Abstract
This empirical study explores participants' perceptions of information and understanding of their children's and their own involvement in a longitudinal screening, the ABIS Study. ABIS (All Babies In Southeast Sweden) is a multicentre, longitudinal research screening for Type 1 diabetes and multifactorial diseases involving 17 005 children and their families. For this study, a random selection of mothers was made, using perinatal questionnaire serial numbers from the ABIS study. In total, 293 of these mothers completed an anonymous questionnaire (response rate 73.3%). Our findings from the questionnaire indicate a marked difference between the reported satisfaction with and understanding of the information provided on the one hand and the significant lack of knowledge of some of the aims and methods of the ABIS screening on the other, namely concerning high-risk identification of involved children, potential prevention and future questionnaires. Two questions evoked by our results are: (1) what information is required for participants in longitudinal studies involving children? and (2) how do we ensure and sustain understanding, and thus in a prolonging, informed consent in these studies? This study underlines the importance of an increased understanding of the ethical issues that longitudinal research on children raise and the need to discuss how information and informed consent strategies should be analysed and designed in longitudinal studies.
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Notes
(for example, World Medical Association (1964) Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects; The Belmont report (1979) Office of the Secretary. Ethical Principles and Guidelines for the Protection of Human Subjects of Research; International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982). Prepared by the Council for International Organisations of Medical Sciences (CIOMS) and WHO; Recommendation No. R (90) 3 Concerning Medical Research on Human Beings. Council of Europe, Committee of Ministers. The Nüremberg Code, the Declaration of Helsinki, and the CIOMS code of 1982 (1993) also emphasise the need, even duty, to ensure that the research subjects have understood the information.)
(Informed consent is here understood in the following way: When someone (A) has given (B) his or her consent to an intervention-trial (T), the following conditions have been met: (1) B has asked A about participation in T; (2) B has given adequate information about T and about B's participation in T; (3) A was a competent person; (4) A sufficiently understood the conditions of participating in T; (5) A consented to participate in T; (6) A's consent was made voluntarily; (7) A notified B of his/her consent to participate in T (authorisation).
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Acknowledgements
We would like to thank all the families who participated in this research. We are grateful to the ABIS nurses and Ann-Christine Gilmore-Ellis for their support during the research process. This study was financially supported by the JDF-Wallenberg Foundation (Grant K98-99JD-12813-01A), the Soderbergs Foundation and the Swedish Child Diabetes Foundation (Svenska Barndiabetesfonden). Ethical approval for the study was obtained from the regional research ethical committee at Linköping University.
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Stolt, U., Helgesson, G., Liss, PE. et al. Information and informed consent in a longitudinal screening involving children: a questionnaire survey. Eur J Hum Genet 13, 376–383 (2005). https://doi.org/10.1038/sj.ejhg.5201336
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DOI: https://doi.org/10.1038/sj.ejhg.5201336
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