Action plan following the Macchiarini case investigations
Numerous measures have been implemented as a result of the deficiencies identified in connection with the Macchiarini case. The measures at Karolinska Institutet (KI) are based on the recommendations of the investigation led by Sten Heckscher and an audit of the department where Paolo Macchiarini was formerly employed. KI's university board decided in 2020 that the measures will in future be incorporated into KI's continuous development work.
The following is a brief description of these measures and changes. Some webpages referred to below are not available in English.
Strengthened ethical orientation
Ethics Council and Scientific representative
There is a special function, scientific representative has been set up with the aim of providing researchers with guidance and in research ethics. The scientific representative shall also work to ensure that the knowledge of research ethics codes, laws, regulations, rules and guidelines is good, spread information about new rules and important principled decisions regarding scientific activities, and prepare an annual report on its activities. The scientific representative also serves as chairman of KI's ethics council. The Council on Ethics initiates seminars to shed light on and discuss important ethical issues and assists the President (Vice-Chancellor) with advice, for example, in the preparation of guidelines that concern ethical principles.
Ethics courses for students
KI works continuously with the development of education within the framework of KI's cohesive quality system. See also below the special paragraph about the quality system. Special measures taken include the review of degree projects and of the teaching of ethics and scientific approaches.
Ethics and quality assurance for doctoral education
It is now mandatory for doctoral students who conduct research with human subjects or that involves the handling of sensitive personal data to complete course on quality assurance in clinical research (GCP). In addition, the syllabi for the existing compulsory courses in research ethics have been reviewed with regard to their purpose and requirements.
With the aim of strengthening quality assurance in postgraduate education, all supervisors must obtain approval from the department, a so-called “green light”, in order to initiate a new doctoral project. The doctoral students' individual study plans are now handled in an electronic system which make them easier to follow up. The quality of KI's doctoral education is monitored regularly, see also a special paragraph below about the quality system.
Ethics in research
See paragraphs below: Procedures in cases of suspected research misconduct and Guidelines and guides for research.
Information on ethics at KI
A comprehensive web page on ethics with guides and hyperlinks has been developed in 2022: Ethics at KI
Increased support for leaders
KI has developed support and advanced training for leaders at all levels in the organisation in areas such as research issues, ethics, collaboration, transparency and in conflict-of-interest situations. Examples are presented below.
KI's Higher Leadership Program (KIHLP)
KI's higher leadership program for heads of department, administrative managers and other senior executives is a recurring training to meet both KI's challenges and our leaders' needs and wishes. The education reflects KI's mission and values and creates a lively dialogue about the importance of leadership in a modern and well-functioning university. The program is implemented in module form and runs over a total of three semesters. Each module is completed over two full days and covers a specific theme.
The first training program with about 25 participants was completed in the autumn of 2019 at the same time as a new training program with new participants was started.
Courses for research group leaders
The course Leadership for Research Group Leaders provides knowledge of responsibilities and roles that are incumbent on a research group leader in the form of, among other things, legal aspects, regulations, and other tools that benefit the creation of a good working environment. The course includes two weeks of full-time studies.
It is now mandatory for research group leaders with delegated work environment responsibility in laboratory activities to take a course in laboratory safety. New heads of department are also offered special training in laboratory safety. The departments are offered a course designed for other employees engaged in laboratory activities.
Introduction and information packages
Information packages for guest researchers and new employees are available in both Swedish and English and adress the requirements for government employees.
The prevention of scientific misconduct
Procedures in cases of suspected research misconduct
A national authority for assessing misconduct cases was established in 2020.
In the same year (2020), KI established the Council for the Investigation of Deviations from Good Research Practice. The council shall investigate cases where there is a suspicion of misconduct in research and advise the President (Vice-Chancellor) on whether the matter shall be submitted to the national board for review. The Council shall also investigate other suspected deviations from good research practice than suspected misconduct in research. The council comprises both lawyers and teacher representatives with broad scientific experience and also includes student representation.
Admissions and recruitment
Review of CVs and references
Prior to the fixed-term and long-term employment of senior lecturers and professors (including adjunct lecturer, adjunct professor and visiting professor), verification of references and a review of application documents are carried out. The assessment means that the candidate's certificate is compared with the information attached to the application. The certificates that are examined are doctoral diplomas, professional credentials, certificates of specialist competence, certificates / equivalent regarding associate professorship (if applicable), certificates / equivalent regarding employment obtained as a professor (if applicable) and employer certificates.
