A canadian perspective on ethics review and neuroimaging: Tensions and solutions

Canadian Journal of Neurological Sciences

Volumn 38, Issue 4, 2011, Pages 572-579

  Racine, Eric ^a,b,c,d,f   Northoff, Georg ^g,h,i,j   Menon, Ravi ^k,l   Kimmelman, Jonathan ^b,e   Illes, Judy ^l,m,n  

^a Neuroethics Research Unit   (Canada)

^b CLIN RESEARCH INSTITUTE OF MONTREAL   (Canada)

^c Biomedical Ethics Unit   (Canada)

^d Division of Experimental Medicine   (Canada)

^e Department of Neurology/Neurosurgery ^*  (Canada)

^f MCGILL UNIVERSITY   (Canada)

^g Departments of Medicine and Social and Preventive Medicine   (Canada)

^h UNIVERSITÉ DE MONTRÉAL   (Canada)

ⁱ Brain Imaging and Neuroethics   (Canada)

^j UNIVERSITY OF OTTAWA   (Canada)

^k ROYAL OTTAWA HEALTH CARE GROUP   (Canada)

^l ROBARTS RESEARCH INSTITUTE   (Canada)

^m UNIVERSITY OF WESTERN ONTARIO   (Canada)

ⁿ UNIVERSITY OF BRITISH COLUMBIA   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CANADA; HUMAN; INCIDENTAL FINDING; INTERPERSONAL COMMUNICATION; MEDICAL EDUCATION; NEUROIMAGING; PRIORITY JOURNAL; RESEARCH ETHICS; RESPONSIBILITY; REVIEW; RISK ASSESSMENT; WRITING; DIAGNOSTIC IMAGING; ETHICS; HEALTH PERSONNEL ATTITUDE; METHODOLOGY; PEER REVIEW; STANDARD;

ATTITUDE OF HEALTH PERSONNEL; CANADA; DIAGNOSTIC IMAGING; HUMANS; INCIDENTAL FINDINGS; PEER REVIEW, RESEARCH;

EID: 80053296404     PISSN: 03171671     EISSN: None     Source Type: Journal    
DOI: 10.1017/S0317167100012117     Document Type: Review

References (39)

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): 9-15.
6. Borrell B.Brain-imaging programme suspended after violations.Nature News.2010. Jul 22 [cited 2011 Feb 3].http://www.nature.com/news/2010/100722/ full/news.2010 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):49-66.
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):3-12.
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):1-10.
19. McDonald M. Canadian governance of health research involving human subjects: is anybody minding the store? Health Law J. 2001;9:1-21.
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.
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):1-7.
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):39-58.
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):68-72.
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):1-5.
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.