非相关（严重）不良事件没有得到运作良好的社会福利制度的覆盖，赞助商和研究人员应制定可行、标准化和透明的方法来提供辅助护理。因此，特别是在中低收入国家，需要国家立法和背景要求，以指导研究人员和赞助商在这一过程中。方案，特别是在“获得医疗保健”方面存在限制的地区进行的临床试验，应包括适当的辅助医疗安排。此外，地方伦理委员会系统地要求提供辅助护理规定，以增强研究参与者的福祉和保护其权利，这一点至关重要。该项目由欧盟地平线 2020 研究和创新计划、欧洲制药工业和协会联合会以及流行病防范创新联盟资助。
