Ethics and compliance for doctoral students

Ethics application

All doctoral research projects that include studies with research subjects, human tissue or sensitive personal information requires an ethics application from the Swedish Ethical Review Authority (EPM). An ethical approval is received by submitting an human ethics application to EPM´s portal Ethix. For clinical pharmaceutical trials, a trial application (which includes ethics), is instead submitted via CTIS.

The research questions, type of data collection and analyses that are planned for the doctoral project must be clearly stated in the ethics application. If there is already an approved ethics application, but for the doctoral project there will be new data/samples, research questions and/or analyses that are not described in that application, an ethics amendment needs to be submitted (via Ethix) that describes these additions.

Compliance & Data Office has drafted a Guide to the application for ethics review which is intended to support researchers when writing the ethics application.

Before an ethics application is submitted, when KI is the applying research principal, the Head of Department must sign it. Please ask the Head of Department to read through KI’s Checklist before signing the ethics application so that everything of relevance has been included.

Requirements for KI to be listed as research principal

For research projects where a doctoral student is involved, KI must be listed as research principal in the ethics application, either as applying or participating research principal. Likewise, this applies if a KI doctoral student or doctoral supervisor also has, for example, clinical employment at a hospital. It is therefore not enough for the Region alone to be the research principal on the ethics application, but rather what actually takes place within the framework of the various organizations (e.g. the hospital and the university) that is decisive. If a researcher is employed at the hospital but research data is analyzed at KI, KI must be included as a research principal in the application to EPM, as research is then conducted at KI. You can read more about this, and see more examples, on or page about Requirements for KI to be listed as research principal.

For research projects where KI and health care providers in Region Stockholm collaborates, there is a guidance on who should be the applying research principal on the ethics application.

Research outside of Sweden

If a research project is carried out outside of Sweden's borders, then as a rule no Swedish ethics permit is needed, but in most cases ethics approval is needed in the country/countries where the research is carried out. Note, however, that if data (sensitive personal data) and/or samples - which require ethics approval in Sweden - are transferred to Sweden, for example when a researcher at KI gets access to the data to conduct analyses, then a Swedish ethics approval is also needed that covers the analyzes carried out in Sweden. This also applies if the data and/or samples are pseudonymised, and the researchers in Sweden do not have access to the code key. Similarly, when coded human samples collected abroad are analyzed in Sweden, provided they are traceable (i.e. there is a code key saved somewhere), a Swedish ethics approval is required.

Fully anonymized data and/or samples do not fall under the Ethics Review Act but be sure that the data/samples are truly anonymous. Note that legislation may vary between countries regarding what should be considered anonymized (e.g., American anonymized data is often pseudonymized according to EU regulations).

The Ethics Review Authority (EPM) has produced two Q&As when it comes to research in Sweden and abroad, which that deal with "When is ethics review required in Sweden?" and "What can be ethically reviewed here and what documentation is required?" (only in Swedish).

Process for agreements

Doctoral projects often involve collaborations with other organisations, such as healthcare providers or universities, where personal data is to be shared between them. When transferring personal data between KI and another organization, agreements may be needed, such as various types of collaboration agreements and data agreements. At KI there is a process for drawing up agreements for the transfer of personal data, where Research Data Office (RDO) and the contract lawyers collaborate with the researchers to assess the most appropriate agreement(s).

Documentation / research data management

All research that is being conducted at KI must be documented in either Swedish or English. The documentation should take place on an ongoing basis and in connection with the continuation of research. For ongoing research, the following must be documented: background and purpose, materials and methods (includes even processing and analysis of data), results (raw and processed data), conclusions. Research documentation at KI must be done electronically in approved systems, which is why KI provides a central ELN system (electronic notebook) for research documentation. Raw data and results can be stored outside of ELN in approved systems but references to these should be stated in the ELN. For more information see KI’s Guidelines for research documentation and data management.

Archiving

Original data from the implementation of the research project must be saved for at least ten years or longer after publication or completion of the project. Samples should be saved for the same period of time if possible. Guidance on which research data is to be preserved and for how long, as well as what can be discarded is described in the document management plan for KI.