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285 Like Highways and Sewers? Community Consent in Large-Scale HIV Vaccine Trials
Joe Wright
Independent HIV Vaccine Advocate, Washington, DC and Sacramento, CA, USA
Background: Grady proposed a model of "community consent" for large HIV vaccine trials, arguing that the community as a whole has an interest in trials distinct from the interests of individuals. However, in practice most research projects focus on community education as a means of informing individual decisions, while seeing community consent as a useful but abstract idea.
Methods: Various proposed and practiced approaches for community consent and community education are considered, including town hall meetings, outreach and information dissemination, and enlisting community organizations and opinion leaders. In addition, this paper considers vaccine trials as a form of "public works" and examines methods of obtaining community consent for large scale projects with community impact (for instance, zoning waivers, highway construction, dams, etc.)
Results: Each of the existing methods has acute limitations, as does a "public works" approach. Most other methods have no means of actually assessing when consent has been given. On the other hand, if vaccine trials are conducted in only a subset of the population, elected representatives may not speak for the community of potential participants. Still, a public works approach has at least the advantages of enlisting an existing process, requiring the approval of officials who are subject to the democratic control of elections, and having a clear outcome.
Conclusions: In democracies, asking for a process of formal approval akin to that needed for a public works project may be a useful additional method in the wider project of obtaining community consent for large-scale HIV vaccine trials. To properly obtain community consent, investigators should consider means of requesting the formal approval of democratically elected bodies, including public hearings, in addition to other methods of community education and consultation.
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