Ethical review

På svenska

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.

Approved research can be conducted on condition that it does not violate any other legislation besides the Act Concerning the Ethical Review of Research Involving Humans.

Sometimes the public authority sets conditions for approval. In that case, the research may be carried out only if these conditions are met.

An approval ceases to apply if the research has not begun within two years of the decision’s entry into force. However, an approved project may be permitted to go on for more than two years.

Rejection

A rejection means that the research is not permitted to begin. For example, the application will be rejected if, in the board’s assessment, the expected knowledge gain does not outweigh the risks or violation of personal integrity entailed by the research.

To be completed

Often, the Ethical Review Board will require changes or additions before it can consider approving an application. In that case, the research is not permitted to begin until the public authority has reviewed and approved a new version of the application.

Dismissal

Applications that fall outside the remit of the Ethical Review Board are to be dismissed, unless an advisory statement is appropriate (see below). Applications are dismissed usually because the public authority does not deem the study to constitute research in the legal sense. This may be the case if the study is considered to be part of continuous quality assurance work at a public authority.

Advisory statement

If the research is not deemed to require permission or if it is exclusively a student project, the public authority has the option of providing an advisory statement. The statement can help the applicant to improve the study from an ethical perspective and also serves to prove that the applicant has not tried to circumvent the law.

Appeal

Decisions by the Ethical Review Board can be appealed to the Ethics Review Appeals Board whose offices are in Stockholm. The procedure and timeframe for appeal is presented together with the notification to the applicant of the board’s decision. Decisions by the Ethical Review Appeals Board cannot in turn be appealed.

Fee for ethical review

The Swedish Ethical Review Authority charges a fee for conducting the ethical review. The fee must be paid before the review process begins. A new application costs SEK 5000, while an amendment to a previously approved application costs SEK 2000. Special rules apply to certain types of research involving multiple principals.

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.

Training on ethical review

As a staff member, you have access to an online course on research ethics that includes the rules for ethical review. You can find the course via Kompetensportalen.
Doctoral students at the university must complete a two-week course in research ethics, which includes information about the Swedish ethical review system. There are currently five versions of the course. You apply for the course through your faculty.
The Swedish Ethical Review Authority has published guidelines and an online course on ethical review.

The Swedish Ethical Review Authority’s guide on ethical review (PDF 2,9 MB, new tab)
The Swedish Ethical Review Authority’s course (Swedish only)

Contact

Do you have any questions regarding research ethics regulations?

Mats Johansson
Research Ethics Advisor/Research Integrity Officer
forskningsetik [at] lu [dot] se (forskningsetik[at]lu[dot]se)