Investigations and other measures related to Macchiarini case

Following the relevations concerning the researcher and surgeon Paolo Macchiarini's actions, a number of investigations and other measures have been initiated.

At Karolinska Institutet

• The inquiry into scientific misconduct is being reopened. Following fresh information, including new details about the first patient, whose case forms the bases of some of Paolo Macchiarini's articles, KI intends to reopen the inquiry into scientific misconduct. This will involve obtaining an official statement from the Central Ethical Review Board’s expert group for misconduct in research.
• An external inquiry is to be conducted into Karolinska Institutet’s handling of the Macchiarini case.The inquiry will be led by lawyer Sten Heckscher, assisted by journalist and author Ingrid Carlberg and Professor Carl Gahmberg. Read more on the inquiry here.
• The rules for extra-mural occupations are to be reviewed.To make it especially clear that all extra-occupational activities conducted abroad must comply with the same ethical rules that apply to corresponding work at KI, the process by which such occupations are reported at KI will now be subject to review. The risks of the damage that such activities may cause to confidence in KI will be compiled, analysed and presented to the University Board.
• The recruitment process is to be reviewed. Employment procedures are to be complemented with special procedures for the recruitment of researchers lacking a distinct base at a specific university. Researchers who present a particular identifiable risk will have the verification of their CV given special close attention. Read more here.
• The vice-chancellor’s delegation rules are to be reviewed. There is to be a review of the vice-chancellor decision-making and delegation rules and the allocation of responsibility to different executives in the departments. The distribution of responsibilities shall be clarified when necessary.

At Karolinska Institutet and Karolinska University Hospital

KI and Karolinska University Hospital have mounted a common review of the boundary between healthcare and research. This review was initiated by KI and the hospital executive following the inquiry into scientific misconduct against Paolo Macchiarini. The aim is to define the boundary between clinical application and research as regards experimental therapy and to draw up clear guidelines for academic healthcare and the university. The review is expected to be concluded at the latest by 31 December 2016. Initially the final review was planned to be presented by the summer of 2016 but the deadline has been extended to the end of 2016.

At Karolinska University Hospital

The hospital is to mount an external investigation into the circumstances surrounding the tracheal operations performed by Paolo Macchiarini on three patients at Karolinska University Hospital in 2011 and 2012. The inquiry is to be led by Kjell Asplund, professor emeritus of medicine and chair of the Swedish National Council on Medical Ethics. The inquiry is expected to be concluded in August.

At other public authorities

• The Health and Social Care Inspectorate (IVO) The transplantation of synthetic tracheas at Karolinska University Hospital was reported to the IVO to ascertain if the hospital had acted wrongly. In order to have the nature of Macchiarini’s work established as healthcare or research, the IVO, in turn, passes the matter on to the police and public prosecutor.
• The Medical Products Agency (LMV). The operations were reported to the LMV as a breach of the medical products act, as no permit had been issued for the transplantation of synthetic trachea. To better understand the legal nature of the matter, the LMV has filed a report with the police and public prosecutor.
• Police and public prosecutor. Both the IVO and LMV have referred the operations to the police and public prosecutor.
• The Swedish Higher Education Authority (UKÄ). On 10 February, UKÄ announced that it had received a report against Karolinska Institutet. UKÄ now demands to be sent the findings of the University Board’s forthcoming investigation as soon they are ready as well as a report from Karolinska Institutet on the measures that the investigation will entail. A decision on how the matter will be handled by UKÄ will be taken after it has received the documentation requested.

By the Government

An inquiry into misconduct proceedings. The minister of higher education and research, Helene Hellmark Knutsson, has appointed a special investigator to look into the need to revise how matters of scientific misconduct are handled and to submit proposals for ensuring clear and legally secure misconduct proceedings. Her report is expected to be submitted on 25 November 2016. KI will be one of the consultative bodies.

At the Royal Swedish Academy of Sciences in association with the Swedish Society of Medicine

The Royal Swedish Academy of Sciences has announced its decisions on a raft or measures to deal with shortcomings in the handling of scientific misconduct and clinical research in connection with Paolo Macchiarini’s research. The academy will also be mounting an investigation with the Swedish Society of Medicine in order to propose recommendations for clinicians and researchers working at the crossroads between clinical research and healthcare.

At the Swedish National Council on Medical Ethics

The Swedish National Council on Medical Ethics is running a project on so-called clinical innovation regarding clinical development work that straddles both clinical research and established healthcare. The project will analyse the problems that can arise and whether clear regulations or guidelines are needed in the field.