Ministry to write new guidelines for medical research
The Public Health Ministry is working on national guidelines for all human research projects.
"While attracting the [international] pharmaceutical industry to launch clinical trials here, we have to protect our people who are going to be the subjects of the research," Dr Chatri Bancheun, director-general of the Medical Services Department, said last week.
The legal measure is the latest in a series of moves by the ministry to make Thailand a hub for clinical trials of newly developed medicines. Chatri said the new regulations would show the world the country has international standards in place to control the ethical execution of all research projects. That would also help in persuading drug companies to conduct their trials here. Biotechnology is now playing a crucial role in medical research, so genetic material needs to be controlled to ensure confidentiality and privacy of the individual. The new law would cover the establishment of a national ethics committee on human research and its guidelines, rights of participants in a research project, and details of a contract that has to be signed before a material transfer can take place. Thailand has hosted many clinical trials and studies on medical treatments over the past decades, with each year seeing several thousands of them involving humans. Chulalongkorn University's Medical Science Faculty last year approved 428 research proposals involving humans. Almost all of them were clinical trials for new drugs or new applications of existing drugs. One of the biggest pharmaceutical projects is a massive Phase III test of an antiretroviral treatment for HIV. Several biotechnology projects have attracted publicity, including stem cell therapy for heart patients at Siriraj Hospital and the collection of genetic materials of tsunami survivors in order to study the potential in developing customised drugs for people suffering from post-traumatic stress disorder and other mental disorders at Rajanukul Hospital. Chatri insists that it is not too late to set up a national ethics committee and draw up national guidelines. Human experiments are now being overseen by ethics committees at each institution, but no organisation exists to police the quality of each ethics committee, he said. Nantana Intanond, a legal expert involved in drawing up the law, said the law would bring the ethics committee of each institution up to the same standard.
Pennapa Hongthong The Nation
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