Ethical review of research involving humans
When your research involves people you might need an ethical review.
When is an ethical review required?
The requirement for ethical review applies to all research that fulfils any of the conditions specified in the Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460). This Act applies to research conducted in Sweden.
It is important to consider the need for ethical review for each new study or project. And to make sure there is enough time to write, send and get the application approved before the start of the research.
About the legal requirements
The ethical review act specifies what research must undergo ethical review. These requirements hold not only for externally funded projects, but also for research funded through one’s employment.
An affirmative answer to any of the questions below indicates that permission must be obtained for the research. It is of no consequence whether the research subjects have consented to the research or the processing of personal data or if the data is freely available (via media or the internet).
Does the research entail the processing of personal data concerning:
- "Racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation" (General Data Protection Regulation - Article 9.1)?
- legal offences involving criminal convictions and offences, procedural coercive measures, or administrative detention?
Does the research entail:
- research subjects, i. e. the living human being the research applies to? (For example, subjects, informants, humans who are filmed, persons whose data occur in the material which is collected or analyzed etc.)?
- a physical intervention on a living human being or a deceased person?
- biological material taken from av living human being or a deceased person?
- methods which aim to affect the research subject physically or mentally or entails an obvious risk of harming the research subject physically or mentally?
Note that an affirmative answer to any of the questions above indicates that permission must be obtained.