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SVERIGEFAKTA
2010–2018·Karolinska Institutet and Karolinska University Hospital

Research misconduct and patient harm in windpipe surgery

Settled/established
What happened
Surgeon Paolo Macchiarini implanted synthetic windpipes in patients. Several patients died. Subsequent investigations found misconduct in the research and failures in ethical review and recruitment.
Who reviewed
An external inquiry led by Sten Heckscher (Karolinska Institutet), the Central Ethical Review Board and later the Board for Assessment of Research Misconduct (NPOF)
Criticism
The Heckscher report established that Karolinska Institutet had failed in recruitment, oversight and its handling of whistleblowers. Macchiarini was convicted in 2022 by the district court and in 2023 by the court of appeal of causing bodily harm.
Outcome
Karolinska Institutet's vice-chancellor Anders Hamsten resigned in 2016. Several members of the leadership left. Sweden gained a new authority (NPOF) and a new act on research misconduct in 2020. The court of appeal sentenced Macchiarini to 2.5 years in prison in 2023.
Agency's own reply
Karolinska Institutet has publicly apologised to the affected patients and their relatives, published an action plan and introduced new procedures for recruitment, clinical research and whistleblowing.

Sources

Primary sourceHeckscher-rapporten — Karolinska Institutets hantering av Macchiarini-ärendet (2016-09-05)Lag (2019:504) om ansvar för god forskningssed och prövning av oredlighet i forskning

Updated 2026-07-08

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SVERIGEFAKTA. (2026). SVERIGEFAKTA. Retrieved 2026-10-03, from https://sverigefakta.com/en/agency-oversight/macchiarini-karolinska
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SVERIGEFAKTA, "SVERIGEFAKTA", https://sverigefakta.com/en/agency-oversight/macchiarini-karolinska (accessed 2026-10-03).
BibTeX
@misc{sverigefakta_2026_en_agencyoversight_macchiarinikarolinska,
  author       = {SVERIGEFAKTA},
  title        = {SVERIGEFAKTA},
  year         = {2026},
  howpublished = {\url{https://sverigefakta.com/en/agency-oversight/macchiarini-karolinska}},
  note         = {Dataset v2026.2, accessed 2026-10-03}
}
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