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Genomic Databases and Biobanks in Denmark.

https://arctichealth.org/en/permalink/ahliterature280292
Source
J Law Med Ethics. 2015;43(4):743-53
Publication Type
Article
Date
2015
Author
Mette Hartlev
Source
J Law Med Ethics. 2015;43(4):743-53
Date
2015
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Biological Specimen Banks - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Databases, Genetic - legislation & jurisprudence
Denmark
Genetic Research - legislation & jurisprudence
Humans
Abstract
Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention.
PubMed ID
26711414 View in PubMed
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The confidentiality of patient and physician information in pharmacy prescription records.

https://arctichealth.org/en/permalink/ahliterature181323
Source
CMAJ. 2004 Mar 2;170(5):815-6
Publication Type
Article
Date
Mar-2-2004
Author
Dick E Zoutman
B Douglas Ford
Assil R Bassili
Author Affiliation
Department of Pathology and Molecular Medicine, Queen's University, 76 Stuart Street, Kingston, Ontario K7L 2V7, Canada. zoutman@cliff.path.queensu.ca
Source
CMAJ. 2004 Mar 2;170(5):815-6
Date
Mar-2-2004
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Canada
Confidentiality - legislation & jurisprudence
Disclosure - legislation & jurisprudence
Drug Prescriptions
Humans
Informed Consent - legislation & jurisprudence
Medical Records Systems, Computerized - legislation & jurisprudence
Pharmacy
Physician-Patient Relations
Notes
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Comment In: CMAJ. 2004 Sep 28;171(7):711-2; author reply 71215451823
PubMed ID
14993178 View in PubMed
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Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results.

https://arctichealth.org/en/permalink/ahliterature131803
Source
CMAJ. 2012 Feb 7;184(2):194-9
Publication Type
Article
Date
Feb-7-2012
Author
Matthew Herder
Author Affiliation
Faculty of Medicine, Dalhousie University, Halifax, NS. Matthew.Herder@Dal.ca
Source
CMAJ. 2012 Feb 7;184(2):194-9
Date
Feb-7-2012
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Canada
Clinical Trials as Topic - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Drug Industry - legislation & jurisprudence
Government Agencies - legislation & jurisprudence
Humans
Mandatory Programs - legislation & jurisprudence
Off-Label Use - legislation & jurisprudence
Prescription Drugs - adverse effects
Public Policy - legislation & jurisprudence
Registries
Notes
Cites: CMAJ. 2004 Feb 17;170(4):487-914970096
Cites: Lancet. 2004 Apr 24;363(9418):1341-515110490
Cites: CMAJ. 2004 May 25;170(11):1678-8615159366
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Cites: CMAJ. 2011 Jul 12;183(10):1125-621502342
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Cites: PLoS Med. 2008 Nov 25;5(11):e217; discussion e21719067477
Cites: BMJ. 2011;342:d257021511787
Cites: BMJ. 2005 Apr 23;330(7497):956-815845980
PubMed ID
21876028 View in PubMed
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