Archive for the ‘lack of IRB approval’ Category
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 authors of a 2011 paper in the Journal of Clinical Microbiology looking at transmission of hepatitis C in a former leper colony in Japan have retracted the article because an ethics panel in that country objected to the scientists’ use of fetal tissue.
The article involves a controversial aspect of modern Japanese history — the country’s efforts to eradicate leprosy, or Hansen’s disease, by isolating patients in a string of state-run sanatoriums. The policy was eventually realized to be unnecessary and ruled unconstitutional in 2001, triggering a wave of apologies to patients and their families.
The Journal of Bone and Joint Surgery has retracted a 2012 paper because of ethical violations, initially flagged by the journal in 2013.
The study, which examined the use of autologous cell therapy in treating Achilles tendinosis, claimed in its abstract to have “conducted a randomized, double-blind study on forty Achilles tendons in thirty-two patients.” Apparently, though, it wasn’t actually a clinical trial but was somehow, according to the retraction notice, “misclassified” as such “in error.”
The problem was originally flagged by the UK’s Medicines and Healthcare products Regulatory Agency, which wrote the journal to tell them that it hadn’t granted ethical approval for the study, as we reported in 2013. At the time, there was a question about whether the lead author had retained records of the results, which is addressed in the retraction notice, signed by editor-in-chief Marc F. Swiontkowski and editor-in-Chief Emeritus Vernon T. Tolo: Read the rest of this entry »
Yes, we are seeing more attacks on academic freedom: guest post by historian of science and medicine
We’re pleased to introduce readers to Alice Dreger, a historian of science and medicine at the Medical Humanities and Bioethics Program in Northwestern University’s Feinberg School of Medicine. Her new book is “Galileo’s Middle Finger: Heretics, Activists, and the Search for Justice in Science,” out this week from Penguin Press. Read to the end for a chance to win a free copy.
The good news: Policy makers and the public seem to be increasingly taking scientific research seriously. The bad news? People who don’t like researchers’ findings seem to be increasingly coming after researchers and their universities. And some of those people are powerful.
Technically, your university is supposed to protect your academic freedom. In my own university’s faculty handbook, academic freedom is the first topic discussed. But as I’ve learned from my own personal experiences, as well as from eight years studying the experiences of other researchers who have gotten into political hot water, your administration may not always have your back. Read the rest of this entry »
The retraction notice indicates that the patients never consented, there was no ethical review, and the university supposedly overseeing the study had no knowledge of it:
Here’s the notice in Cancer Immunology, Immunotherapy for “Immunotherapy of metastatic colorectal cancer with vitamin D-binding protein-derived macrophage-activating factor, GcMAF:” Read the rest of this entry »
Last month, we brought you the story of the retraction of a paper by Nobutu Yamamoto and colleagues about “a protein being used — unapproved by health agencies — to treat diseases including cancer and autism.”
A second paper by the group, about using the protein to treat HIV, has been retracted. Here’s the notice for “Immunotherapy of HIV-infected patients with Gc protein-derived macrophage activating factor (GcMAF),” from the Journal of Medical Virology:
Read the rest of this entry »
A paper about a protein being used — unapproved by health agencies — to treat diseases including cancer and autism has been retracted.
The Annals of the Royal College of Surgeons of England has retracted a 2013 article by a group from Dubai and Italy after learning of serious issues with the data in the report.
The article, “Transanal haemorrhoidal dearterialisation with mucopexy versus stapler haemorrhoidopexy: a randomised trial with long term follow-up,” purportedly described a long-term telephone follow-up study of patients who had undergone the procedure. Here’s the abstract: Read the rest of this entry »