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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.