Ethics review for research on humans
According to the Ethics Review Act (2003:460), the following is considered as research: scientific experimental or theoretical work, scientific studies through observation to acquire new knowledge, development of new methods on a scientific basis, and work intended for publication in a scientific journal.
In this case, an ethics review is required when it involves:
- the processing of sensitive personal data or personal data on violations of the law
- a physical intervention, on both living and dead humans
- a method that aims to affect a person physically or mentally or that involves an obvious risk of harming the research subject/participant
- biological material from living or dead humans and is traceable to a specific individual.
It only applies to research to be carried out in Sweden. An ethics review is required even when not all but parts of the research are to be carried out in Sweden, but only for the Swedish parts. Thus, a Swedish ethics review is needed for research performed in Sweden, even if the research has a permit from another country.
The requirement for ethics review does not include work done as part of undergraduate or higher education (bachelor or master), as long as the work does not overlap with a "regular” research project and is not intended for publication in a scientific journal.
Clinical trials involving pharmaceutical products or medical devices and setting-up of a biobank are also covered by the Ethics Review Act (2003:460) as well as by other specific regulations.