| Informed consent procedure for clinical trials in emergency settings: the Polish perspective. | |
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MedLine Citation:
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PMID: 18210227 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients' to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants' consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant's consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. |
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Authors:
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Piotr S Iwanowski |
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Publication Detail:
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Type: Journal Article Date: 2007-07-28 |
Journal Detail:
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Title: Science and engineering ethics Volume: 13 ISSN: 1353-3452 ISO Abbreviation: Sci Eng Ethics Publication Date: 2007 Sep |
Date Detail:
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Created Date: 2008-01-22 Completed Date: 2008-02-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9516228 Medline TA: Sci Eng Ethics Country: England |
Other Details:
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Languages: eng Pagination: 333-6 Citation Subset: E; IM |
Affiliation:
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Association for Good Clinical Practice in Poland, ul. Postepu 18 (Neptun), Warszawa, 02-676, Poland. piotr.iwanowski@pl.mailgrs.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic
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ethics* Emergency Medicine* / ethics Ethics, Research Europe Humans Informed Consent / ethics*, legislation & jurisprudence* International Cooperation Poland |
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