In Tufts research on "golden rice" in China, the procedure for parents' informed consent was flawed

In research in China on genetically modified "golden rice," Tufts researchers did not provide adequate information to parents whose consent was requested for their children's participation, according to information provided by Tufts University this week.

The rice contains beta carotene, a precursor to vitamin A.  The research by Tufts professor Guangwen Tang and colleagues studied whether the new rice could make a difference in actual vitamin A status in children.  Vitamin A deficiency is a leading preventable cause of blindness in children.

Tufts conducted internal and external reviews of the research, following public criticism of the study in 2012.  In its statement this week, Tufts concluded that there was no safety concern, but there were flaws in informed consent procedures:

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 IRB policy or federal regulations. Reviews found insufficient evidence of appropriate reviews and approvals in China.  They also identified concerns with the informed consent process, including inadequate explanation of the genetically-modified nature of Golden Rice. The principal investigator also did not obtain IRB approval for some changes to study procedures before implementing the changes.

The Tufts statement puts to rest the suspicion by some GMO supporters that the criticism of the informed consent procedures was merely an invention by anti-GMO activists or by Chinese officials who had developed regrets about having approved the research.  On the contrary, the Tufts statement confirms that informed consent procedures were inadequate.  The university announced several changes to human subjects review procedures and will not allow the principal investigator to conduct human subjects research for two years.

Dan Charles reported on this controversy for NPR this week.

Although golden rice is an important high-profile line of research, I consider the two most important strategies for improving vitamin A status in children to be supplementation and increasing dietary diversity through ordinary fruits and vegetables, neither of which requires GM technology.