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Health Research Policy and Systems
Published in: Health Research Policy and Systems 1/2015

Open Access 01-12-2016 | Research

Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

Author: Elina Hemminki

Published in: Health Research Policy and Systems | Issue 1/2015

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Abstract

Background

The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries – England, Canada, the United States of America (USA) – in the late 2000s.

Methods

Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized.

Results

In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland.

Conclusions

The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.
Appendix
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Literature
1.
Veerus P, Lexchin J, Hemminki E. Legislative regulation and ethical research governance of medical research in different European Union countries. J Med Ethics. 2014;40(6):409–13.CrossRefPubMed
2.
Hemminki E, Virtanen J, Veerus P. Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland. Health Res Policy Syst. 2014;12:15.PubMedCentralCrossRefPubMed
3.
4.
Hemminki E. Actors involved in the regulation of clinical research: comparison of Finland to England. Canada and the USA Health Res Policy Syst. 2015;13:20.CrossRefPubMed
5.
Coker R, McKee M. Ethical approval for health research in central and eastern Europe: an international survey. Clin Med. 2001;1:197–9.CrossRef
6.
Liberati A. Research ethics committees: can they contribute to the improvement of clinical research in Europe? J Ambul Care Manage. 2004;27(2):154–65.CrossRefPubMed
7.
Hedgecoe A, Caravalho F, Lobmayer P, Raka F. Research ethics committees in Europe: implementing the directive, respecting diversity. J Med Ethics. 2006;32:483–6.PubMedCentralCrossRefPubMed
8.
9.
Edwards SJL, Stone T, Swift T. Differences between research ethics committees. Int J Technol Assess Health Care. 2007;23:17–23.CrossRefPubMed
10.
11.
Hernandez R, Cooney M, Duale C, Galvez M, Gaynor S, Kardoz G, et al. Harmonization of ethics committees’ practice in 10 European countries. J Med Ethics. 2009;35:696–700.CrossRefPubMed
12.
Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011;6(1):3–19.PubMedCentralCrossRefPubMed
13.
Gluud C, Kubiak C, Whitfield K, Byrne J, Huemer KH, Thirstrup S, et al. Typical investigational medicinal products follow relatively uniform regulations in 10 European clinical research infrastructures network (ECRIN) countries. Trials. 2012;13:27.PubMedCentralCrossRefPubMed
14.
Walanj AS. Research ethics committees: need for harmonization at the national level, the global and Indian perspective. Perspect Clin Res. 2014;5:66–70.PubMedCentralCrossRefPubMed
15.
Hemminki E, Veerus P, Virtanen J, Lehto J. A qualitative study on clinical research in Finland – fragmented governance and volume in the 2000s. BMJ Open. 2013;13:3(2).
16.
Hemminki E, Virtanen J, Veerus P, Regushevskaya E. Clinical research in Finland in 2002 and 2007: quantity and type. Health Res Policy Syst. 2013;11:17.PubMedCentralCrossRefPubMed
17.
18.
Salomon MZ, Bonham AC. Ethical oversight of research on patient care. Ethical oversight of learning health care systems. Hastings Center Report Special Report 43. 2013;1:S2–3.CrossRef
19.
Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Ethical oversight of learning health care systems. Hastings Center Report Special Report 43. 2013;1:S4–15.CrossRef
20.
Silberman G, Kahn K. Burdens on research imposed by institutional review boards: the state of evidence and its implications for regulatory reform. Milbank Q. 2011;89(4):599–627.PubMedCentralCrossRefPubMed
21.
Speckman JL, Byrne MM, Gerson J, Getz K, Wangsmo G, Muse CT, et al. Consortium to Examine ClinicaL Research Ethics. Determining the costs of Institutional Review Boards. IRB. 2007;29(2):7–13.PubMed
22.
Mann H. Research ethics committees and public dissemination of clinical trial results. Lancet. 2002;359:406–8.CrossRef
23.
Lexchin J, Sekeres M, Gold J, Ferris LE, Kalkar SR, Wu W, et al. National evaluation of policies on individual financial conflicts of interest in Canadian academic health science centers. J Gen Intern Med. 2008;23(11):1896–903.PubMedCentralCrossRefPubMed
24.
Angell EL, Bryman A, Ashcroft RE, Dixon-Woods M. An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examined. Qual Saf Health Care. 2008;17:131–6.CrossRefPubMed
25.
Symposium on censorship and institutional review boards. Northwestern University Law Review. 2007. p. 101. Special issue 2.
26.
27.
Hansson MG, van Ommen GJ, Chadwick R, Dillner J. Patients would benefit from simplified ethical review and consent procedure. Lancet Oncol. 2013;14(6):451–3.CrossRefPubMed
28.
Platt R, Kass NE, McGraw D. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA. 2014;311(15):1497–8.CrossRefPubMed
29.
McCarthy M. Rules on protecting people in social and behavioral studies need to be revised, says US panel. BMJ. 2014;348:g147.CrossRefPubMed
30.
Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentional policy. Clin Trials. 2006;3:496–502.CrossRefPubMed
31.
32.
33.
Keith-Spiegel P, Koocher GP. The IRB paradox: could the protectors also encourage deceit? Ethics Behav. 2005;15:339–49.CrossRefPubMed
34.
Taylor HA. Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects research. IRB. 2007;29(5):9–14.PubMed
35.
Coleman CH, Bouesseau M-C. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics. 2008;9:6.PubMedCentralCrossRefPubMed
36.
Russ H, Busta S, Riedel A, Zöllner G, Jost B. Evaluation of clinical trials by ethics committees in Germany: experience of applicants with the review of requests for opinion of the ethics committees – results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA). Ger Med Sci. 2009;7:Doc07.PubMedCentralPubMed
37.
38.
Sugarman J, Califf RM. Ethics and regulatory complexities for pragmatic clinical trials. JAMA. 2014;311(23):2381–2.CrossRefPubMed
39.
O’Reilly M, Dixon-Woods M, Angell E, Ashcroft R, Bryman A. Doing accountability: a discourse analysis of research ethics committee letters. Sociol Health Illn. 2009;31:246–61.CrossRefPubMed
40.
Duley L, Antman K, Arena J, Avezum A, Blumenthal M, Bosch J, et al. Specific barriers to the conduct of randomized trials. Clin Trials. 2008;5:40.CrossRefPubMed
41.
Hemminki E. Kliinisen tutkimuksen ulkoinen säätely tarvitsee muutosta. Duodecim. 2015;131:663–70.PubMed
Metadata
Title
Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States
Author
Elina Hemminki
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Health Research Policy and Systems / Issue 1/2015
Electronic ISSN: 1478-4505
DOI
https://doi.org/10.1186/s12961-016-0078-3

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