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Algorithm for the support of non-related (serious) adverse events in an Ebola vaccine trial in the Democratic Republic of the Congo.
Lemey, Gwen; Larivière, Ynke; Zola, Trésor Matuvanga; Maketa, Vivi; Matangila, Junior; Mitashi, Patrick; Vermeiren, Peter; Thys, Séverine; De Bie, Jessie; Muhindo, Hypolite Mavoko; Ravinetto, Raffaella; Van Damme, Pierre; Van Geertruyden, Jean-Pierre.
Afiliação
  • Lemey G; Global Health Institute, University of Antwerp, Antwerpen, Belgium Gwen.lemey@uantwerpen.be.
  • Larivière Y; Centre for the Evaluation of Vaccination, University of Antwerp, Antwerpen, Belgium.
  • Zola TM; Global Health Institute, University of Antwerp, Antwerpen, Belgium.
  • Maketa V; Centre for the Evaluation of Vaccination, University of Antwerp, Antwerpen, Belgium.
  • Matangila J; Tropical Medicine Department, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
  • Mitashi P; Tropical Medicine Department, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
  • Vermeiren P; Tropical Medicine Department, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
  • Thys S; Tropical Medicine Department, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
  • De Bie J; Global Health Institute, University of Antwerp, Antwerpen, Belgium.
  • Muhindo HM; Centre for the Evaluation of Vaccination, University of Antwerp, Antwerpen, Belgium.
  • Ravinetto R; Global Health Institute, University of Antwerp, Antwerpen, Belgium.
  • Van Damme P; Centre for the Evaluation of Vaccination, University of Antwerp, Antwerpen, Belgium.
  • Van Geertruyden JP; Global Health Institute, University of Antwerp, Antwerpen, Belgium.
BMJ Glob Health ; 6(6)2021 06.
Article em En | MEDLINE | ID: mdl-34183329
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doença pelo Vírus Ebola / Vacinas contra Ebola Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doença pelo Vírus Ebola / Vacinas contra Ebola Idioma: En Ano de publicação: 2021 Tipo de documento: Article