SHANGHAI, CHINA—An official investigation in China has come down hard on a controversial U.S.-funded study in which Chinese schoolchildren were fed genetically modified (GM) rice. In a statement last week, the Chinese Center for Disease Control and Prevention (China CDC) in Beijing said the trial, which finished 4 years ago but was only published in August, violated ethical rules. The study's three China-based authors have been removed from their posts, while parents of the children who participated have been offered generous financial compensation.
The statement also accuses Tang Guangwen of Tufts University in Boston, the corresponding author of the study, of violating Chinese regulations and importing the rice into China without proper approvals.
"This is an alarm bell for biotech scientists on the importance of strictly following ethical and other regulations on research," wrote Huang Jikun, director of the Chinese Academy of Sciences' Center for Chinese Agricultural Policy in Beijing, in an e-mail to ScienceInsider. But Adrian Dubock, who was not directly involved in the work but who is a Switzerland-based manager for the Golden Rice Project, which promotes the development of the engineered crop, believes most of the charges to be baseless.
A Tufts spokesperson said the three researchers at that university involved in the trial would not comment on the Chinese report; Tufts is currently conducting its own review and is declining to comment as well pending its outcome. The principal China-based author, Yin Shi'an of the China CDC, referred ScienceInsider to his employer; another Chinese author, Wang Yin of the Zhejiang Academy of Medical Sciences, did not respond to a request for comments; and contact information for the third, Hu Yuming of the Hunan Province Center for Disease Control and Prevention, could not be located.
At issue is a study funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases and the U.S. Department of Agriculture (USDA) that was conducted on schoolchildren in Hunan province in 2008 and published online in August. According to the China CDC, 25 children at Jiangkou Central Primary School in Hengnan County were fed golden rice, a strain genetically engineered to be high in β-carotene that was designed to fight vitamin A deficiency; 55 others ate either spinach or capsules containing β-carotene in oil. (The published paper reports data on only 68 children, apparently because researchers weren't able to obtain enough blood from some of them.) The publication sparked an uproar in China after Greenpeace China disseminated a press release calling it "a scandal of international proportions."
A key accusation in the China CDC statement concerns consent forms signed by parents of children who participated in the study. On 22 May 2008, the researchers explained their experiment to the parents and guardians without mentioning that one group of children would be fed GM rice, the statement says. The informed consent form did not mention genetic modification either, according to the statement; moreover, parents weren't shown the entire form, but only the page where they had to sign. That page did not mention golden rice. The statement says the scientists together "meticulously concealed the reality" that the experiment involved golden rice.
An English version of the consent form, which ScienceInsider has obtained, does not mention that the rice is genetically modified, but does call it golden rice. "Golden Rice is a new rice which makes β-carotene, thus given [sic] the rice a yellow (Golden) color," the form says.
Dubock, who has kept in touch with the research team, says they avoided the term "genetically modified" because U.S. government guidelines on consent forms ask researchers to explain a study in "language understandable to the subject or the representative," and because the term "genetically modified" has become so loaded that people might equate it with danger. The consent forms have been reviewed by U.S. ethical panels in the United States and China, he says, and a previous study of golden rice in adults in the United States did not use the term "genetically modified" either. Although he was not present at the time, Dubock says it's possible that parents did not see the entire consent form because the study was explained during one or more meetings.
In addition to breaking ethical rules, Yin and Wang "provided false information" during the investigation and attempted to hinder its progress, according to China CDC. Yin is barred from scientific research for 3 years.
Tang, a Chinese-born scientist who works at a USDA-funded nutrition lab at Tufts, is accused of bringing cooked golden rice into China without obtaining the proper Chinese government approvals and beginning the experiment 11 days before required permission had been obtained from the National Institutes of Health (NIH). Dubock disputes that timeline and believes Tang did not require special import permits; China's Customs Clearance Guide for International Passengers prohibits travelers from importing GM organisms, but that does not include cooked rice, he says: "Organisms are living things."
The China CDC statement also contends that the study's authors moved the research site from Zhejiang province to Hunan province in 2008 without reapplying for NIH approval as required. Dubock says the trial was moved because of a measles outbreak in Zhejiang, but says the original approvals were valid in Hunan as well, because the study design remained the same.
China CDC reportedly prepared the statement after dispatching an official to the United States to consult representatives of both Tufts and NIH; Tufts last week confirmed receiving investigators from China in October. The institutions provided the officials with documents and unspecified samples, according to the statement, which was cosigned by the Zhejiang Academy of Medical Sciences and the Hunan Province Center for Disease Control and Prevention.
Local officials in Hunan offered parents of children fed the GM rice the equivalent of $12,800 in compensation in November, the Shanghai-based newspaper Oriental Morning Post reported last week, while parents of children who served as controls were offered $1600. China CDC pledged to strengthen its oversight of research. "Scientists should be careful about how they conduct research," Huang wrote in his e-mail, "and it's a pity that in this case that didn't happen."