Dispute over data privacy halts cancer study
Dispute over data privacy halts cancer study
复制标题
数据隐私争议导致癌症研究停止
作者：
D. Cyranoski
在日本医学会（JMA）指责其领导人未能为参与者的隐私提供足够的保护后，一个重大的癌症研究项目被踩下刹车。这一事件表明，日本医生和临床研究人员之间存在不信任，观察人士说，这种不信任继续阻碍着日本加强临床研究能力的努力。癌症项目旨在研究生活方式和遗传学在决定主要癌症类型易感性方面的各自作用。计划者希望从10万名受试者中收集血液样本，以及饮食、锻炼和睡眠习惯的信息。该项目于5月开始，对广岛附近的一个小镇熊野町的6,000名市民进行了调查。项目组织者计划在8月开始采集血液样本。但7月16日，日本气象厅在回答熊野町居民的询问时，向该项目的资助方文部省发出了一封投诉信，称该项目的数据收集过程无法确保收集到的个人信息的私密性。“他们利用普通公民--那些没有法律的责任保护信息的人--去人们的家里收集信息，”JMA董事会成员Rintaro Sawa说。Sawa声称，这项研究利用了广岛人习惯于回答辐射沉降研究中的此类问题这一事实。该项目的领导人现在告诉教育部，他们将推迟一年的研究，同时他们试图找到一种新的方法来收集数据。项目负责人之一，广岛辐射效应研究基金会的癌症流行病学家KeiNakachi说，他接受JMA的批评。“我们希望诚实和开放，看看我们的问题，“他说。但一些研究人员对日本医学会似乎在他们的工作中扮演的监督者角色感到困惑。日本医学会表示，它别无选择，因为去年5月颁布的一项确保个人信息安全的法律没有要求研究人员监督自己的程序（见Nature 417，689; 2002）。从今年8月起，日本医学协会将成立一个委员会，负责监督研究中个人信息和医学样本的使用。日本医学协会还在监测一个项目，该项目利用来自患有各种疾病或药物副作用的患者的300 000个样本创建遗传信息数据库（见Nature 423，209; 2003）。东京大学的基因组学家、该项目的负责人Yusuke中村说，他计划在该项目200亿日元的五年预算中花费80亿日元（7000万美元）用于收集和存储数据的适当方法，包括建立计算机防火墙来保护数据，以及培训医疗专业人员收集样本。但中村担心，日本医学协会在隐私问题上的激进立场会让参与者感到不安，并吓跑他们。“我们一直非常小心。我不想失去病人的信任，”他说。■新闻
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 radiationfallout 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; 2002). “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 sideeffects (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. ■ news