Protecting the individual
in research

Etikprövningsmyndigheten - vi värnar människan i forskning

Guide to the ethical review of research on humans

Do you want to learn more about the ethical review in Sweden?

This guide is the first of its kind since the law was established in 2004. It is intended to serve as a support in the planning of research projects and outlines noteworthy considerations for anyone assessing whether their research project needs to be ethically reviewed.

It can also be read in its entirety by those unfamiliar with ethical review.

Download the Guide to the ethical review (PDF)

Ethical review

If you are going to do research on people, human tissue or sensitive personal data, you may need to apply for ethical review.

Welcome to Ethix!

If you are applying for ethical review, log in to the Ethix portal. This is where, as well as applying, you receive notifications, decisions and other messages related to your application.

The application must be made in Swedish. To enter Ethix, just click on the link below.

Do you have a question?

The information we provide in English is under development and our FAQ has not yet been translated.

You are welcome to either call or write to us with any queries you might have. Our contact information can be found at the bottom of the page and a member of our team will respond to your query.

It is worth noting that we can never give any advance notice as to whether you need to apply for ethics review or not. We also cannot provide detailed advice on how you should plan your research project to get your ethics review application approved. Only when the authority has received a fully completed application and after it has been reviewed by our appointed members can you receive a formal decision on your proposed study.

5 tips if you are going to apply for ethics review

  1. Describe your project in relevant detail so that an outsider can get a clear picture of what the research entails. Use a language that even laymen understand, in Swedish.
  2. Send the invitation to collaborators in the application process to the correct email addresses.
  3. Make sure the right people sign the application. A principal investigator must have a PhD, otherwise a certificate of active supervision from a supervisor or other person with requisite skills is required. An authorized representative of the entity usually has operational responsibility, which must be stated in the application.
  4. Check that the application fee is paid immediately by your finance department and that the correct OCR number is used for payment.
  5. Many of our decisions for request for information concern the content of the informed consent form. Use our template on informed consent form to minimize this. You will find them in the paragraph above.
Etikprövningsmyndigheten, samtida forskning

This is the Swedish Ethical Review Authority

Our remit is to protect participants involved in research. We do this by examining applications for ethical review of research on humans, but also of research on biological samples and sensitive personal data.

By reviewing research projects in a correct and effective way, we strengthen confidence in Swedish research. The review is carried out by 450 members and experts in various fields. We are located in six locations in Sweden: Göteborg, Linköping, Lund, Umeå, Uppsala and Stockholm.

Read more about the Swedish Ethical Review Authority on this page.

Why in Swedish?

Why can't the application be written in English when the common language in the research society is English?

The Language Act (Swedish Code of Statutes no. 2009:600) stipulates that the language of the courts, administrative authorities and other bodies that perform tasks in the public sector is Swedish. Authorities and other public institutions have a special responsibility for the use of and development of Swedish.

According to the Swedish Ethical Review Authority’s Provisions and General recommendations an application for ethical review can only be made by filling out the application form that is available in the Ethix Portal. Further, the provisions state that the application form must be filled out in Swedish with a content that a lay person can understand.

Among our department members, appointed to review the applications, there are several who represent public interest and they are not expected to be proficient in English. It is of fundamental importance that every member of the department can fully comprehend the contents of an application and of other enclosed documents and that the research participants truly understand how the research project is to be carried out and how it can affect them.

Etikprövningsmyndigheten hjärta


applications all categories included were submitted 2023



substantial amendments were submitted 2023



clinical trials were submitted 2023



applications related
to other types of research than medicine were submitted 2023