In the spring of 2015 when the Faculty of Medicine and Health Sciences at Linköping University received a report of misconduct in a research study, an independent, external review committee was appointed. In their first report to the faculty board, the three professors in the review committee directed criticism at, among other things, the documentation of the study, and held that the researcher had acted carelessly. In January 2016 further information on the same matter was received. Based on these new details, and the researcher’s response to the investigation, the review committee was asked to continue the investigation.
The first matter concerned a study conducted abroad, where implants were transplanted into blind patients. A key component in the report of misconduct was that the material in the implant was intended for animal testing and had not been approved for use in humans.
“This research project is about giving people who suffer from severe pain and impaired vision as a result of corneal injuries a possibility to regain their vision and be free from pain. However the execution can be criticised,” says Johan Dabrosin Söderholm, Dean of the Faculty of Medicine and Health Sciences.
The new information that was received concerned unpublished data in a study on patients, also conducted outside Sweden. According to the review committee’s statement, the implants used in this study had not been satisfactorily tested and had not been transported as previously agreed.
In their continued investigation the reviewers did not amend their previous position concerning carelessness. They note that the work of the research group can be questioned when it comes to handling, checking and documentation, and that in some regards there had been a lack of respect for regulations and ordinances. Moreover the reviewers are critical that the researcher was listed as corresponding author in a publication from the patient study, which is cited in the first report of misconduct, even though at the time of publication the researcher knew that the clinical application had taken place without prior animal testing.
Therefore the faculty’s decision is to criticise the researcher for misconduct for repeated carelessness and erroneous co-authorship.
Vice-Chancellor Helen Dannetun will now assess whether the faculty’s decision will also lead to employment-related consequences for the researcher, such as a warning or a salary deduction.
“This is important research with enormous potential benefits for patients. But its importance does not exempt it from requirements for good research practice. Regulations must be followed and ethical decisions must be made properly,” says Vice-Chancellor Dannetun.
Furthermore, the board of the Faculty of Medicine and Health Sciences has commissioned Dean Johan Dabrosin Söderholm to develop a plan to address the shortcomings of a more general nature that were identified in the investigation.
The researcher, who has been given the opportunity to respond to the criticism, rejects the review committee’s statement and criticises the manner in which the investigation was conducted.