Choosing an applicant entity for the research for the ethical application for a research project where KI collaborates with health care providers in Region Stockholm

Within research, the ethical application is submitted by one applicant entity for the research (sökande forskningshuvudman). If the research involves more than one entity responsible for research is involved in the project, it must be jointly agreed who of them will have a coordinating role towards the Swedish Ethics Review Authority (Etikprövningsmyndigheten, EPM). When KI and Region Stockholm collaborate, there is a guidance on who should be the applicant entity for the research.

KI, together with Region Stockholm, has drafted a joint document called “Guidance for choosing the applicant entity for the research for the ethical application where Karolinska Institutet collaborates with health care providers in Region Stockholm”. This version of the guidance was approved by the Research Council in September 2025 and replaces the previous version from 2022. The document can be found in its entirety further down this page (only available in Swedish).

The main purpose is to provide guidance and a basis for discussion when appointing the applicant and participating entity for the research.

According to the Ethics Review Act, an “Entity for the research” is the government agency or the natural or legal person in whose organisation the research is carried out, for example a university, municipality, region, authority or private company. A research project can be carried out by one or more entities for the research.

The applicant entity for the research refers to the organisation that has a coordinating role towards the Swedish Ethics Review Authority (EPM) and is responsible for ensuring that the ethics application to the Swedish Ethics Review Authority (EPM) is submitted correctly and in its entirety, and for informing all other participating entities for the research of EPM:s decision. The remaining entities become participating entities for the research.

Guidance on collaborative research projects between Karolinska Institutet (KI) and Region Stockholm

  • KI should usually be the applicant entity for the research since most projects are coordinated and run from KI. For example, analysis of biological samples from a healthcare provider.
  • Region Stockholm should primarily be the applicant entity for the research for intervention and/or sampling studies in healthcare where there is more than an insignificant medical risk to research subjects included in the study. The reason is that the responsible manager in healthcare, as a representative of the applicant entity, actively signs the application to the Swedish Ethics Review Authority (EPM). However, there is no formal obstacle to KI being the applicant entity for the research if the participating entities agree to it.
  • When a doctoral student (at KI) is involved in a research project as part of their doctoral education, KI must always be involved as an entity for the research, but not necessarily as the applicant.
  • Which organisation is an entity for the research is determined by the activity in which the research is carried out. An individual's personal employment relationship (e.g. joint employment) is not decisive for which entities should be included in the ethical application. For persons with a joint employment as a senior lecturer or professor at KI, and a doctor or other healthcare professional at Region Stockholm, the entity should be specified based on where the project will be conducted (KI, Region Stockholm or both, depending on the study's design).
  • In the case of multiple entities for the research, the division of roles between KI and Region Stockholm should be described clearly in the application to EPM.
  • Healthcare providers whose only role is to disclose personal data to an educational institution who then uses that data for research purposes are not listed as entities for the research.

CTIS and the role as sponsor or entity for the research

Since the European Medical Agency introduced the Clinical Trials Information System (CTIS), all applications for pharmaceutical trials are handled via this system. The ethics review is incorporated into that process, meaning that no ethics applications is submitted directly to EPM, everything goes via the application in CTIS, which is submitted via the Swedish Medical Products Agency in Sweden. Since the concept of “entity for the research” is missing from European regulation and therefore from CTIS, the entity for the research cannot be specified in the CTIS application. However, it is still important to describe roles and responsibilities in the study protocol in the CTIS application.

If you want help when choosing the applicant entity for the research and/or have other questions related to the ethical application, please contact us at compliance@ki.se.