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 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 review. 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.
Apply for 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 för 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 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 Office för 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 firstname.lastname@example.org at the Office för Research, Engagement and Innovation Services.
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). The changes do not concern what kinds of research that are to be submitted for ethical review, and the exemption for student work remains. Instead, changes include 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 increased from six months to 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 clarifies the responsibility universities have for ensuring that researchers are familiar with the requirements of the law, and sanctions are 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). Examples of preventive measures mentioned in the bill 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. That sanctions are increased also implies that the period of limitation (preskriptionstid) is prolonged from two to five years.
From January 1st 2020, the Ethics Review Appeals Board will be in charge of all supervision of research related to the Ethical Review Act.
If you have questions about ethical review or about how the new rules apply to you, please contact the ethics support function at the Office för Research, Engagement and Innovation Services.
September 18, 2020
Source: Office för Research, Engagement and Innovation Services