| Number-8-wire ethics: a New Zealand ethics committee's response to lengthy international clinical trial information sheets. | |
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MedLine Citation:
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PMID: 19448792 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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USA dominance of international clinical trials mandates complex and lengthy participant information sheets and limits the amount of scrutiny New Zealand ethics committees can have over information sheets form or content. This paper provides an alternative exemplar: a summary of a lengthy participant information sheet written in less than one page, inviting potential participants to read the lengthy document. The succinct invitation provides participants with sufficient information to decline to read the lengthy document or better informs the reading of the longer document. Equally, the one-page letter permits New Zealand ethics committees, researchers, study coordinators, and Maori consultation groups to comment and alter the informed consent process without compromising rigid FDA prescriptions for clinical trial research. |
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Authors:
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Martin Tolich; Jonas Hapuku |
Publication Detail:
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Type: Journal Article Date: 2009-04-24 |
Journal Detail:
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Title: The New Zealand medical journal Volume: 122 ISSN: 1175-8716 ISO Abbreviation: N. Z. Med. J. Publication Date: 2009 Apr |
Date Detail:
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Created Date: 2009-05-18 Completed Date: 2009-06-15 Revised Date: 2010-10-22 |
Medline Journal Info:
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Nlm Unique ID: 0401067 Medline TA: N Z Med J Country: New Zealand |
Other Details:
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Languages: eng Pagination: 3567 Citation Subset: IM |
Affiliation:
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Department of Anthropology, Gender and Sociology, University of Otago, PO Box 56, Dunedin, New Zealand. martin.tolich@otago.ac.nz |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Biomedical Research
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ethics Clinical Trials as Topic / ethics*, standards* Confidentiality / ethics Consent Forms / ethics, standards* Ethics Committees Female Government Regulation Humans International Cooperation Male New Zealand Patient Participation Patient Selection / ethics* United States |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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