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

BACKGROUND: 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 bee...

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Autores principales: Colledge, Flora, De Massougnes, Sophie, Elger, Bernice
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260886/
https://www.ncbi.nlm.nih.gov/pubmed/30477493
http://dx.doi.org/10.1186/s12910-018-0331-0
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author Colledge, Flora
De Massougnes, Sophie
Elger, Bernice
author_facet Colledge, Flora
De Massougnes, Sophie
Elger, Bernice
author_sort Colledge, Flora
collection PubMed
description BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12910-018-0331-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-62608862018-12-10 Consent requirements for research with human tissue: Swiss ethics committee members disagree Colledge, Flora De Massougnes, Sophie Elger, Bernice BMC Med Ethics Research Article BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12910-018-0331-0) contains supplementary material, which is available to authorized users. BioMed Central 2018-11-26 /pmc/articles/PMC6260886/ /pubmed/30477493 http://dx.doi.org/10.1186/s12910-018-0331-0 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Colledge, Flora
De Massougnes, Sophie
Elger, Bernice
Consent requirements for research with human tissue: Swiss ethics committee members disagree
title Consent requirements for research with human tissue: Swiss ethics committee members disagree
title_full Consent requirements for research with human tissue: Swiss ethics committee members disagree
title_fullStr Consent requirements for research with human tissue: Swiss ethics committee members disagree
title_full_unstemmed Consent requirements for research with human tissue: Swiss ethics committee members disagree
title_short Consent requirements for research with human tissue: Swiss ethics committee members disagree
title_sort consent requirements for research with human tissue: swiss ethics committee members disagree
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260886/
https://www.ncbi.nlm.nih.gov/pubmed/30477493
http://dx.doi.org/10.1186/s12910-018-0331-0
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