Judge Decides on GM Rice Retraction

Ethical breaches in a study on the benefits of so-called “golden rice” lead to the paper being pulled from the literature.

By | August 3, 2015

WIKIMEDIA, INTERNATIONAL RICE RESEARCH INSTITUTEA Massachusetts judge has ruled in favor of a journal’s decision to retract a paper on a type of genetically modified rice. The study’s lead author, Guangwen Tang of Tufts University, previously asked for an injuction against the publisher, who yanked the study from the American Journal of Clinical Nutrition because the researchers did not comply with certain ethical guidelines.

According to the retraction notice, posted online July 29, “The authors are unable to provide sufficient evidence that the study had been reviewed and approved by a local ethics committee in China in a manner fully consistent with NIH [National Institutes of Health] guidelines.”

Tang and her colleagues tested how well a genetically modified rice, called golden rice, could provide children with β-carotene. They found that the rice was just as good as a β-carotene supplement and better than spinach.

According to a Tufts spokesperson who spoke with Retraction Watch, no one is questioning the validity of the data. The problem instead lies in how the study was conducted—in particular, a lack evidence that all participants gave full consent. Tufts investigated the situation in 2012. “There was no evidence found of falsification or fabrication of the data that underlie the study’s primary findings,” according to the spokesperson. “Those reviews did, however, determine that the research had not been conducted in full compliance with Tufts research policies and federal research regulations.”

The Clerk of the Massachusetts Superior Court last month (July 17) posted a notice, which Retraction Watch subsequently shared, about Tang’s denied request. “The requested order would be an unconstitutional Prior restraint on speech as well as an unconstitutional order compelling speech.”

According to ScienceInsider, “Adrian Dubock, executive secretary of the Golden Rice Humanitarian Board in Switzerland disputes that there were any ethical irregularities and argues that the retraction is not warranted.”

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Avatar of: Paul Stein

Paul Stein

Posts: 225

August 3, 2015

Frankly, one has to wonder why any ethical committee based on U.S. NIH guidelines should have anything to do with the study if this is done in China.  Gave "full consent"?  Full consent to what?  There are no drugs here, nor would one suspect that anyone eating the rice was blind and not notice the color difference in something eaten at every meal.  This paper is "retracted", but that will have zero effect, both on policy or science.

Avatar of: Baxter Zappa

Baxter Zappa

Posts: 11

August 3, 2015

I agree with Paul's points, and it seems like the study guidelines need to comply with Chinese rules, not US rules, anyway.  I understand that it is important not to experiment with drugs on ususpecting people even if their own country allowes it, but as Paul explained, this is not that. It was a food, not a drug, and the people all knew it was a different food.

Avatar of: samsoto

samsoto

Posts: 1

August 4, 2015

the US produces a lot of rice, why not test golden rice on americans?

Avatar of: CReynolds

CReynolds

Posts: 1

Replied to a comment from samsoto made on August 4, 2015

August 4, 2015

Golden rice was developed specifically to combat blindness and death due to vitamin A deficiency in regions of the developing world, to replace the white rice that serves as a primary calorie source in some of these regions.  There is no need for golden rice in the US, so it seems unlikely that it will ever be produced or used here.  In order to protect human health, it needs to be accepted and utilized in the target global regions where vitamin A deficiency is a health concern and rice is a major nutritional staple.  We already know that golden rice is not harmful, and this research was meant to determine how effective the crop is as a vitamin source with respect to the context I mentioned above.  Therefore, it makes perfect sense to examine potential benefits in a region where long term implementation would have a positive impact on health outcomes. 

Avatar of: PatrikD

PatrikD

Posts: 7

August 4, 2015

Note that this particular legal decision only relates to the standards that the JOURNAL imposes for publication, not on whether anyone actually broke the law in China. The American Journal of Clinical Nutrition requires as a condition for publication in their journal that all studies follow the NIH ethical guidelines *regardless* of where the study was actually performed or who provided the funding for it. That is a fairly universal requirement among US journals.