Renewed process for employment in academic-clinical combination services
Special guidelines for the recruitment process for new appointments for academic-clinical combined positions were developed in 2018 together with Karolinska University Hospital (K). The routines in the joint recruitment process have since been implemented. A well-functioning collaboration has over the years been built up with Karolinska University Hospital's central recruitment center.
- KI and K have together developed websites that can be found on each employer's employee web portal in order to inform HR at the clinic / department about the routines in the joint recruitment process.
- Joint information meetings for clinic/department will be held.
- Work has also begun on designing information for people who already have an academic-clinical combined position or who are interested in applying for such a position.
- KI has prepared new employment agreements for academic-clinical combined positions.
KI has an internal incident reporting system for incidents relating to safety, working environment and the environment, where all employees and students can log in and report risk observations and incidents. The protection of anonymity has been strengthened as, in a special module, it is possible to report malpractice, suspicion of misconduct in research, etc. without logging in. Since March 2020, incidents regarding personal data in research and information security can be reported via a separate channel connected to with the system.
Electronic research documentation
Electronic research documentation via KI ELN is mandatory from 2019 at KI. A general user support system for research documentation is developed in parallel. Electronic logbooks increase information security and make research data traceable.
Cohesive quality system
The cohesive quality system sets the framework for systematic quality development, including quality assurance. The quality system covers research, education at all levels as well as the administrative support.
The quality work, including quality assurance, is based on the fact that the operations undergo a continuous internal follow-up each year. Additonally, and a regular review, in which external experts participate, takes place every 6-8 years. In addition, the Swedish Higher Education Authority (UKÄ) reviews on a regular basis KI's quality assurance work regarding education, and at the next round KI's quality assurance of research will be covered.
Renewed structure for making control documents available
KI's website has been developed in multiple stages during the last years. For example, there is a renewed structure where rules, guidelines, policies, strategies, action plans, and instructions are available for employees and students. The search function on the website has also been developed so that it is possible to filter the type of matches that are desired.
Procedures and guidelines
Guidelines and guides for research
The Swedish Ethics Review Act has been updated with, among other things, clearer responsibility for research principals and that the Board of Appeal for Ethics Review has supervision over compliance with the Act. Amendments to the Ethics Review Act from 1 January 2020 are described on the Ethics Review Authority's website: Amendments to the Ethics Review Act (Sw). The Ethical Review Act is published on the Swedish Parliament's website: The Ethical Review Act (Sw).
Guidelines for research at KI were renewed in the spring of 2020. Ethical principles for human research and animal studies outside Sweden have been renewed by KI in 2022. A comprehensive support page for researchers was published in early 2022 with practical guidelines from different perspectives: Research support services KI
In 2022, KI and the Region Stockholm have together developed new guidance on overarching research responsibility on the basis of current ethics legislation. A certificate of distribution of responsibilities was developed in 2017, which, in an updated version, is still used at Karolinska University Hospital.
Guidelines for side jobs and collaboration
Guidelines and routines for reporting secondary occupations have been clarified and updated. There are also guidelines for intangible assets and business collaboration to clarify how the results of research at KI are to be handled and used. The guidelines follow the recommendation of the European Commission on IP-rights.
Work environment coordination at permanent joint workplaces
The Work Environment Act requires coordination of measures that affect the work environment in cases where two or more entities conduct activities at joint workplaces. Since 2013, there has been an agreement on forms of collaboration between KI and the Karolinska University Hospital regarding the work environment. Thus, there is for example a dedicated person responsible for this coordination appointed at BioClinicum since the start of operations in 2018.
KI has made corresponding agreements with Danderyd Hospital in 2017, with S.t Erik Eye Hospital and Stockholm South General Hospital in 2018, with the Royal Institute of Technology (KTH), Stockholm University and with SciLifeLab.
The agreements prescribe the distributon of responsibilities in different work environment areas including environmental work, e.g. waste management, so that the companies do not expose their own or others' employees to risks at work.
More change initiatives
The management organisation
KI's current management organisation came into force on 1 January 2019. The organisational structure means, among other things, that a faculty board and three departmental groups have been established.