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Informed consent

Research on humans is normally only permitted if the participants have consented to being part of the study. The participants must first, however, have been informed about the purpose of the study, any potential risks and benefits of participating, and much more.

Currently, the requirement for informed consent is a cornerstone of research ethics. The requirement is present in both international guidelines and in Swedish law (Ethical Review Act Sections 13–22).


The Ethical Review Act specifies that consent must be voluntary, explicit and specific to the research in question. In addition, the consent must be documented. Written consent is usually required, but there are situations in which it is not possible to obtain consent in written form. Please note that it is the Act and the Swedish Ethical Review Authority that ultimately determine when, how and under what circumstances consent is to be obtained.

The research volunteer has the right to withdraw his or her consent at any time and with immediate effect. No reason need be provided. Any data already collected may, however, still be used in the research.


A condition for informed consent is that the research volunteer has been given and has understood the relevant information. The Ethical Review Act clarifies that a research volunteer is to be informed of:

  • the overall plan for the research,
  • the purpose of the research,
  • the methods that will be used,
  • the consequences and risks that the research may entail,
  • the person responsible for the research,
  • that participation in the research is voluntary, and
  • that the research volunteer has the right to terminate his or her participation at any time.

On the basis of these requirements, the Swedish Ethical Review Authority has compiled guidelines. All researchers are recommended to have read these guidelines before drawing up their own information material.

In general, information provided to research volunteers is to avoid the use of difficult words and complicated sentences. In addition, the information must be adapted to the intended recipient, which means that it will sometimes be necessary to draw up more than one information letter (for example one for the guardians and one for the child).

In addition, the information is to be factual and neutral. One should therefore avoid downplaying the risks and exaggerating the benefits of taking part in the study. Pressure and persuasive formulations such as “it is essential that you participate in this project” and “Thank you for your commitment!” should also be avoided.

Conditions for a good and independent decision

The research volunteer must have a realistic chance of reaching an independent decision. As a researcher, one must therefore pay attention to elements which could be construed as pressure, not least when the research volunteer is often in a position of dependence in relation to the researcher or to the person offering the opportunity to take part in the research project.

Aspects such as a shortage of time, tiredness and worry can make it more difficult for the research volunteer to reach an independent decision on the offer to take part in a study. This is also something that researchers must bear in mind when planning their study. 

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Any questions?

Do you have any questions regarding research ethics regulations? As an employee of Lund University, you can turn to forskningsetik [at] lu [dot] se


The Swedish Ethical Review Authority has drawn up guidelines concerning information for research participants:

Guidelines on information for research participants (Swe)