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19 records – page 1 of 2.

Canadian research ethics boards and multisite research: experiences from two minimal-risk studies.

https://arctichealth.org/en/permalink/ahliterature142514
Source
IRB. 2010 May-Jun;32(3):12-8
Publication Type
Article
Author
Eric Racine
Emily Bell
Constance Deslauriers
Author Affiliation
Neuroethics Rearch Unit, Institut de recherches cliniques de Montréal, QC, Canada.
Source
IRB. 2010 May-Jun;32(3):12-8
Language
English
Publication Type
Article
Keywords
Canada
Efficiency, Organizational
Ethics Committees, Research - organization & administration
Human Experimentation - ethics
Humans
Multicenter Studies as Topic - ethics
PubMed ID
20590052 View in PubMed
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Clinical trials: the balance between protecting participants and promoting drug and product development.

https://arctichealth.org/en/permalink/ahliterature152049
Source
CMAJ. 2009 Mar 17;180(6):603-6
Publication Type
Article
Date
Mar-17-2009

Community representation: broadening the perspective and value base of research ethics boards.

https://arctichealth.org/en/permalink/ahliterature177438
Source
NCEHR Commun. 2001 Sep;11(1):11-4
Publication Type
Article
Date
Sep-2001

Cooperation or co-optation?: Assessing the methodological benefits and barriers involved in conducting qualitative research through medical institutional settings.

https://arctichealth.org/en/permalink/ahliterature175470
Source
Qual Health Res. 2005 May;15(5):686-97
Publication Type
Article
Date
May-2005
Author
Deborah Parnis
Janice Du Mont
Brydon Gombay
Author Affiliation
Trent University, Peterborough, Ontario, Canada.
Source
Qual Health Res. 2005 May;15(5):686-97
Date
May-2005
Language
English
Publication Type
Article
Keywords
Canada
Ethics Committees, Research - organization & administration
Female
Feminism
Forensic Medicine - standards
Hospital-Patient Relations
Hospitals, Community - ethics - organization & administration - standards
Humans
Interviews as Topic
Paternalism
Program Evaluation
Qualitative Research
Rape - psychology
Research Design
Researcher-Subject Relations - ethics
Abstract
In this article, the authors highlight some benefits of and barriers to doing qualitative research in association with hospital-based services. They first describe an ongoing qualitative research project that involves interviewing women about their post-sexual assault medicolegal experiences in hospital-situated sexual assault centers across a large Canadian province. Their methodological journey led them to engage program coordinators at these centers to assist with locating participants and qualified interviewers, and with negotiating the demands of their respective research ethics boards. They outline the ways in which their project was shaped, positively and negatively, by working with them in medical institutions. They conclude by recommending that hospitals and hospital ethics boards counteract tendencies toward paternalism by recognizing the value of feminist qualitative research contributions to the activities of their own sexual assault centers and to the recovery of sexually assaulted women. Such recognition might be productively engaged by adopting an ethics-in-process approach.
PubMed ID
15802543 View in PubMed
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Determining the level of statistician participation on Canadian-based research ethics boards.

https://arctichealth.org/en/permalink/ahliterature174356
Source
IRB. 2005 Mar-Apr;27(2):11-4
Publication Type
Article
Author
Lehana Thabane
Aaron Childs
Amanda Lafontaine
Author Affiliation
Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada.
Source
IRB. 2005 Mar-Apr;27(2):11-4
Language
English
Publication Type
Article
Keywords
Canada
Committee Membership
Ethics Committees, Research - organization & administration
Human Experimentation - standards
Humans
Research Design
Statistics as Topic - manpower
PubMed ID
15948326 View in PubMed
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Ethics review of multi-centre clinical trials in Canada.

https://arctichealth.org/en/permalink/ahliterature170822
Source
Health Law Rev. 2005;13(2-3):51-7
Publication Type
Article
Date
2005
Author
Michael E Enzle
Rodney Schmaltz
Author Affiliation
Human Research Protection Office, University of Alberta, Canada.
Source
Health Law Rev. 2005;13(2-3):51-7
Date
2005
Language
English
Publication Type
Article
Keywords
Canada
Ethical Review - standards
Ethics Committees, Research - organization & administration
Great Britain
Humans
Models, organizational
Multicenter Studies as Topic - ethics
United States
PubMed ID
16459414 View in PubMed
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Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries.

