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A Canadian Perspective on Ethics Review and Neuroimaging: Tensions and Solutions

Published online by Cambridge University Press:  02 December 2014

Eric Racine ,
Georg Northoff ,
Ravi S. Menon ,
Jonathan Kimmelman  and
Judy Illes
Eric Racine*
Affiliation:
Neuroethics Research Unit, McGill University Institut de recherches cliniques de Montréal; Biomedical Ethics Unit, McGill University Division of Experimental Medicine, McGill University Department of Neurology/Neurosurgery, McGill University Departments of Medicine and Social and Preventive Medicine, Bioethics Programs, University of Montreal, Montreal, Quebec
Georg Northoff
Affiliation:
Mind, Brain Imaging and Neuroethics, University of Ottawa Institute of Mental Health Research, University of Ottawa Royal Ottawa Healthcare Group, Ottawa
Ravi S. Menon
Affiliation:
Robarts Research Institute, University of Western Ontario, London, Ontario Medical Biophysics, University of Western Ontario, London, Ontario
Jonathan Kimmelman
Affiliation:
Institut de recherches cliniques de Montréal; Biomedical Ethics Unit, McGill University Department of Human Genetics, McGill University Department of Social Studies of Medicine, McGill University
Judy Illes
Affiliation:
National Core for Neuroethics, Division of Neurology, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
*
Institut de recherches cliniques de Montréal (IRCM) 110 avenue des Pins Ouest, Montréal, Quebec, H2W lR7, Canada
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Abstract

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Neuroimaging research has raised ethical concerns such as the management of unexpected findings and the classification and assessment of risks. Research ethics boards (REBs) bear responsibility for the oversight of these challenges but neuroimagers struggle with the practical aspects of ethics review and report that administrative load and inconsistency contribute to eroding confidence and trust in ethics review. Our goal was to discuss and propose strategies for institutional and educational change to improve ethics review. We used an iterative and deliberative workshop-based writing process involving multiple disciplines. We propose recommendations in three tension areas: (1) communication between researchers and REBs; (2) collaboration and sharing of expertise between REBs; and (3) practical considerations and the needs of neuroimagers engaged in the ethics review process. Our recommendations are intended as openings rather than endpoints. Researchers and research ethics governance communities should decide on the future uptake of these recommendations.

Type
Review Article
Information
Canadian Journal of Neurological Sciences , Volume 38 , Issue 4 , July 2011 , pp. 572 - 579
Copyright
Copyright © The Canadian Journal of Neurological 2011

