Abstract
Malaria mosquito research in Africa as elsewhere is just over a century old. Early trials for development of mosquito control tools were driven by colonial enterprises and war efforts; they were, therefore, tested in military or colonial settings. The failure of those tools and environmental concerns, coupled with the desperate need for integrated malaria control strategies, has necessitated the development of new malaria mosquito control tools, which are to be tested on humans, their environment and mosquito habitats. Ethical concerns start with phase 2 trials, which pose limited ethical dilemmas. Phase 3 trials, which are undertaken on vulnerable civilian populations, pose ethical dilemmas ranging from individual to community concerns. It is argued that such trials must abide by established ethical principles especially safety, which is mainly enshrined in the principle of non-maleficence. As there is total lack of experience with many of the promising candidate tools (eg genetically modified mosquitoes, entomopathogenic fungi, and biocontrol agents), great caution must be exercised before they are introduced in the field. Since malaria vector trials, especially phase 3 are intrusive and in large populations, individual and community respect is mandatory, and must give great priority to community engagement. It is concluded that new tools must be safe, beneficial, efficacious, effective, and acceptable to large populations in the short and long-term, and that research benefits should be equitably distributed to all who bear the brunt of the research burdens. It is further concluded that individual and institutional capacity strengthening should be provided, in order to undertake essential research, carry out scientific and ethical review, and establish competent regulatory frameworks.
Highlights
Without any doubt, malaria, a mosquito-borne disease, is a leading cause of morbidity and mortality in Africa, where it causes an estimated 300 million cases per annum, and around one million deaths, mainly of young children [1]
Overreliance on using only anti-malarial drugs has over the years led to successive resistance and subsequent loss of first-line drugs
Since existing vector control tools are turning blunt, and are few, biomedical research is being intensified in order to develop new mosquito vector control tools, which must be tested on humans, in the human environment, or on fabrics used by humans
Summary
Malaria, a mosquito-borne disease, is a leading cause of morbidity and mortality in Africa, where it causes an estimated 300 million cases per annum, and around one million deaths, mainly of young children [1]. Community assent as currently used for example in community engagement would not suffice, since in vector control trials, especially where live mosquitoes are released, or in trials of aerial spraying, the entire community population constitutes research participants per se Faced with such unwieldy situations, it has been argued by some ethicists that alternative means be found, for example by having a referendum, plebiscites or other democratic means, as a supplement to informed consent. Besides capacity for scientific and ethical review of clinical and epidemiological research, countries and institutions should have in place capacity for regulatory review of entomological protocols, providing monitoring and oversight of vector intervention trials, which would contribute immensely to the facilitation of national registration of new entomological intervention tools. The guidance will support disease endemic countries and other stakeholders in considering the safety and legal/regulatory aspects, as well as ethical, cultural and social issues, of such deployment [53]
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