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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