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Impossible, impractical, and non-identifiable? : new criteria regarding consent for human tissue research in the declaration of Helsinki

Colledge, Flora and Elger, Bernice S.. (2013) Impossible, impractical, and non-identifiable? : new criteria regarding consent for human tissue research in the declaration of Helsinki. Biopreservation and biobanking, Vol. 11, H. 3. pp. 149-152.

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Official URL: http://edoc.unibas.ch/dok/A6223190

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Abstract

The 2008 revision of the Declaration of Helsinki (Declaration) includes a new paragraph dealing specifically with the standards of informed consent required for research involving identifiable human tissue samples and/or data. In cases where obtaining consent would be impossible or unduly burdensome, researchers may now proceed without it, following approval of the project by an ethics committee. This is a significant development in the Declaration, yet so far it has received little attention. We examine the implications of paragraph 25, and assess its role in the debates on proper sample handling. In particular, we question whether the use of the term “identifiable” weakens the paragraph, as its meaning depends on national context. Relying on this term to designate samples that could be traced to the donor, and therefore carry risk for that donor, is impossible if its meaning is not universally accepted. The Declaration of Helsinki is now entering a new revision phase. In order to protect sample donors, paragraph 25 should be enhanced, and the remit of the Declaration strengthened, by a more precise description of which samples and data count as identifiable.
Faculties and Departments:08 Cross-disciplinary Subjects > Ethik > Institut für Bio- und Medizinethik > Bio- und Medizinethik (Elger)
03 Faculty of Medicine > Departement Public Health > Ethik in der Medizin > Bio- und Medizinethik (Elger)
UniBasel Contributors:Colledge, Flora and Elger, Bernice Simone
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:Mary Ann Liebert
ISSN:1947-5535
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:04 Sep 2015 14:30
Deposited On:04 Sep 2015 14:30

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