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Aspects in bioethics: Theory and practice in a preventive screening for type 1 diabetes
Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
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.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 763
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-26653Local ID: 11218ISBN: 91-7373-520-5 (print)OAI: oai:DiVA.org:liu-26653DiVA: diva2:247202
Public defence
2003-01-10, Berzeliussalen, Hälsouniversitetet, Linköping, 13:00 (Swedish)
Opponent
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2012-09-24Bibliographically approved
List of papers
1. Attitudes to bioethical issues: a case study of a screening project
Open this publication in new window or tab >>Attitudes to bioethical issues: a case study of a screening project
2002 (English)In: Social Science and Medicine, ISSN 0277-9536, E-ISSN 1873-5347, Vol. 54, no 9, 1333-1344 p.Article in journal (Refereed) Published
Abstract [en]

Commonly expressed in theoretical discussions about ethical problems in the context of epidemiology and screening is the need for more data. A study was carried out involving 21 explorative interviews with participant and nonparticipant mothers in a neonatal research screening project in progress in Sweden, ABIS (All Babies in Southeast Sweden). The respondents were asked, by way of open-ended questions, to give their opinions about certain ethical issues: informed consent; reasons for joining/declining; surrogate decision; the collection, analysis and storage of written and “live” material (biobanks); intervention etc.

The ethical implications mentioned in the literature mostly concern the risk of creating distress and anxiety (anxiety and possible stigmatisation in respect of positive or false-positive results, worry about material collected and stored, distress caused by blood sampling procedures, etc.). Our results do not support the idea that the risks are substantial. The respondents rather indicate an attitude of benevolence—they are positive both to the current research on children, to the material they contribute (both written material and “biomaterial”), to possible results and intervention plans. On the other hand the participants expressed concern about the storage of material and the right to be informed of any screening/project results. Further studies in this field are needed and would be of help in theoretical discussion, the work of ethical committees and the designing of, for example, screening and research projects.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-26478 (URN)10.1016/S0277-9536(01)00099-5 (DOI)11029 (Local ID)11029 (Archive number)11029 (OAI)
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2012-09-24Bibliographically approved
2. Advancing the nursing perspective in screening and genetic research: ethics, informed consent and councelling
Open this publication in new window or tab >>Advancing the nursing perspective in screening and genetic research: ethics, informed consent and councelling
(English)Manuscript (preprint) (Other academic)
Abstract [en]

The aim of the present study was to explore ethical attitudes and reflections among nurses and midwives involved in a primaty prevention research screening for Type 1 diabetes, ABIS (All Babies In South-East Sweden). We selected a strategic sample of ten respondents (midwives, paediatric and assistant nurses) from wards involved in all information and sampling procedures. We found a general positive attitude towards this type of screening. Even though no bioethical problems were said to be experienced, there were questions raised concerning the bio-material collected. We also found variations in the respondents understanding of aims and methods, something subsequently reflected in their information to the potential ABIS participants. We argue that the findings and the potential implications can be of importance with regard to several issues of genetic testing and screening: design, information, informed consent and counselling. The study supports the opinion that nursing perspective studies are important, not only in addressing issues in regard of the new genetics, but also because of their potential value in the ethics of nursing and of research ethics.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-81864 (URN)
Available from: 2012-09-24 Created: 2012-09-24 Last updated: 2012-09-24Bibliographically approved
3. Mothers of children in ABIS, a population-based screening for prediabetes, experience few ethical conflicts and have a positive attitude
Open this publication in new window or tab >>Mothers of children in ABIS, a population-based screening for prediabetes, experience few ethical conflicts and have a positive attitude
2002 (English)In: Annals of the New York Academy of Sciences, ISSN 0077-8923, E-ISSN 1749-6632, Vol. 958, 376-381 p.Article in journal (Refereed) Published
Abstract [en]

