Guidelines for research
The guidelines for research at KI summarise how research should be planned, conducted and documented in order to facilitate compliance with rules and regulations for researchers and PhD-students.
Research is surrounded by regulations and recommendations in order to protect laboratory animals, study participants, co-workers and not least the integrity of research.
Several government agencies give permissions (approvals) and are responsible for oversight and supervision. This document is directed towards all researchers and doctoral students at Karolinska Institutet (KI), who should have knowledge on regulations and need to follow those that apply to their own research.
This document covers the whole research process, from the initial thoughts and ideas, through collection and analysis, to the results and dissemination of the research, and includes how research data should be managed, documented and archived correctly.
These guidelines for research at KI summarise how research should be planned, conducted and documented in a way that facilitates compliance with legislation and other regulations for researchers and doctoral students.
Quality assured research
The Higher Education Act (Högskolelagen) and the Higher Education Ordinance (Högskoleförordningen) stipulate specific requirements that form the basis for quality assurance of research at higher education institutions (HEI).
In addition, several national and international frameworks and guidelines for research play an important part in the quality assurance work at KI. Of particular relevance are the European Charter for Researchers and Code of Conduct for the recruitment of researchers and the Association of Swedish Higher Education Institutions (Sveriges universitets- och högskoleförbund, SUHF) National framework, Gemensamt ramverk för lärosätenas kvalitetssäkring och kvalitetsutveckling av forskning.
At KI, as specified in the internal guidelines,Sammanhållet kvalitetssystem vid KI, riktlinjer., quality assurance is defined as ”in a systematic and methodological way and with the help of documented routines assure and maintain high quality”.
A lot of research gets quality audited through peer-review, many times in conjunction with other internal and/or external audits.
Good research conduct, responsibility and ethics
All research at KI shall follow good research conduct and the founding principles as described in the European code of conduct for research integrity ALLEA 2017: reliability, honesty, respect and accountability. Furthermore, the Vancouver guidelines for authorship shall apply for publications. More on good research conduct can be found at the CODEX website (previously coordinated by the Swedish Research Council together with Uppsala University, now the Codex website is run solely by the Center for Research and Bioethics, Uppsala University.) In the event of deviations from good research practice, KI's Guidelines for examining suspected deviations from good research practice apply. For international collaboration, KI's Guidelines for international collaboration apply.
Each individual researcher at KI is responsible for following the regulations that exist. If any other organisation or person is assigned to perform whole or part of the work, the responsible researcher needs to make sure that the right competence for performing the work is in place. When needed, potential bias and conflict(s) of interest need to be addressed (see more at jäv/intressekonflikter).
One of the fundamental research ethical principles is to organise one’s research through documentation and is central for describing the research process according to good research conduct and good data management.
The head of each department has according to the KI delegation rules the ultimate responsibility to ensure that all research at the department, including documentation, data management, storage and archiving is done according to relevant guidelines and regulations.
Scientific representative for guidance
There is a Scientific representative appointed at KI for researchers and PhD-students. The Scientific representative can help with informal, guiding discussions concerning research and research ethics questions.
Approvals and agreements for research
Any approvals needed from the animal ethics committee, the human ethics authority or any other approving agency should be in place before the start of the project and should be updated continuously when needed.
Different types of agreements, for example collaborative agreements or commissioned work, consortium agreements (common in international collaborations), data processor agreements (when sending or receiving personal data), Material Transfer Agreement (when samples are sent or received) and Biobank agreements (for samples taken within the health care system) may also be needed before the project starts.
Approvals and agreements should be registered in the KI registration system (diariet) according to the KI document management plan (dokumenthanteringsplan) and should be easy to trace back to the relevant parts of the performed research.
Approvals and agreements should be continuously updated when needed, and sometimes amendments are needed.
For guidance regarding agreements, please contact the KI legal unit.
Personal data
Personal data is data that can be traced to a living person. Sensitive personal data (special categories) is data consisting of racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, biometric data, data concerning health or data concerning a natural person's sex life or sexual orientation.
Processing of personal data should be reported at KI through a web form.
When processing personal data in research, the data must be protected according to data protection regulations, as well as KI guidelines for information security (informationssäkerhet).
For guidance on processing of personal data, contact the legal unit at dataskyddsombud@ki.se.
Secrecy
The need for secrecy should be considered, for example when processing personal data, patentable inventions and for specific business interests, both during the project and after archiving.
All secrecy claims, for example when processing person data, for patentable inventions and business interests, need a legal reference from the Public Access and Secrecy Act (Offentlighets- och sekretesslagen, OSL, 2009:400) and guidance can be provided by the KI lawyers.
Human samples
When handling human samples specific requirements have to be followed, in particular when samples are collected within the health care system where the Biobank Act applies. For samples taken within the Stockholm Region, the Stockholm Medical Biobank will be the primary biobank for the sample collection, but samples can be transferred to KI.
Guidance is provided by KI Biobank and national templates and instructions can be found on the Biobank Sweden website.
Research documentation and data
All research at KI must be documented, either in Swedish or English. Employees and outsiders with specialist knowledge must be able to follow and review the research. It is important that the entire research process, from idea and planning to results and conclusions, is described in a way and at a sufficiently detailed level for the research to be traceable, interpretable and reproducible.
Research documentation at KI must be done electronically in approved systems, which is why KI provides a central ELN system (electronic notebook).
It is important that data is clearly described, traceable, handled securely and that it is easy to connect, for example, publications to the underlying data. In many cases, data management plans, where the actual management of research data is described, are required.
KI's Guidelines for research documentation and data management describe this in more detail.
Research documentation and original data from the implementation of the research project must be kept for at least 10 years, in most cases longer than 10 years, after publication or completion of the project. Samples should be saved for the same period of time if possible. This so that the researcher knows what the basis for results and conclusions is.
For detailed information on what should be preserved and what can be discarded (destroyed), see the KI document management plan and information on archiving research. Contact the Archive for questions, arkiv@ki.se.
Making research accessible
Research should be as open as possible as part of the overall aim of open science , the FAIR principlesand KIs policy for publishing open access Open science facilitates reproduction of the research and new research.
If the data contains personal data that directly or indirectly can be traced to a living individual, then the data cannot be made completely open. If there is still a need to share these data, access will have to be regulated.