Retraction Watch

Tracking retractions as a window into the scientific process

Archive for the ‘lack of IRB approval’ Category

Study errors “may have placed you or your child at a greater risk of harm”: 2014 letter to parents

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Mani Pavuluri

Mani Pavuluri

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:

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Authors retract paper lacking approval to study asthma in athletes

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british-journal-of-sports-medicineThe authors of a 2014 study about asthma in Norwegian athletes have retracted it after realizing they hadn’t obtained proper approval from an ethical committee.

The study’s first and corresponding author of the study in the British Journal of Sports MedicineJulie 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 your work need IRB approval? Better check, says author of retracted paper

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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:

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Doctor who participated in fake chocolate study fined for violating code of conduct

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Source: AKA

Source: AKA

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 »

Written by Hinnerk Feldwisch-Drentrup

September 22nd, 2016 at 8:00 am

Anesthesia journal pulls study lacking patient consent

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Journal of AnesthesiaAn anesthesia journal has retracted a paper after an author admitted that the study did not obtain appropriate consent from patients receiving a neuromuscular block in muscles on the face and hands. 

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.  

Here’s the retraction notice, issued by the Journal of Anesthesia on August 11: Read the rest of this entry »

Saudi institution didn’t clear genotyping study

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Journal of Pharmacy and Pharmacology

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.

Here’s the retraction notice for “Genotyping of CYP2C19 polymorphisms and its clinical validation in the ethnic Arab population:”

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Written by Shannon Palus

July 28th, 2016 at 11:30 am

Patients did not okay publishing brain surgery details

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Screen Shot 2016-05-03 at 2.37.02 PM

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:

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HIV paper pulled for lack of consent, errors

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AIDS JournalA researcher failed to obtain proper consent from HIV patients included in his study about risky sexual behavior, according to the journal that retracted his paper.

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:

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Publicly available data on thousands of OKCupid users pulled over copyright claim

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okcupidThe 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.

In place of the dataset on OSF, this message now appears: Read the rest of this entry »

Written by Alison McCook

May 16th, 2016 at 3:10 pm

Study on pregnant women with HIV lied about having ethics approval

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Screen Shot 2016-04-12 at 5.47.50 AMWe recently discovered a relatively old retraction notice — from 2014 — of a study on pregnant women with HIV.

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.

Here’s the retraction note for “Effectiveness of option B highly active antiretroviral therapy (HAART) prevention of mother-to-child transmission (PMTCT) in pregnant HIV women:”

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Written by Shannon Palus

May 6th, 2016 at 11:30 am