NOTE: The author is a former researcher at the Chinese Academy of Medical Sciences and deputy editor of a Chinese science publication.

EXTRACTS: It remains unclear whether the children involved in Tufts University's transgenic rice test understood exactly what was happening. It is also strange that the research project was conducted in Hunan while its ethics review and approval was done in Zhejiang, suggesting an attempt to bypass supervision. Such a situation harms the credibility of the lab involved in the tests and additionally, means that the research is neither informative nor transparent, having violated the laws and regulations concerning biomedical research involving human subjects.

...the Chinese institutes involved in the research denied any knowledge of the use of transgenic rice, all of which indicates that laws have been violated and the truth has not been fully disclosed.

All scientific research should be honest, transparent and held to sacred codes of conduct and ethics. The apparently underhand and dishonest measures employed by these transgenic rice tests lead to public confusion, which then translates into a lack of trust in, and even abhorrence of all such future tests.

Testing the limits of credibility
Zhang Tiankan
China.org.cn, September 12 2012 
http://www.china.org.cn/opinion/2012-09/12/content_26503888.htm

News of a transgenic rice experiment conducted on pupils from the rural Jiangkou Town Center Primary School in Hunan Province has finally trickled into the public domain, although details of the experiment remain sketchy.

The case has ignited controversy over whether the rights of the young test subjects and their custodians were guaranteed with sufficient information and facts regarding the experiment.

He Zhongqiu, the school's former headmaster, has insisted that the participants' custodians signed formal agreements. However, the parents of the young test subjects have strongly denied any knowledge of the agreements.

In addition to the issue of information and awareness regarding the transgenic rice experiment on Chinese pupils, Tufts University's Chinese partner in the experiment has only acknowledged collaboration with regards to testing the efficiency of changes of carotenoids of the spinaches in stable isotopes. They made no mention of transgenic rice.

According to the Chinese institute, the program was approved feasible by both Tufts University and the Ethics Committee of the Academy of Medical Sciences in Zhejiang Province.

It is my belief that testing transgenic foods on human subjects is a worthwhile endeavor in order to ensure future food safety and nutritional value. However, it is a sensitive issue and should be handled accordingly.

As with all scientific experiments, the human testing of transgenic foods should comply fully with both domestic and internally laws and norms and test subject volunteers and their families should be fully informed as to the exact nature of the tests. The now controversial transgenic test in Hunan seems to have bypassed the rules in this respect.

At this stage, only a comprehensive investigation can reveal who is telling the truth about the transgenic test agreements.

However, the inconsistencies in the positions of the parents and the school seem to indicate that even if agreements were signed, their terms were likely vague.

There are numerous international agreements on such tests, including "the Declaration of Helsinki" and the "International Ethical Guidelines for Biomedical Research Involving Human Subjects". The latter incorporates 21 codes of conduct for biomedical research on humans. The codes were formulated by the Council for International Organizations of Medical Services (CIOMS) and the World Health Organization (WHO).

Ensuring that test subject volunteers are fully informed about the biomedical research in which they are participating is the central plank of these internationally accepted agreements, which are adhered to by a wide range of institutes and individual researchers. Transgenic food experiments are certainly no exception.

Specific rules are stipulated for the agreements to be signed by both researchers and test subject volunteers. The rules state that there should be a clear and precise articulation of the experiment's targets, methods, sponsors, possible conflicts of predictable benefits, potential risks and possible side effects. In addition, each participant may choose to agree to or refuse these terms, and on agreeing may terminate their participation at any time without consequence.

Also, the candidates selected for tests are entitled to thoroughly scrutinize the stipulations of the agreement and discuss the issue with their family before signing the agreement. The very rudiments of international practice would be violated if an instant signature were required.

In China, the State Food and Drug Administration (SFDA) has specially regulated those experiments which recruit children as test subjects in accordance with "the Provisions for Quality Management in Clinical Trial of Drug". The regulation requires that both the child candidate and their parent or guardian should sign the agreement, meaning that the parent or guardian should also be privy to all information regarding the proposed test.

It remains unclear whether the children involved in Tufts University's transgenic rice test understood exactly what was happening. It is also strange that the research project was conducted in Hunan while its ethics review and approval was done in Zhejiang, suggesting an attempt to bypass supervision. Such a situation harms the credibility of the lab involved in the tests and additionally, means that the research is neither informative nor transparent, having violated the laws and regulations concerning biomedical research involving human subjects.

The investigation would also examine whether the child test participants consumed transgenic rice imported from the United States. As far as we know, spinach provided by the Tufts University was taken to Hunan in May 2008, by Dr. Tang Guangwen, the head researcher in the project, according to the Chinese Center of Disease Control and Prevention.

Meanwhile, it is not known if the purpose for testing the imported spinach was approved by the Ministry of Agriculture, Customs and the Department of Hygiene Inspection and Quarantine in compliance with relevant regulations.

Transgenic rice tests should receive far closer scrutiny in line with the "Measures for the Administration of the Safe Import of Transgenic Agricultural Living Things" carried out by the Ministry of Agriculture in 2002.

According to documents issued by the US side, all the transgenic rice and spinach used in the experiments was imported from the US to Hunan. Yet the Chinese institutes involved in the research denied any knowledge of the use of transgenic rice, all of which indicates that laws have been violated and the truth has not been fully disclosed.

All scientific research should be honest, transparent and held to sacred codes of conduct and ethics. The apparently underhand and dishonest measures employed by these transgenic rice tests lead to public confusion, which then translates into a lack of trust in, and even abhorrence of all such future tests.

The author is currently the deputy editor in chief of the Chinese science magazine, "Encyclopedia Knowledge".

This article was first published in Chinese and translated by Wu Jin.