Ethical review

"A photo of a person's hands working on a laptop keyboard. Next to the laptop is a microscope.""

If you are going to do research on people, human tissue, sensitive personal data, or data concerning criminal offences, you may need to apply for ethical review from the Swedish Ethical Review Authority (Etikprövningsmyndigheten). The purpose of ethical review is to protect the individual in the context of research.

Research may only be approved if it can be carried out with respect for the value of human beings. The requirements for ethical review are set out in the Ethical Review Act (SFS 2003:460) (link to legal text in Swedish). This act applies to research conducted in Sweden. Ethical review is required if the research:

  • involves a physical intervention on a living or deceased person;
  • is carried out using a method that aims to physically or mentally affect the research participant;
  • is carried out using a method that exposes the research participant to obvious risks of physical or psychological harm;
  • is performed on biological material obtained from a living or deceased person and which can be traced back to that person;
  • involves processing of sensitive personal data or personal data about criminal offences.

Read more in the Guide to the Ethical Review of Research on Humans from the Swedish Ethical Review Authority (PDF).

Application process

It is the entity responsible for the research, or research principal (forskningshuvudman), who is responsible for submitting the application for ethical review. In projects involving multiple research principals, the parties must jointly appoint one of them to submit the application on behalf of all involved, and to inform the others of the decision from the Ethical Review Authority. This principal is referred to as the “applicant”, while the others are listed as “additional entities”.

After reviewing the application, the Swedish Ethical Review Authority may issue an approval, a conditional approval, or reject the application. It may also determine that the proposed research does not fall under the scope of the Ethical Review Act – in which case the application is dismissed without formal review. If the researcher has requested it, a non-binding advisory opinion may be provided instead. A rejection may be appealed to the Ethical Review Appeals Board. However, decisions to approve an application cannot be appealed.  

Approval is always granted for a specific project or defined research activity. Research must begin within two years after the approval became final, otherwise the approval expires after two years from the date of the decision. Once research has begun, the approval remains valid for as long as is stated in the application and decision.

Informed consent 

In most cases, research participants must give their consent to participate in the project. Before doing so, they must be informed of the purpose of the research and any potential risks. This requirement is set out in the Ethical Review Act and is referred to as informed consent. Consent must be voluntary, explicit, and specific to a particular research undertaking. It must also be documented.

While written documentation of consent is not legally required, it is recommended to demonstrate that consent was obtained. Note: informed consent to participate in research is not the same as consent as a legal basis for the processing of personal data under the General Data Protection Regulation (GDPR).

Animal research 

If a research project includes animal testing, ethical approval may be required from a regional animal ethics committee. These applications are coordinated by the Swedish Board of Agriculture (Jordbruksverket). Ethical review is required for experiments involving live mammals, birds, reptiles, amphibians, fish, cyclostomes, and cephalopods. In many cases, embryos are also covered.

General ethical principles 

Even if a research project does not fall under any formal ethical review requirement, research should always adhere to good research practice and the general ethical standards developed within the research community. Some of these principles are outlined in international codes of conduct.

One key document is the European Code of Conduct for Research Integrity by ALLEA, All European Academies. It provides a framework of ethical principles related to the conduct of research, the handling of results, relationships with colleagues, citation practices, and publication.  

See also the Swedish Research Council’s publication God forskningssed 2024 (Good Research Practice 2024, in Swedish only).