title: Bioethical theory and practice in genetic screening for type 1 diabetes.
abstract: Due to the potential ethical and psychological implications of screening, and especially in regard 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 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 the ethical criteria of autonomy and respect, were emphasised by our respondents. We believe the issues brought up may promote further discussion, and do suggest issues for consideration by, among others, researchers, bioethicists and Institutional Review Boards.
authors.affiliation: Department of Molecular and Clinical Medicine, Division of Paediatrics, Faculty of Health Sciences, Linköping University, SE-581 85 Linköping, Sweden. ulrgu@imk.liu.se
authors.forename: U
authors.initials: U
authors.lastname: Gustafsson Stolt
authors.forename: J
authors.initials: J
authors.lastname: Ludvigsson
authors.forename: P E
authors.initials: PE
authors.lastname: Liss
authors.forename: T
authors.initials: T
authors.lastname: Svensson
mesh_terms: D000328:Adult; D001294:Attitude to Health; D001675:Bioethics; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis* / Q000235:genetics / Q000517:prevention & control; D032984:Ethics, Research; D005260:Female; D005820:Genetic Testing / Q000941:ethics*; D006801:Humans; D009035:Mothers / Q000523:psychology*; D010358:Patient Participation; D011795:Surveys and Questionnaires; D013548:Sweden