Action plan following the Macchiarini case investigations
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 at the department where Paolo Macchiarini was formerly employed. The following is a brief description of these measures.
Strengthened ethical orientation
A special position of scientific representative has been appointed with the aim of providing researchers with guidance and advice on research ethics. The scientific representative shall also work to ensure that the knowledge of research ethics codes, laws, regulations, rules and guidelines is good, inform others 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 new ethics council.
Ethics courses for students
KI works continuously with the development of education within the framework of KI's cohesive quality system. Special initiatives have included 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 take a course on quality assurance in clinical research. 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. A so-called ISP system is planned to be introduced, which means that the doctoral students' individual study plans will be digital and thus easier to follow up. For doctoral students, new research projects must now be documented in an electronic system approved by KI (see KI ELN below).
Increased support for leaders
KI has developed support 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 have been produced in both Swedish and English and include requirements for employees of public authorities.
The prevention of scientific misconduct
New procedures in cases of suspected research misconduct
A new national authority for assessing misconduct cases has been established in 2020. This also entails new requirements for the working methods of research principals (higher education institutions). For several years, KI has had a working model in which academic expertise and the Legal Office at the University Administration prepare cases to ensure a legally secure process.
In the spring of 2020, KI decided to establish the Council for the Investigation of Deviations from Good Research Practice. The council shall investigate whether there is a suspicion of misconduct in research and advise the President (Vice-Chancellor) on whether a decision shall be made that 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.
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 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 created new websites that can be found on each employer's employee portals 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.
- KI has prepared new employment agreements for academic-clinical combined positions.
For a few years now, KI has had an internal incident reporting system for 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 and information security can also be reported via a separate channel in connection with the system.
Electronic research documentation
Electronic research documentation via KI ELN is mandatory from 2019 at KI. A general user support for research documentation is developed in parallel. Electronic logbooks increase information security and make research data traceable.
Cohesive quality system
The cohesive quality system prescribes how KI shall conduct a systematic and effective quality assurance, quality evaluation and quality development of activities within the university, including research and education as well as the administrative support.
In addition to the development and coordination of internal quality assessments, significant efforts has been put into external, national evaluations of education on the initiative of the Swedish Higher Education Authority (UKÄ). This is now followed by national evaluations of research activities.
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 regulations, guidelines 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 clinical research
Guidelines for research at KI (both clinical and experimental) were renewed in the spring of 2020.
Terms and division of responsibilities in clinical research in collaboration between Karolinska Institutet and Karolinska University Hospital were clarified in 2017 through a certificate of division of responsibilities. Two guiding documents were developed simultaneously, one for clinical research and one specifically for pharmaceutical research. Work is underway in 2020 in collaboration between KI and the Stockholm Region to develop and update guidelines and responsibility documents for clinical research throughout the region.
New guidelines for side jobs and collaboration
Guidelines and routines for reporting secondary occupations have been clarified and updated. There are also new 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.
Work environment coordination at permanent joint workplaces
The Work Environment Act requires coordination of work environment work when two or more entities conduct activities at joint workplaces. Since 2013, there has been an agreement on forms of collaboration between Karolinska University Hospital and KI regarding the work environment. In its spirit there are e.g. a person responsible for coordination appointed at BioClinicum since the start of operations in 2018.
KI has made corresponding agreements with the Royal Institute of Technology, Stockholm University, SciLifeLab and Danderyds Hospital in 2017 and with S.t Erik Eye Hospital and Stockholm South General Hospital in 2018.
The agreements prescribe the division 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
Renewed long-term strategy including value-based work
Increased international focus on research ethics issues
President Ole Petter Ottersen has taken the initiative, in collaboration with other distinguished organisations, to establish discussions and further clarify research ethics issues. The university board has allocated resources for a tentative commission on ethical issues in research.