Published: 07-02-2018 14:45 | Updated: 09-02-2018 12:53

Researcher cleared of misconduct but does not escape criticism

On Tuesday, Karolinska Institutet’s vice-chancellor Ole Petter Ottersen reached the conclusion that the implementation of the clinical research study "Infusion av amniocyter från fosterhinna och liknande bindvävsstamceller vid vävnadsskada, blödning och/eller transplantat kontra värdreaktion" (Infusion of amniocytes from extraembryonic membranes and similar mesenchymal stem cells in cases of tissue damage, haemorrhage and/or graft-versus-host disease) and the research projects conducted during 2009-2017 did not constitute misconduct in research. However, the studies are criticised for flaws relating to research methodology and documentation.

During the years 2011-2015, a clinical research study was conducted at Karolinska Institutet with the aim of improving the situation for patients who had been treated using stem cells from another person, and who had subsequently suffered from serious rejection reactions.

In June 2015, questions were raised regarding patient safety and an inquiry was launched by Karolinska University Hospital, resulting in the cessation of the treatment. By then, 68 children and adults had been experimentally treated with decidual cells cultivated from donated placentas.

On 11 April 2016, Karolinska Institutet’s acting vice-chancellor Karin Dahlman-Wright decided to begin an investigation into suspected misconduct in research. The researchers who participated in the study were Olle Ringdén, Mehmet Uzunel, Mats Remberger, Jonas Mattsson, Silvia Nava, Birgitta Omazic, Zuzana Potáková and Helen Kaipe, all of whom worked at Karolinska Institutet.

In his decision, vice-chancellor Ole Petter Ottersen confirms that the research project had demonstrable shortcomings with regard to research methodology and documentation.

Karolinska Institutet, in common with the Expert Group on Misconduct in Research at the Central Ethical Review Board, finds that the requisite permits were in place from the Medical Products Agency, ethical review board and radiation protection committee.

However, the confirmed flaws in the research mean that no authoritative data has been obtained. KI therefore finds Ole Ringdén to be culpable for the flaws in the implemented research, although not to such a degree as to constitute misconduct