Numerous measures have been implemented and are planned as a result of the deficiencies identified in connection with the Macchiarini case. The measures are based on the recommendations of the independent investigation led by Sten Heckscher and an internal audit by CLINTEC, Department of Clinical Science, Intervention and Technology, where Paolo Macchiarini was formerly employed. The following is a brief description of these measures.
A reinforced focus on ethics
Scientific ombudsman
The special position of scientific ombudsman has been established, with the aim of providing researchers with guidance and advice on ethical issues related to research. The scientific ombudsman shall also promote good knowledge of codes of research ethics, as well as of laws, regulations, rules and guidelines related to research. Moreover, he/she shall inform KI employees and researchers of new rules and important fundamental decisions relevant to the scientific activities of KI. He/she will also prepare an annual report on said activities.
Ethics courses for students
A strengthened scientific and ethical approach has been developed for students at both the undergraduate and graduate level. The further development of evidence-based clinical working methods to be used in the activity-integrated training is underway, in cooperation with the Stockholm County Council, SLL.
Action plan for doctoral education
It is now mandatory for doctoral students active in research involving humans or sensitive personal data to take a course in quality assurance in clinical research. In addition, the syllabi of other mandatory courses in research ethics have been looked over regarding purpose and requirements.
With the purpose of strengthened the quality assurance in doctoral education, all supervisors must since 2017 have the approval from their department, so called “green light”, to be allowed to initiate a new doctoral project. Also, the new ISP-system is to be introduced at KI during 2018 which means that the individual study plans of doctoral students become digital and therefore easier to follow up.
The prevention of scientific misconduct
New procedures in cases of suspected scientific misconduct
Since the spring of 2017, KI has employed a special administrator with a high degree of academic expertise who assists in the preparation and assessment of cases of suspected scientific misconduct. People must be appointed to the Misconduct Board which is supposed to be established. KI's administrator with specific responsibility for misconduct cases is Pierre Lafolie (Associate Professor, Legal Office, KI).
Preparation for the introduction of a National Misconduct board
At the national level, the establishment of a new national Agency for the Assessment of Misconduct Cases has been proposed. At KI, preparations are in place to introduce the necessary positions whenever this national plan is implemented, tentatively in 2019.
Admissions and recruitment
Review of CVs and references
The procedures for the review of application documents and reference checks have been strengthened. New appointment procedures in effect from 2018.
Guidelines for clinical combination services
Specific guidelines for the recruitment process for clinical combination services have been developed in cooperation with Karolinska University Hospital. The next step is to elaborate and implement the corresponding joint recruitment process at other healthcare units.
Support systems
Incident reporting
The procedures for the reporting of incidents have been reviewed and changed, including through a new incident reporting system. The protection of anonymity has been strengthened – for example, reports of suspected misconduct can be filed without logging in.
Electronic logbook
Electronic research documentation through KI ELN – an electronic log book – will be compulsory from 2019. A general user support system for research documentation is to be developed in parallel with the ELN. Electronic logbooks heighten information security and makes research data traceable. Staring in August 2018, PhD students must document new research projects in one of the KI-approved electronic systems.
Procedures and guidelines
New guidelines for ancillary activities
The guidelines and procedures for reporting ancillary activities have changed. In order to clarify how the results of research at KI shall be managed and used, there are also new guidelines for intangible assets and corporate alliances. The guidelines comply with the recommendation of the EU Commission.
Allocation of OHS responsibilities
A new agreement has been struck concerning the coordination of OHS responsibilities between Karolinska Institute, Karolinska University Hospital, Danderyd Hospital and SciLifeLab for premises used jointly for healthcare and research. The allocation of OHS responsibilities will also be developed for Stockholm South General Hospital and Bioclinicum, Karolinska University Hospital, and research centers in Solna.
Affidavit of the division of responsibilities
Agreements between Karolinska Institute and Karolinska University Hospital have been clarified though an affidavit of the division of responsibility and terms and conditions for collaboration in clinical research. Cooperation with Danderyd Hospital has also been clarified. Cooperation with Stockholm South General Hospital will be clarified.
Mandatory course in laboratory safety for the research group leaders
It is now mandatory for research group leaders with delegated OHS responsibility in laboratory activities to take a laboratory safety course. Special training in laboratory safety is also offered to new heads of department. The departments are offered courses aimed at other employees involved in laboratory activities.
More change initiatives
Increased communication support
The KI Communications Department has developed support for managers and employees in matters relating to research issues, ethics, collaboration, transparency, conflict of interest situations, etc.
Introduction and information packets for visiting scientists and new employees
Information packets have been developed in both Swedish and English. Among other things, they present the requirements for government employees.
Increased focus on ethical issues related to research
President Ole Petter Ottersen, has taken the initiative to implement various forms of action that highlight ethical issues related to research. He has also proposed a special Lancet Commission.
KI’s management organization is to be changed
The basis of KI's new management organization, which enters into force on January 1, 2019, has been determined. The new structure includes the establishment of a faculty board chaired by the President of KI, as well as a faculty council, which will contribute to positive and well-functioning collegial influence on the strategic level. More about the organizational change at KI.
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