References

1.Illes, J, Kirschen, MP, Edwards, E, et al.Incidental findings in brain imaging research. Science. 2006;311(5762):783–4.CrossRefGoogle ScholarPubMed
2.Wolf, SM, Lawrenz, FP, Nelson, CA, et al.Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics. 2008;36(2):219–48.CrossRefGoogle Scholar
3.Marshall, J, Martin, T, Downie, J, Malisza, K.A comprehensive analysis of MRI research risks: in support of full disclosure. Can J Neurol Sci. 2007;34(1):11–7.CrossRefGoogle ScholarPubMed
4.Schmidt, MH, Downie, J.Safety first: recognizing and managing the risks to child participants in magnetic resonance imaging research. Account Res. 2009;16(3):153–73.CrossRefGoogle ScholarPubMed
5.Marshall, J, Hadskis, MR.Canadian research ethics boards, MRI research risks, and MRI risk classification. IRB. 2009;31(4): 9–15.Google ScholarPubMed
6.Borrell, B.Brain-imaging programme suspended after violations. Nature News 2010 Jul 22 [cited 2011 Feb 3] Available from: http://www.nature.com/news/2010/100722/full/news.2010.370.html?s=news_rssCrossRefGoogle Scholar
7.Deslauriers, C, Bell, E, Palmour, N, Pike, B, Doyon, J, Racine, E.Perspectives of Canadian researchers on ethics review of neuroimaging research. J Empir Res Hum Res Ethics. 2010;5 (1):49–66.CrossRefGoogle ScholarPubMed
8.Illes, J, Moser, MA, McCormick, JB, et al.Neurotalk: improving the communication of neuroscience research. Nat Rev Neurosci. 2010;11(1):61–9.CrossRefGoogle ScholarPubMed
9.Illes, J, Tairyan, K, Federico, CA, Tabet, A, Glover, GH.Reducing barriers to ethics in neuroscience. Front Hum Neurosci. 2010 Oct 4;4. pii: 167.CrossRefGoogle ScholarPubMed
10.Beagan, B, McDonald, M.Evidence-based practice of research ethics review? Health Law Rev. 2005;13(2-3):62–8.Google ScholarPubMed
11.The ethical neuroscientist. Nat Neurosci. 2008;11(3):239.CrossRefGoogle Scholar
12. Ethical neuroscience. Nat Neurosci. 2010;13(2):141.CrossRefGoogle Scholar
13.Fins, JJ, Illes, J, Bernat, JL, Hirsch, J, Laureys, S, Murphy, E.Neuroimaging and disorders of consciousness: envisioning an ethical research agenda. Am J Bioeth. 2008;8(9):3–12.CrossRefGoogle ScholarPubMed
14.Illes, J, Rosen, A, Greicius, M, Racine, E.Prospects for prediction: ethics analysis of neuroimaging in Alzheimer’s disease. Ann NY Acad Sci. 2007;1097:278–95.CrossRefGoogle ScholarPubMed
15.de Champlain, J, Patenaude, J.Review of a mock research protocol in functional neuroimaging by Canadian research ethics boards. J Med Ethics. 2006;32(9):530–4.CrossRefGoogle ScholarPubMed
16.Downie, J, Marshall, J.Paediatric neuroimaging ethics. Camb Q Healthc Ethics. 2007;16:147–60.CrossRefGoogle ScholarPubMed
17.Illes, J, Kirschen, MP, Edwards, E, et al.Practical approaches to incidental findings in brain imaging research. Neurology. 2008; 70(5):384–90.CrossRefGoogle ScholarPubMed
18.Racine, E, Illes, J.Emerging ethical challenges in advanced neuroimaging research: review, recommendations and research agenda. J Empir Res Hum Res Ethics. 2007;2(2):1–10.CrossRefGoogle ScholarPubMed
19.McDonald, M.Canadian governance of health research involving human subjects: is anybody minding the store? Health Law J. 2001;9:1–21.Google ScholarPubMed
20.Lemmens, T.Federal regulation of REB review of clinical trials: a modest but easy step towards an accountable REB review structure in Canada. Health Law Rev. 2005;13(2-3):39–50.Google ScholarPubMed
21.Mallick, AA, O’Callaghan, FJ.Research governance delays for a multicentre non-interventional study. J R Soc Med. 2009;102(5): 195–8.CrossRefGoogle ScholarPubMed
22.Hebert, P, Saginur, R.Research ethics review: do it once and do it well. CMAJ. 2009;180(6):597–8.CrossRefGoogle Scholar
23.Koski, G, Aungst, J, Kupersmith, J, Getz, K, Rimoin, D.Cooperative research ethics review boards: a win-win solution? IRB. 2005;27 (3):1–7.CrossRefGoogle Scholar
24.Enzle, ME, Schmaltz, R.Ethics review of multi-centre clinical trials in Canada. Health Law Rev. 2005;13(2-3):51–7.Google ScholarPubMed
25.Burris, S, Moss, K.U.S. Health researchers review their ethics review boards: a qualitative Study. J Empir Res Hum Res Ethics. 2006;1(2):39–58.CrossRefGoogle ScholarPubMed
26.Greene, SM, Geiger, AM.A review finds that multicenter studies face substantial challenges but strategies exist to achieve institutional review board approval. J Clin Epidemiol. 2006;59 (8):784–90.CrossRefGoogle ScholarPubMed
27.Whitney, SN, Alcser, K, Schneider, C, McCullough, LB, McGuire, AL, Volk, RJ.Principal investigator views of the IRB system. Int J Med Sci. 2008;5(2):68–72.CrossRefGoogle ScholarPubMed
28.Lombera, S, Fine, A, Grunau, RE, Illes, J.Ethics in neuroscience graduate training programs: views and models from Canada. Mind Brain Educ. 2010;4(1):20–7.CrossRefGoogle Scholar
29.Taylor, HA, Currie, P, Kass, NE.A study to evaluate the effect of investigator attendance on the efficiency of IRB review. IRB. 2008;30(1):1–5.Google ScholarPubMed
30.Department of Health and Human Services. Protection of human subjects (Attachment 5-8 Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure) Title 45 Code of Federal Regulations Part 46; 1998.Google Scholar
31.Environmental Health Directorate HPB. Safety Code 26: Guideline to the exposure to electromagnetic fields from magnetic resonance imaging clinical systems. Ottawa, ON; 1987.Google Scholar
32.Sunstein, CR.Infotopia: how many minds produce knowledge. Oxford: Oxford University Press; 2006. p. 288.CrossRefGoogle Scholar
33.Canadian Institutes of Health Research. Stem cell oversight committee. Ottawa, ON: Canadian Institutes of Health Research; 2010.Google Scholar
34.Illes, J, Desmond, JE, Huang, LF, Raffin, TA, Atlas, SW.Ethical and practical considerations in managing incidental findings in functional magnetic resonance imaging. Brain Cogn. 2002. 50 (3):358–65.CrossRefGoogle ScholarPubMed
35.Palmour, N, Affleck, W, Bell, E, et al.Informed consent for MRI and fMRI research: analysis of a sample of Canadian practices, BMC Med Ethics. 2011 [epub ahead of print].CrossRefGoogle Scholar
36.Food and Drug Administration. Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Rockville, MD; 2008.Google Scholar
37.U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Radiological Devices Branch, Division of Reproductive A, and Radiological Devices, Office of Device Evaluation. Guidance for industry and FDA staff: criteria for significant risk investigations of magnetic resonance diagnostic devices. Rockville, MD; 2003.Google Scholar
38.U.S. Department Of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, et al.Guidance for industry: guidance for the submission of premarket notifications for magnetic resonance diagnostic devices. Rockville, MD; 1998.Google Scholar
39.Department of health and human services, Food and Drug Administration, Center for Devices and Radiological Health. A primer on medical device interactions with magnetic resonance imaging systems. Silver Spring, MD; 1997.Google Scholar