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M94A2286.TXT
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Document 2286
DOCN M94A2286
TI HIV preventive vaccines: social, ethical and political considerations
for domestic efficacy trials.
DT 9412
AU Hodel D; Burke D; Chesney M; Fullilove R; Osborn J; Stevens C; Vermund
S; AIDS Action Foundation, Washington, DC.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):339 (abstract no. PC0293). Unique
Identifier : AIDSLINE ICA10/94370289
AB OBJECTIVES: Through a consensus building process involving a diverse
range of stakeholders, to identify and develop recommendations
concerning the social, ethical, and political factors involved in the
conduct of large-scale, domestic, HIV preventive vaccine efficacy
trials, for use by industry, federal officials, academic and other
research centers, and target communities, in designing and implementing
such trials. METHODS: A multi-disciplinary group of 26 scientists,
academics, prevention services providers, manufacturers, community
advocates, and federal officials was recruited. The group reviewed the
literature, examined the differential impact of HIV preventive vaccine
efficacy trials on communities already heavily burdened by HIV disease
and other social stigmatization, and identified the support services,
trial design factors, and informed consent issues that must be addressed
to insure the ethical conduct of such trials. RESULTS: Because the
scientific requirements of HIV preventive vaccine efficacy trials will
necessitate the recruitment of large cohorts from among society's most
disenfranchised communities, combined with an ethical imperative to
provide suitable informed consent counseling with respect to HIV risk
reduction, both in the context of an epidemic at least partially
preventable through behavior modification, the design and implementation
of such trials will present a challenge of extraordinary complexity.
CONCLUSIONS: The successful conduct of domestic HIV preventive vaccine
efficacy trials will require an unprecedented partnership between the
federal government, industry and targeted communities. Current
feasibility studies and infrastructure preparation are critical and must
be sharply expanded.
DE AIDS Vaccines/*ADMINISTRATION & DOSAGE Clinical Trials/*STATISTICS &
NUMER DATA Cohort Studies Developing Countries *Ethics, Medical
Feasibility Studies Health Education Human HIV Infections/*PREVENTION
& CONTROL/TRANSMISSION Patient Care Team *Politics *Psychosocial
Deprivation MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).