Tribune. AIDS, H1N1 pandemic influenza, Ebola: we all know these infectious diseases for which there are now treatments and, in some cases, vaccines to treat or prevent them. On the other hand, few know that the proof of the harmlessness and the effectiveness of these treatments was possible thanks to people who agreed to test new molecules, by accepting the risk, admittedly controlled, of adverse effects more or less serious, as well as the constraints of participating in clinical research. Several thousand healthy research volunteers (VSRs) in France and around the world accept these risks and constraints to allow the development of treatments for many diseases.
Their motivations are of course variable, in particular according to socio-economic contexts. Some expose themselves out of pure altruism with the sole desire to advance science, others do so out of solidarity with loved ones affected by the disease. But for the most vulnerable, the motivation will mainly be remuneration, and sometimes the possibility of access to primary care. France, like the United Kingdom, has included in the regulations governing clinical research the obligation for the promoters of research to register VSRs in a national file. For France, the limitation of the annual sum they can receive is specified.
The purpose of these provisions is to limit both the individual risk and the collective risk incurred by “professional volunteers”. Other countries that often use VSRs, such as Brazil and India, do not have similar protections in place. However, it is these countries that are helping to test a number of treatments that we will use in France and more generally in Europe. Too often, these volunteers who are exposed to the risks associated with these new molecules will not have access to these treatments.
“Infectious challenges”
These volunteers sometimes agree to expose themselves to significant risks, such as participating in “infectious challenges”. These practices consist in administering to them the candidate vaccine (whose effectiveness by definition is not known) then in exposing them to an attenuated infectious agent and observing whether they are protected from this infection. In several countries (United Kingdom, Belgium, United States), this approach is authorized in the search for vaccines against pathologies as varied as influenza, malaria or Shigella infection (bacteria responsible for violent dysentery). The interest of this approach is obvious from the point of view of a utilitarian ethics, because it avoids exposing many patients if, from the first studies on healthy volunteers, the vaccine candidate shows no benefit.
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