The authors are unable to substantiate through documentary evidence that all parents or children involved in the study were provided with the full consent form for the study.
The American Journal of Clinical Nutrition is retracting a scientific paper that claimed to show that genetically engineered rice serves as an effective vitamin A supplement after a Massachusetts judge denied the first author's motion for an injunction against the publisher.
The journal announced plans to retract the paper last year following allegations that the paper contained ethical mis-steps, such as not getting informed consent from the parents of children eating the rice, and faking ethics approval documents.
Last July, first author Guangwen Tang at Tufts University filed a complaint and motion for preliminary injunction against the journal's publisher, the American Society for Nutrition, to stop the retraction.
Grave concerns: no proof of parental consent
According to the ASN, on July 17, a Massachusetts Superior Court "cleared the way" for the publisher to retract the paper. So they have, as of July 29. Here's more from the retraction notice:
"The article cited above, which was originally published in the September 2012 issue and prepublished on 1 August 2012, has been retracted by the publisher for the following reasons:
"1. 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 guidelines. Furthermore, the engaged institutions in China did not have US Federal Wide Assurances and had not registered their Institutional Review Board (or Ethics Review Committee).
"2. The authors are unable to substantiate through documentary evidence that all parents or children involved in the study were provided with the full consent form for the study.
"3. Specific eligibility issues were identified in regard to 2 subjects in the study."
In an unusual move, the publisher issued a press release about the retraction, which presents more information about the case:
"A ruling by the Massachusetts Superior Court, Judge Salinger, on July 17, 2015 has cleared the way for the American Society for Nutrition (ASN) to retract the article 'β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children' which was published in the September 2012 issue of The American Journal of Clinical Nutrition (Am J Clin Nutr 2012 96:658-66). The article was retracted by the American Society for Nutrition on July 29, 2015.
"In July 2014, Dr. Guangwen Tang filed a complaint and a motion for preliminary injunction against ASN. A hearing on Dr. Tang's motion for preliminary injunction was ultimately held on July 17, 2015. After oral argument, the Court denied Dr. Tang's motion, ruling that the injunction would constitute an unconstitutional prior restraint on speech as well as an unconstitutional order compelling speech. ASN is very pleased that the Massachusetts courts have upheld the organization's First Amendment rights and have allowed ASN to move forward with the retraction of the article."
A retraction notice was published online ahead of print on July 29, 2015 and will be published in print and online in the September 2015 issue of the American Journal of Clinical Nutrition.
A clerk's notice about the case lists the plaintiff's motion for a Preliminary Injunction as "DENIED": "The requested order would be an unconstitutional Prior restraint on speech as well as an unconstitutional order compelling speech."
A spokesperson for ASN declined to comment further: "We do not have an additional statement at this time. There is still an active lawsuit associated with the retraction and we have been advised by legal counsel not to comment further on this matter."
Greenpeace: children used as 'guinea pigs'
After a year-long investigation, Tufts concluded that Tang had indeed breached ethical regulations, and banned her from conducting human research for two years. In addition, she would have to be supervised in order to conduct any future research.
Tang declined to comment, saying: "We do not comment on pending litigation."
Retraction Watch has contacted Tufts, last author Robert Russell, and the journal's editor for comment. They have also asked the Massachusetts Superior Court for any additional court documents, and will update with any information received.
Further objection - unrealistic diet would boost absorption
A further objection raised to the scientific work is that the children were fed on a diet rich in fat and protein - both of which would artificially raise the absorption of the beta-carotene, which is fat soluble. The meals comprised 20% fat by energy content and included 100g or 110g of pork meat, also eaten with egg, spinach and tomato soup.
Given that Golden rice is promoted as a means to raise the standard of nutrition among poor and malnourished children, a diet so rich in meat, fat, protein and vegetables is unrealistic and thus uninformative as far as the enhanced nutrition of the 'target group' is concerned.
Indeed, anyone eating so rich a diet as that given the the child subjects would be at little danger of suffering from vitamin A deficiency in the first place, since spinach, along with other green vegetables, is a good source of the necessary nutrients.
However this question was not taken into account in the AJCN's decision to retract the paper, which was taken entirely on ethical grounds.
With the paper's retraction, a major scientific support of the case for Golden rice has now been lost by its proponents.
This article was originally published by Retraction Watch.
This version includes additional reporting by The Ecologist, namely the entire final section below the heading 'Further objection - unrealistic diet would boost absorption.'