RESEARCH ETHICS

How to handle informed consent in longitudinal studies when participants have a limited understanding of the study

G Helgesson¹, J Ludvigsson² and U Gustafsson Stolt³

¹ The Centre for Bioethics at Karolinska Institutet and Uppsala University, Sweden
² The Division of Paediatrics at the Department of Molecular and Clinical Medicine, Linköping University, Sweden
³ The Division of Paediatrics at the Department of Molecular and Clinical Medicine, Linköping University, Sweden

Correspondence to:
Correspondence to:
Gert Helgesson
PhD in philosophy, Researcher at the Centre for Bioethics at Karolinska Institutet and Uppsala University, Sweden; Gert.Helgesson{at}bioethics.uu.se

Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of knowledge they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected.

Keywords: information; consent; longitudinal studies; screening; understanding

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