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:

  • handling of sensitive personal data pursuant to 13§ of the Personal Data Act (e.g. ethnic background, political opinions, religious conviction, health, sexual life).
  • handling of personal data regarding violations of law that include crimes, judgments in criminal cases, penal law sanctions, or administrative deprivation of liberty, as defined in 21§ of the Personal Data Act.
  • 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. It is not possible to apply for approval of a project that one has already started or finished.

It is not always easy to judge whether or not one’s planned research requires ethical vetting according to the law. One might e.g. be uncertain regarding what counts as 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. Etikprövningsnämnderna, 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. If you have questions, please do not hesitate to contact Jonas Åkerman at the Research Support Office.