//BREEDSAFCA: ethics review and pharmacovigilance in Cameroon

BREEDSAFCA: ethics review and pharmacovigilance in Cameroon

From independence, there was no law regulating human health research in Cameroon until 1987, when the text setting up the first ever ethics committee with national competencies was signed. This committee, however, had difficulties in functioning due to the absence of a national regulation on which the evaluation of research protocols was based. The 2002 decree organising the Ministry of Public Health created the Division of Health Operations Research and assigned to it, among others, the responsibility of ensuring research participant protection. Much progress has been made following the establishment of this department in terms of regulations among which are the 2009 order on the modalities of administrative authorisation for research and the 2012 order for organising the national ethics system for the evaluation of research protocols. This 2012 regulation organises the national ethics evaluation system, creating and organising the functioning of national, regional and institutional ethics committees.

The ethical evaluation system was still limited as there was no locally adapted regulation for research participant protection during the planning, ethical evaluation, and implementation of a study (observational, clinical and all other interventions). The objective of Strengthening the regulatory framework to upgrade ethical review of clinical research and drugs safety monitoring in Cameroon (BREEDSAFCA) was to contribute to developing a regulation for ethical evaluation regarding health research for the protection of participants.

During the implementation of the BREEDSAFCA project, several regulatory instruments were developed and submitted for approval. The process of reviewing these proposed regulations stimulated the finalisation of the draft law on medical research that was in the process of development since 2013. Most of the regulatory instruments that were in the process of elaboration in BREEDSAFCA were integrated into the law on Medical Research that was sent to the Presidency and finally adopted by the legislative as Law N° 2022/08 of 27 April 2022 relation to Medical Research Involving Human Subjects in Cameroon.

This law:

  • Outlines research ethics principles
  • Defines concepts and research stakeholders
  • Defines the rights of research participants including that of vulnerable groups
  • Outlines the ethics basis for research on pregnant women including the foetus
  • Regulates research in emergency situations
  • Regulates research on bio banks
  • Defines the obligations of the sponsor and investigator
  • Lays down the basis for clinical trial evaluation
  • Defines sanctions for non-respect of ethics principles.

This law has completely changed the human health research landscape in Cameroon thanks to the stimulating contribution of the EDCTP2-funded project BREEDSAFCA.

Besides contributing to improving the health research legal framework, the project has also contributed to improving ethics. The first ethics committee was created in 1987, but its functioning was centralised and thus could not adapt the ethical review process to the various cultural realities of the regions in Cameroon. The 2012 order on the ethical system of evaluation reorganised the ethical review system by creating and assigning missions to national, regional and institutional review organs.

As a result of limited resources, only two of the 10 regions of Cameroon had regional ethics committees. The BREEDSAFCA project planned to improve the coverage in the country by creating two additional regional ethics committees, namely the Littoral and the West Regional ethics committee. However, due to administrative difficulties, the planned institutional ethics committee at the University of Dschang could not be set up and was replaced by the two additional regional committees in the North West and North Regions. The West Regional Ethics Committee was created on 27 August 2021 and the Littoral Regional Ethics Committee was created on 16 September 2021. The ethics committees are operational. Two more Regional Ethics Committees will shortly be established, namely the Regional ethics committee of the North West and the Regional Ethics committee of the North Region. With the creation of these ethics committees, the regional coverage of ethics committees will be raised to 60%.

Conclusion

With the implementation of BREEDSAFCA, the landscape for the protection of health research participants has been improved with the enactment of the law on human health research. This law has regulated several aspects of health research ethics evaluation and the implementing regulatory instruments of this law will be developed to make it usable to all key partners. The national coverage of the system of health research ethics evaluation has been greatly improved in Cameroon and will contribute to ameliorating and adapting the research ethics evaluation system to various cultures.