OBJECTIVES: Collecting PRO survey data in multiple Nordic regions concurrently is not without its challenges. The Nordic countries are known to have similar cultural backgrounds and healthcare systems making collaborative research achievable. However, when it comes to clustering these countries together for the purpose of research, there are important regulatory, ethical and cultural differences that need to be considered. To this effect, this work aims to characterize the differences between Norway, Finland and Sweden when seeking ethical approval to initiate survey research.

METHODS: During the study start-up phase of a PRO survey study assessing the QoL and disease burden in a rare disease, Real World Evidence (RWE) specialists investigated the regulatory requirements for collecting Quality of Life data in Nordic countries (i.e., Finland, Sweden & Norway). A lessons-learned assessment was conducted to identify the different countries’ requirements and best practices to overcome challenges.

RESULTS: There are important regulatory differences in terms of informed consent, research permit requirements and IRB boards that need to be considered. Furthermore, translation and licensing of PRO into local languages (i.e., Swedish & Finnish for Finland, Swedish for Sweden, Norwegian for Norway) can impact study-start-up.

CONCLUSIONS: While Nordic countries are well-known for their cooperation in research, there are certain regulatory and cultural differences that need to be considered during planning and initiation. Nordic regulatory requirement differences need to be understood in order to streamline study-start-up phases for PRO collection requirements in RWE.