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Research ethics committees: agents of research policy?

The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials. DISCUSSION: The Finnish law makes an arbitrary distinction between medical research and other health research, and...

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Autor principal: Hemminki, Elina
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2005
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1262747/
https://www.ncbi.nlm.nih.gov/pubmed/16202153
http://dx.doi.org/10.1186/1478-4505-3-6
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author Hemminki, Elina
author_facet Hemminki, Elina
author_sort Hemminki, Elina
collection PubMed
description The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials. DISCUSSION: The Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug trials. The starting point of current rules is that clinical trials are lesser in the interest of patients and society than routine health care. However, commercial interests are not considered unethical. The contrasting procedures in research and normal health care may tempt physicians to continue introducing innovations into practice by relying on unsystematic and uncontrolled observations. Tedious and bureaucratic rules may lead to the disappearance of trials initiated by researchers. Trying to accommodate the special legislative requirements for new drug trials into more complex interventions may result in poor designs with unreliable results and increased costs. Meanwhile, current legal requirements may undermine the morale of ethics committee members. CONCLUSION: The aims and the quality of the work of ethics committees should be evaluated, and a reformulation of the EU directive on good clinical trials is needed. Ethical judgement should consider the specific circumstance of each trial, and ethics committees should not foster poor research for legal reasons.
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spelling pubmed-12627472005-10-22 Research ethics committees: agents of research policy? Hemminki, Elina Health Res Policy Syst Commentary The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials. DISCUSSION: The Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug trials. The starting point of current rules is that clinical trials are lesser in the interest of patients and society than routine health care. However, commercial interests are not considered unethical. The contrasting procedures in research and normal health care may tempt physicians to continue introducing innovations into practice by relying on unsystematic and uncontrolled observations. Tedious and bureaucratic rules may lead to the disappearance of trials initiated by researchers. Trying to accommodate the special legislative requirements for new drug trials into more complex interventions may result in poor designs with unreliable results and increased costs. Meanwhile, current legal requirements may undermine the morale of ethics committee members. CONCLUSION: The aims and the quality of the work of ethics committees should be evaluated, and a reformulation of the EU directive on good clinical trials is needed. Ethical judgement should consider the specific circumstance of each trial, and ethics committees should not foster poor research for legal reasons. BioMed Central 2005-10-04 /pmc/articles/PMC1262747/ /pubmed/16202153 http://dx.doi.org/10.1186/1478-4505-3-6 Text en Copyright © 2005 Hemminki; 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 cited.
spellingShingle Commentary
Hemminki, Elina
Research ethics committees: agents of research policy?
title Research ethics committees: agents of research policy?
title_full Research ethics committees: agents of research policy?
title_fullStr Research ethics committees: agents of research policy?
title_full_unstemmed Research ethics committees: agents of research policy?
title_short Research ethics committees: agents of research policy?
title_sort research ethics committees: agents of research policy?
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1262747/
https://www.ncbi.nlm.nih.gov/pubmed/16202153
http://dx.doi.org/10.1186/1478-4505-3-6
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