Are you planning to conduct research that involves people or the processing of personal data? If so, perhaps you need to apply for ethical permission. 

Below is information about the rules that apply for ethical review in Sweden as well as the review procedure. You can also find tips about aspects you should consider when completing your ethical application. 

When is ethical permission 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.

About the legal requirements

The ethical review act specifies what research must undergo ethical review. An affirmative answer to any of the questions below means that permission must be obtained for the research:

Does the research entail the processing of personal data concerning:

  • race or ethnic origin?
  • political views?
  • religious or philosophical convictions?
  • trade union membership?
  • health?
  • sexual orientation or sex life?
  • genetic data?
  • biometric data?
  • legal offences involving crimes, criminal convictions, procedural coercive measures or administrative detention?

Does the research entail a physical intervention on 

  • a living human being?
  • a deceased person?

Is the research conducted according to a method which

  • aims to affect the research subject physically or mentally?
  • entails an obvious risk of harming the research subject physically or mentally?

Does the research concern studies on biological material taken from

  • a living person and traceable to that individual?
  • a deceased person for medical purposes and traceable to that individual?

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). If the answer to any of the questions above is yes, ethical review must take place. 

Processing and decisions regarding ethical review matters

Ethical reviews are conducted by the Swedish Ethical Review Authority, which is based in Uppsala. 

This public authority is divided into six regional divisions which in turn are divided into a number of sections. In addition to a chair, who is a judge or former judge, each section consists of 15 members. Ten of these are researchers and five represent the public. Applications are assigned on a random basis to one of the regions – a region where the applicant is not working and where the research will not be conducted.   

After processing of the matter, the Swedish Ethical Review Authority makes a decision. The decision can be appealed to the Ethics Review Appeals Board, which is based in Stockholm. The procedure and timetable for the appeal is presented in connection with the notification of the board’s decision sent to the applicant. A decision by the Ethics Review Appeals Board cannot be appealed.

Read more about the Swedish Ethical Review Authority’s decision options (PDF 18kB, new window) 

Supervisory matters at the Ethics Review Appeals Board 

The Ethics Review Appeals Board also has the task of exercising a supervisory role. Suspected contraventions of the ethical review act can be reported directly to this public authority. Depending on the nature of the research, other supervisory authorities may be involved, such as the Swedish Data Protection Authority, the Swedish Medical Products Agency or the Health and Social Care Inspectorate.

The concept of research and student projects

All knowledge gathering does not constitute research in the legal sense. Studies within the framework of first and second cycle education are not considered as research. However, if the project is intended for publication in a scientific context or is part of a doctoral thesis, it is considered as research. The fact that degree projects are made accessible via the internet as a matter of routine does not mean that they are published in a scientific context.

In those cases where the Swedish Ethical Review Authority deems that a study is only being conducted within the framework of first and second cycle education, the public 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.

Contact

Do you have any questions regarding research ethics regulations?

Mats Johansson
forskningsetik [at] lu [dot] se