Archive for the ‘lack of IRB approval’ Category
The Open Science Framework (OSF) has pulled a dataset from 70,000 users of the online dating site OkCupid over copyright concerns, according to the study author.
The release of the dataset generated concerns, by making personal information — including personality traits — publicly available.
Emil Kirkegaard, a master’s student at Aarhus University in Denmark, told us that the OSF removed the data from its site after OkCupid filed a claim under the Digital Millennium Copyright Act (DMCA), which requires the host of online content to remove it under certain conditions. Kirkegaard also submitted a paper based on this dataset to the journal he edits, Open Differential Psychology. But with the dataset no longer public, the fate of the paper is subject to “internal discussions,” he told us.
The paper was retracted two years ago when BMC Research Notes discovered the authors falsely claimed they had obtained ethics approval from an institution in Kenya.
The study looked at the effectiveness of an antiretroviral therapy in 50 women who were receiving care at a center in Nairobi, Kenya. But the authors did not have permission from the center to use data from the women, nor the necessary ethics approval from Moi University to carry out the work.
Surgeon Paolo Macchiarini did not apply for the necessary ethics approval to perform the pioneering transplants he’s known for, according to the Swedish Research Council.
Chief Legal Counsel Anna Hörnlund, who wrote a letter in this week’s The Lancet, says Macchiarini’s work needed to obtain ethical approval from one of six regional ethical review boards, as required by Swedish law — and neither Macchiarini nor his former employer, Karolinska Institutet, did so:
The journal is not retracting the paper outright, it says, because the study was non-invasive and likely would have received ethics approval.
During the study, teenagers with and without progressive scoliosis underwent a physical examination and participated in an interview along with a parent, with the goal of trying to uncover risk factors for the condition.
Here’s the full erratum from Scoliosis and Spinal Disorders for “Physical activities of Patients with adolescent idiopathic scoliosis (AIS): preliminary longitudinal case–control study historical evaluation of possible risk factors:”
Authors have pulled a paper on an antifungal drug that is potentially toxic because it lacked final approval from their institution.
The study describes a patient who had experienced liver toxicity after taking voriconazole. During the study, the authors re-administered the drug to the patient using “a slow dose titration.” But their institution didn’t approve the study before it was published online.
Here’s the retraction note for “Successful Rechallenge with Voriconazole following Medication-Induced Hepatotoxicity,” published in Antimicrobial Agents and Chemotherapy. Read the rest of this entry »
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 »