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Access and benefits sharing of genetic resources and associated traditional knowledge in northern Canada: understanding the legal environment and creating effective research agreements

https://arctichealth.org/en/permalink/ahliterature284320
Source
Pages 912-920 in N. Murphy and A. Parkinson, eds. Circumpolar Health 2012: Circumpolar Health Comes Full Circle. Proceedings of the 15th International Congress on Circumpolar Health, Fairbanks, Alaska, USA, August 5-10, 2012. International Journal of Circumpolar Health 2013;72 (Suppl 1):912-920
Publication Type
Article
Date
2013
  1 document  
Author
Geary J1, Jardine CG, Guebert J, Bubela T.
Author Affiliation
School of Public Health, University of Alberta, Edmonton, Canada
Source
Pages 912-920 in N. Murphy and A. Parkinson, eds. Circumpolar Health 2012: Circumpolar Health Comes Full Circle. Proceedings of the 15th International Congress on Circumpolar Health, Fairbanks, Alaska, USA, August 5-10, 2012. International Journal of Circumpolar Health 2013;72 (Suppl 1):912-920
Date
2013
Publication Type
Article
Digital File Format
Text - PDF
Physical Holding
University of Alaska Anchorage
Keywords
Access to Information/legislation & jurisprudence
Biomedical Research/legislation & jurisprudence
Biomedical Research/organization & administration
Canada
Community-Institutional Relations/legislation & jurisprudence
Culture
Financing, Government
Genetics, Medical/legislation & jurisprudence
Genetics, Medical/organization & administration
Health Policy
Humans
Indians, North American/ethnology
Indians, North American/genetics
Indians, North American/legislation & jurisprudence
Documents
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Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts.

https://arctichealth.org/en/permalink/ahliterature279361
Source
Biopreserv Biobank. 2016 Jun;14(3):201-6
Publication Type
Article
Date
Jun-2016
Author
Jane Kaye
Linda Briceño Moraia
Colin Mitchell
Jessica Bell
Jasper Adriaan Bovenberg
Anne-Marie Tassé
Bartha Maria Knoppers
Source
Biopreserv Biobank. 2016 Jun;14(3):201-6
Date
Jun-2016
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence - organization & administration
Biomedical Research - legislation & jurisprudence
Cooperative Behavior
Databases, Factual
European Union
Finland
Germany
Humans
Information Dissemination - legislation & jurisprudence
Interprofessional Relations
Netherlands
Norway
United Kingdom
Abstract
Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy "harmonization." Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes.
PubMed ID
27183185 View in PubMed
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Actors involved in the regulation of clinical research: comparison of Finland to England, Canada, and the USA.

https://arctichealth.org/en/permalink/ahliterature269574
Source
Health Res Policy Syst. 2015;13:20
Publication Type
Article
Date
2015
Author
Elina Hemminki
Source
Health Res Policy Syst. 2015;13:20
Date
2015
Language
English
Publication Type
Article
Keywords
Administrative Personnel
Biomedical Research - legislation & jurisprudence
Canada
Conflict of Interest
Drug and Narcotic Control
England
Ethics Committees, Research
Finland
Government Regulation
Interviews as Topic
Qualitative Research
United States
Abstract
The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011.
Several approaches and data sources were used, including semi- or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones.
Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics.
This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action.
Notes
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Cites: Clin Pharmacol Ther. 2012 Mar;91(3):535-4122318614
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Cites: Health Res Policy Syst. 2013;11:1723680289
Cites: Lancet. 2014 Jan 11;383(9912):176-8524411646
Cites: Health Res Policy Syst. 2014;12:1524666735
Cites: J Med Ethics. 2014 Jun;40(6):409-1323665856
PubMed ID
25888977 View in PubMed
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Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project.

