Choosing an applying research principal 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 applying research principal (sökande forskningshuvudman). If the research project involves more than one research principal, 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 applying research principal.

KI, together with Region Stockholm, has drafted a joint document called “Guidance for selecting the Applying Research Principal in ethics applications for research involving collaborations between Karolinska Institutet and healthcare 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 applying and participating research principal (entity for the research).

According to the Ethics Review Act, a “research principal” 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 research principals.

The applying research principal 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 EPM is submitted correctly and in its entirety, and for informing all other research principals of EPM:s decision. The remaining research principals become participating research principals.

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

  • KI should generally be the applying research principal since most projects are coordinated and managed from KI’s operations. For example, analysis of biological samples from a healthcare provider.
  • Region Stockholm should primarily be the applying research principal for intervention and/or sampling studies in healthcare where there is more than minimal medical risk to research participants. This ensures that the responsible healthcare manager, as representative of the applying research principal, actively signs the application to EPM. However, there is no formal obstacle to KI being the applying research principal if all participating research principals agree.
  • When a doctoral student at KI is involved in a research project as part of their education, KI must always be listed as a research principal, though not necessarily as the applying research principal. It is sufficient for KI to be included as a participating research principal in this scenario.
  • Research principal status is determined by where the research is conducted. An individual’s employment status (e.g., dual employment at both Region Stockholm and KI) does not determine research principal status and the individual cannot decide which organisation is the research principal based on their preference. For individuals with dual employment as lecturers or professors at KI and healthcare professionals in Region Stockholm, the research principal should be designated based on where – under whose operations – the project is conducted (KI, Region Stockholm, or both, depending on the study design).
  • If multiple research principals are involved, the division of roles between KI and Region Stockholm must be clearly specified in the application to EPM.
  • Healthcare providers that only release personal data for research purposes to KI but are not otherwise involved in the study/trial are not considered research principals.

CTIS and the role as sponsor or research principal

Since the European Medical Agency introduced the Clinical Trials Information System (CTIS), all applications for pharmaceutical clinical trials are handled through this system. The ethics review is integrated into that process, meaning that no separate ethics applications is submitted directly to EPM; instead, everything goes through CTIS, via the Swedish Medical Products Agency. As the term “research principal” does not appear in European regulation and also not in in CTIS, the research principal cannot be specified in the CTIS application. Therefore, it is important to describe roles and responsibilities of all research principals in the study protocol that is submitted to CTIS.

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