Information på svenska om etikprövning av forskning som avser människor

Ethical review is required for some research

According to the Ethical Review Act (lag (2003:460) om etikprövning av forskning som avser människor) ethical review is required for certain kinds of research involving humans. The Ethical Review Act has been in force since 2004, and applies to research carried out in Sweden which involves any of the following:

  • processing of special categories of personal data according to the General Data Protection Regulation (EU 2016/679), that is personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual orientation
  • processing of personal data regarding violations of law that include crimes, judgments in criminal cases, penal law sanctions, or administrative deprivation of liberty
  • physical interventions on research subjects or deceased persons
  • methods with the purpose of affecting a research person physically or mentally, or which includes an apparent risk of injuring the research subject either physically or mentally
  • studies of biological material that has been taken from a living or deceased person, and can be traced to that person

If your research involves any of this, you must apply for ethical review before you begin the research. Note that this holds not only for externally funded project, but also for research funded through one’s employment. Hence, it is important to consider the need for ethical review for each new study or project, and plan ahead to make sure there is enough time to write, send and get one’s application approved before one needs to get started. You can find more information on ethical review on the website of the Ethical Review Authority (Etikprövningsmyndigheten). 

This applies to research taking place abroad

Only research performed in Sweden is to be reviewed in the Swedish system. However, it is often the case that even if some parts of a research project take place abroad, other parts take place in Sweden and these may require ethical review approval. For example, when data including sensitive personal data are collected abroad, there is a need for ethical review approval to use the data in research in Sweden. In such cases you should apply for ethical review before you begin collecting data abroad. In your application, you describe the entire project but only seek approval of the research that will be carried out in Sweden.

Note that requirements concerning ethical review vary between countries. You may therefore need to apply for ethical review also in other countries where you carry out research.

Student work is typically not to be reviewed

The Ethical Review Act does not apply to work carried out only as part of first-cycle (undergraduate) and second-cycle (Master’s) courses and study programmes. This exception from ethical review is called the ”student exception”. You can find arguments concerning the student exception in section 6.2 of the Government bill 2018/19:165 which was approved by the Parliament.

If, however, there are research ambitions with the student work involving anything on the list above, ethical review is required. Examples of what is meant by research ambitions are plans to publish the work in an academic journal, intentions to include the work in a doctoral thesis, or that the work is done in collaboration with a researcher as part of his/her research. For further guidance, see the document on the application of the term research published by the Central Ethical Review Board (Centrala etikprövningsnämnden, CEPN), now called the Ethic Review Appeals Board (Överklagandenämnden för etikprövning, ÖNEP). 

The reason why student work involving what would require ethical review if done as part of research is not to be reviewed is that students should not be tasked with the responsibility that comes with those kinds of studies. Student work that would require ethical review if carried out as research should therefore as per default not be permitted, but this decision is for each department to take. Furthermore, it is the responsibility of the department to ensure that student work is ethically defensible, in accordance with established research ethical practice and good research practice as well as legal requirement, for example concerning the processing of personal data.

How to apply for ethical review 

You must apply for ethical review and have it approved before you begin doing research requiring ethical review. Applications for ethical review are handled by The Ethical Review Authority. Further information and instructions on how to apply are to be found on its website (only in Swedish).

It is not always easy to determine whether or not one’s planned research requires ethical review according to the law. To make it somewhat easier for you, the Office for Research, Engagement and Innovation Services has (in collaboration with other parts of the University) developed the Ethical review tool which is an interactive tool, giving you an indication of whether ethical review is required or not, based on your answers to a number of key questions.

Many of the questions may be difficult to answer. One might for instance be uncertain regarding what counts as sensitive personal data, or whether applying one’s methods amounts to the kind of influence or risk specified by the law. Several sources provide useful information on these issues, such as the Swedish Authority for Privacy Protection and CODEX.

If you cannot find what you are looking for on your own, the Office for Research, Engagement and Innovation Services, in collaboration with Stockholm University’s legal experts, offers qualified support in these matters. Do not hesitate to contact us at etik@fs.su.se at the Office for Research, Engagement and Innovation Services.

Responsibilities, sanctions and supervision concerning ethical review

On January 1st 2020, changes to the Ethical Review Act entered into force. These changes were proposed in the government bill Etikprövning av forskning – tydligare regler och skärpta straff (prop. 2018/19:165) and included increased sanctions for breaching the Ethical Review Act. The maximum sanction for researchers who intentionally have failed to apply for ethical review of research that should be reviewed is now two years imprisonment; in cases of gross negligence sanctions that researchers may face range from fines to a maximum of six months imprisonment (in minor cases punishment will not be imposed). The bill also clarified the responsibility universities have for ensuring that researchers are familiar with the requirements of the law, and sanctions were increased also for research principals (forskningshuvudmän) who intentionally (maximum two years imprisonment) or with gross negligence (maximum six months imprisonment) fail to take measures to prevent research being carried out in the course of its operations without ethical review or in in conflict with conditions associated with ethical review approval (in minor cases punishment will not be imposed). That sanctions were increased also implied that the period of limitation (preskriptionstid)was prolonged to five years.

From January 1st 2020, the Ethics Review Appeals Board (ÖNEP)is in charge of all supervision of research related to the Ethical Review Act. Every year, ÖNEP publishes its plan for supervision (in Swedish) where information can be found on what research areas that will be prioritized for the supervision the authority itself initiates.

How departments can develop preventive measures

As mentioned above, universities are responsible for ensuring that researchers are aware of the requirements of the ethical review act and to take measures to prevent that research is carried out in violation of the law. At Stockholm University, the heads of department are tasked with this responsibility according to decisions on the delegation of tasks.

Examples of preventive measures mentioned in the government bill prop. 2018/19:165  are the creation of good routines for information, follow-up and control of issues concerning ethical review within the organisation and to ensure that PhD students, researchers and others working in research get necessary training in the Ethical Review Act. Note that the idea is not that heads of department are to carry out detailed control of all research at the department. Instead, they are to create favourable conditions for their colleagues to take their responsibility. The ethics support function at the Office for Research, Engagement and Innovation Services has produced a supporting document with suggestions of preventive measures that can be taken. The document is in Swedish and can be found below. A number of departments have developed routines and forms for their preventive work. You are welcome to contact the Ethics support function for tips and suggestions concerning this.

Contact

If you have questions about ethical review, please contact the ethics support function at the Office for Research, Engagement and Innovation Services.