Ethics in question, Tufts researcher’s paper retracted

"The authors are unable to provide sufficient evidence that the study had been reviewed and approved by a local ethics committee in China in a manner fully consistent with NIH [National Institutes of Health] guidelines," the American Journal of Clinical Nutrition said in a July 29 retraction notice on its website.

The authors were also unable to provide documentation that "all parents or children involved in the study were provided with the full consent form for the study," the journal said.

Tang sought an injunction to block the journal from retracting the study, but on July 17, Middlesex Superior Court posted a notice rejecting her request. She referred a request for comment to her lawyer, who declined to be interviewed.

Tufts University would not comment directly on the situation, saying it is the subject of pending litigation, but released a statement to the website Retraction Watch, which tracks scientific retractions and was the first to report about the retraction. A Tufts official referred the Globe to that statement, which noted that the journal had not raised questions about the accuracy of Tang's research or the safety of the study's subjects.

Several editors of the journal also declined to comment, citing pending litigation. It was unclear whether Tufts and journal editors were referring to an appeal of the injunction or another suit.

After concerns about the research became public in 2012, Tufts convened an external review committee. "There was no evidence found of falsification or fabrication of the data that underlie the study's primary findings," according to the statement. "Those reviews did, however, determine that the research had not been conducted in full compliance with Tufts research policies and federal research regulations."

Tufts confirmed 2012 reports in the journal Nature and other publications that Tang was prohibited from conducting clinical research for two years. She remains an associate professor at Tufts, where she studies vitamin A nutrition, according to her website.

The Tufts statement said the university "has not been served with any complaint from Dr. Tang's attorneys relating to these issues."

Litigation between scientific journals and academics, such as Tang's pursuit of an injunction, remains quite rare, but is increasing, said Ivan Oransky, cofounder of Retraction Watch.

"In general, we see researchers lawyering up more often," said Oransky. "I'm concerned if the growing presence of lawyers in publishing decisions means that journals will be afraid to do the right thing, or do what they believe is right for the scientific record."

The advocacy group Greenpeace first raised questions about the research and continues to be concerned about it, said Jing Zhang, a food and agriculture campaigner for Greenpeace East Asia.

"It's really outrageous that Chinese children are being studied by feeding them GMO golden rice without proper information, without proper review from the authorities," Zhang said.

Although feeding the children a small amount of modified rice is unlikely to be harmful, Zhang said she thinks genetically modified food is dangerous for human health and the environment, and bad public policy. Children with nutritional deficits are usually short many other vitamins in addition to vitamin A, she said.

Back in 2008, Greenpeace asked the Chinese Ministry of Agriculture about the study, which they found referenced on a Tufts website. Zhang said ministry officials told Greenpeace that the research had been stopped because the scientists didn't have the right to test genetically modified foods in China.

According to a 2001 Chinese regulation, the testing, production, and marketing of genetically modified products must be approved by the government.

Zhang said Greenpeace contacted the Chinese government again shortly after the paper was published in June 2012, at a time when public opposition to GMO foods was high.

The government opened an investigation, determined that the researchers did not have the appropriate permissions, and, according to a 2012 article in the journal Nature, fired three government officials for not flagging the ethical breach.

According to the study and a federal record of it on clinicaltrials.gov, the researchers wanted to test whether one serving of the rice would boost levels of vitamin A in the children's blood as much as spinach or a beta carotene pill.

The children's blood levels of vitamin A were checked several times over the next few weeks. The rice is high in beta carotene, the nutrient that gives carrots their color, which converts to vitamin A in the body.

The children were randomly divided into groups, with one-third eating the golden rice, another eating spinach, and the remainder consuming beta carotene in a pill. The study found that the children who received the pill and those who ate the golden rice both had roughly the same amount of vitamin A in their blood, while those who ate spinach had less.

The paper has since been cited by 30 other scientific publications, according to American Journal of Clinical Nutrition website.

The journal's move to withdraw the golden rice paper was unusual. Approximately 5 percent of retracted papers concern violations of regulations designed to protect human research subjects, according to a current paper in the journal Accountability in Research.

Golden rice, which was developed to help prevent vitamin A deficiencies, has been controversial because it is not clear that the saffron-colored rice is any better than other, potentially less expensive approaches.

Vitamin A promotes good vision; helps form and maintain healthy skin, teeth, skeletal and soft tissue, and mucus membranes; and may be necessary for reproduction and breast-feeding, according to the National Library of Medicine.

Karen Weintraub can be reached at weintraubkaren@gmail.com.