New guidance for choosing an applicant entity for the research where KI collaborates with Region Stockholm

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.