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A plan to improve integrity

Karolinska Institute establishes new measures to prevent cases of misconduct in response to the Paolo Macchiarini scandal

ESTÚDIO REBIMBOCAKarolinska Institutet in Stockholm, Sweden, has reviewed the first year of its action plan, which was designed to address the flaws that have recently endangered the integrity of the institution, one of the most respected in Europe and known for selecting the Nobel Prize winners in Physiology or Medicine. One of the key elements of the strategy involves new administrative procedures for recruiting researchers, obtaining references, and verifying résumés. Responsibility for investigating cases of misconduct is now shared between the vice-chancellor and the institution’s legal office, with the support of a specialist appointed to coordinate the investigation.

The plan was based on the recommendations of an internal audit and a report produced by lawyer Sten Heckscher, who led an independent investigation into the misconduct case involving Italian surgeon Paolo Macchiarini, a pioneer in tracheal transplants. The investigations concluded that the physician gave false information on his résumé and published biased data on the performance of transplants in seven scientific articles. The institution was criticized for maintaining the researcher’s contract despite the evidence of misconduct, for failing to enforce regulations and monitor research data, and for its flawed recruitment process. Three members of the Karolinska Institutet leadership resigned last year because of the scandal.

Macchiarini was hired in 2010 with a dual role: as a visiting professor at Karolinska Institutet, in charge of conducting basic stem-cell research; and as a surgeon at the institution’s teaching hospital. The Italian proposed an experimental operation that used artificial tracheas coated with the patient’s own stem cells. In 2012, the technique was used on three patients who had exhausted all other treatment options, and the results were discouraging: only one survived, and remains hospitalized.

In 2013, the teaching hospital stopped the transplants and decided not to extend Macchiarini’s contract. The Italian continued working solely as a researcher at Karolinska. He then announced his intention to continue performing artificial trachea surgeries at a medical school in Krasnodar, Russia, and the Swedish institution authorized him to do so.

In 2014, a Belgian researcher accused Macchiarini of scientific misconduct, but he was cleared by the institute. He was then reported for two different instances of publishing biased data in seven scientific papers, accused of incorrectly describing the postoperative status of the patients and the functionality of the transplants. The claims were made by Macchiarini’s colleagues at the teaching hospital, some of whom were coauthors of the papers under suspicion. Bengt Gerdin, professor emeritus at Uppsala University, analyzed the case and concluded that there was evidence of scientific misconduct, but the Italian was acquitted anyway, with Karolinska Institutet conceding only that his research had not met the quality standards required by the institution. At the end of 2015, Macchiarini’s contract at Karolinska Institutet was renewed.

The case gained worldwide attention in early 2016, when American magazine Vanity Fair published a profile of Macchiarini, showing that he inflated his résumé with prestigious university positions that he never actually held. At the same time, a documentary aired on Swedish television showing how his transplant patients had suffered and died after surgery, raising questions about the level of care and research ethics involved. One of the cases reported was that of a young woman who underwent surgery at the Russian hospital, and died. In Sweden, she would not have been eligible for the experimental operation because her condition was not life-threatening.

In February, Karolinska Institutet decided to open a broad independent investigation into the researcher’s conduct. Shortly after, biologist Urban Lendahl resigned as secretary of the Nobel Committee at Karolinska in light of the pending investigation. Vice-Chancellor Anders Hamsten also resigned and announced the start of a new inquiry, having received evidence that the surgeon had falsified data from a pioneering transplant he performed in Iceland, which served as the foundation for several of his scientific papers. Dean of Research Hans-Gustaf Ljunggren also resigned. Only then was Macchiarini’s contract terminated.

ULF SIRBORN / KAROLINSKA INSTITUTET Swedish institute: set of strategies in response to the scandalULF SIRBORN / KAROLINSKA INSTITUTET

Ethics committee
Those responsible for implementing the action plan say that the task is taking longer than expected. Karin Dahlman-Wright, pro-vice-chancellor and a molecular endocrinology professor at Karolinska Institutet, spoke to the Science Business website: “We have begun to implement certain components; improving communication within the organization and investigating laboratory environments for example. However, the big picture is far from complete,” he said. One proposal that has not yet been put into practice is the formation of an ethics committee, charged not with investigating cases of misconduct, but with promoting good practices at the institution—its members will be appointed in the near future. “This is an important element in KI’s ongoing work to create a solid ethical platform for the organization,” said Dahlman-Wright.

Since 2010, an electronic system has been available for recording research data. Its use was not previously mandatory, but as of next year it will be. The division of responsibilities between the institute and its hospital has been improved. Now, the manager of the teaching hospital, the leader of the project at Karolinska Institutet, and the head of the department to which he or she is attached are jointly responsible for the integrity of the clinical research.

The plan also focuses on leadership training. Starting in 2018, it will be mandatory for all department heads and managers to take a course on ethics and management, based on guidelines that are still being determined. Other types of training will also be implemented. New researchers and staff will take short-term courses focused on ethics and research data management. There are plans for a user-friendly website to guide staff on the institution’s regulations and best practices.

When taking office as new vice-chancellor in late September, neuroscientist Ole Petter Ottersen summed up the challenges faced by the Karolinska Institute. “There are so many fantastic things going on at Karolinska Institutet, not least all the new buildings that are taking shape and all the opportunities this will open up for research and education. But the prerequisite for excellence in research and education is a good work culture and ethical awareness,” he said, according to the institute’s website.