The Royal Swedish Academy of Sciences has decided on a number of actions to combat deficiencies in the management of scientific misconduct and clinical research, which have been exposed through the controversy surrounding Paolo Macchiarini’s research. A new statement from the Academy presents, among other things, a demand that the previous enquiry into scientific misconduct is reopened.
A series of recent television programmes and newspaper articles have examined surgeon Paolo Macchiarini’s activities at Karolinska Institutet, Karolinska University Hospital and overseas.A number of shortcomings and ethically indefensible working methods have been uncovered, leading to a crisis of confidence in Swedish medical research.The Royal Swedish Academy of Sciences takes a serious view of the situation and emphasises the urgency of the case being examined by external reviewers, regarding both research and medical care.
The Academy demands that the enquiry into scientific misconduct is reopened and transferred from Karolinska Institutet to the Central Ethical Review Board.It is of the greatest importance that the case is decided in an impartial manner that gains general acceptance and repairs the credibility of medical research.
Last autumn, the Academy appointed a review panel that will put forward proposals during the spring for better and more legally certain management of these important cases.The review is led by Professor Dan Larhammar, Uppsala University, and cooperates with the expert appointed by the Swedish Government to investigate the management of scientific misconduct.
The Academy find it deeply unfortunate that the well-publicised report about the first operation with an artificial trachea, published in The Lancet in 2011, remains unchanged on the journal’s website.The Academy demands that a supplement is added to the journal, accounting for the further events, the complications and the patient’s death.
The Macchiarini case also shows that the boundary between clinical research and advanced medical care needs be clearer, and that the regulations governing the use of new treatment methods on seriously ill patients are sometimes not respected.
Therefore, the Academy and the Swedish Society of Medicine are appointing a review panel to investigate these issues, with the task of proposing recommendations for clinicians and scientists working at the boundary between clinical research and medical care. The review will be led by Professor Olle Lindvall, Lund University.
Reinforcing the practical application of research ethics in daily work, both at management level and by individual scientists, is an extremely pressing matter. The Academy will make an active contribution to such development and will also continue monitoring developments in the Macchiarini case.
Göran K. Hansson
Professor of experimental cardiovascular research
Secretary General of the Royal Swedish Academy of Sciences
Professor of Medical Biochemistry
Chairman of Class for medical sciences
Tel +46 8 673 95 44
Mobile +46 70 673 96 50