Based on extensive clinical questionnaire data, this paper explores the relation between research subjects’ self-assessed understanding and actual knowledge of a large-scale predictive screening study, and its implications for the proper handling of information and consent routines in longitudinal studies. The intitial data show that low self-assessed understanding among participants was correlated with limited knowledge, concern over participation and collected samples, less satisfaction with information, and feeling passive or negative towards the study. Among those reporting high understanding, a non-negligible number (...) displayed a lack of knowledge regarding central aspects of the study. Regarding high assessed understanding, the multivariate analysis identified the main predictor variables to be knowledge, having a positive attitude towards participation and the study itself, being satisfied with information, having a stable psychosocial background and feeling calm regarding the handling of samples. These findings indicate that to evaluate participants' understanding through self-assessment may not be reliable method. Self-assessed understanding may rather be a good indicator of general attitudes than a tool for analysing content. The data also show that actual understanding varies considerably among participants, suggesting that more effort needs to be put into adjusting the information to the needs of different subgroups. It is argued that when doing this, researchers in longitudinal studies must be careful not to exhaust participants with excessive information that they do not want and that may cause them to drop out. The ethical relevance of obtaining repeated consents in longitudinal research is discussed. (shrink)

Based on extensive questionnaire data, this paper focuses on parents’ views about children’s right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at (...) some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings. (shrink)

The objective of the present paper is to explore parents' views on safety and confidentiality, information and consent, the importance of different kinds of research, and their responsibilities regarding children's participation. A questionnaire was distributed to 2500 families in south-east Sweden with children born during the years 1997–1999; 1302 responded. The sample was chosen to include views of families with and without earlier research experience. A clear majority of responding parents stated that parents have a moral responsibility to let their (...) children participate in research that is considered important, safe and moderately time-consuming. Respondents stressed the importance of thorough review and control of research involving children. Respondents also found it important that parents are guaranteed the right to decide about their children's participation and that they are thoroughly informed on central aspects of the study. (shrink)

Pediatric biobanking is considered important for generating biomedical knowledge and improving health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent (...) into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research. Although personalized assent will require certain efforts, the pediatric community must be aware of its importance. The investment and trust earned can result in ongoing engagement, important longitudinal information, and stability in/for the research infrastructure, as well as increased knowledge among its participants about research activity. Implementing personalized assent will both respect the child and support biobank research. (shrink)

Data from the 5–6 year control questionnaire of the ABIS study, a Swedish prospective screening of children for Type 1 diabetes, indicates a genuine trust in the researchers—very few participating families expressed concern about their participation. Nevertheless, a majority do not want their research data to be used beyond the agreement of the original consent. They want to be asked for renewed consent in such cases. A vast majority also want potential high-risk information about their child to be communicated to (...) them. Most participating families want this regardless of whether any preventive treatment is available. Although potential benefits for their child is a motivation for participation for a majority of the respondents, they also claim to be motivated by altruistic reasons. These results are compared to results from two similar studies in the UK. (shrink)