Research on humans, human tissue and personal data

If research is to be carried out on humans, human tissue or sensitive personal data, an application for an ethical review must be sent to the Swedish Ethical Review Authority.

• Research on human beings: research involving a physical action on either the living or the deceased, research that is carried out using a method that aims to affect a person physically or mentally or involves a clear risk of harming the research subject physically or mentally.
• Research on human tissue: research carried out on biological material derived from living or deceased humans and which can be traced.
• Research on sensitive personal data: research involving the processing of sensitive personal data or data on criminal offences. 

Research may only be carried out if the research subject has consented to the research concerning them. Note that approval from the Swedish Ethical Review Authority must be completed before research can begin. The law requires that research may only be carried out if an ethical review has first approved it. No research stage, such as recruiting research subjects or collecting data or samples, may begin before an ethical review. Research that has already been carried out cannot be approved retroactively. This means such research may not continue and cannot be published or used in any context.

Note that approval expires if the research is not started within two years of the decision becoming final.