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Acceptability and profile of the clinical drug trials underway in Finnish university hospitals in the 1990s: applications reviewed by ethics committees.

https://arctichealth.org/en/permalink/ahliterature192044
Source
Methods Find Exp Clin Pharmacol. 2001 Sep;23(7):415-23
Publication Type
Article
Date
Sep-2001
Author
T. Keinonen
S. Nieminen
V. Saareks
V. Saano
P. Ylitalo
Author Affiliation
Department of Pharmacology and Toxicology, University of Kuopio, Finland. tuija.keinonen@medfiles.fi
Source
Methods Find Exp Clin Pharmacol. 2001 Sep;23(7):415-23
Date
Sep-2001
Language
English
Publication Type
Article
Keywords
Clinical Protocols - standards
Clinical Trials Data Monitoring Committees - statistics & numerical data
Clinical Trials as Topic - standards - statistics & numerical data
Ethics Committees, Research - statistics & numerical data
Finland
Hospitals, University - statistics & numerical data
Humans
Informed Consent - statistics & numerical data
Multicenter Studies as Topic - statistics & numerical data
Patient Selection
Practice Guidelines as Topic
Research Design - standards - statistics & numerical data
Retrospective Studies
Abstract
There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
PubMed ID
11771857 View in PubMed
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Access to medical records for research purposes: varying perceptions across research ethics boards.

https://arctichealth.org/en/permalink/ahliterature158011
Source
J Med Ethics. 2008 Apr;34(4):308-14
Publication Type
Article
Date
Apr-2008
Author
D J Willison
C. Emerson
K V Szala-Meneok
E. Gibson
L. Schwartz
K M Weisbaum
F. Fournier
K. Brazil
M D Coughlin
Author Affiliation
Centre for Evaluation of Medicines, St Joseph's Healthcare, McMaster University, 105 Main Street East, P1, Hamilton, ON L8N 1G8, Canada. willison@mcmaster.ca
Source
J Med Ethics. 2008 Apr;34(4):308-14
Date
Apr-2008
Language
English
Publication Type
Article
Keywords
Biomedical Research - ethics - standards
Canada
Confidentiality - legislation & jurisprudence - psychology - standards
Ethics Committees, Research - ethics - standards
Humans
Medical Records - legislation & jurisprudence
Privacy - legislation & jurisprudence - psychology
Research Subjects - legislation & jurisprudence - psychology
Abstract
Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.
To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.
Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually.
Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record.
Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.
PubMed ID
18375687 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
Cites: IRB. 2007 Mar-Apr;29(2):7-1317847609
Cites: N Engl J Med. 2011 Sep 22;365(12):1145-5021787202
Cites: Milbank Q. 2011 Dec;89(4):599-62722188349
Cites: Clin Pharmacol Ther. 2012 Mar;91(3):535-4122318614
Cites: Trials. 2012;13:2722452964
Cites: Trials. 2012;13:5322540886
Cites: Int J Risk Saf Med. 2012;24(4):233-4223135338
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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An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results.

https://arctichealth.org/en/permalink/ahliterature153525
Source
Eur J Clin Pharmacol. 2009 Mar;65(3):315-8
Publication Type
Article
Date
Mar-2009
Author
Ola P Hole
Sigurd Nitter-Hauge
Henrik R Cederkvist
Finn O Winther
Author Affiliation
Faculty Division Rikshospitalet, University of Oslo, 0027 Oslo, Norway.
Source
Eur J Clin Pharmacol. 2009 Mar;65(3):315-8
Date
Mar-2009
Language
English
Publication Type
Article
Keywords
Academies and Institutes - economics - statistics & numerical data
Biomedical Research - economics - ethics - statistics & numerical data
Clinical Trials as Topic - economics - ethics - statistics & numerical data
Drug Industry - economics - ethics - statistics & numerical data
Ethics Committees, Research - ethics - standards
Hospitals, Private - economics - statistics & numerical data
Hospitals, Public - economics - statistics & numerical data
Humans
Information Dissemination - ethics
Norway
Publishing - ethics - standards - statistics & numerical data
Questionnaires
Research Design - standards - statistics & numerical data
Research Support as Topic - ethics - statistics & numerical data
Time Factors
Abstract
In Norway, very little data are available on the relation between the total number of research projects on the clinical development of drugs that have been started, the number of these projects in which the research phase has been completed and the number of projects for which results have been published. The aim of this study was to determine the number of projects in which the research phase had been completed and the results published.
Information on research projects carried out on the clinical development of drugs during the year 2000 was obtained from the archives of the Norwegian Research Ethical Committee (REC) and subsequently analysed.
The final analysis revealed that 245 research projects on the clinical development of drugs had been started in 2000. Of these, 178 (73%) completed the research phase as planned. The results of 131 (54%) of these projects were published in a scientific journal, and another 34 (14%) were reported as a congress abstract or as report to a sponsor; 80 (33%) were not published at all. Industrial sponsors seemed to promote both the completion of the research process and the publication of results in scientific journals.
PubMed ID
19104790 View in PubMed
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Are we asking the right questions? A review of Canadian REB practices in relation to community-based participatory research.

