• Kyodo

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A research team at Yokohama City University carried out analysis on the genes of several patients suffering from colon cancer without their consent, it was learned Wednesday.

Researchers also forged documents to make it appear that the patients had consented to the analysis, while a portion of their results was made public at last autumn’s gathering of the Japanese Cancer Association, sources familiar with the case said.

The team in question was jointly studying the genetic patterns behind colon cancer with the Institute of Physical and Chemical Research (Riken), a public corporation under the jurisdiction of the Education, Culture, Sports, Science and Technology Ministry.

According to the university, a member of the research team performed several operations on patients suffering from colon cancer and polyps while he was working at a private hospital in the city of Mito, Ibaraki Prefecture, in the spring of 2000.

The researcher preserved some tissue samples from patients he had treated, without having obtained the patients’ approval, saying only that the samples would be checked for cancer.

The samples were then taken to the institute for DNA analysis. The researcher was identified only as a graduate student at Yokohama City University in his 30s.

Riken’s ethics committee reviewed the research procedure late last year, but the research group submitted falsified documents to make it appear as though all 30 samples used in the study were provided with the consent of patients at the university hospital, according to the university. University officials added that an in-house probe has already been launched.

It was agreed in the contract between the institute and the city university, which was signed upon starting the joint study, that all samples used should be collected from surgical patients at the university’s hospital upon securing their consent.

The graduate student approached one of his professors on Sunday to confess his role in the use of samples without patients’ consent, adding that he could not obtain the necessary data for the research from samples taken at the university hospital alone.

This revelation has shocked many observers due to the highly sensitive and private nature of human genes, which are believed to store a significant amount of personal information including an individual’s chances of suffering from a disease in the future.

The ministry said Wednesday that it would launch a probe into the incident. Government officials added that relevant ministries would issue in April a set of ethical guidelines for genetic researchers. These guidelines include the need to secure informed consent from patients who offer samples.

Some experts pointed to the fact that many in the medical profession were used to the notion of not obtaining patient approval before obtaining samples for research.

As a result, the researchers in question may have taken lightly the fact that they were handling people’s genetic information, they added.

State names hospitals

The government released Wednesday the names of 803 hospitals and clinics at which inpatients may have been administered blood products that were tainted with different strains of the hepatitis virus during treatment for ailments other than hemophilia between 1972 and 1988.

The Health, Labor and Welfare Ministry estimates that around 1,000 inpatients at these institutions may have been infected with hepatitis B or hepatitis C during treatment involving the use of blood products during the 16-year period.

Akira Miyajima, chief of the ministry’s Pharmaceutical and Medical Safety Bureau, said people who had endured serious bleeding while undergoing surgery at these institutions should undergo tests soon to examine whether they were infected.

Those who may be at risk include former inpatients who suffered bleeding as newborn babies, as well as former inpatients who suffered serious bleeding due to hepatic cirrhosis, fulminant hepatitis or esophageal varices. Other former inpatients who may be at risk are those who endured sustained bleeding during surgery. Women who lost a considerable amount of blood during childbirth should also be tested.

The health ministry will accept telephone inquiries on the matter, while the relevant medical facilities will provide free checkups until July 31.

The 803 institutions include 695 hospitals whose names were released in 1996 in connection with the possibility of HIV infection through the use of unheated blood products during treatment for ailments other than hemophilia.

The list also includes some institutions that have since been shut down or moved to unidentified locations.

The phone number for inquiries at the health ministry is 03-5253-1111, extensions 2730, 2731 or 2732. Phone calls will be taken from 10 a.m. to 5 p.m. The list of the medical institutions in question will also be available on the ministry’s home page at www.mhlw.go.jp/

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