Tokyo

The brakes have been slammed on a major cancer-research project, after the Japan Medical Association (JMA) accused its leaders of failing to provide adequate protection for participants' privacy.

The incident illuminates the distrust between physicians and clinical researchers in Japan which, observers say, continues to dog efforts to bolster the country's clinical research capacity.

The cancer project seeks to study the respective roles of lifestyle and genetics in determining susceptibility to major cancer types. Its planners want to collect blood samples, as well as information on diet, exercise and sleeping habits, from 100,000 subjects.

The project began in May with a survey of 6,000 citizens in Kumano-cho, a small town near Hiroshima. Project organizers planned to start taking blood samples in August.

But on 16 July, the Tokyo-based JMA, reacting to enquiries from Kumano-cho residents, sent a letter of complaint to the education ministry, which funds the project. The letter said that the project's data-collection process could not ensure that the personal information gathered would remain private.

“They were using ordinary citizens — people who had no legal responsibility to protect the information — to go to people's houses and collect it,” says Rintaro Sawa, a member of the JMA's board of trustees. Sawa claims that the study took advantage of the fact that people in Hiroshima are used to answering such questions for radiation-fallout studies.

The project's leaders have now told the education ministry that they will postpone the study for a year while they try to find a new way of collecting the data. One of the project leaders, Kei Nakachi, a cancer epidemiologist at the Radiation Effects Research Foundation in Hiroshima, says he accepts the JMA's critique. “We want to be honest and open and look at our problems,” he says.

But some researchers are perplexed by the watchdog role that the JMA seems to be assuming over their work. The JMA says it has no choice, as a law enacted in May last year to ensure the security of personal information fails to require researchers to monitor their own procedures (see Nature 417, 689; 200210.1038/417689a). “There's no one else to do it,” says Sawa. From August, the JMA will establish a committee to oversee the use of personal information and medical samples in research.

The JMA is also monitoring a project to create a database of genetic information using 300,000 samples from patients who suffer from various diseases or drug side-effects (see Nature 423, 209; 2003).

Yusuke Nakamura, a genomicist at the University of Tokyo and that project's leader, says he plans to spend ¥8 billion (US$70 million) of the project's ¥20-billion five-year budget on proper methods for collecting and storing data, including the establishment of computer firewalls to protect the data, and training of medical professionals to collect samples.

But Nakamura worries that the JMA's aggressive stance on privacy will make participants uneasy, and scare them away from his study. “We have been very careful. I don't want to lose the patients' trust,” he says.