Medical trial volunteers must be given full access to all trial
research and results and be protected from intimidation, China's
Ministry of Health has warned.
Volunteers must also be given complete confidentiality, the
ministry ordered in a circular to health organizations.
"Trial patients must be volunteers, and should be respected and
informed about the whole process, and able to withdraw at any
stage," says the document of the ethics of human drug trial.
Patients involved in diagnostic research and studies on the
prevention and treatment of diseases must also be protected and
treated with respect, according to the circular.
The health and safety of volunteers must come before the
scientific and social value of trials, and they are to be properly
compensated and receive free treatment in the event of any
problems.
Volunteers should be informed about the storage of their
personal information, with extra care shown to vulnerable groups
such as children, pregnant women, illiterate people, the poor and
the mentally ill.
The ministry last year issued a regulation stipulating that
organ donations must be on a voluntary basis and refuted foreign
media reports that organs of executed prisoners were sold.
The Guangzhou-based Southern Weekly reported in October
last year that the Shanghai East Hospital had been implicated of
conducting medical trials on patients without their knowledge
during heart operations.
The hospital denied the accusation and is to sue the newspaper
for libel.
The case is to be heard next month.
(Xinhua News Agency January 27, 2007)