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Incapacity to give informed consent

There are situations in which the research participant lacks the capacity to give informed consent on participation in a research study. Such incapacity can be the result of illness or injury, but it can also be based on the person in question being too young to take a decision on taking part in the study.

As a researcher, one can often choose to refrain from including incapable people in a particular study, but this is not always a viable alternative. Sometimes it is precisely thesituation of these people that is the object of the study.

A complete ban on research on incapable people would hinder essential research and, in the long term, it would negatively affect people suffering from a reduced decision-making capacity. This is why the law allows some margin for such research. Below is a description of the requirements set by the Ethical Review Act on this type of research. Please note, however, that it is the Swedish Ethical Review Authority that determines whether these requirements have been met and whether the research is permitted to go ahead.

Children under the age of 15

If the research volunteer is under the age of 15, both the child’s legal guardians are to consent to the child’s participation in the study. The child is to be informed about the research to the extent possible. If the child objects to taking part, the research may not go ahead even if both guardians have consented to it.

In addition, the Central Ethical Review Board has decided (Ö24-2008) that research on children, somewhat simplified, is not permitted (a) if it could be conducted on legal adults, (b) if its purpose is to be relevant to a group other than that to which the research volunteer belongs, or (c) if it entails more than an insignificant risk of damage or more than insignificant discomfort.

People who are between the ages of 15 and 18

If the research volunteer is between 15 and 18 years old, he or she is to consent personally to participating in the research. Please note that the consent of guardians is not to be sought in this case.

If the person in question lacks the capacity to understand what the research entails for the volunteer, the same rules apply as for volunteers under the age of 15.

Adults with impaired decision-making capacity

People who are over 18 but who cannot take a decision on participation in research due to illness, injury or cognitive impairment, may be included in a study under certain specific circumstances. The Ethical Review Board s responsible for establishing whether the research in question meets these requirements.

Firstly, the research must be expected to provide knowledge which cannot be obtained through research conducted with the consent of the participants. Here it is of course not sufficient for it to be difficult to recruit other people (who are in a position to consent) for the research. The research issue is to be such that it can only be resolved by including people from the group (with impaired decision-making capacity) to which the research volunteer belongs.

In addition, the research must be expected to be (a) directly useful to the research participant or (b) to contribute to a result which can be useful to the research participant or to someone suffering from the same or similar condition or illness.

If the research is not expected to be directly beneficial to the research participant (the normal case), it is only permitted to entail an insignificant risk of damage and insignificant discomfort.

The research participant’s next of kin are also to be consulted (as well as the person’s guardian or administrator if the issue is included in their mandate). If any of these people objects to the research, the research participant is not to be included in the study. The preparatory work on the Act states that the next of kin is primarily the spouse, registered partner or cohabiting partner. If there is no such person, or if that person him/herself is not in a position to take a decision, the first-degree relatives are to be consulted, i.e. children, parents or siblings in that order.

Finally, the research participant is to be personally informed about the research as far as possible. If the research volunteer expresses unwillingness to participate, in any way, the research is not permitted. Similarly to the case concerning children, this right of veto applies for the duration of the project. 

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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