Lack of permits, ‘selective’ data halt research at Swedish prosthetics research center

In the late afternoon at a conference in Cartagena last year, a team of Swedish researchers presented their work on a technique that uses machine learning to translate the body’s own electric signals used to move a limb. They had tested it on a minor recovering from a stroke. 

Documents from an internal investigation shared by Chalmers University have now revealed, however, that this case study was part of a series of regulatory lapses and suspicious research practices at the Centre for Bionics and Pain Research (CBPR) where the clinical research was conducted. The researchers seem to have conducted the study before Max Ortiz-Catalán, the center’s founder and former manager, had secured regulatory approval from the relevant Swedish agency. 

Chalmers, the Centre’s home, has now suspended it after also suspecting that its data and research participants seemed “systematically selected” so that treatments appeared effective, and excluded data when treatments caused health problems. The investigation also uncovered the center had no person responsible for compliance, which is a requirement under Swedish law, and that personal data had been handled poorly. 

This isn’t the first time CBPR has come under scrutiny for questionable research practices. Two years ago, a divided committee absolved several of its researchers from charges of misconduct after a local newspaper pointed out serious omissions in a published paper. 

In September 2022, Forskning & Framsteg reported that researchers affiliated with CBPR, again including Ortiz-Catalán, had excluded the life-threatening complications — such as sepsis and infection — experienced by a patient who had received a prosthetic arm. The paper, ‘Self-Contained Neuromusculoskeletal Arm Prostheses’ published in the New England Journal of Medicine, had generated buzz for its advances in ‘mind-controlled’ prosthetic limbs. 

CBPR had conducted the research in collaboration with Swedish prosthetics company, Integrum. When the deficiencies in the paper were first reported, Integrum CEO Rickard Brånemark said the omissions were “regrettable” and that the authors’ intention was not to hide information, since the complications had been reported at conferences. A month later, in October 2022, the authors published a lengthy correction explaining the patient’s adverse events. 

But when the correction was published, an investigation into alleged falsification was still underway. Chalmers University had submitted a case to Sweden’s national board for research misconduct one day after the newspaper’s report, followed by the University of Gothenburg submitting the same suspicions to the board a month later. 

The authors argued that the patient who experienced the life-threatening complications had received a different kind of prosthetic arm, and that they had intended to publish the medical complications in a subsequent paper, according to the board’s decision published in June 2023. The authors also claim the Journal’s editor wanted the patient to be included, despite the team’s initial plan to exclude them from the paper because of issues with follow-up. 

The board found the authors not guilty of research misconduct, though three members dissented, writing: 

When the article was ready for publication, the authors knew about the complications that affected Patient 4. However, the reasons why Patient 4, who is mentioned in several places in the article, was excluded are not made clear and the context in which complications arose is not knowable either…

We consider it was gross negligence not to report the complications that arose in one of the few research participants included in the study described in the article.

Ortiz-Catalán left CBPR while an internal investigation was being carried out due to “issues in his leadership,” media relations manager Henrik Dahlberg wrote in an email to Retraction Watch. “I won’t go into any detail here,” he added. Ortiz-Catalán has since moved to Australia, where he works at the Bionics Institute in Melbourne.  He has not responded to several requests for comment. 

New information about operational issues at CBPR came from a staff tip-off in March 2024, prompting the latest internal investigation at Chalmers that has resulted in the center’s suspension. “The ethics committee decided that they needed to investigate, since what had been revealed indicated irregularities in the research that had been carried out at CBPR,” Dahlberg wrote. 

The investigators examined 50 publications that were published between 2020 and 2024 which include Ortiz-Catalán as an author. They found a large number of ethical permits, but only one regulatory permit since the CBPR was formed — dated several weeks after researchers had presented their clinical case study at the conference in Colombia. 

The report also noted a lack of legal agreement between Integrum, the company that collaborated in the 2020 study, and Chalmers University. 

“It is our assessment that the activities at CBPR violate the law regarding regulatory permits.” the investigators wrote, noting that this carries a maximum imprisonment of two years according to Swedish law. “In addition, there is a suspicion that they do not comply with the European regulations for medical devices and do not live up to the Declaration of Helsinki,” the report continues. The investigators also found issues with security in the management of personal data. 

While the investigation focused on whether permits were in place for the work, the report suggests that data was selected to appear favorable to the treatments. Chalmers and the other collaborating institutions — the University of Gothenburg and Sahlgrenska University Hospital — agreed to suspend CBPR’s operations and have asked Swedish research authorities to review work from the group dating back to 2020. 

In response to questions about whether this affects research produced collaboratively between Integrum and CBPR, Integrum CEO Rickard Brånemark wrote: 

The NEJM article you refer to has already been thoroughly re-examined, after which a correction was published on November 1, 2022. Moreover, an academic research evaluation confirmed that no misconduct had been committed. I feel confident that everything in that paper is correct and balanced. To my current knowledge, there are no reasons to correct or retract any of the other articles I have co-authored with researchers at CBPR. Should the evaluation following the closure of CBPR find any inconsistencies in any publication, we will of course make sure to correct these.

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