Archive for the ‘lack of IRB approval’ Category
A high-profile pediatric oncologist quietly left his former institution in 2015 after it concluded his clinical trials had been affected by significant “administrative problems.” But now the results of the university’s investigations and what followed have become public, after a paper in Belgium published a series of news reports last month.
We’re still hazy on some details of the case. The recent news reports allege that Van Gool started some clinical trials without proper ethical approvals and informed consent, and may have misled patients and their families about the benefits and potential side effects of his experimental treatment. Meanwhile, the CEO University Hospitals Leuven (UZLeuven) told us that Stefaan Van Gool, who had appointments at both the hospital and the university (KULeuven), left the hospital in 2015 as a result of administrative problems, but did not disclose the specific nature of these issues.
For the past 15 years or so, Van Gool has been developing and studying a vaccine to treat various cancers, initially at UZLeuven and, after September 2015, at a private clinic in Germany. Today, patients travel to his private clinic from all over the world and pay tens of thousands of dollars to receive the vaccine. But according to Flemish daily newspaper De Standaard, several years ago, UZLeuven began investigating his research and patient care practices. The outcome of these investigations was kept private until last month, after De Standaard published its reports.
Marc Decramer, the CEO of UZLeuven, confirmed that Van Gool left the hospital in 2015 and the university in 2016, but did not provide the specific reasons for his exit:
A Swedish university has concluded that two professors studying tissue engineering are guilty of misconduct in two published papers, including a 2012 study in The Lancet.
The two researchers are Suchitra Sumitran-Holgersson and Michael Olausson, both based at the University of Gothenburg. The university investigation — launched after several of Holgersson’s papers were questioned on PubPeer — has concluded that the researchers didn’t follow proper ethical procedures in the two papers.
Here’s a statement from a university spokesperson:
When two surgeons in Greece learned that a patient had developed a rare side effect following weight loss surgery, they were eager to publish the case.
After extensive testing, the patient was diagnosed with Wernicke’s encephalopathy—a neurological disorder caused by thiamine deficiency—following a sleeve gastrectomy procedure. As the authors note in the paper, they had seen only eight other cases following the procedure in the literature.
It turns out, theirs was not the ninth. After the patient unfortunately died, he was examined by a coroner, who ruled he did not, in fact, have Wernicke’s encephalopathy. So Dimitrios Manatakis and Nikolaos Georgopoulos, both based at Athens Naval and Veterans Hospital in Greece, have retracted their 2014 case study.
When the first learned of the patient, the authors wanted to alert the surgical community to the case, given the rarity of this side effect, Manatakis told us: Read the rest of this entry »
A researcher in South Korea has retracted a 2015 paper after telling the journal he falsified the institutional approval required to conduct the animal experiments.
In the article, the author explicitly says that the Animal Experiment Review Board of a university based in Seoul, South Korea approved the experiments, but according to the journal, “the author did not receive an approval by the board and he used a false approval number.”
Here’s the retraction notice for “The role of compensatory movements patterns in spontaneous recovery after stroke,” published in the Journal of Physical Therapy Science (JPTS) in September 2015 and retracted in December: Read the rest of this entry »
Researchers have agreed to pull a 2015 study exploring whether a plant extract can safeguard tanners from ultraviolet exposure after not obtaining formal approval from an ethics committee.
According to the first author, the problem lay in a misunderstanding – when they originally applied for approval six years ago, the researchers believed they didn’t need to go through a formal approval process, since the compound was commercially available without a prescription. Once they realized their mistake, they chose to retract the paper.
Here’s the retraction note for “Oral Polypodium leucomotos increases the anti-inflammatory and melanogenic responses of the skin to different modalities of sun exposures: a pilot study,” published in Photodermatology Photoimmunology & Photomedicine. Read the rest of this entry »
Mukund Jagannathan, the journal’s editor-in-chief and a plastic surgeon in India, told Retraction Watch:
The patient wrote to the editor, mentioning that her photo was present in the article originally published, and politely asked us to remove her photos from public display on the Internet.
Asked whether the journal considered issuing a partial retraction to only hide the patient’s identity, Jagannathan said: Read the rest of this entry »
Three psychiatric studies of children contained a myriad of problems that may have put participants at greater risk than was disclosed by consent forms, according to a 2014 letter sent to hundreds of the participants and their families.
Through a public records request, we’ve obtained a copy of the letter — which lists a host of problems in the studies, ranging from enrolling ineligible patients, not informing families of the risks associated with the studies, and skipping tests intended to minimize the risks associated with lithium.
In 2013, Mani Pavuluri told the University of Illinois at Chicago that one of her study participants had been hospitalized — an event which prompted the university to halt three of her studies, launch a misconduct probe, and send letters to approximately 350 families of children participating in the research, notifying them of what happened.
The letter concludes:
The study’s first and corresponding author of the study in the British Journal of Sports Medicine — Julie Stang from the Norwegian School of Sports Sciences in Oslo — told us the authors had struggled to obtain ethical approval for the research, but believed the issue had been resolved.
However, earlier this year, a member of an ethical committee wrote an article in the Norwegian press about his concerns regarding the study, which tested the effects of three drugs on top athletes’ breathing. In it, he said the Regional Committees for medical and health professional research ethics (REC) had not approved the study, as members were concerned the presumably healthy athletes were being exposed to drugs used to treat asthma, which could enhance their performance.
Stang has denied that the study had anything to do with boosting athletic performance.
Stein Evensen, the committee member who wrote the article, declined to comment beyond the published text. So we’ve gotten the kronikk article translated from Norwegian using One Hour Translation. It reads: Read the rest of this entry »
Does an article that discusses anonymized student projects about how to catalog data count as research on human subjects?
One of the students included in the paper thought so, and complained to the journal after learning that it had published the case study of the program without the approval required for studying people. The authors admitted they didn’t get consent from participants, because they didn’t realize the work required it. The mix-up has prompted both them and the journal to reconsider their policies regarding ethics approval of studies.
In the meantime, “A Project-Based Case Study of Data Science Education” has been retracted, with this notice:
A German district attorney has fined a doctor who participated in a bogus study showing chocolate helps weight loss, designed to illustrate how shady science can make the news, arguing it was unethical to ask people to participate unknowingly in such a scam.
As soon as the study was published, critics raised questions over whether it was appropriate to include volunteers in a bogus clinical trial, which included giving blood. Recently, a German district attorney for professional conduct of physicians ruled that it was not.
In an anonymized version of a decision from the district attorney – who investigates on possible violations of the physicians’ professional law – he fined the doctor who participated in a bogus study about the health benefits of chocolate 500 Euros for not obtaining proper consent from the people who volunteered to participate, and for not involving an ethics committee. Read the rest of this entry »