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4) The investigator, which the Ethics Committee of Ministry of Public Health,

Thailand made requirement that the principal investigator must be a Thai
citizen,and his team had done their duty well both for scientific aspect and
human subjects protections. Those activities were:
Ô To work collaboratively with a leading national research institute,the School
of Tropical Medicine, and the HIV/AlDS Collaboration Centerwhich is

ajoint research activity between US CDC and Ministry of Public Health,
Thailand to prepare the research proposal specifically for study in Thailand
not the same protocol that conducted in the US and Western Europe.

Ô The investigator team and all the units participating in the study which
included almost 20 centers and almost 400 medical and paramedical
personnel in Bangkok and periphey, were trained and prepared to run the
study project.
Ô The Protocol has been strictly followed after review and amendment by

both scientific and Ethics Committee.

Overall, the AIDSVAX Phase III Trial in Thailand is a good example for human

subjects protections. But the case may not be the majority of the clinical research both in
developing and in developed countries. In fact, the history of an attempt to protect human
subjects is quite long, started after WW H. There are many good international wid national
ethical guidelines for research involving human subjects, e.g., the Nuremberg Code, the
Declaration of H elsinki, t he B elmont R eport, a nd t he C IOMS' Guidelines as some

examples.

But guidelines are guidelines. They are not rules or laws which have legal

binding mechanism for one to follow.

The ICH GCP Guidelines which is accepted widely is a very good operational
guideline for clinical research, has stated very clearly in its introduction that:

"Compliance with this standard provides public assurance that the rights,
safety and well-being of trial subjects are protected, consistent with the
principles that have their origin in the Declaration of Helsinki, and that the