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)

Due to the potential ethical and psychological implications of screening, and especially inregard of screening on children without available and acceptable therapeutic measures, there is a common view that such procedures are not advisable. As part of an independent research- and bioethical case study, our aim was therefore to explore and describe bioethical issues among a representative sample of participant families (n = 17,055 children) in the ABIS (All Babies In South-east Sweden) research screening for Type 1 diabetes (IDDM).The primary (...) aim is the identification of risk factors important for the development of diabetes and other multifactorial immune-mediated diseases. Four hundred, randomly chosen, participant mothers were asked to complete a questionnaire exploring issues of information, informed consent, bio-material, confidentiality and autonomy, and of prevention/intervention. 293 completed the questionnaire, resulting in a response rate of 73.3%. The majority of questions had the form of 6-point Likert-type response scales (1–6).We found that the majority of respondents felt calm in regard of samples and written material, and also concerning the possibility of their child in the future being identified as having high risk of developing Type 1 diabetes. An important finding concerning access and control of mainly biological data was indicated, with the respondents expressing concern for potential future use. We believe our findings indicate that this kind of empirical studies can substantially contribute to our understanding of bioethical issues of medical research involving genetics. Issues, such as safeguards ensuring theethical criteria of autonomy and respect, were emphasised by our respondents. We believe theissues brought up may promote further discussion, and do suggest issues for consideration by, among others, researchers, bioethicists and Institutional Review Boards. (shrink)

Due to the potential ethical and psychological implications of screening, and especially inregard of screening on children without available and acceptable therapeutic measures, there is a common view that such procedures are not advisable. As part of an independent research- and bioethical case study, our aim was therefore to explore and describe bioethical issues among a representative sample of participant families (n = 17,055 children) in the ABIS (All Babies In South-east Sweden) research screening for Type 1 diabetes (IDDM).The primary (...) aim is the identification of risk factors important for the development of diabetes and other multifactorial immune-mediated diseases. Four hundred, randomly chosen, participant mothers were asked to complete a questionnaire exploring issues of information, informed consent, bio-material, confidentiality and autonomy, and of prevention/intervention. 293 completed the questionnaire, resulting in a response rate of 73.3%. The majority of questions had the form of 6-point Likert-type response scales (1–6).We found that the majority of respondents felt calm in regard of samples and written material, and also concerning the possibility of their child in the future being identified as having high risk of developing Type 1 diabetes. An important finding concerning access and control of mainly biological data was indicated, with the respondents expressing concern for potential future use. We believe our findings indicate that this kind of empirical studies can substantially contribute to our understanding of bioethical issues of medical research involving genetics. Issues, such as safeguards ensuring theethical criteria of autonomy and respect, were emphasised by our respondents. We believe theissues brought up may promote further discussion, and do suggest issues for consideration by, among others, researchers, bioethicists and Institutional Review Boards. (shrink)