Alleged ethics violations surface in Tufts-backed study

The American Journal of Clinical Nutrition in August published a study co-authored by Tufts-affiliated researchers, which, critics allege, violated international and scientific ethics laws.

The study assessed whether a genetically modified type of rice called “Golden Rice” could provide Vitamin A to humans as effectively as other foods, such as beta-carotene oil and spinach. 

Golden Rice has been modified to contain beta-carotene, a natural compound that converts to Vitamin A in the human body. Providing Vitamin A to undernourished children could save 1.9 to 2.7 million lives each year, according to the study. 

Researchers fed Golden Rice to a trial group of 24 children between the ages of six and eight in the Hunan province of China and tracked the responses in their Vitamin A levels, according to the study.

However, human rights workers allege that the rice is not necessarily safe for human consumption and may have been used in the experiment without consent from the participants or the Chinese government, according to an email from Aaron Gray-Block, international media officer at Greenpeace International.

The study lists Guangwen Tang, an associate professor at the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, as the lead author of the paper along with Yuming Hu, Shi-a Yin, Yin Wang, Gerard Dallal, Michael Grusak and Robert Russell. 

Tang, Dallal and Russell are all affiliated with the Human Nutrition Research Center on Aging (HNRCA) at Tufts. None responded to an email request for comment.

The United States Department of Agriculture (USDA) supports the HNRCA. The Tufts Medical Center Institutional Review Board and Ethics Review Committee of Zhejiang Academy of Medical Sciences in China approved the experiment, according to the study.

Tufts is “deeply concerned” by the allegations and is currently reviewing the experiment’s protocols, Andrea Grossman, assistant director of public relations for Tufts’ Boston campus, told the Daily in an email.

Proponents of Golden Rice claim that it is useful in providing Vitamin A to populations in undernourished areas where the climates support rice growth, according to the International Rice Research Institute (IRRI). 

Chinese government officials issued “a clear directive against this very experiment” in 2008, according to Gray-Block.

Greenpeace East Asia first contacted the Chinese Ministry of Agriculture about the experiment in 2008 and confirmed that it had stopped, Fang Lifeng, Sustainable Agriculture Campaigner at Greenpeace East Asia, told the Daily in an email.

“This study could not have taken place without a serious breach of scientific and medical ethics, and goes against a Chinese government decision to abort plans for the trial,” Lifeng’s statement said.

Greenpeace also questioned the relevance of the study, which tested the effect of Golden Rice on healthy children instead of a population that is Vitamin A-deficient.

“Beta carotene is a safe source of Vitamin A,” Sophie Clayton, public relations manager for the IRRI, wrote in an email to the Daily. “The beta carotene in Golden Rice is the same as the beta carotene that is found in other foods.” 

The IRRI is still in the process of further evaluating the safety of Golden Rice, according to Clayton.

Greenpeace questioned whether the parents of the children involved in the study gave informed consent for their participation in the experiment, according to Gray-Block.

According to the Institutional Review Board (IRB) Guidebook, “Informed consent assures that potential human subjects will understand the nature of the research and can knowledgably and voluntarily decide whether or not to participate.” 

Parents may give proxy consent for their children or minors to be subjects in an experiment, according to the IRB Guidebook. The IRB usually requires children to agree to participate.

According to the IRB Guidebook, “when the research offers the child the possibility of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research, the IRB may determine that the assent of the child is not necessary.”  

Tang’s research focuses on Vitamin A and related compounds, and in 2009 Tang published a study in the American Journal of Clinical Nutrition that concluded that the beta-carotene in Golden Rice could provide Vitamin A to humans. The study used five Boston-area volunteers. 

The two non-Tufts authors, Yin and Yuming, are based in China. Yin told the People’s Daily that he helped collect data for the study but did not know the study involved Golden Rice, according to the Daily Mail. 

Yuming denied his involvement in the study, according to the Daily Mail. 

Golden Rice is not the best solution for addressing widespread Vitamin A deficiency, Greenpeace’s email statement said. The organization supports other programs, such as those that support pro-Vitamin A pills, according to Greenpeace’s email.


Editor’s Note: In an earlier version of this story, Sophie Clayton was misquoted as saying, “Golden Rice is a safe source of Vitamin A.” In fact, it should read, “Beta carotene is a safe source of Vitamin A.”