https://arctichealth.org/en/permalink/ahliterature279368
Source
Biopreserv Biobank. 2016 Jun;14(3):195-200
Publication Type
Article
Date
Jun-2016
Author
Jane Kaye
Linda Briceño Moraia
Liam Curren
Jessica Bell
Colin Mitchell
Sirpa Soini
Nils Hoppe
Morten Øien
Emmanuelle Rial-Sebbag
Source
Biopreserv Biobank. 2016 Jun;14(3):195-200
Date
Jun-2016
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence
Biomedical Research - legislation & jurisprudence - organization & administration
Consent Forms - organization & administration
Ethics Committees, Research - legislation & jurisprudence
European Union - organization & administration
Finland
France
Germany
Humans
Netherlands
Norway
United Kingdom
Abstract
Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue regulation. In the absence of harmonized regulation, there is considerable scope for national legal variation. This article analyzes the legislative frameworks that apply to biobanking activities to identify differences in legal requirements between the BioSHaRE-EU project countries: Finland, France, Germany, the Netherlands, Norway, and the United Kingdom. This article highlights the primary role of consent and accompanying governance mechanisms, such as research ethics committee oversight, which enable consent exemptions in the context of research. Our analysis identifies a complicated legal landscape, whereby broadly similar provisions are contained in varied sources of law in each jurisdiction. The challenge for researchers is locating the applicable legal provisions within each national legal framework.
PubMed ID
27145287 View in PubMed
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Did the Health Research Act turn out as intended?

https://arctichealth.org/en/permalink/ahliterature264787
Source
Tidsskr Nor Laegeforen. 2015 May 5;135(8):731
Publication Type
Article
Date
May-5-2015
Author
Geir Wenberg Jacobsen
Source
Tidsskr Nor Laegeforen. 2015 May 5;135(8):731
Date
May-5-2015
Language
English
Norwegian
Publication Type
Article
Keywords
Biomedical Research - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Humans
Legislation, Medical - standards
Norway
PubMed ID
25947583 View in PubMed
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The effect of privacy legislation on observational research.

https://arctichealth.org/en/permalink/ahliterature158151
Source
CMAJ. 2008 Mar 25;178(7):871-3
Publication Type
Article
Date
Mar-25-2008
Author
Andrea S Gershon
Jack V Tu
Author Affiliation
Department of Medicine, University of Toronto and the Institute for Clinical Evaluative Sciences, Toronto, Ont. andrea.gershon@utoronto.ca
Source
CMAJ. 2008 Mar 25;178(7):871-3
Date
Mar-25-2008
Language
English
Publication Type
Article
Keywords
Biomedical Research - legislation & jurisprudence
Canada
Confidentiality - legislation & jurisprudence
Humans
Informed Consent - legislation & jurisprudence
Medical Records - legislation & jurisprudence
Patient Advocacy - legislation & jurisprudence
Notes
Cites: Health Serv Res. 1999 Apr;34(1 Pt 2):417-2510199685
Cites: BMJ. 2005 Apr 16;330(7496):877-915778230
Cites: BMC Health Serv Res. 2003 Nov 18;3(1):2114622444
Cites: N Engl J Med. 2004 Aug 5;351(6):612-4; author reply 612-415295059
Cites: BMJ. 2004 May 1;328(7447):1029-3015117769
Cites: Arch Fam Med. 2000 Nov-Dec;9(10):1111-811115216
Cites: BMJ. 2002 May 18;324(7347):1210-312016192
Cites: N Engl J Med. 2004 Apr 1;350(14):1414-2115070791
Cites: J Fam Pract. 1998 Nov;47(5):361-59834771
PubMed ID
18362384 View in PubMed
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Family privacy and death--Antigone, war, and medical research.

https://arctichealth.org/en/permalink/ahliterature176331
Source
N Engl J Med. 2005 Feb 3;352(5):501-5
Publication Type
Article
Date
Feb-3-2005

Freedom to be altruistic: allowing for risk/knowledge ratios in decisions concerning multiple sclerosis research.

https://arctichealth.org/en/permalink/ahliterature129974
Source
Open Med. 2011;5(1):e26-7
Publication Type
Article
Date
2011

The future of health research is hanging in the balance.

https://arctichealth.org/en/permalink/ahliterature160677
Source
CMAJ. 2007 Oct 23;177(9):1057-8
Publication Type
Article
Date
Oct-23-2007
Author
Christopher J Paige
Author Affiliation
University Health Network in Toronto, Toronto, Ont. paige@uhnresearch.ca
Source
CMAJ. 2007 Oct 23;177(9):1057-8
Date
Oct-23-2007
Language
English
Publication Type
Article
Keywords
Biomedical Research - legislation & jurisprudence
Canada
Health Knowledge, Attitudes, Practice
Humans
Politics
Questionnaires
Research Support as Topic - legislation & jurisprudence
Notes
Cites: CMAJ. 2007 Oct 23;177(9):1045-5117954894
Comment On: CMAJ. 2007 Oct 23;177(9):1045-5117954894
PubMed ID
17954896 View in PubMed
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16 records – page 1 of 2.