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14 records – page 1 of 2.

Source
Nature. 2005 Oct 6;437(7060):794-5
Publication Type
Article
Date
Oct-6-2005
Source
Nature. 2005 Oct 6;437(7060):794-5
Date
Oct-6-2005
Language
English
Publication Type
Article
Keywords
Alaska
Biomedical Research - ethics - legislation & jurisprudence
Bioterrorism - prevention & control
Evolution, Molecular
Female
History, 20th Century
Humans
Influenza, Human - epidemiology - history - prevention & control - virology
Orthomyxoviridae - genetics - pathogenicity
Publishing
Time Factors
Virulence - genetics
Virulence Factors
Notes
Comment In: Nature. 2006 Jan 19;439(7074):26616421546
Comment On: Nature. 2005 Oct 6;437(7060):889-9316208372
Erratum In: Nature. 2005 Oct 13;437(7061):940
PubMed ID
16208326 View in PubMed
Less detail

Consent procedures in pediatric biobanks.

https://arctichealth.org/en/permalink/ahliterature273261
Source
Eur J Hum Genet. 2015 Sep;23(9):1129-34
Publication Type
Article
Date
Sep-2015
Author
Giesbertz NA
Bredenoord AL
van Delden JJ
Source
Eur J Hum Genet. 2015 Sep;23(9):1129-34
Date
Sep-2015
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - ethics
Biomedical Research - ethics - legislation & jurisprudence
Child
Confidentiality - ethics - legislation & jurisprudence
Female
Great Britain
Health Knowledge, Attitudes, Practice
Humans
International Cooperation
Male
Motivation - ethics
Netherlands
Norway
Parent-Child Relations
Parental Consent - ethics - legislation & jurisprudence
Pediatrics
Surveys and Questionnaires
Abstract
The inclusion of children's samples in biobanks brings forward specific ethical issues. Guidelines indicate that children should be involved in the consent procedure. It is, however, unclear how to allocate an appropriate role for children. Knowledge of current practice will be helpful in addressing this issue. Therefore, we conducted an international multiple-case study on the child's role in consent procedures in pediatric biobanks. Four biobanks were included: (1) LifeLines, (2) Prevention and Incidence of Asthma and Mite Allergy (PIAMA), (3) Young-HUNT3 and (4) the Oxford Radcliffe Biobank contribution to the Children's Cancer and Leukaemia Group tissue bank (ORB/CCLG). Four themes linked to the child's role in the consent procedure emerged from the multiple-case study: (1) motives to involve the child, (2) informing the child, (3) the role of dissent, assent and consent and (4) voluntariness of children to participate. We conclude that biobank characteristics influence the biobank's motives to include children in the consent procedure. Moreover, the motives to include children influence how the children are involved in the consent procedure, and the extent to which children are able to make voluntary decisions as part of the consent procedure. This insight is valuable when designing pediatric biobank governance.
Notes
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PubMed ID
25537361 View in PubMed
Less detail

Constructing populations in biobanking.

https://arctichealth.org/en/permalink/ahliterature272957
Source
Life Sci Soc Policy. 2015;11:5
Publication Type
Article
Date
2015
Author
Aaro Tupasela
Karoliina Snell
Jose A Cañada
Source
Life Sci Soc Policy. 2015;11:5
Date
2015
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - ethics - legislation & jurisprudence - standards - trends
Biomedical Research - ethics - legislation & jurisprudence
Consumer Participation
Denmark
European Union
Genomics
Humans
Informed Consent - ethics
Policy Making
Public Opinion
Public Policy - legislation & jurisprudence
Quality Control
Social Responsibility
Abstract
This article poses the question of whether biobanking practices and standards are giving rise to the construction of populations from which various biobanking initiatives increasingly draw on for legitimacy? We argue that although recent biobanking policies encourage various forms of engagement with publics to ensure legitimacy, different biobanks conceptualize their engagement strategies very differently. We suggest that biobanks undertake a broad range of different strategies with regard to engagement. We argue that these different approaches to engagement strategies are contributing to the construction of populations, whereby specific nationalities, communities, societies, patient groups and political systems become imbued or bio-objectified with particular characteristics, such as compliant, distant, positive, commercialized or authoritarian. This bio-objectification process is problematic in relation to policy aspirations ascribed to biobanking engagement since it gives rise to reified notions of different populations.
Notes
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PubMed ID
26194269 View in PubMed
Less detail
Source
Tidsskr Nor Laegeforen. 2010 May 20;130(10):1044-5
Publication Type
Article
Date
May-20-2010
Author
Arild Hals
Author Affiliation
Regional komité for medisinsk og helsefaglig forskning, Midt-Norge Medisinsk teknisk forskningssenter, Norges teknisk-naturvitenskapelige universitet, 7489 Trondheim, Norway.
Source
Tidsskr Nor Laegeforen. 2010 May 20;130(10):1044-5
Date
May-20-2010
Language
Norwegian
Publication Type
Article
Keywords
Biomedical Research - ethics - legislation & jurisprudence
Confidentiality - ethics - legislation & jurisprudence
Ethics, Research
European Union
Guidelines as Topic
Humans
Norway
Registries - standards
PubMed ID
20489809 View in PubMed
Less detail

[External regulation of clinical research requires a change].