https://arctichealth.org/en/permalink/ahliterature142686
Source
J Empir Res Hum Res Ethics. 2010 Jun;5(2):35-46
Publication Type
Article
Date
Jun-2010
Author
Adrian Guta
Michael G Wilson
Sarah Flicker
Robb Travers
Catherine Mason
Gloria Wenyeve
Patricia O'Campo
Author Affiliation
University of Toronto, Toronto, Ontario, Canada. adrian.guta@utoronto.ca
Source
J Empir Res Hum Res Ethics. 2010 Jun;5(2):35-46
Date
Jun-2010
Language
English
Publication Type
Article
Keywords
Benchmarking
Canada
Community-Based Participatory Research - ethics
Cross-Sectional Studies
Ethics Committees, Research
Humans
Linear Models
Abstract
Access barriers to effective ethics review continue to be a significant challenge for researchers and community-based organizations undertaking community-based participatory research (CBPR). This article reports on findings from a content analysis of select (Behavioural, Biomedical, Social Sciences, Humanities) research ethics boards (REBs) in the Canadian research context (n = 86). Existing ethics review documentation was evaluated using 30 CBPR related criteria for their sensitivity to relevant approaches, processes, and outcomes. A linear regression was conducted to determine whether specific organizational characteristics have an impact on the CBPR sensitivity: (1) region of Canada, (2) type of institution (university or a healthcare organization), (3) primary institutional language (English or French) and (4) national ranking with respect to research intensiveness. While only research intensiveness proved statistically significant (p = .001), we recognize REB protocol forms may not actually reflect how CBPR is reviewed. Despite using a single guiding ethical framework, REBs across Canada employ a variety of techniques to review research studies. We report on these differences and varying levels of sensitivity to CBPR. Finally, we highlight best practices and make recommendations for integrating CBPR principles into existing ethics review.
PubMed ID
20569148 View in PubMed
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Barriers to research on research ethics review and conflicts of interest.

https://arctichealth.org/en/permalink/ahliterature105569
Source
IRB. 2013 Sep-Oct;35(5):14-9
Publication Type
Article

Bridging the divide between genomic science and indigenous peoples.

