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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 research animals, human subjects, co-workers and not least the integrity of the research.

It is important to cover the whole research process when planning, conducting and documenting research; starting with the original thoughts and ideas, through collection and analysis, to results and dissemination of the research. 

The guidelines for research at KI are summarised below, and are supplemented with links and references. Please note that it is the steering document that regulates research at KI, not this webpage.

Quality assured research

Besides the Act of Higher Education (Högskolelagen) and the Higher Education Ordinance (Högskoleförordningen) different national and international frameworks and guidelines for quality assurance play an important role 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 we also have the internal document, Sammanhållet kvalitetssystem vid KI, riktlinjer.

Much of the research today 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 Swedish Research Council’s CODEX website.

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

Depending on the type of research, different approvals and agreements are needed for the execution of the project.

The most common approvals at KI are for animal ethics or human ethics and they are needed before that start of the research.

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 withing 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.

Planning and documentation

All research at KI should be documented, either in Swedish or English. Co-workers and, within the field, knowledgeable persons should be able to follow and review the research. It is important to describe the whole research process, from idea and planning to the results and conclusions in a way that is detailed enough to be able to trace, interpret and reproduce the research. Support to researchers in research documentation – what should be documented? – and data management questions is available on the Research Data Office’s (RDOs) website.

Research documentation at KI should be done in approved electronic systems, and this is why electronic notebooks (KI ELN) are provided centrally.

Data management

It is important to describe data in a clear way, make sure that data is traceable, is managed in a secure way and that it is easy to connect publications and results to the underlying data. If data is not collected in a standard format, it may have to be migrated before long-term storage and archiving. External requirements for project specific data managements plans are increasing steadily, guidance and templates can be found on the KI website.  

Store and archive

Research documentation and original data from the research project should be stored for at least 10 years, in many cases even longer, after publication or close-out of the project. If possible, samples should be stored for the same time period.

It is important to make sure that the formats used for the documentation and data can be accessed and read during the long-term storage period. If needed, migration to more persistent archiving formats may have to be done before long-term storage.

In addition to long-term storage after publication or project close-out, decisions are needed with regards to archiving – that is when that data and/or documentation should be stored for all eternity. For detailed information on what to keep and what can be discarded, see the KI document management plan and information for archiving of research.

For guidance, contact the KI Archive

Making research accessible

Research should be as open as possible as part of the overall aim of open science and the FAIR principles. This means that publications should be made available through open access as soon as possible, and also data, if possible, should be open. 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.

Research Data Office (RDO)