Tuesday, October 1, 2013

Tufts University: Ethical Violations on Golden Rice Study

University officials have admitted that Tufts-affiliated researchers violated scientific ethics laws after feeding genetically modified rice to children in China without proper consent in a study about “Golden Rice.”
A recent university announcement confirmed accusations from Greenpeace that researchers in the study had tested the rice on children without disclosing the true nature of the experiment.
Golden Rice, which contains beta carotene, was developed as a solution for Vitamin A deficiency in children.The deficiency causes blindness in approximately 250,000 children annually, and about half of those children die within a year as a result of the sight loss.
During the 2008 study, they gave 72 primary school children in China’s Hunan province rations of the modified rice. All children were between the ages of six and eight years old.
On Sept. 17 of this year, Tufts issued an email statement to media outlets standing by the findings of the study, but conceding an ethical violation.“While the study data were validated and no health or safety concerns were identified, the research itself was found not to have been conducted in full compliance with policy or federal regulations,” the university said
According to the announcement, Tang will be barred from conducting research on human subjects for two years, during which time she will be retrained on human subject research regulations and policies.
“The Chinese show great shock and anger on this unbelievable misconduct of golden rice trial,” Jiangli Yu, senior campaigner at Greenpeace East Asia, “Especially for those parents of children who were involved in the trial, they feel hurt since they were not told the details.”
After Greenpeace first questioned the study in August 2012, the CDC began a three-month investigation of the experiment, which resulted in the organization firing two members of its own staff., including principal investigator Shi’an Yin.
Tufts’ has revised its policies and procedures to ensure that in the future, research conducted outside of the United States is reviewed more carefully, according to the email to the media.
Golden Rice, which contains beta carotene, was developed as a solution for Vitamin A deficiency in children, Kritz told the Daily in an email. Such deprivation causes blindness in approximately 250,000 children annually, and about half of those children die within a year as a result of the sight loss.
According to the announcement, Tang will be barred from conducting research on human subjects for two years, during which time she will be retrained on human subject research regulations and policies. As a result, Tang has decided to close her lab next year.
“The general [Chinese] public show great shock and [anger] on this unbelievable misconduct of golden rice trial,” Jiangli Yu, senior campaigner at Greenpeace East Asia, told the Daily in an email. “Especially for those parents of children who were involved in the trial, they feel hurt since they were not told the details which they were supposed to know.”
The study was published in The American Journal of Clinical Nutrition (AJCN) in August 2012 and concluded that Golden Rice was a promising source of Vitamin A for Chinese children.. After Greenpeace first questioned the study in August 2012, the CDC began a three-month investigation of the experiment, which resulted in the organization firing two members of its own staff, including principal investigator Shi’an Yin.
Kritz said that Tufts, despite the violation, stands by the results of the study.“These multiple reviews found no concerns related to the integrity of the study data, the accuracy of the research results or the safety of the research subjects,” the media statement read. “In fact, the study indicated that a single serving of the test product, Golden Rice, could provide greater than 50 percent of the recommended daily intake of Vitamin A in these children, which could significantly improve health outcomes if adopted as a dietary regimen.”

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