Published: 05-02-2016 09:34 | Updated: 10-02-2016 12:42

The Board initiates external investigation

The Karolinska Institutet University Board (Konsistoriet) has today announced its decision to arrange an external investigation into the “Macchiarini case”. The process will cover events taking place at Karolinska Institutet (KI) since the recruitment of surgeon Paolo Macchiarini as visiting professor in 2010 until the present day, when he has been notified by the Vice Chancellor that his contract will not be extended. The University Board deems such an inquiry to be an important part of restoring the confidence of the public, the scientific community, staff and students in the university.

The University Board is charged by the Higher Education Act with ultimate responsibility for the university’s business, which includes establishing and auditing processes for internal control, risk management and general management. The University Board is also vested by the Higher Education Ordinance with a critical role in the appointment of the vice-chancellor and the responsibility of regularly ensuring that the vice-chancellor and the senior managers he or she appoints do not fail in their competence and judgement.

The investigation will be led by a highly experienced lawyer, who will subsequently be writing the final report. Well-qualified medical researchers, ideally not from Sweden, should assist in this work. The person tasked with leading the work will decide on who is to take part in the investigation and on what resources will be needed to bring the inquiry to a satisfactory conclusion. KI’s internal audit office, which answers direct to the University Board, will also be a resource available to the investigation.

It is hoped that the investigative team will be formally appointed next week.

The decision-making rights of the university board are defined by chapter 2, section 6 of the Higher Education Act. Since the board may not rule on issues requiring scientific competence, it may not, for example, decide on whether KI shall conduct research on synthetic trachea or sit in judgement on suspected scientific misconduct or overrule decisions on such.

The investigation will cover that which falls within the University Board’s sphere of responsibility, and will thus not be examining matters of a medical-scientific nature. Issues that that external investigation should consider are:

Was any law broken or other formal transgression committed on Macchiarini’s recruitment or later during his period of employment at KI?
Were adequate inquiries made in connection with his recruitment?
Was sufficient effort made at a departmental and university management level to ensure that Macchiarini’s activities were conducted in a proper scientific manner with due respect to research ethics?
Has his research been documented in a manner consistent with the rules and praxis in effect at KI?
Has the division of responsibility between KI and Karolinska University Hospital been sufficiently clear, and has their collaboration been adequate from a research and clinical perspective?
Has the chain of responsibility from department to Vice-Chancellor and the University Board been sufficiently effective?
Was anything – or enough – done to ensure that Macchiarini’s extramural activities complied with KI’s scientific and ethical requirements?
Were the allegations of scientific misconduct levelled against Macchiarini handled correctly?
Why was Macchiarini’s employment contract extended in 2015 in spite of the obvious doubts there were about his activities?

The University Board would like the investigation to draw up recommendations on, for example, amendments to the internal rules and control system, should this be deemed warranted. It also welcomes proposed amendments to the national regulations for forwarding by the University Board to the relevant government offices.

It is the University Board’s hope that the investigation will be concluded by the summer, but if a longer time is needed to ensure a high standard of inquiry, this will take precedence.

The University Board has full confidence in Vice Chancellor Anders Hamsten and has urged him to remain in office during the investigation. Whether the outcome of the investigation will lead the board to change its stance in this respect is not a matter for speculation at present.