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North Carolina Journal of International Law and Commercial Regulation

Giving Bioethics Bite: A Look at What Underlies the Golden Rice Study Scandal

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Professor Anne-Marie Duguet, M.D., Ph.D. (in law) visited the University of North Carolina School of Law from l’Université Paul Sabatier in Toulouse, France to address the recent controversy in China surrounding a study done on children and genetically modified rice. Specifically, Tang et al (“Tang”) performed a study on the nutritional value of Golden Rice – genetically modified rice that is rich in ß-carotene as a source of vitamin A, a vital nutrient for children – in the Hunan province of China.[1] Seventy-two children from the ages of six to eight were subjected to the study.[2] The children were then split into two randomized groups: a control group that ate natural foods high in ß-carotene and vitamin A and a test group of children who ate Golden Rice.[3]

Whether or not the authors obtained informed consent of the test subjects was controversial. The authors claim “[b]oth parents and pupils consented to participate in the study.”[4] Greenpeace initiated a three-month investigation and a forty-five minute televised investigative report where neither the parents nor the children knew the rice was genetically modified.[5] Tang lied about obtaining informed consent because the Chinese public is skeptical about the safety of ingesting genetically modified rice.[6] Tang proceeded without informed consent because 2.3 million children die of malnutrition.[7]

Professor Duguet posed the following question: Is it okay to bypass consent in the interest of potentially alleviating world malnourishment? Utilitarian thinkers may scoff at this question, but Professor Duguet suggests more is at stake than mere exploitation of the few for the good of the many. Professor Duguet posits that since the study claims to have been approved by the Institutional Review Board, Tufts Medical Center, and the Ethics Review Committee of Zhejiang Academy of Medical Sciences in China,[8] the alleged violation calls the ethics standards of those two institutions into question. Professor Duguet argues that the alleged violations may even call the entire approval process into question. Professor Duguet also argues that these types of questionable conduct causes considerable distrust among future research subjects in developing countries.

The medical community – in anticipation of this exact problem – promulgated widely followed guidelines. However, these guidelines are unenforceable without legislative adoption. Guideline 4 of the International Ethical Guidelines for Biomedical Research Involving Human Subjects suggests that “informed consent” must be obtained from the subject or the subject’s guardian.[9] Professor Duguet pointed out that the EU explicitly protects people involved in a study who are legally unable to give consent.[10] However, legally enforcing the preceding guidelines may not solve the problem practically. Those parents and children involved in the Golden Rice study in the Hunan province will most likely never pursue legal retribution. Further, as research moves into more underdeveloped vulnerable populations, the risk of exploitation increases. The potential gains from research dwarf the unlikely risk of legal censure. Perhaps, it is time to legally unify bioethical standards that carry bite outside the court of public opinion.


[1] Guangwen Tang, Yuming Hu, Shi-an Yin, Yin Wang, Gerard E. Dallal, Michael A. Grusak, and Robert M. Russell, ß-Carotene in Golden Rice is as good as ß-carotene in oil at providing vitamin A to children, 96 Am. J. Clinical Nutrition 658, 658-59 (2012), available athttp://ajcn.nutrition.org/content/96/3/658.full.pdf+html.

[2] Id.

[3] Id.

[4] Id.

[5] Jane Qiu, China sacks officials over Golden Rice controversy, Nature (Dec. 10, 2012), http://www.nature.com/news/china-sacks-officials-over-golden-rice-controversy-1.11998.

[6] Id.

[7] Fact Sheet N° 178: Spetember 2012, Children: reducing mortality, World Health Organization (last visited, Mar. 20, 2013) http://www.who.int/mediacentre/factsheets/fs178/en/.

[8] Tang et al., supra note 2, at 659.

[9] International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guideline 4 (2002), available athttp://www.cioms.ch/publications/layout_guide2002.pdf; see also id. at Guideline 13 (demanding that researchers have a “special justification” for using “vulnerable” people, described as those who are unable to protect their own interests due to a lack of education or other circumstances, as subjects and that these subjects’ rights are strictly protected); see alsoid. at Guideline 3 (requesting sponsoring country to verify that research is being done in accordance with these guidelines).

[10] See Council Directive 2001/20/CE, art. 3 (EC).


Posted by Seth T. Lawrence on Mon. March 25, 2013 9:15 PM
Categories: Medical Markets, Symposium

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