https://arctichealth.org/en/permalink/ahliterature78964
Source
J Med Ethics. 2007 Feb;33(2):107-12
Publication Type
Article
Date
Feb-2007
Author
Moerman C J
Haafkens J A
Söderström M.
Rásky E.
Maguire P.
Maschewsky-Schneider U.
Norstedt M.
Hahn D.
Reinerth H.
McKevitt N.
Author Affiliation
Department of General Practice, Room J2-222, Academic Medical Center, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands. c.j.moerman@amc.uva.nl
Source
J Med Ethics. 2007 Feb;33(2):107-12
Date
Feb-2007
Language
English
Publication Type
Article
Keywords
Ethics Committees, Research - organization & administration - standards
Europe
Female
Humans
Male
Sex Factors
Women's Rights
Abstract
BACKGROUND: Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. OBJECTIVE: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: (1) Do existing procedures promote representation of women and gender expertise in the committee? (2) How are sex and gender issues dealt with in protocol evaluation? METHODS: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents (regulations, guidelines and review tools in use in 2003). RESULTS: All countries have rules (mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk-benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. CONCLUSIONS: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs.
PubMed ID
17264199 View in PubMed
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Human rights and ethical considerations in oral health research.

https://arctichealth.org/en/permalink/ahliterature156812
Source
J Can Dent Assoc. 2008 Jun;74(5):439
Publication Type
Article
Date
Jun-2008
Author
Richard P Ellen
Richard Singleton
Author Affiliation
CIHR in Matrix Dynamics, Dental Research Institute, University of Toronto, Faculty of dentistry, 124 Edward Street, Toronto ON M5G 1G6. richard.ellen@dentistry.utoronto.ca
Source
J Can Dent Assoc. 2008 Jun;74(5):439
Date
Jun-2008
Language
English
Publication Type
Article
Keywords
Canada
Clinical Trials as Topic - standards
Conflict of Interest
Dental Research - ethics - standards
Ethics Committees, Research - organization & administration - standards
Human Experimentation - ethics - standards
Human Rights - standards
Humans
Informed consent
International Cooperation
Oral Health
Truth Disclosure
Abstract
Although international agreements set the framework for research ethics, countries vary in their interpretation and execution. The Government of Canada guidelines are based on the Tri-council policy statement: ethical conduct for research involving humans (2005) and the new CIHR guidelines for health research involving Aboriginal people (2007). In this critical review, we address 3 areas of educational value to practitioners who care for the oral health needs of the public, research trainees and research investigators who advance knowledge pertaining to oral health: protection of human study participants, conflicts of interest and investigator integrity. Its main message is that ethical health care should be supported by a strong foundation of ethical research.
PubMed ID
18538067 View in PubMed
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Institutional review board and regulatory solutions in the dental PBRN.

https://arctichealth.org/en/permalink/ahliterature149018
Source
J Public Health Dent. 2010;70(1):19-27
Publication Type
Article
Date
2010
Author
Gregg H Gilbert
Vibeke Qvist
Sheila D Moore
D Brad Rindal
Jeffrey L Fellows
Valeria V Gordan
O Dale Williams
Author Affiliation
Department of Diagnostic Sciences, School of Dentistry, University of Alabama at Birmingham, AL 35294-0007, USA. ghg@uab.edu
Source
J Public Health Dent. 2010;70(1):19-27
Date
2010
Language
English
Publication Type
Article
Keywords
Clinical Trials as Topic - ethics - legislation & jurisprudence
Computer Communication Networks
Dental Research - ethics - legislation & jurisprudence - organization & administration
Ethics Committees, Research - organization & administration
Financing, Government - ethics - legislation & jurisprudence
Government Regulation
Humans
Informed consent
Research Subjects - legislation & jurisprudence
Scandinavia
United States
Abstract
Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network called "DPBRN" (http://www.DPBRN.org) comprises dentists in two health maintenance organizations, several universities, seven US states, and three Scandinavian countries. Our objectives are to describe: a) the various human participants and regulatory requirements and solutions for each of DPBRN's five regions; b) their impact on study protocols and implementation; and c) lessons learned from this process.
Following numerous discussions with IRB and grants administrative personnel for each region, some practitioner-investigators are attached to their respective IRBs and contracting entities via sub-contracts between their organizations and the network's administrative site. Others are attached via Individual Investigator Agreements and contractually obligated via Memoranda of Agreement.
IRBs approve general operations under one approval, but specific research projects via separate approvals. Various formal IRB and grants administrative agreements have been arranged to customize research to the network context. In some instances, this occurred after feedback from patients and practitioners that lengthy written consent forms impeded research and raised suspicion, instead of decreasing it.
Instead of viewing IRBs and institutional administrators as potentially adversarial, customized solutions can be identified by engaging them in collegial discussions that identify common ground within regulatory bounds. Although time-intensive and complex, these solutions improve acceptability of practice-based research to patients, practitioners, and university researchers.
Notes
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PubMed ID
19694937 View in PubMed
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19 records – page 1 of 2.