Legal roles in the submission process

Legal and organisational questions are part of the submission process, but they should not stop you from creating the initial submission request. The request does not need to include information about the research principal(s) (forskningshuvudman/forskningshuvudmän), data controller(s), or ethics documentation. FEGA Sweden will follow up on these matters after the initial request.

This page explains the two legal roles that FEGA Sweden needs to confirm during the submission process: research principal(s) and data controller(s). It is practical guidance for submitters, not legal advice. You can use it to understand the roles early or return to it when the FEGA Sweden Helpdesk follows up after your submission request.

Research principal(s)

A research principal (forskningshuvudman) is a role defined in Swedish ethics legislation. In broad terms, it is an organisation in whose activities the research is carried out. This may be a university, healthcare region, company, authority, or another legal entity.

A research project may have one or more research principals. Confirming the research principal(s) is important because the role is connected to responsibility for the research project and to the ethical approval. In collaborations, responsibility may need to be checked against the ethics documentation and local project records.

A research principal is not the same thing as the GDPR data controller, although the same organisation may often have both roles.

Data controller

Under the GDPR, the data controller is the organisation that determines the purposes and means of processing personal data. For research at a Swedish university or higher education institution, the data controller is usually the organisation rather than the individual researcher. In some collaborations, there may be more than one data controller.

Before data can be submitted, the relevant data controller(s) need to be confirmed. This affects which organisational arrangements and agreements may be needed before FEGA Sweden can receive the data.

If the relevant roles are unclear, FEGA Sweden can help identify which organisations or local support functions may need to be involved during follow-up. For formal advice about your project’s legal setup, contact your organisation’s legal function, data protection officer (DPO), research support, or other relevant local contact.

External guidance