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Informed consent

Informed consent

When research involves humans, they are, with few exceptions, to be informed about the research and its effects, as well as be able to freely decide whether they wish to participate. This is a condition in Good Clinical Practice and the research council's ethics rules, as well as being established in the fundamental codes as described in the section on research involving humans. It is furthermore a requirement of the Health and Medical Service Act's § (SFS 2017:30) that health and medical research involving subjects who are patients particularly be based on respect for the patient's self-determination and integrity and shall, to the extent possible, be designed and conducted in consultation with the patient.

1 January 2004, the Act concerning the Ethical Review of Research Involving Humans (SFS 2003:460) went into effect. The law is applicable to, among other things, research comprising work with sensitive personal information as well as that involving physical encroachment on a subject, or research 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. The basic rule here is that research is allowed only if the subject has consented to the research that concerns him or her. Consent is valid only if the subject has received information on the research beforehand. The consent is to be voluntary, explicit, and specific to a certain research project, as well as documented. Consent may be rescinded at any time, effective immediately.

Empirical research has shown that forms providing information to study participants can sometimes be faulty. Some are not specific enough; for example, it often happens that they do not provide enough information on risks and the difference between treatment and research is not presented. Often, they are simply too difficult to understand when it comes to wording and content. They sometimes contain so much information that the reader is not able to absorb the essential parts. Great care should thus be exercised in this phase of the research.

The information one should give

Which information should people be given before consenting? The basic requirement of good information is that the researcher ensure that the intended patient or subject be informed in a way and with language that he or she understands. As a rule, the information is to be provided both in writing and verbally. The main principle (according to the Medical Research Council) is that the information should contain everything that can be reasonably considered to have an effect on the subject's decision to participate.

According to the law on ethical review, it is required that the subject be informed about:

According to Good research practice, the information is also to comprise:

See also the template "Information for research participants" from the Central Ethical Review Board.

Furthermore, additional demands upon the level and extent of information may be suitable for special kinds of research. For example, when doing genetic research on isolated populations, it has been suggested that information concerning the reasons why the population was chosen, on the opportunities for benefit sharing, and on genetic privacy be included ("Comparison of participant information and informed consent forms of five European studies in genetic isolated populations"). Good guidance can be found in the EU Commission guidance on informed consent.

Research on those unable to consent

According to the Act, research may be conducted also with those unable to consent, if it is believed that it will offer knowledge that is impossible to obtain through research with consent, and if the research is expected to be of direct benefit to the subject. Even if the latter condition is not met, the research may be conducted if its aim is to contribute to a result that can be of benefit to the subject or another person suffering from a similar disease, and if the research poses only an insignificant risk of injury or discomfort to the subject. Cases such as this are to be ruled on by a research ethics committee. Note that research cannot be initiated if the subject of the research has indicated in any way that he or she does not wish to participate or if a custodian or relative is opposed to the undertaking. A complication in Sweden is that the 22 paragraph of the Act states that there must be a consultation with the closest relatives of the person who is participating in the research. Research on for example emergency patients can thus be hard or impossible to do. The Swedish Medical Products Agency strictly adhere to the principle from 13§ Läkemedelslagen [Medicinal Products Act, SFS 2015:315], that in clinical trials, for those not able to consent, an authorization must be collected from a custodian. In practice, this means that these persons will not be included in such research, as a working system of custodianship is at present missing in this country.

Last updated: 2020-04-12

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