Hostname: page-component-586b7cd67f-2brh9 Total loading time: 0 Render date: 2024-11-26T06:30:12.602Z Has data issue: false hasContentIssue false

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

Published online by Cambridge University Press:  11 January 2011

Extract

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

Type
Special Section: Open Forum
Copyright
Copyright © National Research Council of Canada 2010. Published by Cambridge University Press. All rights reserved. 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Field, MJ, Behrman, RE, eds. Ethical Conduct of Clinical Research Involving Children, Washington, DC: The National Academies Press; 2004Google Scholar; Mazur, DJ.Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members. Baltimore, MD: The Johns Hopkins University Press; 2007.Google Scholar

2. Diekema, DS. Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations. Journal of Pediatrics 2006;149:S3–11.CrossRefGoogle ScholarPubMed

3. Kopelman, LM. Children as research subjects: A dilemma. Journal of Medicine and Philosophy 2000;25:745–64CrossRefGoogle ScholarPubMed; Baleb, R, Blyth, E, Calabretto, H, Fraser, C, Horrocks, C, Manby, M. Involving children in health and social research—Human beings or active beings? Childhood: A Global Journal of Child Research 2006;13:29–48.Google Scholar

4. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 1998 (with 2000, 2002, and 2005 amendments); available at http://pre.ethics.gc.ca/eng/policy-politique/tcps-eptc/readtcps-lireeptc/ (last accessed 21 Oct 2010); Maschke, KJ. US and UK policies governing research with humans. Psychopharmacology 2003;171:47–55CrossRefGoogle ScholarPubMed; US Department of Health and Human Services. Additional Protections for Children Involved as Subjects in Research. 45 C.F.R. part 46 (1983):401–4.

5. Racine, EIJ. Emerging ethical challenges in advanced neuroimaging research: Review recommendations and research agenda. Journal of Empirical Research on Human Research Ethics 2007;2:1–10CrossRefGoogle ScholarPubMed; Downie, J, Hadskis, M. Finding the right compass for issue-mapping in neuroimaging. American Journal of Bioethics 2005;5:27–9.CrossRefGoogle ScholarPubMed

6. Hinton, VJ. Ethics of neuroimaging in pediatric development. Brain and Cognition 2002;50:455–68CrossRefGoogle ScholarPubMed; Downie, J, Marshall, J. Pediatric neuroimaging ethics. Cambridge Quarterly of Healthcare Ethics 2007;16:147–60.CrossRefGoogle ScholarPubMed

7. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; available at http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf, DHEW Pub.no. (OS)78-0012 (last accessed 21 Oct 2010).Google ScholarChildress, JF, Meslin, EE, Shapiro, HT. Belmont Revisited: Ethical Principles for Research with Human Subjects. Washington, DC: Georgetown University Press; 2005.Google Scholar

8. The World Medical Association. World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. 2001; available at http://www.wma.net/en/30publications/10policies/b3/index.html (last accessed 21 Oct 2010).Google Scholar

9. Andorno, R.Global bioethics and human rights. Medicine and Law 2008;27:1–14Google ScholarPubMed; Goodyear-Smith, F, Lobb, B, Davies, G, Nachson, I, Seelau, SM. International variation in ethics committee requirements: Comparisons across five Westernized nations. BMC Medical Ethics 2002;3:E2CrossRefGoogle Scholar; Lenk, C, Radenbach, K, Dahl, M, Wiesemann, C. Non-therapeutic research with minors: How do chairpersons of German research ethics committees decide? Journal of Medical Ethics 2004;30:85–7CrossRefGoogle ScholarPubMed; see note 4, Maschke 2003; Sauer, PJ. Ethical and practical issues regarding research in children: The European perspective. Toxicology and Applied Pharmacology 2005;207:668–72CrossRefGoogle ScholarPubMed; Schwartz, B. Safety in human research: Past problems and current challenges from a Canadian perspective. HEC Forum 2008;20:277–90CrossRefGoogle ScholarPubMed; Strode, AG, Grant, C, Slack, C, Mushariwa, M. How well does South African’s National Health Act regulate research involving children? South African Medical Journal 2005;95:265–8.Google Scholar

10. See note 4, Canadian Institutes of Health Research 1998.

11. The Code of Federal Regulations for the United States Department of Health and Human Services. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (last accessed 21 Oct 2010).

