About the Authority

The Swedish Ethical Review Authority was established 1 January 2019 and its headquarters is in Uppsala. From 2004-2018, the ethical review was conducted at six regional ethical review boards, located in Göteborg, Linköping, Lund, Stockholm, Umeå and in Uppsala.

Our remit

Our remit is to protect participants involved in research. We do this by examining applications for ethical review in line with various Swedish statutes:

• the Act (2003:460) concerning the ethical review of research involving humans (“Ethical Review Act”)
• the Act (2018:1091) with provisions on ethical review to supplement the Regulation on clinical trials of medicinal products for human use (“EU Clinical Trials Regulation”, CTR)
• the Act (2021:603) with provisions on ethical review to supplement the Regulation on medical devices (“EU Medical Devices Regulation”, MDR)
• the Act (2017:746) with provisions on ethical review to supplement the Regulation on in vitro diagnostic medical devices (“EU in vitro diagnostic medical devices”, IVDR)
• the Act (2002:297) on biobanks in medical care etc. (“Biobanks Act”).

Under the statutory rules, research ethics review by the Authority is a mandatory precondition for commencement of all research and clinical trials planned in Sweden that

• involves physical intervention, on living and deceased persons alike
• is carried out with a method that aims to affect the research participant physically or mentally, or involves an obvious risk of harm to them in body or mind
• are performed on biological material from a living or deceased human being and can be traced back to that person
• involves processing of sensitive personal data or of personal data relating to criminal offences.

The basic principles of ethical review are that research may be approved only if it can be carried out with respect for human dignity and that the review must always take human rights and fundamental freedoms into consideration.

Human well-being must take precedence over the needs of society and science. Research may be approved only if its scientific value outweighs the risks it may entail for the research participants’ health, safety and personal data privacy.

Research may be approved only if the expected results are unattainable in another way that poses lesser risks to the research participants’ health, safety and personal integrity.

Processing of sensitive personal data or personal data concerning breaches of the law may be approved only if this is necessary for the research to be carried out.

Finally, research may only be approved if it will be operated or supervised by an investigator with the scientific skills considered necessary for the project.

Our organisation­

Our work take place in six locations in Sweden. From north to south, these are Umeå, Uppsala, Stockholm, Linköping, Göteborg and Lund. In each city, two to six departments have been set up. Of the nationwide 21 departments, 15 review medical research and the rest review other types of research. Ethical review is conducted by department members appointed for the purpose, and each department consists of 16 permanent members. The department chair must be or have been a permanent judge in a Swedish court, while ten members must have research expertise and five represent the public interest.

When you submit an initial application, it will be allocated at a decision meeting to one of the departments with the earliest processing opportunities outside the region of operations where the entity responsible for your research is based, or where the research is to be conducted.

In most cases, amendment applications are examined by the department that has reviewed and decided on the initial application.

Since 1 January 2020, the Swedish Ethical Review Authority has been the government agency hosting the Swedish National Board for Assessment of Research Misconduct (NPOF). Read more about the Board and its activities at www.oredlighetsprovning.se.

Processing of personal data

Your personal data will be processed within the framework of the application you submitted to the Swedish Ethical Review Authority and to the extent necessary, given the casework it may entail.

The Authority’s data protection officer can be reached at the following email address: [email protected]. If you have any questions regarding the processing of your personal data, you can contact the data controller (the natural or legal person who determines the purposes and the means of processing personal data) or the data protection officer.

The Authority processes your personal data in accordance with article 6.1.e of the EU General Data Protection Regulation (GDPR), that is, on the legal grounds of such processing being necessary for a task performed in the public interest and/or the exercise of official authority. Permitted recipients of the personal data are employees of the Authority or others who need to access the data in their casework. The information may also be disclosed in the event of a request för access to an official document unless the information is subject to confidentiality. The Authority will process your personal data particulars for as long as they are needed.

Data in official documents will be archived for as long as the archival legislation prescribes.

Right to rectification, erasure and restriction, and right to object

You have the right to request that the Authority rectifies any incorrect personal data.

You may also have the right to request erasure of your personal data.

You have the right to request restriction of, and object to, the processing of personal data.

These rights are strictly limited while a case is being dealt with. Rights are also restricted/limited by archival legislation since official documents may not be altered or destroyed.

If you request rectification or erasure, or object to the handling of a case and request its restriction, the Authority will investigate whether to act on your request.

Right to complain to the supervisory authority

If you think the Swedish Ethical Review Authority has processed your personal data in a manner that contravenes current regulations on such processing, you can lodge a complaint with the Swedish Authority for Privacy Protection, www.imy.se.