Swedish law requires an ethics approval prior to conducting certain kinds of research on people, human tissues or sensitive personal information. Please note that the Swedish system of ethics review differs from many other countries. Use this checklist to assess whether you need an ethics approval before starting your project.

KTH is obliged to prevent that research where an ethics review is required is performed without a prior ethics approval. The President of KTH has delegated the responsibility for the preventive work to the Head of Schools. The Head of Schools may further delegate the responsibility to Head of Departments.

The system of ethics review in Sweden is jointly organized by the Ethics Review Authority. The Authority is a national agency separate from any university. The Authority distribute applications for ethics review to ethics committees consisting of researchers and public representatives, which may approve, approve with requirements, deny or dismiss applications. The Authority also offers an advisory opinion, but a full application is necessary to receive such an opinion.

An ethics approval issued by the Ethics Review Authority is legally required for any scientific or scholarly research activity that fulfill at least one of the following criteria.

there is a physical intervention upon the research person (alive or deceased)
the research method is intended to physically or psychologically affect the research person
the research persons will be exposed to an obvious risk of physical or psychological harm
biological matter from the research persons (alive or deceased) is used and traceable to them
sensitive personal data or personal data concerning the crime record are handled.

‘Sensitive personal data’ is legally defined by the General Data Protection Regulation (EU) article 9.1 as data that can be traced to a single, identifiable individual and concerns ethnic background, political opinions, religious or philosophical convictions, union membership, health, sexual habits or orientation, genetical or biometrical data.

Remember that an ethics approval must always be granted before the research starts!

Exempted from the scope of the act is:

First and second cycle projects (bachelor's and master's theses).
- Exception is void if the work is published in peer-reviewed, scientific or scholarly channels.
Any research activity performed outside Sweden.
Unintentionally handling sensitive personal data.
Handling sensitive personal data for other purposes than research.
Research that is not legally defined as "vetenskaplig".

Consider costs for translation when planning your project.

The application fee is normally 5.000 SEK, and sometimes 16.000 SEK. The application fee must be paid in Swedish crowns. Time before decision may be up to three months and sometimes longer. You may also be asked to provide supplementary information, which may further delay the procedure.

The fee for an application for amendment is 2.000 SEK and should be submitted if changing a project in a way to affect the risk-benefit balance. Time before decision may be up to a month and sometimes longer.

The application is normally signed by the principal investigator and the Head of Department (prefekt). This assumes that the Head of School has delegated the right to sign the ethics review application to the Head of Department. If the principal investigator is a doctoral student, the application also needs to be signed by the supervisor.

You may find more information from KTH about the ethics review procedure here.

The online application system (Ethix) and further information including FAQ and templates for information letters and consent forms may be found on The Ethics Review Authority's webpage (mostly in Swedish).

* Check at an early stage whether ethics review is legally required. Plan for time and costs. Do not start the research before acquiring and ethics approval. *

Please go on to the next page for examples of research projects where ethics review is required.