When is an ethical review required?
The Ethical Review Act applies to research that will be conducted in Sweden. Before each research project – or new part of an ongoing project – you need to consider whether it is subject to the ethical review obligation. If so, it is important to allow enough time for writing the application, submitting it and waiting for approval before starting the research.
Ethical review is required if, for example, your research:
- involves procedures – even on deceased persons;
- uses methods that affect a research participant physically or psychologically;
- processes biological material from a living person who can be identified; or
- includes sensitive personal data or data relating to a violation of the law.
What is considered sensitive personal data?
According to the GDPR, personal data are considered sensitive if they concern:
- health
- sex life or sexual orientation
- ethnic origin or race
- religious or philosophical beliefs
- political opinions
- trade union membership
- genetic data
- biometric data that uniquely identify a person.
How to apply
You can complete your application online via the Swedish Ethical Review Authority’s Ethix portal. You also receive decisions and other messages there.
Go to the Ethixs portal (etikprovningsmyndigheten.se)
Remember that:
- the application must be made in Swedish;
- you are responsible as a researcher for drawing up the application; and
- the research must not start before you receive approval.
Guidance on ethical review
Need help interpreting the applicable rules? The Ethical Review Authority has produced a guide explaining what is covered by the Ethical Review Act and how to manage every aspect, from initial planning to the Authority’s decision.
Open the Guide to Ethical Review for Research on Humans (Ethical Review Board)
Facts: Ethical Review Act
The Swedish Act concerning the Ethical Review of Research involving Humans (2003:460) exists to protect the individual and respect for human dignity. It regulates when and how an ethical review must be carried out, and how consent from participants must be managed.
The Ethical Review Act requires that the research is conducted with due care for the physical and mental health of participants, as well as their privacy. It also aims to strengthen transparency in research and gives the public an influence on ethical questions. Legal certainty for both researchers and participants is key.
Terms used in the Ethical Review Act
- Research
The Ethical Review Act defines research as “scientifically experimental or theoretical work or scientific studies using observation, intended to result in new knowledge and development outcomes on a scientific basis.” Studies carried out only in the context of higher education programmes at undergraduate or Master’s level (i.e. first- or second-cycle level) in most cases are not considered to be research. - Entity responsible for research
The public authority, organisation or legal entity on whose behalf the research is carried out. - Research participant
A living person to whom the research pertains.
