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).