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TUFTS UNIVERSITY STATEMENT – GOLDEN RICE
September 17, 2013
Tufts University has always been and remains deeply committed to the highest ethical and scientific standards in research. When questions were raised about whether a study published in the American Journal of Clinical Nutrition adhered to requirements for human subjects research, the Tufts Institutional Review Board (IRB) and Tufts University launched both internal and external reviews of the study activities. The University also conducted a scientific review to determine whether the journal manuscript accurately reported the study research methods, measurements and findings. In undertaking these reviews, the IRB members and the external reviewers examined the study documentation and interviewed a number of research team members.
These multiple reviews found no concerns related to the integrity of the study data, the accuracy of the research results or the safety of the research subjects. In fact, the study indicated that a single serving of the test product, Golden Rice, could provide greater than 50 percent of the recommended daily intake of vitamin A in these children, which could significantly improve health outcomes if adopted as a dietary regimen.
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.
Tufts has taken substantive corrective and preventive actions to address these findings. The principal investigator is unable to conduct human subjects research for two years, during which time she will be retrained on human subjects research regulations and policies. For the two years following, she will be eligible to conduct human subjects research as a co-investigator under the direct supervision of a principal investigator. The IRB has also revised its policies and procedures to ensure that in the future, research conducted outside the United States and/or in cultural contexts with which the IRB is not adequately familiar is reviewed more carefully. We have notified all relevant agencies in the United States and China of our findings, and the principal investigator has also notified the publishing journal.
We regret that deviations from certain approved protocols and standards occurred. Tufts has strengthened our policies and procedures to prevent recurrence of such problems, and we remain committed to conducting research of the highest quality, with rigorous oversight.
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