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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: 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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Attitudes of different groups of women in Sweden to oocyte donation and oocyte research.

https://arctichealth.org/en/permalink/ahliterature206010
Source
Acta Obstet Gynecol Scand. 1998 Mar;77(3):317-21
Publication Type
Article
Date
Mar-1998
Author
G. Westlander
P O Janson
U. Tägnfors
C. Bergh
Author Affiliation
Department of Obstetrics and Gynaecology, Sahlgrenska Hospital, Göteborg University, Sweden.
Source
Acta Obstet Gynecol Scand. 1998 Mar;77(3):317-21
Date
Mar-1998
Language
English
Publication Type
Article
Keywords
Abortion, Therapeutic - psychology
Attitude
Cohort Studies
Female
Fertilization in Vitro - economics - legislation & jurisprudence - psychology
Humans
Infertility, Female - psychology
Oocyte Donation - economics - legislation & jurisprudence - psychology
Questionnaires
Research - legislation & jurisprudence - statistics & numerical data
Sweden
Turner Syndrome - psychology
Abstract
To evaluate attitudes of Swedish women towards oocyte donation and oocyte research.
Five different groups of women, with approximately 50 patients in each, were asked anonymously about their attitudes to legislation, tentative roles as donors or recipients, anonymity, suitable donors or recipients, research on fetuses and cadavers as a source of oocytes, age limits and economic aspects. The groups were: 1. Women undergoing IVF treatment (IVF). 2. Infertile women during work-up (INF). 3. Recently delivered women attending a maternity unit (MAT). 4. Women attending a family planning center applying for therapeutic abortion (FPC). 5. Women with Turner's syndrome (TUR).
More than 90% of women in all groups investigated advocated amendment of the law in order to permit oocyte donation. The women of infertile groups were more in favor of donating oocytes compared to women of fertile groups (p
PubMed ID
9539279 View in PubMed
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Bioethics for clinicians: 17. Conflict of interest in research, education and patient care.

https://arctichealth.org/en/permalink/ahliterature203787
Source
CMAJ. 1998 Oct 20;159(8):960-5
Publication Type
Article
Date
Oct-20-1998
Author
T. Lemmens
P A Singer
Author Affiliation
Centre for Addiction and Mental Health, Toronto, Ont. trudo.lemmens@utoronto.ca
Source
CMAJ. 1998 Oct 20;159(8):960-5
Date
Oct-20-1998
Language
English
Publication Type
Article
Keywords
Bioethics
Biomedical research
Canada
Conflict of Interest
Disclosure
Education, Medical - legislation & jurisprudence - standards
Empirical Research
Ethics, Medical
Gift Giving
Health Policy
Humans
Patient Care - standards
Research - legislation & jurisprudence - standards
Social Control, Formal
Trust
Truth Disclosure
Abstract
A conflict of interest occurs in a situation in which professional judgement regarding a primary interest, such as research, education or patient care, may be unduly influenced by a secondary interest, such as financial gain or personal prestige. Conflicts of interest exist in every walk of life, including medicine and science. There is nothing inherently unethical in finding oneself in a conflict of interest. Rather, the key questions are whether one recognizes the conflict and how one deals with it. Strategies include disclosing the conflict, establishing a system of review and authorization, and prohibiting the activities that lead to the conflict.
Notes
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Comment In: CMAJ. 1999 Mar 23;160(6):78410189418
PubMed ID
9834723 View in PubMed
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[Cause of death registry--an important data source for medical research].

https://arctichealth.org/en/permalink/ahliterature187057
Source
Tidsskr Nor Laegeforen. 2002 Oct 30;122(26):2551-4
Publication Type
Article
Date
Oct-30-2002
Author
Finn Gjertsen
Author Affiliation
finn.gjertsen@ssb.no
Source
Tidsskr Nor Laegeforen. 2002 Oct 30;122(26):2551-4
Date
Oct-30-2002
Language
Norwegian
Publication Type
Article
Keywords
Cause of Death
Confidentiality
Ethics, Research
Humans
Mortality
Norway - epidemiology
Public Health Informatics
Registries - classification - ethics - standards
Research - legislation & jurisprudence
Abstract
Statistics on mortality and cause of death are of crucial importance to epidemiological research. The Cause of Death Register kept by Statistics Norway is the only national register including information on cause of death for all deceased persons registered as residents in Norway at their time of death, whether death occurred in Norway or abroad. This article presents historical information and guidelines for research access to individual data on cause of death.
PubMed ID
12522884 View in PubMed
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The Circles of Care evaluation: doing participatory evaluation with American Indian and Alaska Native communities.

https://arctichealth.org/en/permalink/ahliterature178726
Source
Am Indian Alsk Native Ment Health Res. 2004;11(2):139-54
Publication Type
Article
Date
2004
Author
Pamela Jumper Thurman
James Allen
Pamela B Deters
Author Affiliation
Tri Ethnic Center for Prevention Research, Colorado State University, Ft. Collins 80523, USA. pjthurman@aol.com
Source
Am Indian Alsk Native Ment Health Res. 2004;11(2):139-54
Date
2004
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Affective Symptoms - diagnosis - psychology - therapy
Community Health Services - organization & administration - standards
Cultural Characteristics
Delivery of Health Care - legislation & jurisprudence - organization & administration
Health Planning Support
Health Services Research - legislation & jurisprudence - methods - organization & administration
Health Services, Indigenous - organization & administration
Humans
Indians, South American - statistics & numerical data
Inuits - statistics & numerical data
Terminology as Topic
United States
Abstract
Little information exists regarding mental health and special needs related to American Indian and Alaska Native (AI-AN) families. In this paper we emphasize the use of oral tradition during the Circles of Care initiative, which was essential in understanding cultural history and historical trauma of AI-ANs while giving a greater understanding of an AI-AN-based definition of severe emotional disturbance (SED). The success of these methods serves as a template for improving systems of care and may be useful in evaluation among a wide range of ethnic communities.
PubMed ID
15322981 View in PubMed
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Common sense won: engagement from experts repealed Norwegian restrictions for ICU research.

https://arctichealth.org/en/permalink/ahliterature162713
Source
Intensive Care Med. 2007 Oct;33(10):1827-8
Publication Type
Article
Date
Oct-2007

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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60 records – page 1 of 6.