Document 0889
 DOCN  M9440889
 TI    Ethical, behavioral, and social aspects of HIV vaccine trials in
       developing countries.
 DT    9404
 AU    Lurie P; Bishaw M; Chesney MA; Cooke M; Fernandes ME; Hearst N;
       Katongole-Mbidde E; Koetsawang S; Lindan CP; Mandel J; et al; Center for
       AIDS Prevention Studies, University of California, San; Francisco 94105.
 SO    JAMA. 1994 Jan 26;271(4):295-301. Unique Identifier : AIDSLINE
       MED/94125504
 AB    ISSUE--Several investigators are preparing to conduct efficacy trials of
       human immunodeficiency virus (HIV) vaccines in the developing world.
       Failure to adequately address the unique ethical, behavioral, and social
       issues that surround vaccine testing in that setting will jeopardize the
       success of these trials and future acquired immunodeficiency syndrome
       (AIDS) research in the host nation. DESCRIPTION OF THE PROJECT--Twelve
       investigators from Africa, Asia, North America, and South America
       reviewed previous experience with HIV trials in developing countries and
       explored potential solutions to these issues. CONCLUSIONS--Host country
       scientists, government officials, and media must be actively involved in
       all aspects of the trials. Minimum prerequisites for conducting the
       trial include the following: (1) researching vaccines active against
       developing world HIV isolates; (2) establishing and maintaining an
       adequate technological infrastructure; (3) assessing the feasibility of
       recruitment in countries where the existence of HIV may be denied; (4)
       designing methods to obtain informed consent from each individual
       subject, rather than exclusively from family members or community
       elders; (5) creating locally appropriate instruments to measure risk
       behavior; (6) identifying a behavioral intervention for placebo and
       treatment groups; (7) making available laboratory methods to distinguish
       between natural HIV infection and vaccine-induced seropositivity; and
       (8) guaranteeing that an effective vaccine is available free of charge
       to the placebo group and at affordable prices to other host country
       residents.
 DE    *AIDS Vaccines/STANDARDS  *Clinical Trials/STANDARDS  *Developing
       Countries  Ethics  Human  International Cooperation  Quality Control
       Risk-Taking  Social Conditions  Support, Non-U.S. Gov't  Support, U.S.
       Gov't, P.H.S.  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).