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University admits Golden Rice ethics violation

Published: Tuesday, October 1, 2013

Updated: Tuesday, October 1, 2013 08:10

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, according to Tufts Deputy Director of Public Relations Jennifer Kritz. The team was led by Guangwen Tang, an associate professor at the Friedman School of Nutrition Science and Policy.

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.

During the 2008 study, researchers gave 72 primary school children in China’s Hunan province rations of the modified rice, according to a Sept. 18 article in ScienceInsider. 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 [institutional review board (IRB)] policy or federal regulations,” the university said in the statement.

According to the announcement, Tang will be bared 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, ScienceInsider reported.

“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.”

On the other hand, the Chinese government’s Ministry of Agriculture, a department responsible for genetically modified organism bio-safety management, has not given any official response, Yu said. The Chinese academic circle, which includes scientists involved in genetic engineering research, does not believe the experiment is a major concern.

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. No punitive action has been taken by the journal thus far.

“The [AJCN] and the Society that owns the [AJCN] have not made a final decision on action(s) that will be taken on the information recently made available to us,” Editor-in-Chief of AJCN Dennis Bier told the Daily in an email.

According to a Dec. 10 article in the science journal Nature, the Tufts researchers conducted the study with the Chinese Center for Disease Control and Prevention’s Nutrition and Food Safety Institute (CDC). 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.

A China Central Television broadcast later revealed that Yin had sent an email to Tang in which a CDC official had changed the wording of information given to the children’s parents. The new wording avoided mentioning Golden Rice because it was “too sensitive,” according to the article in Nature.

During the time of the Golden Rice study, co-author and Tufts affiliate Gerard Dallal was responsible for meeting with investigators to discuss overall study design and analyzing the data after the study in accordance to protocol. He was not, however, involved in carrying out the actual experiment.

“I leave implementation to the principal investigator,” Dallal told the Daily in an email. “I don’t have a hand in the actual data collection.”

Dallal explained that the IRB had approved the study and that he had seen no reason to monitor the goings on between protocol approval and data delivery.

“I would not stick my head in the sand to ignore any unethical behavior, were I to have observed any,” he added.

Tufts’ own IRB had investigated the ethical procedures for scientific fraud or data manipulation, according to the media statement. Following additional reviews by internal and external panels, however, the Tufts IRB found that Tang had provided insufficient evidence to show that the study had been approved by an ethics review board in China and that the consent forms for the study had been tampered with.

Because of this, Tufts’ IRB 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.

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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