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Table 3 Regulatory framework for ethics approval of CHHI in The Netherlands and Gabon, and CHI-S in Uganda

From: Establishing a controlled hookworm human infection (CHHI) model for Africa: A report from the stakeholders meeting held in Lambaréné, Gabon, November 10–11, 2019

Country Institutional and National Ethics review boards Process of ethical approval for CHI studies Legislation
The Netherlands Universities have their own institutional ethics committees Approval given by LUMC local medical ethics committee Applicable law is the Wet medisch-wetenschappelijk Onderzoek in mensen (WMO): in English, Medical Research involving human subjects Acta
Gabon Institutional review board (CERMEL) and National Ethics Committee (NEC) Scientific approval from institution precedes submission for institutional ethics review. This is then followed by submission to the NEC Under auspices of the Ministry of Health
Uganda There are 23 Institutional Research Ethics Committee in Uganda. All these are accredited and regulated by the Uganda National Council for Science and Technology (UNCST) Scientific approval from institution precedes submission for institutional ethics review. This is then followed by submission to the UNCST No legislation or acts pertaining to human challenge studies exist in Uganda. Ministry of Health does not directly regulate research in Uganda
  1. a CHHI is not formally a study with a medicinal product so European Medicines Agency regulations do not apply