@article{fdi:010094226,
  title = {{R}egulator experiences of trials during {E}bola epidemics in {S}ierra {L}eone, {G}uinea, and the {D}emocratic {R}epublic of the {C}ongo},
  author = {{K}asonia, {K}. and {B}aiden, {F}. and {L}e {M}arcis, {F}r{\'e}d{\'e}ric and {L}apika, {B}. and {K}iyulu, {J}. and {K}imina, {H}. and {B}ikioli, {F}. and {A}ttas, {F}anny and {M}ansaray, {A}. and {B}urns, {R}. and {N}ouvet, {E}. and {T}hys, {S}. and {P}aviotti, {A}. and {M}anno, {D}. and {F}ahnbulleh, {M}. {K}. and {L}eigh, {B}. and {S}amai, {M}. and {G}reenwood, {B}. and {L}ees, {S}. and {M}ulopo, {P}. {M}. and {W}atson-{J}ones, {D}.},
  editor = {},
  language = {{ENG}},
  abstract = {{I}ntroduction {D}uring the 2014-2016 {E}bola epidemic in {W}est {A}frica and the {E}bola outbreaks between 2018 and 2020 in the {D}emocratic {R}epublic of {C}ongo, vaccines and other tools for prevention and treatment had to be taken through trials in exceptional circumstances using accelerated processes. {M}aterials and methods{W}e interviewed members of ethics committees, health authorities, health professionals, and political authorities in the {D}emocratic {R}epublic of {C}ongo in 2021 and held a workshop with ethics committee members and regulatory authorities from {S}ierra {L}eone and {G}uinea 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. {R}esults {S}imilar barriers were identified in the three countries. {T}hese were related to weak legal frameworks and partnerships between ethics committees and regulatory bodies. {I}nadequate human resources, outdated standard operating procedures and guidelines, and lack of finance to support timely reviews were identified. {W}e 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. {O}pportunities identified by the institutions in the countries concerned included training ethics committee members and networking with experienced international platforms like the {A}frican {V}accine {R}egulatory {F}orum. {L}aws on regulating research have been updated in {S}ierra {L}eone and in {G}uinea, but not yet in the {D}emocratic {R}epublic of {C}ongo. {C}onclusion {R}egulatory 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. {N}etworking has been an opportunity for these regulators to mitigate these impediments.},
  keywords = {{C}ommittee ; {E}bola ; {E}pidemic ; {E}thics ; {R}egulators ; {REPUBLIQUE} {DEMOCRATIQUE} {DU} {CONGO} ; {SIERRA} {LEONE} ; {GUINEE}},
  booktitle = {},
  journal = {{T}ropical {M}edicine & {I}nternational {H}ealth},
  volume = {30},
  numero = {6},
  pages = {539--546},
  ISSN = {1360-2276},
  year = {2025},
  DOI = {10.1111/tmi.14111},
  URL = {https://www.documentation.ird.fr/hor/fdi:010094226},
}