What the Act says
Research may only be approved if it can be conducted with respect for human dignity.
The purpose of the Ethical Review Act is to protect individuals and the respect for human dignity in research. Risks and knowledge gains are two factors that must be balanced against each other in the reviews.
The Swedish Act (2003:460) concerning the ethical review of research involving humans
Purpose (Section 1)
The purpose of the Act is to protect individuals and human dignity when research is conducted.
Research participants must be protected against the risk of detriment, whether physically, mentally or in terms of personal data privacy. The public must be given access to and influence over the ethical review of research. The legal certainty of research participants and researchers alike must be safeguarded.
Definitions (Section 2)
Research: scientific experimental or theoretical work or observational research studies, if the work or studies are carried out to acquire new knowledge, and/or development work on a scientific basis, but not such work or studies that are performed solely within the framework of higher education at basic or advanced level.
Entity responsible for research: a government agency or a natural or legal person in whose activities the research is conducted.
Research participant: A living person who takes part in research as its subject.
Processing of personal data: The processing specified in Article 4.2 of the EU General Data Protection Regulation.
Scope (Sections 3–5)
The Act applies to research conducted in Sweden if the research
- involves physical intervention, on living and deceased persons alike
- is carried out with a method that aims to affect the research participant physically or mentally, or involves an obvious risk of harm to them in body or mind
- are performed on biological material from a living or deceased human being and can be traced back to that person
- involves processing of sensitive personal data or of personal data relating to criminal offences.
Basics of ethical reviewing (Sections 7–11)
The research may only be approved if it can be conducted with respect for human dignity, Section 7.
Human rights and fundamental liberties must always be considered in ethical reviewing, as must the scope for new knowledge through research. Human welfare should always be given precedence over the needs of society and science, Section 8.
Research may be approved only if the risks it may pose to the health, safety and personal integrity of research participants are counterbalanced by its scientific value, Section 9.
Research cannot be approved if the anticipated result is attainable by some other means that entails lesser risks for the health, safety, and personal integrity of the research participants. Processing of sensitive personal data and information relating to criminal acts may only be approved if this is necessary for the research to be carried out, Section 10.
The research may be approved only if it is to be conducted by, or under the supervision of, a researcher who possesses the requisite research expertise, Section 11.
Information and consent (Sections 13–19)
Research including a physical intervention on a living person, making use of a method that aims to affect a human being physically or mentally, involving an obvious risk of detriment to the research participant in body or mind, or carried out on biological material from a living human being and traceable back to that person, may be carried out only if the research participants have consented to the research that concerns them personally.
This consent must be voluntary, explicit, and specific to particular research. The consent must be documented.
Consent is valid only if the research participant has previously received information about
- the overall plan for the research
- the purpose of the research
- the methods to be used
- the consequences and risks the research might entail
- the identity of the entity responsible for the research
- the voluntary nature of participation in the research, and
- the research participant’s right to stop taking part at any time.
If a research participant is in a situation of dependency with respect to the entity responsible or a researcher, or if the subject may be presumed to have difficulties in asserting his or her personal rights, issues relating to information and consent should receive particular attention during the ethical review.
Despite the custodians’ consent, the research may not proceed if research participants below age 15 understand what it entails for them personally and are opposed to its implementation. Young people aged 15–17 give their own consent if they understand what the research means for themselves personally.
Consent may be withdrawn at any time with immediate effect. However, the data collected before the withdrawal date may be used in the research.
Research without consent (Sections 20–22)
Research may be conducted without consent if illness, mental disorder, a weakened state of health and/or other similar circumstances affecting the research participants and preventing them from expressing their opinions, provided that
- the research may be expected to result in knowledge that is not possible to obtain by means of research based on informed consent, and
- the research may be expected to be of direct benefit to the research participant.
Even if the latter condition is not fulfilled the research may be carried out, provided that:
- the purpose is to contribute to a result that may be of benefit to the research participant or anyone else who suffers from the same or similar illness or disorder, and
- the research entails an insignificant risk of injury and negligible discomfort for the research participant.
Even if a research participant’s opinion is unobtainable, the subject must, as far as possible, be personally informed about the research. There must be consultation with the subject’s closest relatives. Consultation must also take place with a custodian of the potential research participant or other legal representative, as defined in Chapter 11 of the Swedish Children and Parents Code, if the issue forms part of such a person’s mandate. The research may not be implemented with respect to individual research participants who, in any way, express personal reluctance to take part, or if anyone whom consultation has taken place with is opposed to its implementation.
Special conditions
An approval from the Ethical Review Authority must be in place before the research can begin.
An approval expires if the research does not commence within two years after the decision has gained legal effect.
Anyone who intentionally or through gross negligence conducts research without approval or violates the terms of an approval may be fined or given a custodial sentence.