Consent requirements for research with human tissue: Swiss ethics committee members disagree.

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_A5AA862B13F1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Consent requirements for research with human tissue: Swiss ethics committee members disagree.
Journal
BMC medical ethics
Author(s)
Colledge F., De Massougnes S., Elger B.
ISSN
1472-6939 (Electronic)
ISSN-L
1472-6939
Publication state
Published
Issued date
26/11/2018
Peer-reviewed
Oui
Volume
19
Number
1
Pages
93
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee (REC) before it can be allowed to take place. However, as the demand for such tissue has rapidly increased in recent years, and biobanks have been created to meet these needs, committees have had to deal with a growing number of such demands. Detailed instructions for evaluating every kind of tissue request are scarce. Committees charged with evaluating research protocols therefore sometimes face uncertainty in their decision-making.
We examine how a pool of Swiss REC members deal with a number of cases involving human tissue, in order to determine the standards they adhere to, and their understanding and implementation of existing laws and guidelines.
There is considerable divergence in the approaches and decisions of Swiss REC members regarding human tissue sample requests, particularly concerning the issue of informed consent. Despite recent trends towards less strict consent requirements for biosample research, many of our respondents continue to employ demanding standards for researchers. The question of informed consent, and the circumstances in which it is required, continues to result in differences of opinion.
While room for local and cultural interpretation is essential to the workings of an REC, misunderstanding of existing guidelines, or an absence of regulation in sensitive areas, will only lead to suboptimal functioning of the REC itself. Our data suggests that there is uncertainty and disagreement on the question of consent for human tissue sample, which existing laws and guidelines may not fully clarify. Methods to address these uncertainties should be implemented in order to ensure efficient and harmonious review of research protocols.
Keywords
Ethics committee, Informed consent, Institutional review board
Pubmed
Web of science
Open Access
Yes
Create date
04/01/2019 14:22
Last modification date
20/08/2019 15:10
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