Archive for the ‘lack of IRB approval’ Category
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 »
The first author, Yuhji Saitoh, has the same name as a co-author of Yoshitaka Fujii, the all-time record holder with 183 retractions listed on our leaderboard. Thirty-six of those retracted papers include a co-author with the name of Yuhji Saitoh, but we were unable to confirm this is the same person listed on the newly retracted paper.
A journal is retracting a paper that sought to validate genotyping techniques after learning the authors skipped a key step.
The authors scanned blood samples from 500 people who visited “the Blood Bank of our institution,” as they note in the abstract, to validate the use of genotyping techniques in the Saudi population. But the authors didn’t obtain the proper clearance from their institution, King Faisal Specialist Hospital, to publish the work.
BioMed Central has retracted a paper after realizing it shared details on the brain surgeries of four patients without their consent.
Darlene Lobel, a neurosurgeon at the Cleveland Clinic in Ohio, agreed to the retraction, and told us she didn’t know that she needed consent from the patients since all identifying details had been removed. The paper describes a technique for craniotomy — opening up the skull to access the brain — and included CT scans of hemorrhaging and swelling that the patients experienced, as well as other details such as their gender and age.
Here’s the retraction notice:
The study, based on interviews with 154 men and women living with HIV, concluded that experiencing negative life events correlated with risky sexual behavior. But although the author claimed to have complied with the journal’s standard of consent, the journal disagreed, and retracted the paper in 2014 (we think this case is interesting enough to share with you now). What’s more, according to the journal, the paper contains errors that invalidate its conclusions.
Here’s the notice: