Skip to main content Accessibility help
×
Home

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

  • Eric Racine (a1) (a2) (a3) (a4) (a5), Georg Northoff (a6) (a7) (a8), Ravi S. Menon (a9) (a10), Jonathan Kimmelman (a2) (a11) (a12) and Judy Illes (a13)...

Abstract

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.

    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      A Canadian Perspective on Ethics Review and Neuroimaging: Tensions and Solutions
      Available formats
      ×

      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      A Canadian Perspective on Ethics Review and Neuroimaging: Tensions and Solutions
      Available formats
      ×

      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      A Canadian Perspective on Ethics Review and Neuroimaging: Tensions and Solutions
      Available formats
      ×

Copyright

Corresponding author

Institut de recherches cliniques de Montréal (IRCM) 110 avenue des Pins Ouest, Montréal, Quebec, H2W lR7, Canada

References

Hide All
1.Illes, J, Kirschen, MP, Edwards, E, et al.Incidental findings in brain imaging research. Science. 2006;311(5762):783–4.
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.
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.
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.
5.Marshall, J, Hadskis, MR.Canadian research ethics boards, MRI research risks, and MRI risk classification. IRB. 2009;31(4): 915.
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_rss
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):4966.
8.Illes, J, Moser, MA, McCormick, JB, et al.Neurotalk: improving the communication of neuroscience research. Nat Rev Neurosci. 2010;11(1):61–9.
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.
10.Beagan, B, McDonald, M.Evidence-based practice of research ethics review? Health Law Rev. 2005;13(2-3):62–8.
11.The ethical neuroscientist. Nat Neurosci. 2008;11(3):239.
12. Ethical neuroscience. Nat Neurosci. 2010;13(2):141.
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):312.
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.
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.
16.Downie, J, Marshall, J.Paediatric neuroimaging ethics. Camb Q Healthc Ethics. 2007;16:147–60.
17.Illes, J, Kirschen, MP, Edwards, E, et al.Practical approaches to incidental findings in brain imaging research. Neurology. 2008; 70(5):384–90.
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):110.
19.McDonald, M.Canadian governance of health research involving human subjects: is anybody minding the store? Health Law J. 2001;9:121.
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):3950.
21.Mallick, AA, O’Callaghan, FJ.Research governance delays for a multicentre non-interventional study. J R Soc Med. 2009;102(5): 195–8.
22.Hebert, P, Saginur, R.Research ethics review: do it once and do it well. CMAJ. 2009;180(6):597–8.
23.Koski, G, Aungst, J, Kupersmith, J, Getz, K, Rimoin, D.Cooperative research ethics review boards: a win-win solution? IRB. 2005;27 (3):17.
24.Enzle, ME, Schmaltz, R.Ethics review of multi-centre clinical trials in Canada. Health Law Rev. 2005;13(2-3):51–7.
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):3958.
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.
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):6872.
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.
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):15.
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.
31.Environmental Health Directorate HPB. Safety Code 26: Guideline to the exposure to electromagnetic fields from magnetic resonance imaging clinical systems. Ottawa, ON; 1987.
32.Sunstein, CR.Infotopia: how many minds produce knowledge. Oxford: Oxford University Press; 2006. p. 288.
33.Canadian Institutes of Health Research. Stem cell oversight committee. Ottawa, ON: Canadian Institutes of Health Research; 2010.
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.
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].
36.Food and Drug Administration. Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Rockville, MD; 2008.
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.
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.
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.

Related content

Powered by UNSILO

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

  • Eric Racine (a1) (a2) (a3) (a4) (a5), Georg Northoff (a6) (a7) (a8), Ravi S. Menon (a9) (a10), Jonathan Kimmelman (a2) (a11) (a12) and Judy Illes (a13)...

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed.