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Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland

BACKGROUND: To present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012. METHODS: Notes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulatio...

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Autores principales: Hemminki, Elina, Virtanen, Jorma I, Veerus, Piret
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987656/
https://www.ncbi.nlm.nih.gov/pubmed/24666735
http://dx.doi.org/10.1186/1478-4505-12-15
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author Hemminki, Elina
Virtanen, Jorma I
Veerus, Piret
author_facet Hemminki, Elina
Virtanen, Jorma I
Veerus, Piret
author_sort Hemminki, Elina
collection PubMed
description BACKGROUND: To present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012. METHODS: Notes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulation of clinical research and patient care were addressed. REC chairpersons’ opinions on three imaginary cases of clinical research projects challenging current research ethics rules (vignettes) were requested with a questionnaire; 18 of the 22 interviewed chairpersons responded. RESULTS: Based on REC chairpersons’ interviews, the differences between care and research regulation were not considered important issues in Finland. In the vignettes, REC chairpersons’ assumptions on how their REC would decide varied in regard to allowing research without informed consent, while solutions that are not allowed by current law were even anticipated. Mostly, but not always, the chairpersons’ own personal view agreed with their REC. CONCLUSIONS: The distinction between care and research regulation has not been publicly challenged by Finnish RECs, even though it is a challenge when research relevant to health care is carried out. There is a need for debate and changes in laws and practices.
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spelling pubmed-39876562014-04-16 Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland Hemminki, Elina Virtanen, Jorma I Veerus, Piret Health Res Policy Syst Research BACKGROUND: To present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012. METHODS: Notes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulation of clinical research and patient care were addressed. REC chairpersons’ opinions on three imaginary cases of clinical research projects challenging current research ethics rules (vignettes) were requested with a questionnaire; 18 of the 22 interviewed chairpersons responded. RESULTS: Based on REC chairpersons’ interviews, the differences between care and research regulation were not considered important issues in Finland. In the vignettes, REC chairpersons’ assumptions on how their REC would decide varied in regard to allowing research without informed consent, while solutions that are not allowed by current law were even anticipated. Mostly, but not always, the chairpersons’ own personal view agreed with their REC. CONCLUSIONS: The distinction between care and research regulation has not been publicly challenged by Finnish RECs, even though it is a challenge when research relevant to health care is carried out. There is a need for debate and changes in laws and practices. BioMed Central 2014-03-25 /pmc/articles/PMC3987656/ /pubmed/24666735 http://dx.doi.org/10.1186/1478-4505-12-15 Text en Copyright © 2014 Hemminki et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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
Hemminki, Elina
Virtanen, Jorma I
Veerus, Piret
Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland
title Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland
title_full Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland
title_fullStr Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland
title_full_unstemmed Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland
title_short Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland
title_sort varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in finland
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987656/
https://www.ncbi.nlm.nih.gov/pubmed/24666735
http://dx.doi.org/10.1186/1478-4505-12-15
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