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Etikprövningsmyndigheten is the Swedish Ethical Review Authority: the national body that decides whether research involving people, human biological samples or sensitive personal data may go ahead in Sweden. If your project falls under the Swedish Ethical Review Act (2003:460), it needs the authority’s approval before the research starts. Its own stated remit is to “protect participants involved in research.”
This guide explains in plain English when approval is required, how an application works in the authority’s Ethix portal, how appeals and penalties work, and how the authority differs from the research-misconduct board Npof. It is written for researchers, research administrators and international collaborators who meet the Swedish system for the first time.
What is Etikprövningsmyndigheten?
Etikprövningsmyndigheten is the Swedish Ethical Review Authority, the single national authority that carries out ethical review of research in Sweden. It reviews research on humans, on human tissue and biological samples, and research that processes sensitive personal data. Review is carried out from six locations: Göteborg, Linköping, Lund, Umeå, Uppsala and Stockholm, with 450 members and experts taking part.
Its purpose follows the Act’s first section, which states the aim of protecting the individual and respect for human dignity in research. The authority’s English site is organised under labels such as “For applicants”, “For members”, “About the Authority”, “How it works”, “Responsibility for research”, “Fee for ethical review” and “What the Act says”.
The authority’s own 2023 figures give a sense of scale: 7,953 applications, 3,426 substantial amendments, 473 clinical trials and 1,931 non-medical applications.
Who needs approval under the Ethical Review Act?
Research needs approval if the Act applies to it, and the Act is defined by what the research does, not by who does it. According to the Act, it covers research that processes sensitive personal data or data on offences (3 §), and research that involves a physical intervention on a research subject or certain studies on biological material taken from a living person (4 §). Under 6 §, covered research may be carried out only if it has been approved in an ethical review. The approval can carry conditions, and it lapses if the research has not started within two years (check 6 § for how the period is counted).
The student exception
The Act (2 §) excludes work done only within the framework of higher education at first-cycle or second-cycle level (grundnivå or avancerad nivå, roughly bachelor’s and master’s level).
When you are not sure
The authority states that it cannot say in advance whether a particular project needs review. The research principal (forskningshuvudman, usually the university or other organisation carrying out the research) is the party named in the Act’s appeal rules, so ask your research office before you assume that a project is outside the Act. For the general concept of an independent body that reviews human-subject research, see Research Ethics Board (REB).
An upcoming change
An amendment, SFS 2026:1229, is listed as taking effect on 1 July 2027 and changes several sections, including new exemptions in a new 6 a §. Always read the current text of the Act before relying on any summary, including this one.
How to apply: the Ethix portal
Applications are made through the authority’s Ethix portal, which requires a login, and the application itself must be written in Swedish. Decisions and messages from the authority also arrive in Ethix. The authority distinguishes two main application types:
- Initial application (grundansökan) for a new project.
- Amendment (ändringsansökan) for changes to a project that already has approval.
Practical points the authority itself gives to applicants:
- The principal investigator needs a PhD. Without one, a supervisor’s certificate of active supervision is required.
- Pay the review fee promptly, using the OCR number supplied. The fee amount is set out under “Fee for ethical review” on the authority’s site, so check the official site for the current figure rather than relying on a copy.
- Use the authority’s own consent templates (forskningspersonsinformation and samtyckesblankett) from the support materials. A general explanation of what such a form contains is in ICF (Informed Consent Form).
- The authority publishes a “Guide to the ethical review” as a PDF. Read it before filing.
Decisions, appeals and penalties
A decision of the authority can be appealed by the research principal to the Överklagandenämnden för etikprövning (the Appeals Board for Ethical Review) if the decision went against it, and that board’s decision cannot be appealed further. The Act sets this out in 36 § and 37 §.
Breaching the requirement is a criminal matter under 38 §: intentionally carrying out covered research without approval can lead to fines or up to two years in prison, and gross negligence to up to six months.
Etikprövningsmyndigheten vs Npof
The two bodies are often confused because they are connected and both deal with research ethics. They answer different questions.
| Body | Question it answers | When |
|---|---|---|
| Etikprövningsmyndigheten (Swedish Ethical Review Authority) | May this planned research on people, samples or sensitive data be carried out? | Before the research starts (prospective review) |
| Npof (National Board for Assessment of Research Misconduct) | Was research misconduct committed? | After the fact, on referral |
Npof is a separate board with a different task. Our guide to Npof, Sweden’s National Board for Assessment of Research Misconduct covers how misconduct cases are assessed. Institutions may also have a research integrity officer (see Research Integrity Officer (RIO)). For the shared principles behind all three, see the European Code of Conduct for Research Integrity and the Declaration of Helsinki.
Common problems
- Filing in English. The application must be in Swedish. International teams should plan for this.
- Missing PhD or supervisor certificate. The principal investigator must have a PhD; without one, a certificate of active supervision from a supervisor or other person with the requisite skills is required.
- Unpaid fee. The authority asks for prompt payment with the correct OCR number.
- Changing the project without an amendment. The authority has a separate amendment application type for projects that already have approval.
- Letting approval lapse. Under 6 § an approval lapses if the research does not start within two years.
- Assuming a student project is always exempt. The exception covers work done only within first-cycle or second-cycle (grundnivå or avancerad nivå) higher education, nothing broader.
Frequently asked questions
What does Etikprövningsmyndigheten do?
It reviews research on humans, human biological material and sensitive personal data in Sweden and decides whether it may proceed, with or without conditions.
Is the application in English or Swedish?
Swedish. The authority’s website has an English version, but the application in Ethix must be in Swedish.
Does every research project in Sweden need its approval?
No. Only research covered by the Ethical Review Act does. The authority says it cannot tell you in advance whether your project is covered, so ask your institution’s research office.
Does the review apply to student projects?
Work done only within first-cycle or second-cycle higher education is outside the Act (2 §). The exception covers nothing broader than that.
How much does review cost?
There is a fee. Check the “Fee for ethical review” page on the official site for the current amount.
Can a decision be appealed?
Yes, by the research principal to the Överklagandenämnden för etikprövning when the decision went against it. The board’s decision cannot be appealed.
Sources
- Swedish Ethical Review Authority (Etikprövningsmyndigheten), English site, https://etikprovningsmyndigheten.se/en/, checked 2026-10-29.
- Lag (2003:460) om etikprövning av forskning som avser människor (Ethical Review Act), text checked 2026-10-29 at https://lagen.nu/2003:460; the official source is the Swedish statute book.
