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The problems of obtaining informed consent in screening for Type 1 diabetes involving small children
Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
Linköping University, Department of Department of Health and Society. Linköping University, Faculty of Health Sciences.
Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
Linköping University, Department of Behavioural Sciences. Linköping University, Faculty of Health Sciences.
(English)Manuscript (preprint) (Other academic)
Abstract [en]

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.

National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-81867OAI: diva2:556142
Available from: 2012-09-24 Created: 2012-09-24 Last updated: 2012-09-24Bibliographically approved
In thesis
1. Aspects in bioethics: Theory and practice in a preventive screening for type 1 diabetes
Open this publication in new window or tab >>Aspects in bioethics: Theory and practice in a preventive screening for type 1 diabetes
2003 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

From a clinical perspective, as well as societal and global, the present rapid increase in the number of people diagnosed with diabetes is a cause of great concern. Simultaneously, our understanding of the aetiology and pathogenesis of type 1 diabetes (IDDM) remain limited. As of now there are two main approaches to predict the risk of diabetes development: either before by assessing the genetic factors presumably involved, or after by a combination of immunological (IAA, la-2, GAD) and genetic typing. The problems are for example that only 10% of those that develop diabetes have a first-degree relative, and that only a proportion of those with a genetic susceptibility will eventually develop type 1 diabetes Theoretically, prevention of type 1 diabetes can be done at three different levels: primary, secondary and tertiary intervention. However, it is argued that more basic research is needed before effective and safe prevention of type 1 can be introduced. More effort is also needed to identify the environmental factors and potential triggers.

Screening for pre-diabetes belong to one of the two type of genetic testing and screening who are generally considered being ethically controversial: predictive, pre-symptomatic testing of children for disorders that do not usually (or where there are uncertainty in progression rate) manifest until adult life, and for which an effective intervention measure is not available. There are risks for creation of distress and anxiety, risks for false-positive results, risks of bypassing informed consent and stigmatisation in case of potential positive results. Discussed are also issues concerning the upholding of individual autonomy, confidentiality and integrity. Simultaneously, it has been argued that the ethical discussion is based on empirical premises that are not sufficiently studied, and that we furthermore lack empirical data.

Thematically this thesis belongs to the discipline of descriptive ethics. Our aim was to empirically explore and describe the attitudes and opinions of to, on the basis of the empirical results, point at and discuss issues of bioethical relevance. Our case was ABIS (All Babies In Southeast Sweden) an ongoing prospective longitudinal cohort study for the prediction and prevention of type 1 diabetes (n=17,005). The research design included both qualitative studies: interviews with participating and non-participating mothers, as well as health professionals involved, and a quantitative study: consisting of a designed questionnaire exploring bioethical issues.

The interview data indicate a positive attitude both to the ABIS aims and methods and there were less concern over research material, screening results, prevention than often assumed. However, there were concern expressed of issues concerning confidentiality, integrity and restrictions. The reasons for declining participation varied: not wanting their child put through frequent blood testing, fear of "experimentation". The interviews with the staff involved gave important data regarding information procedures and research design, for example the importance of identifying and informing all actors in research involving humans. The questionnaire data support at large earlier empirical findings: a benevolent attitude, less concern over biological samples and written material. Similar concerns were raised of confidentiality and integrity: material used to initial purposes, protection of identity, renewed consent. The majority wanted to know about high-risk status, even though no available intervention. Our interest in information and informed consent was renewed since participants showed a lack of knowledge/understanding regarding basic aims and methods. The problem of informed consent was discussed in the last two papers: the first focusing on the problem of obtaining informed consent, while the second explored potential alternatives of action if we have reason to believe the participants lack a sufficient understanding.

Place, publisher, year, edition, pages
Linköping: Linköpings universitet, 2003. 74 p.
Linköping University Medical Dissertations, ISSN 0345-0082 ; 763
National Category
Medical and Health Sciences
urn:nbn:se:liu:diva-26653 (URN)11218 (Local ID)91-7373-520-5 (ISBN)11218 (Archive number)11218 (OAI)
Public defence
2003-01-10, Berzeliussalen, Hälsouniversitetet, Linköping, 13:00 (Swedish)
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2012-09-24Bibliographically approved

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