Regulator experiences of trials during Ebola epidemics in Sierra Leone, Guinea, and the Democratic Republic of the Congo.

IF 2.6 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Kambale Kasonia, Frank Baiden, Frédéric Le Marcis, Bruno Lapika, Joel Kiyulu, Henri Kimina, Freddy Bikioli, Fanny Attas, Anthony Mansaray, Rose Burns, Elysée Nouvet, Séverine Thys, Antea Paviotti, Daniela Manno, Mukeh Kenneth Fahnbulleh, Bailah Leigh, Mohamed Samai, Brian Greenwood, Shelley Lees, Patrick Mitashi Mulopo, Deborah Watson-Jones
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引用次数: 0

Abstract

Introduction: During the 2014-2016 Ebola epidemic in West Africa and the Ebola outbreaks between 2018 and 2020 in the Democratic Republic of Congo, vaccines and other tools for prevention and treatment had to be taken through trials in exceptional circumstances using accelerated processes.

Materials and methods: We interviewed members of ethics committees, health authorities, health professionals, and political authorities in the Democratic Republic of Congo in 2021 and held a workshop with ethics committee members and regulatory authorities from Sierra Leone and Guinea in 2022 in order to document their experiences of reviewing, approving, and regulating current and new studies during epidemics and outbreaks, and to document lessons learnt and their recommendations for the rapid review of clinical trial protocols during public health emergencies.

Results: Similar barriers were identified in the three countries. These were related to weak legal frameworks and partnerships between ethics committees and regulatory bodies. Inadequate human resources, outdated standard operating procedures and guidelines, and lack of finance to support timely reviews were identified. We also noted a lack of awareness from politicians, scientists, and communities about the existence and functions of regulatory bodies/ethics committees, a lack of independence, and low interest in research. Opportunities identified by the institutions in the countries concerned included training ethics committee members and networking with experienced international platforms like the African Vaccine Regulatory Forum. Laws on regulating research have been updated in Sierra Leone and in Guinea, but not yet in the Democratic Republic of Congo.

Conclusion: Regulatory bodies have been facing many challenges in terms of a lack of a legal framework, a lack of finance, and a lack of support from politicians, scientists, and communities. Networking has been an opportunity for these regulators to mitigate these impediments.

塞拉利昂、几内亚和刚果民主共和国埃博拉疫情期间监管机构的试验经验。
导言:在2014-2016年西非埃博拉疫情期间以及2018年至2020年刚果民主共和国埃博拉疫情期间,疫苗和其他预防和治疗工具必须在特殊情况下通过加速进程进行试验。材料和方法:我们于2021年采访了刚果民主共和国的伦理委员会成员、卫生当局、卫生专业人员和政治当局,并于2022年与塞拉利昂和几内亚的伦理委员会成员和监管当局举行了一次研讨会,以记录他们在流行病和疫情爆发期间审查、批准和规范当前和新研究的经验。并记录经验教训及其建议,以便在突发公共卫生事件期间快速审查临床试验方案。结果:在三个国家发现了类似的障碍。这些问题与薄弱的法律框架以及伦理委员会与监管机构之间的伙伴关系有关。指出人力资源不足、标准作业程序和准则过时以及缺乏资金支持及时审查。我们还注意到,政治家、科学家和社区对监管机构/伦理委员会的存在和功能缺乏认识,缺乏独立性,对研究的兴趣不高。各机构在有关国家确定的机会包括培训伦理委员会成员和与非洲疫苗管制论坛等经验丰富的国际平台建立联系。塞拉利昂和几内亚已经更新了管理研究的法律,但刚果民主共和国还没有。结论:监管机构在缺乏法律框架、缺乏资金以及缺乏政治家、科学家和社区的支持方面面临着许多挑战。网络是这些监管机构减轻这些障碍的一个机会。
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来源期刊
Tropical Medicine & International Health
Tropical Medicine & International Health 医学-公共卫生、环境卫生与职业卫生
CiteScore
4.80
自引率
0.00%
发文量
129
审稿时长
6 months
期刊介绍: Tropical Medicine & International Health is published on behalf of the London School of Hygiene and Tropical Medicine, Swiss Tropical and Public Health Institute, Foundation Tropical Medicine and International Health, Belgian Institute of Tropical Medicine and Bernhard-Nocht-Institute for Tropical Medicine. Tropical Medicine & International Health is the official journal of the Federation of European Societies for Tropical Medicine and International Health (FESTMIH).
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