https://arctichealth.org/en/permalink/ahliterature140399
Source
J Law Med Ethics. 2010;38(3):684-96
Publication Type
Article
Date
2010
Author
Bette Jacobs
Jason Roffenbender
Jeff Collmann
Kate Cherry
LeManuel Lee Bitsói
Kim Bassett
Charles H Evans
Author Affiliation
O'Neill Health Law Institute, Georgetown University.
Source
J Law Med Ethics. 2010;38(3):684-96
Date
2010
Language
English
Publication Type
Article
Keywords
Consumer Participation
Developing Countries
Ethics Committees, Research
Genetic Research - ethics
Genomics - ethics
Guidelines as Topic
Humans
Indians, North American - genetics
Informed Consent - ethics
International Cooperation
Mexico
Population Groups - genetics
United States
Abstract
The new science of genomics endeavors to chart the genomes of individuals around the world, with the dual goals of understanding the role genetic factors play in human health and solving problems of disease and disability. From the perspective of indigenous peoples and developing countries, the promises and perils of genomic science appear against a backdrop of global health disparity and political vulnerability. These conditions pose a dilemma for many communities when attempting to decide about participating in genomic research or any other biomedical research. Genomic research offers the possibility of improved technologies for managing the acute and chronic diseases that plague their members. Yet, the history of particularly biomedical research among people in indigenous and developing nations offers salient examples of unethical practice, misuse of data, and failed promises. This dilemma creates risks for communities who decide either to participate or not to participate in genomic science research. Some argue that the history of poor scientific practice justifies refusal to join genomic research projects. Others argue that disease poses such great threats to the well-being of people in indigenous communities and developing nations that not participating in genomic research risks irrevocable harm. Thus, some communities particularly among indigenous peoples have declined to participate as subjects in genomic research. At the same time, some communities have begun developing new guidelines, procedures, and practices for engaging with the scientific community that offer opportunities to bridge the gap between genomic science and indigenous and/or developing communities. Four new approaches warrant special attention and further support: consulting with local communities; negotiating the complexities of consent; training members of local communities in science and health care; and training scientists to work with indigenous communities. Implicit is a new definition of "rigorous scientific research," one that includes both community development and scientific progress as legitimate objectives of genomic research. Innovative translational research is needed to develop practical, mutually acceptable methods for crossing the divide between genomic researchers and indigenous communities. This may mean the difference between success and failure in genomic science, and in improving health for all peoples.
PubMed ID
20880250 View in PubMed
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British and Canadian views on the ethics of paediatric clinical trials.

https://arctichealth.org/en/permalink/ahliterature164629
Source
Eur J Clin Pharmacol. 2007 May;63(5):431-6
Publication Type
Article
Date
May-2007
Author
H M Sammons
J. Malhotra
I. Choonara
D S Sitar
D. Matsui
M J Rieder
Author Affiliation
Academic Division of Child Health, University of Nottingham, Medical School, Derbyshire Children's Hospital, Uttoxeter Road, Derby, DE22 3DT, UK. helen.sammons@nottingham.ac.uk
Source
Eur J Clin Pharmacol. 2007 May;63(5):431-6
Date
May-2007
Language
English
Publication Type
Article
Keywords
Attitude of Health Personnel
Canada
Child
Controlled Clinical Trials as Topic - ethics
Cross-Cultural Comparison
Ethics Committees, Research
Ethics, Research
Great Britain
Human Experimentation - ethics
Humans
Pediatrics
Physicians
Pilot Projects
Placebos
Questionnaires
Research Personnel
Abstract
Ethical problems are quoted as a reason not to perform clinical trials in children. Little is known about the views of researchers regarding ethics.
A pilot study was conducted to assess the applicability of a questionnaire design containing trial scenarios to examine views regarding the use of children in drug trials and to elicit possible international differences.
Paediatricians and researchers in the United Kingdom and Canada.
Responders were presented with a questionnaire containing direct questions and six trial scenarios, each containing an ethical dilemma. Responders were asked regarding their own approval and their perceived opinion of whether an ethical review board (ERB) would approve.
One hundred questionnaires (50 each country) were received. Few responders had research ethics training (14% United Kingdom and 8% Canada). Most (80 and 88%) felt children could be harmed by participation in trials and half (47 and 59%) felt children should only participate if they receive direct benefit. Many (58 and 61%) disagreed with payments beyond travel expenses. In the trial scenarios, 34% of responders were willing to enter healthy children in a pharmacokinetics study of an antibiotic for cystic fibrosis and 22% considered their ERBs would approve. Only a third (33%) would enter children in an analgesia trial that was placebo-controlled.
Using healthy children and placebos in trials caused concern. Similar views were found between the two countries. The majority had no training in research ethics. The study highlights the usefulness of a questionnaire with clinical trial scenarios to try to elicit views on the ethics of conducting research in children.
PubMed ID
17364191 View in PubMed
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169 records – page 1 of 17.