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
{"title":"Regulator experiences of trials during Ebola epidemics in Sierra Leone, Guinea, and the Democratic Republic of the Congo.","authors":"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","doi":"10.1111/tmi.14111","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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 Inadequate human resources, outdated standard operating procedures and guidelines, and lack of finance to support timely reviews were identified.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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23962,"journal":{"name":"Tropical Medicine & International Health","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tropical Medicine & International Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/tmi.14111","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
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.
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).