The American Journal of Clinical Nutrition is retracting a paper that showed 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.
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article cited above, which was originally published in the September 2012 issue and prepublished on 1 August 2012, has been retracted by the publisher for the following reasons: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 The article was retracted by the American Society for Nutrition on July 29, 2015.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.
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.
We’ve contacted Tang (as well as her lawyer), Tufts, last author Robert Russell, and the journal’s editor for comment. We’ve also asked the Massachusetts Superior Court for any additional court documents, and will update with any information we receive.
Update 7/30/15 3:23 p.m. eastern: Tang declined to comment:
We do not comment on pending litigation.
Update 7/31/15 8:41 a.m. eastern: We’ve heard from a spokesperson at Tufts:
We are aware that the American Journal of Clinical Nutrition has retracted the paper “β-carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children”, published in its September 2012 issue by a team led by a Tufts researcher. The journal indicated that its retraction was based on the fact that the authors were unable to provide sufficient evidence that the study had been reviewed and approved by a local ethics committee in China and that parents and children involved in the study had been provided the full informed consent form as well as eligibility issues identified in regard to two subjects in the study. No questions were raised about the integrity of the study data, accuracy of the research results or safety of the research subjects. The decision to retract a paper is ultimately a matter between the journal and the authors, and we must respect an academic journal’s editorial process and decisions.
Tufts University has always been and remains deeply committed to the highest ethical and scientific standards in research. In September 2012, we became aware, from the Chinese Center for Disease Control and Prevention, of various concerns relating to this study, which had been conducted under an approval issued by the Tufts Institutional Review Board (IRB). Tufts convened an external review committee to interview those involved and to review documentation of the study. The Tufts IRB also reviewed the study. There was no evidence found of falsification or fabrication of the data that underlie the study’s primary findings. Those reviews did, however, determine that the research had not been conducted in full compliance with Tufts research policies and federal research regulations.
Tufts has not been served with any complaint from Dr. Tang’s attorneys relating to these issues.
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