Screening is supposed to create less anxiety among first-degree relatives of diabetic patients where the risk of developing diabetes already is well known. It has also been argued that screening of a general child population should never be performed unless identified high-risk individuals can be offered intervention to prevent diabetes. However, the empirical data are scarce, especially regarding what opinions patients or their parents have of these matters/issues themselves. We have therefore tried to evaluate mothers' attitudes to and ethical views on participation in a research screening for prediabetes in an unselected birth cohort. All 21,700 mothers of children in southeast Sweden born between 1 October 1997 and 1 October 1999 were asked to participate in ABIS (All Babies in Southeast Sweden). They were given information about the design of the study and that HLA types and autoantibodies will be determined in order to predict diabetes, but that no prevention of diabetes will be offered unless future studies show effective methods. After informed consent, 78.6% of mothers let their babies participate (17,055 children) despite a quite laborious study protocol. Explorative in-depth semistructured interviews were performed in 21 mothers, of whom 15 were strategically selected to get as many various attitudes as possible and of whom 6 chose not to participate in ABIS. All interviewed mothers were positive to the ABIS project. We conclude that a well-designed screening program to detect individuals in the general population with high risk of developing diabetes does not evoke anxiety nor severe ethical conflicts.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-26475 (URN)10.1111/j.1749-6632.2002.tb03007.x (DOI)11026 (Local ID)11026 (Archive number)11026 (OAI)
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2012-09-24Bibliographically approved
4. Bioethical theory and practice in genetic screening for type 1 diabetes
Open this publication in new window or tab >>Bioethical theory and practice in genetic screening for type 1 diabetes
2003 (English)In: Medicine, Health care and Philosophy, ISSN 1386-7423, E-ISSN 1572-8633, Vol. 6, no 1, 45-50 p.Article in journal (Refereed) Published
Abstract [en]

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.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-26477 (URN)10.1023/A:1022556705853 (DOI)11028 (Local ID)11028 (Archive number)11028 (OAI)
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2012-09-24Bibliographically approved
5. The problems of obtaining informed consent in screening for Type 1 diabetes involving small children
Open this publication in new window or tab >>The problems of obtaining informed consent in screening for Type 1 diabetes involving small children
(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
Identifiers
urn:nbn:se:liu:diva-81867 (URN)
Available from: 2012-09-24 Created: 2012-09-24 Last updated: 2012-09-24Bibliographically approved
6. Understanding and informed consent in longitudinal studies: what action we take when we have reason to believe subjects lack sufficient understanding?
Open this publication in new window or tab >>Understanding and informed consent in longitudinal studies: what action we take when we have reason to believe subjects lack sufficient understanding?
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Taking the point of departure in empirical research data we discuss what action should we take when we are uncertain of to what extent participants in a prospective, longitudinal screening for pre-diabetes lack sufficient understanding?

The empirical case study showed that, on one hand, an overall majority of respondents reported being satisfied with the information in several respects, but, on the other hand their knowledge and comprehension of aim, purpose and potential benefit varied widely to the extent that doubt must be put as to whether they have sufficient understanding. In this situation we need criteria or guidance as to what constitutes a sufficient understanding. A brief sutvey of ethical codes and ethical theory show, we argue, that while they enumerate some important items that the subject should be informed about, like aims, methods, anticipated benefits and potential risks, nothing substantial is said that can guide us as to what the meaning of "a sufficient understanding" is. The second question concems what is then the ethically right thing to dor We propose we have five possible alternatives: a), we can ignore the data, b), we can exclude individuals who lack sufficient understanding, c) we can give complementary information, without renewed consent, d), inform and ask for a renewed consent, and finally we can ask participants if they want to increase their understanding. We conclude that due to the ethical problems involved in screening and genetic testing of children, there is a need to develop theories or principles for guidance.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-81868 (URN)
Available from: 2012-09-24 Created: 2012-09-24 Last updated: 2012-09-24Bibliographically approved

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