12. See note 1, Field, Behrman 2004; Gill, D.Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). European Journal of Pediatrics 2004;163:53–7CrossRefGoogle Scholar; McIntosh, N, Bates, P, Brykczynska, G, Dunstan, G, Goldman, A, Harvey, D, et al. . Guidelines for the ethical conduct of medical research involving children. Royal College of Paediatrics, Child Health: Ethics Advisory Committee. Archives of Disease in Childhood 2000;82:177–82Google ScholarPubMed; John, JE.The child’s right to participate in research: Myth or misconception? British Journal of Nursing 2007;16:157–60CrossRefGoogle ScholarPubMed; Edwards, SD, McNamee, MJ. Ethical concerns regarding guidelines for the conduct of clinical research on children. Journal of Medical Ethics 2005;31:351–4CrossRefGoogle Scholar; Ungar, D, Joffe, S, Kodish, E. Children are not small adults: Documentation of assent for research involving children. Journal of Pediatrics 2006;149:S31–3CrossRefGoogle Scholar; Martin, RA, Robert, JS. Is risky pediatric research without prospect of direct benefit ever justified? American Journal of Bioethics 2007;7:12–5CrossRefGoogle ScholarPubMed; Neill, SJ. Research with children: A critical review of the guidelines. Journal of Child Health Care 2005;9:46–58CrossRefGoogle Scholar; Yan, EG, Munir, KM. Regulatory and ethical principles in research involving children and individuals with developmental disabilities. Ethics and Behavior 2004;14:31–49.CrossRefGoogle ScholarPubMed

13. Code of Federal Regulations Title 21, The Food and Drug Administration. 21 C.F.R. 26; available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (last accessed 21 Oct 2010).

14. Fisher, CB, Kornetsky, SZ, Prentice, ED. Determining risk in pediatric research with no prospect of direct benefit: Time for a national consensus on the interpretation of federal regulations. American Journal of Bioethics 2007;7:5–10CrossRefGoogle ScholarPubMed; Spriggs, M. When “risk” and “benefit” are open to interpretation—as is generally the case. The American Journal of Bioethics 2007;7:17–9CrossRefGoogle ScholarPubMed; Shah, S, Whittle, A, Wilfond, B, Gensler, G, Wendler, D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA 2004;291:476–82CrossRefGoogle ScholarPubMed; Iltis, A.Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: Challenging 45 CFR 46.406. Accountability in Research 2007;14:19–34CrossRefGoogle ScholarPubMed; Resnik, DB. Eliminating the daily life risks standard from the definition of minimal risk. Journal of Medical Ethics 2005;31:35–8CrossRefGoogle ScholarPubMed; Wendler, D, Jenkins, T. Children’s and their parents’ views on facing research risks for the benefit of others. Archives of Pediatrics and Adolescent Medicine 2008;162:9–14CrossRefGoogle Scholar; Wendler, D, Glantz, L. A standard for assessing the risks of pediatric research: Pro and con. Journal of Pediatrics 2007;150:579–82CrossRefGoogle ScholarPubMed; See note 12, Martin, Roberts 2007; Boser, S. Power, ethics and the IRB—Dissonance over human participant review of participatory research. Qualitative Inquiry 2007;13:1060–74CrossRefGoogle Scholar; Kopelman, LM. When can children with conditions be in no-benefit, higher-hazard pediatric studies? American Journal of Bioethics 2007;7:15–7.CrossRefGoogle ScholarPubMed

15. Pub.L. Best Pharmaceuticals for Children Act. No. 107-109 409i(d)(1)(A); 2002:1409–11; Pub.L. Food and Drug Administration Modernization Act. No. 105-115 111; 1997:2305–9 (codifed as amended in scattered sections of 21 U.S.C.).

16. Sharav, VH. The impact of the Food and Drug Administration Modernization Act on the recruitment of children for research. Ethical Human Sciences and Services: An International Journal of Critical Inquiry 2003;5:83–108Google ScholarPubMed.

17. Frost, N, Levine, RJ. The dysregulation of human subjects research. JAMA 2007;298:2196–8.CrossRefGoogle Scholar

18. See note 17, Frost, Levine 2007:2197.

19. Willison, DJ, Emerson, C, Szala-Meneok, KV, Gibson, E, Schwartz, L, Weisbaum, KM, et al. . Access to medical records for research purposes: Varying perceptions across research ethics boards. Journal of Medical Ethics 2008;34:308–14CrossRefGoogle ScholarPubMed.

20. Burris, SWJ. Regulatory paradox: A review of enforcement letters issued by the Office for Human Research Protection. Northwestern University Law Review 2007;1:643–85Google Scholar; de Champlain, J, Patenaude, J. Review of a mock research protocol in functional neuroimaging by Canadian research ethics boards. Journal of Medical Ethics 2006;32:530–4.CrossRefGoogle ScholarPubMed

21. Schuppli, CA, Fraser, D. Factors influencing the effectiveness of research ethics committees. Journal of Medical Ethics 2007;33:294–301.CrossRefGoogle ScholarPubMed

22. See note 20, de Champlain, Patenaude 2006.

23. Marshall, J, Martin, T, Downie, J, Malisza, K. Acomprehensive analysis of MRI research risks: In support of full disclosure. Canadian Journal of Neurological Sciences 2007;34:11–7.CrossRefGoogle ScholarPubMed

24. Guidelines on Exposure to Electromagnetic Fields from Magnetic Resonance Clinical Systems—Safety Code 26; available at http://www.hc-sc.gc.ca/ewh-semt/pubs/radiation/87ehd-dhm127/guidance-directrices-eng.php.