Do read The Scientist's earlier coverage of exactly what the researchers did wrong in this study. In short, they failed to inform the parents that their kids would be eating genetically modified rice, and they may not have had import permission to bring the rice into China in the first place:

http://www.the-scientist.com/?articles.view/articleNo/33666/title/GM-Rice-Researchers-Sacked/

This case caused a lot of controversy inside of China, and the Chinese scientists have been fired. So it is likely the study *did* break some of the rules in China - but that has nothing to do with this latest US court case.

 

Avatar of: Eric J. Murphy

Eric J. Murphy

Posts: 20

August 4, 2015

The number one question should be which is the overriding authority for scientific work done in another jurisdiction?  For all journals publishing work done in human subjects, the only critical issue is was the work done in a manner that followed the Declaration of Helsinki.  Yes or No. 

Frankly, NIH has no jurisdiction in China, hence whether the work done in China followed NIH guidelines is irrelevant.  What is relevant is did the study follow the Declaration of Helsinki?  In this case, it appears to overriding factor is informed consent. 

While Paul and Baxter identify the jurisdictional issue, it is important that regardless of whether it is an experimental drug, a dietary feeding study, or merely taking a blood sample, written, informed consent must be given.  Since 2006 I have had one and only one situation of oral informed consent and that was in a group of individuals in an area with no written language.  Hence, the researchers did their best to follow the spirit of ethical use of humans in research. 

Should the paper be retracted?  That hinges entirely on whether the metric of written, informed consent was reached for each and every subject included in the study.  Without reading the entire judicial explanation, I would surmise that this was indeed the case. 

 

 

 

Avatar of: Eric J. Murphy

Eric J. Murphy

Posts: 20

August 4, 2015

The number one question should be which is the overriding authority for scientific work done in another jurisdiction?  For all journals publishing work done in human subjects, the only critical issue is was the work done in a manner that followed the Declaration of Helsinki.  Yes or No. 

Frankly, NIH has no jurisdiction in China, hence whether the work done in China followed NIH guidelines is irrelevant.  What is relevant is did the study follow the Declaration of Helsinki?  In this case, it appears that the overriding factor is informed consent. 

While Paul and Baxter identify the jurisdictional issue, it is important that regardless of whether it is an experimental drug, a dietary feeding study, or merely taking a blood sample, written, informed consent must be given.  Since 2006 I have had one and only one situation of oral informed consent and that was in a group of individuals in an area with no written language.  Hence, in that case the researchers did their best to follow the spirit of ethical use of humans in research. 

Should the paper be retracted?  That hinges entirely on whether the metric of written, informed consent was reached for each and every subject included in the study.  Without reading the entire judicial explanation, I would surmise that this metric was not reached and hence the retraction.  

 

 

 

Avatar of: Green91

Green91

Posts: 1

August 6, 2015

To some extent, I personally can't accept genetically modified food. But it seems that we can't aviod it. Here, I'd like to share an article also about GMO: http://www.creativebiomart.net/blog/do-you-regard-gmo-labels-as-negative-warnings/

Avatar of: Mellow Guy

Mellow Guy

Posts: 8

August 7, 2015

There is a possibility that golden rice could cause an overdose of carotene which is present in many plants.

Carotene in rice may increase spoilage.

 

Avatar of: S.Chaudhuri

S.Chaudhuri

Posts: 1

August 12, 2015

Those who are against Golden Rice, whichever nationality they may belong to, should simultaneously find and name a clean edible source of Vitamin A, preferably of plant origin for the billions of poor Latin American, African and Asian people. especially the children who suffer from acute Vit.A deficiency.

Science has taught to be human for the sake of humanity.

 

Avatar of: Bob Phelps

Bob Phelps

Posts: 3

Replied to a comment from CReynolds made on August 4, 2015

August 20, 2015

Genetically Manipulated Vit A bananas developed in Queensland, Australia, are ostensibly destined for cultivation in Africa and India. So why are they to be fed to women university students at Iowa State University? http://afsafrica.org/us-human-trials-of-gm-banana-for-africa-widely-condemned/

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