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Published on September 22, 2007

 A central ethics committee to review all stem-cell research projects will be established soon to prevent patients becoming "guinea pigs" in a very new and sophisticated field of research.

The idea to establish the committee came yesterday after a three-hour meeting of a working group on the regulation of stem-cell research. The group is headed by Dr Wichai Chokewiwat, a senior doctor.

Wichai said stem cells were a new and sophisticated issue and any trial project in the area must be carefully reviewed by experts before it is allowed to be conducted on humans.

"Stem-cell research projects should not be reviewed by any institutional ethics committee, due to the possibility of conflicts of interest. As the issue is so sophisticated, the review of any research must be done by an independent committee," he said.

The structure of the panel will be detailed later by the Food and Drug Administration (FDA), he said, before being approved by the Cabinet.

Nineteen hospitals are conducting stem-cell research on humans. Under the current regulations, each hospital could set up its own ethics committee to review its own research projects.

Wichai said the ongoing research could be continued only if it meets the criteria to be set up by the FDA. Existing research projects that do not meet the criteria, he said, must be suspended and the principle investigator must resubmit the research proposal to the central ethics committee for review.

Wichai added that the very basic principles in conducting clinical trials on humans were that the patients recruited for a research project must be well informed and clearly understand the risks and benefits of the research. "Genuine consent from the research subject is needed, and all patients taking part in a research project must not be charged for any expenses," he added.

Dr Thiravat Hemachudha, a member of the stem-cell working team, said the idea to establish the central ethics panel to review research was a clear message to the public that stem-cell therapy had not yet been approved as a standard medical procedure as some might believe.

Dr Nipan Issasena, head of the stem-cell unit at Chulalongkorn Hospital, welcomed yesterday's resolution of the stem-cell working group, saying that it was for the benefit of patients.

The working group yesterday also agreed that the FDA and the Health Service Support Department would have legal authority to oversee the use of stem cells in the country.

The FDA would regulate when stem cells were used for medical treatment, while the department would control the practice of stem-cell banking.

Pennapa Hongthong

 The Nation