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                           clinical data are credible."



                        According to this statement the human subjects protections should be the first
               priority to be implemented. But the situation now is in the opposite direction. The GCP
               training mostly for investigators was widely done with strong support from the pharmaceutical
               industry. The aim of training is more focus on the credibility of clinical data, which will be

               used for submitting for drug registration. The concerns of human subjects protections
               became second priority.



                        At national level it is a big surprise for me when I have learned that even in the
               most developed country like the United States which has a long history of development on
               human subjects protection, the system had been unsatisfactory.


                        According to an article written by Greg Koski, the first Director of Office for

               Human Research Protection, I quote:


                           "While few deny that human subjects in research are better protected today

                           than they were forty years ago, most agree with the conclusions first published
                           in 1998 in the report from the Department of Health and Human Service
                           Office ofthe Inspector General that the system was in serious need of reforrn
                           a system that is long on procedure but short on effective protections."



                        In a book entitled, "Responsible Research: A Systems Approach to Protecting
               Research Participants", prepared by the Committee on Assessing the System for Protecting
               Human Research Participants, appointed by the Institute of Medicine of The National

               Academies in the US; it was noted that:


                           " In may 1999, the federal office charged with overseeing federally funded
                           research, the office for Protection from Research Risks (OPRR), halted
                           human research studies at Duke University Medical Center. This was

                           shocking to the research community and the public, for if a highly respected
                           institution such as Duke could be noncompliant, then problems were likely to
                           be more wide spread than previously imagined. From October 1998 through
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