One of the papers is the seminal 2011 article in The Lancet, which described the first case of a transplant using an artificial trachea seeded with the patient’s own stem cells, and now bears an expression of concern from The Lancet editors. Over time, multiple authors have asked to be removed from the paper.
The Expert Group on Scientific Misconduct at the Central Ethical Review Board has determined that concerns over that paper — and five others co-authored by Macchiarini, once based at the Karolinska Institutet (KI) — were justified. In a press release, it says:
The Expert Group state that the transplantations are described successfully in the articles, which is not the fact. The Expert Group also establish that the information in the articles are misleading and beautifying regarding the patients conditions and furthermore that information has been withhold in this purpose and that this constitutes scientific misconduct. In addition, there is false information of ethical approval, which also constitute scientific misconduct.
Macchiarini is mainly responsible for what happened, the board says:
The Expert Group finds that all co-authors to the six articles are guilty of scientific misconduct. The responsibility is however different amongst the authors. The main responsibility lies on Paolo Macchiarini as the main author and research-leader and others who have had a more prominent role in the research and the authorship. The more detailed responsibility and the future consequences for the respective authors is up to their employers to decide.
Earlier today, KI issued a statement about the Expert Group’s decision:
In June 2016, Karolinska Institutet requested that CEPN express its opinion in order to investigate suspected misconduct in research. The authors of the articles will now also be invited to give their opinions before the vice-chancellor of Karolinska Institutet reaches a decision on the matter of misconduct in research. At the present time, it is not possible to state the date on which this decision will be made.
The Central Ethical Review Board flagged six articles that were reviewed by Bengt Gerdin of Uppsala University, during his initial external review commissioned by KI. Gerdin’s report flagged seven papers; it’s unclear why the review board — relying on expert advice from Martin Björck at Uppsala and Detlev Ganten at Berlin-Brandenberg Academy of Sciences — focuses on six.
Here are six papers flagged by the review board:
- “Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study,” The Lancet, 2011. Cited 249 times (including 50 times since its expression of concern), according to Clarivate Analytics’ Web of Science.
- “Engineered whole organs and complex tissues,” The Lancet, 2012. Cited 229 times.
- “Verification of cell viability in bioengineered tissues and organs before clinical
Transplantation,” Biomaterials, 2013. Cited 12 times.
- “Are synthetic scaffolds suitable for the development of clinical tissue-engineered tubular organs,” Journal of Biomedical Materials Research, 2014. Cited nine times.
- “Airway transplantation,” Thoracic Surgery Clinics, 2014. Cited 16 times.
- “Biomechanical and biocompatability characteristics of electrospun polymeric tracheal scaffolds,” Biomaterials, 2014. Cited 19 times.
Last year, the Swedish government announced it was re-thinking its procedure for investigating misconduct, in which universities must ask the Central Ethical Review Board to review a misconduct case against an accused researcher. In the most recent case, KI requested a review by the Expert Group on Scientific Misconduct at the Central Ethical Review Board.
The Macchiarini story has had many twists and turns — for instance, KI had to re-open its misconduct investigation. We’ve done our best to keep up with the story; for a run-down, see our timeline. The ethical review board’s decision has also been reported by Leonid Schneider.
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