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Biobanks and informed consent: An anthropological contribution to medical ethics
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
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.

Place, publisher, year, edition, pages
2004. , 123 p.
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 929
Keyword [en]
Medical ethics, empirical ethics, social anthropology, policy, informed consent, stored human tissue
Research subject
Ethics
Identifiers
URN: urn:nbn:se:umu:diva-358ISBN: 91-7305-767-3 (print)OAI: oai:DiVA.org:umu-358DiVA: diva2:143229
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
List of papers
1. “Science Is Really Needed – That’s All I Know”: Informed Consent and the Non-Verbal Practices of Collecting Blood for Genetic Research in Northern Sweden
Open this publication in new window or tab >>“Science Is Really Needed – That’s All I Know”: Informed Consent and the Non-Verbal Practices of Collecting Blood for Genetic Research in Northern Sweden
2003 (English)In: New genetics and society (Print), ISSN 1463-6778, E-ISSN 1469-9915, Vol. 22, no 3, 229-244 p.Article in journal (Refereed) Published
Abstract [en]

In Västerbotten County in northern Sweden a start-up biotech company has recently gained all commercial rights to one of the worlds largest population based research biobanks. The biobank and the company have publicly emphasized that all donors have given their informed consent to participate, but within the academy it has become debated whether people have been adequately informed. Based on anthropological fieldwork it is shown that many people do not read the information provided. The data do not, however, suggest that donors themselves perceive a lack of information. This article endeavours to make meaningful the apparent lack of interest among donors in the information they are offered. It is argued that the donation of blood should be analysed in its social and historical context rather than as a response to rational assessment of information of research purposes. It implies a conceptualisation of agency more aware of the intersubjective nature of moral negotiation than usually implied in studies of informed consent.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:umu:diva-4220 (URN)10.1080/1463677032000147199 (DOI)15115024 (PubMedID)
Available from: 2004-11-11 Created: 2004-11-11 Last updated: 2017-12-14Bibliographically approved
2. Conflicting Notions of Personhood in Genetic Research
Open this publication in new window or tab >>Conflicting Notions of Personhood in Genetic Research
2002 (English)In: Anthropology Today, ISSN 0268-540X, E-ISSN 1467-8322, Vol. 18, no 5, 9-13 p.Article in journal (Refereed) Published
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:umu:diva-4221 (URN)10.1111/1467-8322.00129 (DOI)17333599 (PubMedID)
Available from: 2004-11-11 Created: 2004-11-11 Last updated: 2017-12-14Bibliographically approved
3. Informed Consent and Biobanks: A Population-Based Study of Attitudes Towards Tissue Donation for Genetic Research
Open this publication in new window or tab >>Informed Consent and Biobanks: A Population-Based Study of Attitudes Towards Tissue Donation for Genetic Research
2004 (English)In: Scandinavian Journal of Public Health, ISSN 1403-4948, E-ISSN 1651-1905, Vol. 32, no 3, 524-529 p.Article in journal (Refereed) Published
Abstract [en]

AIMS: The procurement and usage of tissue samples has begun receiving increasing legal and ethical attention. The authors' aim was to develop an empirically based understanding of public attitudes to the use of tissue for research. METHOD: A questionnaire was distributed to a randomized sample (n=1,000) of the population in the age group 18-85 in Västerbotten County, Sweden. RESULTS: The response rate was approximately 60%. There was a general acceptance of genetic research based on biobank material (71%) but, though it is often a prerequisite for tissue-based research, a majority (62%) would not allow researchers to examine their healthcare records without specific consent. A majority (66.8%) accepted surrogate decisions by research ethical committees; 48% of the respondents estimated that they would feel respected if they were notified each time a sample was used. When compared and ranked with other issues, informed consent was a principal concern to a minority (4%) only. Should research efforts generate information on future health risks, a majority (55%) would want to be told only if treatment was available. CONCLUSION: Though genetic research in bioethical debate is often viewed as a potential threat to the integrity of the donor, the confidentiality of medical records still seems to concern donors more. Research ethical committees have support in the majority of the population for some surrogate decisions. The current emphasis on the question of informed consent in policy making for biobank-based research does not seem to be reflected unambiguously in the concerns of the general public.

Keyword
biological specimen banks, informed consent, public opinion, research ethics
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:umu:diva-4222 (URN)10.1080/14034940310019506 (DOI)15204184 (PubMedID)
Available from: 2004-11-11 Created: 2004-11-11 Last updated: 2017-12-14Bibliographically approved
4. The ethics of research using biobanks: reason to question the importance attributed to informed consent.
Open this publication in new window or tab >>The ethics of research using biobanks: reason to question the importance attributed to informed consent.
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.

Keyword
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:nbn:se:umu:diva-14701 (URN)10.1001/archinte.165.1.97 (DOI)15642883 (PubMedID)
Available from: 2007-12-03 Created: 2007-12-03 Last updated: 2017-12-14Bibliographically approved
5. Motivating donors to genetic research? Anthropological reasons to rethink the role of informed consent.
Open this publication in new window or tab >>Motivating donors to genetic research? Anthropological reasons to rethink the role of informed consent.
2006 (English)In: Medicine, Health care and Philosophy, ISSN 1386-7423, E-ISSN 1572-8633, Vol. 9, no 1, 13-23 p.Article in journal (Refereed) Published
Abstract [en]

In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors' motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:umu:diva-19463 (URN)10.1007/s11019-005-5067-1 (DOI)16645794 (PubMedID)
Available from: 2009-03-05 Created: 2009-03-05 Last updated: 2017-12-13Bibliographically approved

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