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

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

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 Act^a
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

^a CHHI is not formally a study with a medicinal product so European Medicines Agency regulations do not apply

ISSN: 2049-3258