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The ethics of research using biobanks: reason to question the importance attributed to informed consent.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Clinical Pharmacology.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
2005 (English)In: Archives of Internal Medicine, ISSN 0003-9926, E-ISSN 1538-3679, Vol. 165, no 1, 97-100 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: During the past decade, the use of stored tissue has become an object of increased ethical query. A Swedish biobank and a biotech company have been praised for solving the ethical problems with explicit informed consent procedures, and we decided to investigate donors' perceptions of the system. METHODS: A questionnaire was sent to a randomized sample of 1200 donors who had donated blood and signed informed consent forms. RESULTS: The response rate was 80.9%. Of the respondents, 64.5% were aware that they had consented to donate a blood sample, 55.4% thought that they had consented to donate phenotypic information, and 31.6% believed that they could withdraw their consent. Among respondents, 3.9% considered informing donors about the research objective as the most important ethical issue in relation to biobanks, and 5.6% were unsatisfied with the information they had been given. There was 85.9% acceptance of surrogate decision making by regional research ethics committees. CONCLUSIONS: Considering that the donors in this study were not always aware of their donation but generally were not unsatisfied with the information they had received, and that they did not rate being informed about the research objective as an important issue, informed consent seems to be an inadequate measure of public acceptance of biobank-based research.

Place, publisher, year, edition, pages
2005. Vol. 165, no 1, 97-100 p.
Keyword [en]
Biotechnology/*ethics, Blood Banks/*ethics, Blood Donors, Ethics; Research, Female, Humans, Industry/ethics, Informed Consent/ethics/psychology, Male, Questionnaires, Sweden, Tissue Banks/*ethics
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:umu:diva-14701DOI: 10.1001/archinte.165.1.97PubMedID: 15642883OAI: oai:DiVA.org:umu-14701DiVA: diva2:154373
Available from: 2007-12-03 Created: 2007-12-03 Last updated: 2017-12-14Bibliographically approved
In thesis
1. Biobanks and informed consent: An anthropological contribution to medical ethics
Open this publication in new window or tab >>Biobanks and informed consent: An anthropological contribution to medical ethics
2004 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: 1985 saw the beginnings of a population-based biobank in Västerbotten County, Sweden. In 1999, a start-up genomics company, UmanGenomics, obtained ‘all commercial rights’ to the biobank. The company introduced an ethics policy, which was well received in prestigious journals, focusing on public oversight and informed consent.

Aims: To explore how social anthropology can aid understanding of the challenges posed by the new role of the biobank in Västerbotten, and thus complement more established traditions in the field of medical ethics. An anthropological study of the ethics policy was executed.

Theoretical perspective: Inspired by the anthropology of policy and social science perspectives on ethics and morality, the policy was studied at three analytical levels: policymakers (who formulate the policy), policy workers (who implement the policy, primarily nurses who obtain informed consent) and target group (for whom and on whom the policy is supposed to work: the potential donors to the biobank).

Methods: Policymakers, nurses, and potential donors were interviewed, donations observed, and official documents analysed to mirror the moral problematizations made at the three levels in each other and to study the practical implications of the policy. To extend the reliability of the findings two surveys were executed: one among the general population, one among donors.

Results: The qualitative studies show that policymakers distinguish between blood and data differently to potential donors. Informed consent seems more important to policymakers than potential donors, who are more concerned about political implications at a societal level. Among the respondents from the survey in the general public, a majority (66.8%) accepted surrogate decisions by Research Ethics Committees; a minority (4 %) stated informed consent as a principal concern; and genetic research based on biobank material was generally accepted (71%). Among the respondents to the survey in donors, 65% knew they had consented to donate a blood sample, and 32% knew they could withdraw their consent; 6% were dissatisfied with the information they had received; and 85% accepted surrogate decisions by Research Ethics Committees.

Discussion: The ethics policy constitutes a particular naming and framing of moral problems in biobank-based research which overemphasises the need for informed consent, and underemphasises other concerns of potential donors. This embodies a political transformation where access to stored blood and medical information is negotiated in ethical terms, while it also has unacknowledged political implications. In particular, the relations between authorities and citizens in the Swedish welfare state are apparently transforming: from mutual obligation to individual contracts.

Conclusion: Anthropology contributes to medical ethics with increased awareness of the practical implications of particular research ethical initiatives. This awareness promotes appreciation of the political implications of ethics policies and raises new issues for further consideration.

Publisher
123 p.
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 929
Keyword
Medical ethics, empirical ethics, social anthropology, policy, informed consent, stored human tissue
Research subject
Ethics
Identifiers
urn:nbn:se:umu:diva-358 (URN)91-7305-767-3 (ISBN)
Public defence
2004-12-11, Sal D, Tandläkarhögskolan 9 tr., Norrlands universitetssjukhus, Umeå, 00:00 (English)
Opponent
Available from: 2004-11-11 Created: 2004-11-11 Last updated: 2010-05-07Bibliographically approved

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