25. Food and Drug Administration. Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Washington, DC: U.S. Department of Health and Human Services.Google Scholar Food and Drug Administration. Center for Devices and Radiological Health. November 14, 1998; available at http://www.fda.gov/cdrh/ode/mri340.pdf; Food and Drug Administration. Significant and Nonsignificant Risk Medical Device Studies; October 1995; available at http://www.fda.gov/cdrh/d861.html; Kanal, E, Barkovich, AJ, Bell, C, Borgstede, JP, Bradley, WG Jr, Froelich, JW et al. . ACR guidance document for safe MR practices: 2007. American Journal of Roentgenology 2007;188:1447–74.CrossRefGoogle ScholarPubMed

26. The Food and Drug Administration. Medical Devices; available at http://www.fda.gov/cdrh/ode/guidance/793.html.

27. Institute for Magnetic Resonance Safety, Education and Research. Homepage; available at http://www.imrser.org; MRIsafety.com. Homepage; available at http://MRIsafety.com.

28. Malisza, KL, Martin, T, Shiloff, D, Malainey, ME, Yu, CT. Prevalence of fear in young children towards the mri environment. In: Proceedings of the ISMRM 17th Scientific Meeting and Exhibition, Honolulu, HI 2009, Abstract 1248Google Scholar; DVD obtainable from ISMRM, http://www.ismrm.org/bookstore (last accessed 21 Oct 2010).

29. Martin, T, Shiloff, D, Malisza, K, Yu, CT. Graduated exposure to a mock MRI scanner increases willingness and comfort in young children. Conference presentation at: Brain Matters—New Directions in Neuroethics Conference 2009.Google Scholar

30. See note 23, Marshall et al. 2007.

31. Intemann, KK, de Melo-Martin, I. Regulating scientific research: Should scientists be left alone? Federation of American Societies for Experimental Biology Journal 2008;22:654–8CrossRefGoogle ScholarPubMed; DeVille, KA.Things fall apart. Can the center hold? Human subject research regulation and participant safety. Journal of Legal Medicine 2007;28:579–91.Google Scholar

32. Sayers, GM. Should research ethics committees be told how to think? Journal of Medical Ethics 2007;33:39–42CrossRefGoogle Scholar; Garrard, E, Dawson, A. What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics. Journal of Medicine and Ethics 2005;31(7):419–23CrossRefGoogle ScholarPubMed; Borenstein, J. The expanding purview: Institutional review boards and the review of human subject research. Accountability in Research 2008;15:188–204CrossRefGoogle Scholar; Bamber, GJ, Sappey, J. Unintended consequences of human research ethics committees: Au revoir workplace studies? Monash Bioethics Review 2007;26:26–36CrossRefGoogle ScholarPubMed; Bevan, JC. Towards the regulation of research ethics boards. Canadian Journal of Anaesthesiology 2002;49:900–6CrossRefGoogle ScholarPubMed; Coleman, CH, Bouesseau, MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Medical Ethics 2008;9:6CrossRefGoogle ScholarPubMed; Albrecht, RR. A step toward truly protecting human subjects: Reviewing the review boards. American Journal of Bioethics 2004;4:54–5CrossRefGoogle ScholarPubMed; 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 Review 2005;13:39–50Google Scholar.

33. See note 31, Intemann, de Melo-Martin 2008.

34. See note 32, Borenstein 2008:202.

35. Hales, BPP. The checklist—A tool for error management and performance improvement. Journal of Critical Care 2006;21:231–5CrossRefGoogle ScholarPubMed.

36. Luijin, H, Musschenga, A, Keus, R, Aaronson, NK. Evaluating the risks and benefits of Phase II and III cancer clinical trials: A look at Institutional Review Boards in the Netherlands. IRB: Ethics and Human Research 2007;29(1):13–8.Google Scholar

37. Emery, L, Harvey, C, Andersen, CM. Formative evaluation using checklists to improve research proposals. Perspectives in Health Information Management 2006;3:1–11.Google ScholarPubMed

38. Mahoney, DM. Institutional review boards (IRBs) and risk considerations for children. Human Research Report 2004;19:1–3.Google Scholar