Keio University plans to discipline two doctors who extracted bone marrow fluid samples from 31 lung cancer and other patients during surgery without seeking their permission.
A professor of respiratory system and a lecturer at the university’s medical school took the samples from October to January for use in clinical research aimed at developing a method that can predict effective treatment.
But taking samples without patients’ prior consent violates ethical guidelines for clinical research set by the Ministry of Health, Labor and Welfare.
“We are overwhelmed with shame as (the doctors’ actions) amounted to an utter disregard of the guidelines for clinical research, in which the interest of the patients comes first,” said Makoto Suematsu, dean of the Keio University School of Medicine. “We offer anew our apologies to each individual we have caused trouble.”
The prestigious university said its officials have briefed and apologized to the patients affected, and that the extraction of the samples caused no health damage.
The violation was brought to light by a whistle-blower who alerted the head of Keio University Hospital in January.
The doctors told an in-house investigation they took the samples without the patients’ consent because they wanted to obtain results as quickly as possible.
According to the university, the two extracted bone marrow fluid from 26 lung cancer patients, aged 40 to 84, during surgery between Oct. 24 and Jan. 11 without asking their permission.
The doctors also did not go through ethical review procedures set by the school for taking samples.
In addition, they extracted samples from five patients with pneumothorax or lung infections to compare them with the samples from the lung cancer patients.
They took 2 milliliters of bone marrow fluid from each patient.
The university has suspended 23 other clinical research projects at the school’s respiratory surgery section to check if any other wrongdoing has been committed.
The university reported the incident to the health ministry and education ministry.
The health ministry instructed Keio University to prevent a recurrence.
(This article was written by Ayako Tsukidate and Maiko Kobayashi.)
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