Page 50 - Untitled-4

48 «“√ “√°“√·æ∑¬å·ºπ‰∑¬·≈–°“√·æ∑¬å∑“߇≈◊Õ° ªï∑’Ë Ú ©∫—∫∑’Ë Ú °ÿ¡¿“æ—π∏å-情¿“§¡ ÚıÙ˜

December 2001, OPRR and its successor, the DHHS Office for Human

Research Protections (OHRP) restricted or suspended a number of multiple
project assurances and cited 113 research organizations for non-compliance;
the Food and Drug Administration (FDA) has also suspended clinical
research at other organizations."

In 1999, an 18 year old Jesse Gelsinger died in a Phase I gene transfer study at
the University of Pennsylvania. The FDA found that the consent form had been altered
from the original approved document and that data relevant to safety had not been reported.

It was concluded that : "The failure to protect this young man in many ways was paradigmatic
of failures in the system of protections itself - lack of accountability, conflicts of interest of
the investigators and the institutions, insufficient monitoring upon trial commencement, a
questionable scientific review procudure, and inadequate resource for comprehensive and
stringent review and oversight."

A similar case was happened in another famous research institute, Johns Hopkins,
where a healthy volunteer who is an employee of a research unit died in a Phase I study.

And the OHRP suspended all the clinical studies at Johns Hopkins.

The developed country like the US who invested tremendously in clinical
research, and highly concern. in the human subjects protections, still had tragic
experiences. In developing countries, the problems are worse. The trial subjects are prone

to be exploited and less protected. A decade ago or even nowadays, a number of developing
countries are still unfamiliar with the Declaration of Helsinki or the CIOMS' Guidelines.
There are no Ethics Committee or national guidelines for research involving human

subjects in many countries. Most of Ethics Committees in developing countries work under
the constraints of insufficient support. Deficiencies are found in every aspect: man, money,
material and training. The works done by Ethics Committee are usually recognized as an
extra job. It was not evaluated as a part of performance. Most of members of Ethics
Committee do not work as full time or even a part time basis, but "once upon a time basis."

For most of Ethics Committee, the works are usually finished at the end of the protocol
review only. Very few committees continue their work to oversee the conducting of
research until complete.