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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
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