Archive for the ‘lack of IRB approval’ Category
One describes a case in which the researchers removed a mass from a 64-year-old woman’s small intestine; the other describes how the authors removed a growth from a patient’s pancreas. They conclude that the surgery techniques used — like a laparoscopic pancreaticoduodenectomy, a take on the “Whipple Procedure” — can be “feasible, safe, and effective” in certain patients.
The papers share several authors, including a first author, Akihiro Cho, whose affiliation on the papers is Chiba Cancer Center Hospital in Japan. They also share a retraction note, which explains how the journal learned of the issue:
A journal is retracting a paper about a heart surgery technique after discovering the researchers did not have ethics approval to perform a the procedure on 130 patients. What’s more, the local cardiac surgical society had asked the first author to stop using the method in 2004, six years before the study was complete.
The patients in the study had atrial septal defects — a congenital hole in their hearts that allows blood to leak between chambers. The retraction note concludes with the editor in chief advising other surgeons to not use the method to close the hole described in the retracted article, “Long-term assay of off-pump atrial septal defect closure using vena caval inflow occlusion and minimally invasive approaches in 130 cases.”
A concern from a reader unraveled the paper. The retraction note explains how:
A paper that compared two gauges of needles to take samples of pancreatic masses has been retracted after authors unintentionally included patients from another trial.
“Randomized Trial Comparing the Flexible 19G and 25G Needles for Endoscopic Ultrasound-Guided Fine Needle Aspiration of Solid Pancreatic Mass Lesions,” published a year ago in Pancreas, notes that:
A total of 100 patients with solid pancreatic mass lesions constituted the study cohort and were randomized equally to the 2 needle groups.
The problem? According to the retraction note, some of those patients weren’t supposed to be included:
Obesity has retracted a study that suggested overweight people may be less depressed than their slimmer counterparts in cultures where fat isn’t stigmatized, after realizing the authors lied about having ethical approval to conduct the research.
The authors claimed their research protocol had been approved by Norwegian and Bangladeshi ethical committees, but, according to the retraction note, part of the study “was conducted without the required approval of the university ethics board.” The journal’s managing editor told us that there is no evidence that there was harm to the study subjects.
We’ve found two recent retractions and an expression of concern for Joachim Boldt, former prominent anesthesiologist and currently Retraction Watch leaderboard’s 2nd place titleholder. He now has 94 retractions.
One of the retracted articles contains falsified data, along with a researcher who didn’t agree to be a co-author, according to an investigation by the Justus Liebig University Giessen, where Boldt used to work. The expression of concern is regarding some questionable data. The other new retraction is actually one of 88 papers that a group of editors agreed to retract back in 2011, after they were “unable to verify” approval by the Institutional Review Board (IRB) for the studies.
One of those 88 papers, we’ve discovered, has still has not been retracted. According to an editor at the journal, they haven’t removed it because one of Boldt’s co-authors has threatened them with legal action. Read the rest of this entry »
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: