The study this case refers to includes transplants of biosynthetic corneas in patients in Ukraine. In a written communication to the university, an anonymous informer thought that the head of research was guilty of deficiencies in handling and documenting the study. Among other things, the material used to produce the implant was said to be of dubious quality.
The management of the Faculty of Health Sciences commissioned a group of three professors at Karolinska Institutet and Umeå University to review the case.
In their statement, the reviewers were critical of such facts as the composition and production of the material being changed over the course of the project without this being reported or having become the subject of new applications at the Swedish Medical Products Agency. This means that applicable regulations were ignored.
In their response document, the head of the research group repudiated the reviewer’s statement, stating that it contained unclear, sweeping formulations and that not all of the materials of the investigation had been taken into account. The research group also stated that the decision on the study in Ukraine was taken by Ukrainian eye surgeons and had been approved by the Ukrainian ethics board.
“The investigation shows that there could be grounds for levelling criticism at the actions of the research group,” says John D. Söderholm, dean of the Faculty of Health Sciences.
“A number of unclear points remain, however. Last week, an additional report also came in, that added investigation material. We have therefore commissioned the review group to continue their work,” Mr Söderholm said.
“At its meeting today, the board of the Faculty of Health Sciences decided to postpone the case while waiting for the supplementary investigation. A decision will therefore be taken at the next board meeting on March 3. Based on this, it will then be up to the Vice-Chancellor of the university to decide on any action.