by Kira Wohland
A university investigation into the ethics of research done on beta-carotene-rich Golden Rice has concluded. The investigation was prompted by allegations that a study conducted in China by Tufts researcher Dr. Guangwen Tang and colleagues failed to follow some portions of the Institutional Review Board (IRB) protocols regarding human subjects research.
According to a spokesperson for the Human Nutrition Research Center on Aging (HNRCA), a review of the research protocols found “insufficient evidence of appropriate reviews and approvals in China,” as well as “concerns with the informed consent process.” Importantly, investigators found no evidence to suggest that the integrity of the data collected during the Golden Rice study was in any way unsound.
The study, which aimed to test the ability of genetically engineered Golden Rice to deliver vitamin A to children, was published in August 2012 in the American Journal of Clinical Nutrition. Researchers found that a single serving of Golden Rice could provide more than 50 percent of the recommended daily intake of vitamin A in these children.
Vitamin A deficiency is estimated to affect nearly one in three children under the age of five worldwide. If left untreated, vitamin A deficiency can result in blindness and even death. An estimated 670,000 deaths in children can be attributed to vitamin A deficiency annually. These staggering statistics make clear the importance of finding an efficient and sustainable way to treat vitamin A deficiency. Golden Rice is one proposed method, which, if implemented on a large scale, has the potential to save hundreds of thousands of lives and drastically improve the health of children in poor and developing nations.
The public health implications of Golden Rice are clear, but not everyone is convinced that it should be grown and used as humanitarian tool. Some groups argue that nutrition efforts should focus on growing more foods that are naturally rich in vitamin A and beta-carotene, while others generally oppose the use of genetically engineered crops in the food supply.
Concerns are not just about Golden Rice; genetically engineered crops in general are met with much skepticism, making research difficult and sometimes impossible. The topic remains controversial despite the majority of studies demonstrating that GMOs do not pose a safety risk. Dr. Jeff Blumberg, a professor at Friedman and director of the Antioxidants Laboratory at the HNRCA notes that the development of genetically engineered crops is an iterative process: “Can you make something bad or dangerous? Of course, and then those indicating potential for an adverse reaction are dropped and R&D continues on efficacy. I don’t think that people realize that [genetically-engineered foods] are evaluated and tested for safety”.” Just as is true of drug development and pharmaceuticals, GMOs undergo extensive testing before they are deemed safe for consumers.
In the case of the Golden Rice study, a clear distinction must be made when considering the impact of this study and the subsequent investigation. “There is a difference between whether there is a violation of a rule and whether harm was done,” Dr. Blumberg points out.
While no harm was done by researchers in the Golden Rice study, a breach of IRB guidelines did occur. According to a spokesperson for the HNRCA, this controversy led Tufts to modify its IRB protocols, particularly those dealing with research conducted outside the United States. The revised guidelines will ensure that research done in different cultural contexts is reviewed more carefully to avoid miscommunications or oversights.
Dr. Tang’s lab at the HNRCA, the Carotenoids and Health Laboratory, will close in April 2014 for reasons unrelated to the Golden Rice study.
Kira Wohland is a second year student in the dual MS/MPH program, studying biochemical and molecular nutrition and health communication. Her academic interests include child development, school nutrition, and cognition. When she isn’t at Friedman, you can find her serving guests at Lineage in Brookline, baking way too many cookies, or dominating her fantasy football league. To learn more, visit our Meet Our Writers page.