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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
Cites: JAMA. 2000 Jan 19;283(3):373-8010647801
Cites: J Law Med Ethics. 1997 Summer-Fall;25(2-3):98-110, 8211066504
Cites: CMAJ. 2000 Oct 31;163(9):1146-811079059
Cites: CMAJ. 2002 Aug 20;167(4):393-612197705
Cites: BMJ. 2003 Feb 15;326(7385):37312586673
Cites: CMAJ. 2003 Jul 8;169(1):5, 712847016
Cites: CMAJ. 1998 Oct 20;159(8):997-10169834730
Comment In: CMAJ. 2004 Sep 28;171(7):711-2; author reply 71215451823
PubMed ID
14993178 View in PubMed
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Transparency in drug regulation: mirage or oasis?

https://arctichealth.org/en/permalink/ahliterature177289
Source
CMAJ. 2004 Nov 23;171(11):1363-5
Publication Type
Article
Date
Nov-23-2004
Author
Joel Lexchin
Barbara Mintzes
Author Affiliation
Emergency Department, University Health Network, School of Health Policy and Management, York University, Toronto, Ont. joel.lexchin@utoronto.ca
Source
CMAJ. 2004 Nov 23;171(11):1363-5
Date
Nov-23-2004
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Antidepressive Agents - therapeutic use
Bias (epidemiology)
Canada
Cardiovascular Diseases - chemically induced
Clinical Trials as Topic - standards
Cyclooxygenase Inhibitors - adverse effects
Drug Approval - organization & administration
Drug Industry - legislation & jurisprudence
Hormone Replacement Therapy - adverse effects
Humans
Publishing - standards
Pyrazoles
Sulfonamides - adverse effects
Notes
Cites: JAMA. 2001 Nov 21;286(19):2398-40011712925
Cites: Lancet. 2000 Feb 12;355(9203):566-910683020
Cites: JAMA. 2000 Sep 13;284(10):1247-5510979111
Cites: JAMA. 2001 Nov 21;286(19):2398; author reply 2399-40011712924
Cites: BMJ. 1997 Jul 19;315(7101):149-539251544
Cites: JAMA. 2002 Jul 17;288(3):321-3312117397
Cites: BMJ. 2003 May 31;326(7400):1171-312775615
Cites: BMJ. 2004 Feb 28;328(7438):518-2014988197
Comment In: CMAJ. 2005 Jun 21;172(13):1664; author reply 1664-515967953
PubMed ID
15557590 View in PubMed
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