The extensive report of the independent investigation committee of the University of Iceland and Landspítali University Hospital regarding the synthetic trachea scandal sheds light on the serious circumstances and arrangements at Karolinska University Hospital (KUH) and Karolinska Institutet (KI). By establishing a centre for advanced airway surgery, with a focus on cutting-edge surgical procedures, the lives of three patients at KUH were systematically put at high risk, and all three patients are now deceased.
Following the release of reports by independent investigators about the case, conducted on behalf of KUH and KI respectively, the Rector of the University of Iceland as well as the CEO of Landspítali University Hospital considered it necessary to carry out a comparable investigation, focussing on Iceland's involvement. One of the objectives of the investigation committee was to give a reasoned opinion as to whether the decisions of Icelandic healthcare professionals at Landspítali University Hospital in connection with the case were in accordance with applicable laws, regulations, and procedures. The role of the committee was, furthermore, to investigate the legal and ethical basis for the participation of Icelandic doctors in writing and publishing an article on the subject in the academic journal Lancet in November 2011, as well as for a symposium held at the University of Iceland in the summer of 2012.
The report states that certain staff members of the University of Iceland and Landspítali University Hospital were involved in the case in 2011, when a patient of Landspítali University Hospital was referred to Sweden for further examination due to cancer of the trachea. After arriving in Sweden, the patient in question gave a doctor at the Swedish hospital his consent to undergo a medical procedure which entailed implanting a synthetic trachea. This procedure did not lead to the patient's recovery, and he died at KUH in January 2014. The report states that at the time the surgery was performed, there was not an adequate scientific foundation for a human transplant of a synthetic trachea. The idea not only contradicted established scientific knowledge and experience, but it was, moreover, too early to conduct such experimental research on human subjects.
Overall, the case illustrates the importance of professional review and criticism whenever it comes to experimental scientific and medical research, as well as the importance of following relevant procedures and ethical and legal regulations. It is important for the University of Iceland, Landspítali University Hospital, the Icelandic academic community, and the staff members in question to learn from the mistakes made during the synthetic trachea case.
Even though a variety of procedures and structures have been changed, the report reveals new and important information. Landspítali University Hospital and the University of Iceland are taking this case very seriously. The report of the investigation committee plays an important role for the internal audit and responsibility analysis, as well as for reforming procedures and laws and improving ethics. The tasks and responsibilities of Landspítali University Hospital and the University of Iceland as well as their special status in society demand that the institutions learn from the mistakes made during the synthetic trachea scandal, both in Sweden and Iceland, and to inform the public about their work and steps to be taken in this matter. Both institutions will work together to achieve this goal. Their next step is to review how to respond to the findings of the report.
Reykjavík, Monday, 6 November 2017
Jón Atli Benediktsson, Rector of the University of Iceland.
Páll Matthíasson, CEO of Landspítali University Hospital
Main Conclusions of the Report in English on page 233-262: