According to the Ethical Review Act (Lag om etikprövning av forskning som avser människor 2003:460), ethical vetting is required for certain kinds of research involving humans. The law 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), i.e. 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

According to the law, such research may only be conducted if it has been approved subsequent to an ethical vetting. 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 vetting 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.

Ethical review tool

It is not always easy to determine whether or not one’s planned research requires ethical vetting according to the law. To make it somewhat easier for you, The Research Support Office has (in collaboration with other parts of the University) developed an interactive tool, which gives you an indication of whether ethical vetting 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 e.g. 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, e.g. Datainspektionen and CODEX.

If you cannot find what you are looking for on your own, the Research Support Office, in collaboration with Stockholm University’s legal experts, offers qualified support in these matters. Do not hesitate to contact us at at the Research Support Office.

Forthcoming legal changes

Some changes to the Ethical Review Act are suggested in the Government bill Etikprövning av forskning – tydligare regler och skärpta straff (prop. 2018/19:165). The changes include increased sanctions for violations of the Ethical Review Act, and the bill clarifies the responsibility universities have for ensuring that researchers are familiar with the requirements of the law.