Ethical Review of Research
On 1 January 2004, the Act concerning the Ethical Review of Research Involving Humans (SFS 2003:460) was introduced. The law 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. 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.
By a change of the Act effectuated 2008, the definition of research is clarified s o that the activities subject to review is defined. Research is now understood to be 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. Also, the definition of handling personal data is redefined. Research involving handling of certain sensitive personal data shall from now on 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.
Applications for ethical examination of research are scrutinized by regional committees, which constitute authorities. A regional committee is divided into two or more departments, which investigates cases within certain areas of research. A department consists of a chairman and fifteen other members. Of these other members, ten must have scientific competence and five must represent public interests. Members are appointed to serve for a designated period of time by the government.
To what regional committee shall an application be sent to? Each head of research (the governmental authority or entity that performs the research) belong to a region that is defined in an appendix to the Statute containing instructions for the Central Ethical Review Boards (SFS 2007:1068).
There is also a supervisory central committee for ethical examination of research, composed of a chairman and six other members. Of the other members, four must have scientific competence and two must represent public interests. All members are appointed to serve for a designated time by the government. If a research ethics committee is in disagreement over the results of the ethical examination, it is to submit the case to its central committee for ruling. A regional committee's rejection can be appealed at the central committee, but the central committee's decision in the case cannot be appealed. It is a punishable offense to conduct research that falls under this law without approval.
What the boards do
The committees' first duty is to preliminarily inspect planned research projects sent to the committee. The research ethics committee is to, firstly, judge whether the project is scientifically sound and defensible in terms of the knowledge it will generate. This means that the committee must make a judgment of whether the project's expected benefits outweigh the possible risks that it could entail for the individual subject. Secondly, the committee is to make certain that subjects are given enough information about what participation entails and give their consent to participate in a satisfactory manner.
Regulation for the committees' work is to be found in the Statute (SFS 003:615) concerning the ethical vetting of research involving humans, the Statute containing instructions for regional ethical review boards (SFS 2007:1069), the Statute containing instructions for the Central Ethical Review Boards (SFS 2007:1068), and the Swedish Research Council's Provisions and Guidance on Ethical Review of Research Involving Humans (VRFS 2009:1). The Personal Data Act is also of importance.
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 Swedish National Board of Health and Welfare.
Last updated: 2016-02-05