https://arctichealth.org/en/permalink/ahliterature265713
Source
Duodecim. 2015;131(7):663-70
Publication Type
Article
Date
2015
Author
Elina Hemminki
Source
Duodecim. 2015;131(7):663-70
Date
2015
Language
Finnish
Publication Type
Article
Keywords
Biomedical Research - ethics - legislation & jurisprudence
Codes of Ethics
England
Ethical Review
Ethics Committees, Research - legislation & jurisprudence
Ethics, Research
Finland
Government Regulation
Humans
Interviews as Topic
Ontario
United States
Abstract
Key findings and recommendations from a study comparing clinical research regulation in Finland with those in England, Canada (Ontario) and USA are presented. Data were collected with various methods, including interviewing key experts. While the norms and ethical codes were similar, the interpretation partly differed. In each country there were various actors in regulation and practical arrangements differed. Research ethics committees (REC) were crucial, as well as drug authorities in research with drugs. Recommendations include reforming the medical research law, widening the dimensions of ethics judgment, restricting the REC tasks, including a central committee, and introducing quality assurance and restricting the drug control authority tasks.
PubMed ID
26233984 View in PubMed
Less detail

Incentives for research participation: policy and practice from Canadian corrections.

https://arctichealth.org/en/permalink/ahliterature123450
Source
Am J Public Health. 2012 Aug;102(8):1438-42
Publication Type
Article
Date
Aug-2012
Author
Flora I Matheson
Pamela Forrester
Amanda Brazil
Sherri Doherty
Lindy Affleck
Author Affiliation
Centre for Research on Inner City Health, St Michael's Hospital, the Dalla Lana School of Public Health, University of Toronto, and the Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. mathesonf@smh.ca
Source
Am J Public Health. 2012 Aug;102(8):1438-42
Date
Aug-2012
Language
English
Publication Type
Article
Keywords
Adult
Biomedical Research - ethics - legislation & jurisprudence
Canada
Government Regulation
Guidelines as Topic
Health Policy - legislation & jurisprudence
Human Experimentation - ethics - legislation & jurisprudence
Humans
Prisoners - legislation & jurisprudence
Questionnaires
Abstract
We explored current policies and practices on the use of incentives in research involving adult offenders under correctional supervision in prison and in the community (probation and parole) in Canada. We contacted the correctional departments of each of the Canadian provinces and territories, as well as the federal government department responsible for offenders serving sentences of two years or more. Findings indicated that two departments had formal policy whereas others had unwritten practices, some prohibiting their use and others allowing incentives on a case-by-case basis. Given the differences across jurisdictions, it would be valuable to examine how current incentive policies and practices are implemented to inform national best practices on incentives for offender-based research.
Notes
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Cites: Am J Med Sci. 2011 Oct;342(4):290-321817878
PubMed ID
22698018 View in PubMed
Less detail

Individual genetic and genomic research results and the tradition of informed consent: exploring US review board guidance.

https://arctichealth.org/en/permalink/ahliterature126746
Source
J Med Ethics. 2012 Jul;38(7):417-22
Publication Type
Article
Date
Jul-2012
Author
Christian Simon
Laura A Shinkunas
Debra Brandt
Janet K Williams
Author Affiliation
Department of Internal Medicine, University of Iowa, Roy J. and Lucille A. Carver School of Medicine, 500 Newton Drive, 1-103 MEB, Iowa City, IA 52242-1190, USA. christian-simon@uiowa.edu
Source
J Med Ethics. 2012 Jul;38(7):417-22
Date
Jul-2012
Language
English
Publication Type
Article
Keywords
Biomedical Research - ethics - legislation & jurisprudence
Canada
Data Collection - ethics - legislation & jurisprudence
Disclosure - ethics - legislation & jurisprudence
Ethics Committees, Research - ethics - legislation & jurisprudence
Europe
Genomics - ethics - legislation & jurisprudence
Humans
Incidental Findings
Informed Consent - ethics - legislation & jurisprudence
United States
Abstract
Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond.
To explore publicly accessible IRB websites for guidance in this area, using summative content analysis.
Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of 'significant new findings' (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level.
IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined.
PubMed ID
22361295 View in PubMed
Less detail

Legal and ethical issues in ART "outcomes" research.

https://arctichealth.org/en/permalink/ahliterature167004
Source
Health Law J. 2005;13:165-86
Publication Type
Article
Date
2005
Author
Erin L Nelson
Author Affiliation
Faculty of Law and Research Associate, Health Law Institute, University of Alberta.
Source
Health Law J. 2005;13:165-86
Date
2005
Language
English
Publication Type
Article
Keywords
Biomedical Research - ethics - legislation & jurisprudence
Canada
Humans
Informed Consent - legislation & jurisprudence
Outcome Assessment (Health Care)
Prospective Studies
Reproductive Techniques, Assisted
PubMed ID
17044326 View in PubMed
Less detail

Medical research on minors in Finland.

https://arctichealth.org/en/permalink/ahliterature154374
Source
Eur J Health Law. 2008 Jul;15(2):135-44
Publication Type
Article
Date
Jul-2008
Author
Salla Lötjönen
Author Affiliation
University of Helsinki, Finland.
Source
Eur J Health Law. 2008 Jul;15(2):135-44
Date
Jul-2008
Language
English
Publication Type
Article
Keywords
Biomedical Research - ethics - legislation & jurisprudence - standards
Child
Child Welfare
Decision Making
Ethics Committees, Research
Ethics, Research
Finland
Humans
Minors - legislation & jurisprudence
Abstract
This article concerns the legal regulation of medical research on children in Finland. The topic is covered by the Medical Research Act of 1999 and by the Recommendations issued by the Working group on medical research on children in 2003. The Decisions of the Parliamentary Ombudsman also play an important role in this area in Finland. The article focuses on two specific issues: involvement of guardians in decision-making for the child, and the expansion of the right to self-determination of minors. Two case examples on these topics are also discussed. Overall, the author comes to the conclusion that the Finnish legislation, policy-makers, investigators and the industry have succeeded well in taking into account international legislation in this area, although there is also room for improvement.
PubMed ID
18988592 View in PubMed
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14 records – page 1 of 2.