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Ethical review of research involving humans

Photo of two hands showing a pair of glasses with a built-in camera.

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.

In that case, the next step is to send an application for ethical review to the Swedish Ethical Review Authority (Etikprövningsmyndigheten– Some information is being translated at the moment, according to the Ethics review board.).

In some cases, the questions above may be difficult to answer. For instance, one might be uncertain regarding what counts as sensitive personal data, or whether applying one’s methods amounts the kind of influence or risk specified by the law. Several sources provide useful information on these issues, such as the Swedish Authority for Privacy Protection, CODEX and as mentioned, the Swedish Ethical Review Authority. If you cannot find what you are looking for on your own, you are welcome to contact X who offers qualified support in these matters. Contact: mail address

To conduct research which demand Ethical review approval, without having obtained such a permission, imply far-reaching consequences. In those situations, the University has an obligation to make a report which can lead to prosecution.

Only research performed in Sweden is to be reviewed in the Swedish system. However, it is often the case that even if some parts of a research project take place abroad, other parts take place in Sweden. Then the latter may require ethical review approval. For example, when data including sensitive personal data are collected abroad, there is a need for ethical review approval to use the data in research in Sweden. 

As requirements concerning ethical review vary between countries, you may also need to apply for ethical review in other countries where you carry out research.

The Ethical Review Act does not apply to work carried out only as part of first-cycle (undergraduate) and second-cycle (Master’s) courses and study programs. Further arguments on this matter can be found in section 6.2 of the Government bill 2018/19:165 which was approved by the Parliament.

However, if there are research ambitions with the student work involving anything on the list above, ethical review is required. For further definitions of “research ambitions”, see the document on the application of the term published by the Central Ethical Review Board (Centrala etikprövningsnämnden, CEPN), now called the Ethic Review Appeals Board (Överklagandenämnden för etikprövning, ÖNEP)

In those cases where the Swedish Ethical Review Authority deems that a study is being conducted only within the framework of first and second cycle education, the authority may issue an advisory statement. This may help the applicant to improve the study from an ethical perspective or act as a reminder of other relevant legislation. The advisory statement is also proof that the applicant has not tried to circumvent the law if any doubts should arise.

More information on what needs to be considered can be found in the public agencies  below. They also have a supervisory function for different parts of the research being conducted.