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Ethical Review of Research

The Act concerning the Ethical Review of Research Involving Humans (SFS 2003:460) applies to situations such as research that involves physical encroachment on a subject or is conducted according to a method that aims to affect the subject physically or psychologically, as well as studies on biological material traceable to specific individuals. Research involving handling of sensitive personal data shall be examined regardless of whether research subjects give their informed consent or not. Research that clearly involves a risk of harming subjects, something that might happen also when conducting interviews or surveys for example, shall likewise be ethically examined. It is fundamental that research only be approved if it can be conducted with respect for human dignity and if human rights and fundamental freedoms are constantly heeded. A person's welfare should be prioritized over the needs of society and science. A subject is therefore allowed to, for instance, withdraw his/her consent to participate in a research project at any time, effective immediately. It is the Helsinki Declaration's guidelines that constitute the foundation for the examination of medical research ethics.

The definition of research is scientific experimental or theoretical work to gain new knowledge, and developmental work on scientific grounds, but not such work performed at undergraduate level at universities. Research not under the scope of the law can still have an interest in being vetted by an ethics committee. Many journals and conferences demands it in order to publish articles and allowing conference talks. Or researchers and students might have a wish to discuss ethical aspects of a project as it is felt to be sensitive in ways other than that envisaged by the law. Then an advisory statement can be asked for.

Organisation

Applications for ethical examination of research are scrutinized by the new Swedish Ethical Review Authority from 1 januari 2019. They have offices in 6 places: Göteborg, Linköping, Lund, Umeå, Uppsala and Stockholm, each divided in several committees. Applications are randomly assigned to them. In total there are 18 committees, each consisting of a chairman and fifteen other members. Of these other members, ten must have scientific competence and five must represent public interests. There is also a supervisory Ethics review appeals board. A rejection can be appealed to them.

What the authority does

The authority's first duty is to preliminarily inspect planned research projects. The authority is to, firstly, judge whether the project is scientifically sound and defensible in terms of the knowledge it will generate. This means that it must make a judgment of whether the project's expected benefits outweigh the possible risks that it could entail for the individual subject. Secondly, it is to make certain that subjects are given enough information about what participation entails and give their consent to participate in a satisfactory manner.

The Medical Products Agency (LVFS 20011:19) establishes that the prerequisite for conducting a clinical trial is that permission be granted by the Medical Products Agency and that approval be granted by the ethics committe, and that the principles for good clinical practice (GCP) and from the latest version of the Helsinki Declaration shall be applied (Ch 3, 1§). Regarding clinical trials, there are European and international guidelines that specifies how the application and the review should be done (see list to the right).

Animal research is vetted according to its own system.

Other approvals that might be needed

In addition to permission from the ethics board, one sometimes need other permits for research involving human subjects. In clinical trials involving interventions authorization from the MPA are required under the Medicines Act (SFS 2015:315). They also approve of clinical trials that ivolve the deliberate release into the environment of genetically modified organisms (Läkemedelsverkets föreskrifter och allmänna råd LVFS 2004:10 om avsiktlig utsättning vid klinisk prövning av läkemedel som innehåller eller består av genetiskt modifierade organismer). For research projects that irradiates subjects with ionizing radiation a permit from a local radiation safety committee is required (Radiation Safety Regulations on general duties at the medical and dental activities with ionizing radiation - SSMFS 2008:35). To keep a biobank, you need to register it with the Health and Social Care Inspectorate.

Last updated: 2019-10-07

Rules & guidelines

See further

CODEX, Centre for Research Ethics & Bioethics, BMC, Husarg. 3, Uppsala | Webmaster | About the web site | Accessibility statement