The work “Recruitment and engagement in preventive trials: context, social aspects and mediation” follows a scientific event organized on June 12, 2015, by C. Ollivier-Yaniv and M. Couderc for the Vaccine Research Institute (VRI) at Université Paris-Est Créteil. This work, which is concerned with preventive and vaccine trials involving healthy volunteers, covers close to 3 decades of the scientific and social history of HIV. Over these 30 years, HIV has gone from a rapid and fatal affliction to a severe chronic infection that still involves life-long treatment. Progress in our understanding of the infection, the immune response, the replication mechanisms, and the possibility of control by means of treatment still requires experiments to be conducted in humans such as therapeutic trials, preventive trials, vaccine trials, drug prophylaxis trials, or behavioral intervention trials.
The experiments conducted by the ANRS and the VRI on healthy people are very representative of what the Denver Principles imply for research, which were laid down by associations of AIDS sufferers in 1983: “Nothing about us without us.” This basic principle expresses the role of the people and associations concerned in any decision that may be made at any time in the research process, from the design of the trial to the distribution of the results.
The numerous questions (social, moral, political, and ethical) raised by a fatal sexually transmitted disease, the injection of drugs, or the administration of blood products immediately engaged researchers in the social sciences, who sought to understand the determining factors and reactions to AIDS, as well as to define effective and ethical responses.
The ANRS therefore organized the research from the outset on the basis of multiple disciplines, combining the biological disciplines, clinical research, the human and social sciences, and the public health disciplines.
The subject of this work is original research on prevention trials in the social sciences [following the event on June 12, 2015 organized by C. Ollivier-Yaniv and M. Couderc for the Vaccine Research Institute (VRI) at Université Paris-Est Créteil].
It recounts the transformations that took place in how the infection and epidemic are controlled. These changes alleviate the risks that volunteers are exposed to or fear exposure to, for example, the risk of contamination during preventive trials and the “false seropositivity” induced by candidate vaccines. However, constants can also be observed regarding attitudes which favor or disfavor engagement in this particular research, the motivations of volunteers, and factors which may, in the view of the investigators, compromise volunteers' safety or participation until the end of the experiment (apart from biological and clinical criteria).
Based on a desire to conduct research that corresponds to the needs of populations, their conditions, or their lifestyles (drug users, men who have sex with men, vulnerable populations, people with comorbidities, or addictions), the profile of the volunteers varied over the years and “normalized” to a certain extent, thereby reflecting society and the ultimate beneficiaries of future discoveries more accurately. However, altruistic, philosophical, and highly personal motivations still persist.
In 2017, associations of people with HIV met in Paris at the ninth conference of the International Aids Society to revise and update the Denver Principles. The new charter [https://pariscommunitydeclaration.blog/ (viewed on January 20, 2018)] is intended for all stakeholders throughout the world, including the scientific community. It asks the latter “to include the key populations in the research ethics committees and to share the results of research with the communities involved.”
Thus, 35 years after the very first research on AIDS, research is still highly dependent on an alliance with the volunteers as well as the associations. This research itself is also undergoing transformation and changing the topic of its focus. Sometimes, it requires very large numbers of subjects and intensive or complex procedures that can only be conducted with the strong adherence of volunteers and communities.
It is by respecting and strengthening this alliance that the MR and the ANRS undertakes its current projects, especially the vaccine trials, in the pursuit of control over the HIV epidemic.