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                           Ô The UNAIDS has organized forum to discuss ethical issues until a

                             guidance has been published, and it is a very good document for all
                             persons concerned in the vaccine trials to refer to and to guide the decision
                             making. The UNAIDS has served very well as clearing house to gather
                             scientific knowledge from every comer of the world to provide support for
                             proper decision especially for scientists and all persons concerned in

                             developing country like Thailand.
                        2) At national or country level, Thailand has strengthened the system for human
                           subjects protections. A scientific committee has been set up specifically for

                           this study to work collaboratively with the existing Ethics Committee, both
                           before and during the study.
                           Ô The research protocol has been reviewed rigorously and care-fully, both
                             on scientific and ethical issues.
                           ÔA readiness workshop was organized as a pre-requisite by scientific

                             committee before commencement of the study,
                           Ô It was the first time that the investigators were asked to prepare the
                             standard operating procedure or SOP for counseling of the volunteers. An

                             oversight committee was established to monitor the counseling process.
                        3) The sponsor of this project understood and agreed to invest more funding
                           support especially to follow ethical guidance for human research and human
                           subjects protections.
                           ÔA candidate vaccine made from virus subtype E which was,prevalent in

                             Thailand has been developed and added to the original B/B strain to be
                             suited for testing in Thailand. Support Uly for project staff to follow SOP
                             for counseling although an effective counsefling can affect directly to the

                             study, the reduction in infection rate might lead to the necessity of increasing
                             sample size which will in turn increase investment. Furthermore, if the
                             reduction rate is high enough in both vaccine and placebo groups, the
                             study may have to be terminated with no result; the sponsor was agreed to
                             accept all the consequence. The infi-astucture for research especially the

                             development of serum repository and the data management had been
                             invested.
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