Purpose As part of a research ethical case study our objective was to explore existing and potential bioethical issues with regard to a research screening for Type 1 involving 17,000 children and their families (present outcome: 78.6%).
Research design and methods The setting was ABIS (All Babies In Southeast Sweden), a presently ongoing Swedish research screening designed as a multi-centre, longitudinal and geographically located research screening for Type 1 Diabetes in an unselected birth cohort. From the perinatal questionnaire serial numbers we made a random selection of participating mothers. 293 completed the anonymous questionnaire, resulting in a response rate of 73.3%.
Results The overall majority of respondents reported (1), being satisfied with the information, (2), looking upon the information as sufficient for their decision, (3), having fully understood the information and (4), having made a fully voluntary decision to participate. However, knowledge about the study varied widely and we found several variations of misunderstandings, even regarding basic facts. For example, one in three respondent was unsure (or indeed unaware) with regard to one aim being the identification of children at high risk.
Condusions We have recorded flaws in research participants understanding of their own and their child's participation in a prospective screening programme, even though attention was paid to distributing information through a variety of methods. This points to the importance of giving information: in a variety of methods and also repeatedly in long-term studies.