The Macchiarini case: The external inquiry into Karolinska Institutet completed – KI criticised on several counts

The external investigation was conducted by Sten Heckscher, Ingrid Carlberg and Carl Gahmberg, and covers a period of time extending from the initial correspondence between KI and Macchiarini in autumn 2009 to 4 February 2016. Matters under scrutiny include the recruitment of Macchiarini in 2010, the extensions of his contract in 2013 and 2015, the division of responsibilities between KI and Karolinska University Hospital as regards the controversial transplantations, and KI's handling of the allegations of scientific misconduct levelled against Macchiarini.

Their report concludes that Karolinska University Hospital bears responsibility for the transplantations of synthetic tracheae performed there. However, the investigators also find that Karolinska Institutet can not be completely absolved of responsibility for these operations. For example, the university cited the transplantations as research successes in its evaluations of research funding utilisation and people from KI took part in discussions preceding and following up the operations. Consequently there was also a responsibility on KI to ensure that they were performed in accordance with the rules and regulations.

Moreover, Karolinska Institutet is accused of nonchalance in the application of the law, including the Freedom of the Press Act and the Administrative Procedure Act, an attitude that caused failings in the recruitment of Macchiarini and the extensions of his contract. The report also criticises the manner in which the allegations of scientific misconduct against Macchiarini were dealt with. For example, decisions were not justified in the way provided by Administrative Procedure Act.

The investigators proceed to discuss how responsibility is to be divided and how the consequences of failing to act upon this responsibility should be assessed. The report concludes with a discussion on structural issues that could have contributed to the errors and mistakes made.

View the report in full at ki.se/nyheter/macchiarini For a printed version, write to registrator@ki.se

Further information: Sten Heckscher, +46 (0)70-583 20 99

Sten Heckscher is a former president and justice of the Supreme Administrative Court of Sweden, cabinet minister, under-secretary of state and national police commissioner.

Ingrid Carlberg is an author and journalist, and honorary doctor of medicine at Uppsala University.

Carl Gahmberg is professor of biochemistry at Helsinki University.

Pia Cedermark, Justice of the Swedish Administrative Court of Appeal, served as secretary to the inquiry.