The therapeutic misconception: A threat to valid parental consent for pediatric neuroimaging research

Accountability in Research

Volumn 15, Issue 3, 2008, Pages 133-151

  Hadskis, Michael ^a   Kenny, Nuala ^a   Downie, Jocelyn ^a   Schmidt, Matthias ^b   D'Arcy, Ryan ^c  

^a DALHOUSIE UNIVERSITY   (Canada)

^b IWK HEALTH CENTRE   (Canada)

^c NATIONAL RESEARCH COUNCIL CANADA   (Canada)

Author keywords

Consent; Institutional review boards; Pediatric neuroimaging; Regulation of research; Research ethics; Therapeutic misconception

Indexed keywords

ARTICLE; COMPREHENSION; DIAGNOSTIC IMAGING; ETHICS; HUMAN; HUMAN EXPERIMENT; MEDICAL RESEARCH; NEUROLOGY; PARENTAL CONSENT; PEDIATRICS;

BIOMEDICAL RESEARCH; COMPREHENSION; DIAGNOSTIC IMAGING; HUMAN EXPERIMENTATION; HUMANS; NEUROLOGY; PARENTAL CONSENT; PEDIATRICS;

EID: 55449124963     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620801946917     Document Type: Review

References (39)

1. Ackerman, R.H. (1995) Neuroimaging looks to the future. Journal of the Neurological Sciences, 128(2): 117-121.
2. Appelbaum, P.S., Lidz C.W., and Grisso T. (2004) Therapeutic misconception in clinical research: frequency and risk factors. IRB: Ethics & Human Research 26(2): 1-8.
3. Appelbaum, P.S., Roth, L.H., and Lidz, C. (1982) The therapeutic misconception - informed consent in psychiatric research. International Journal of Law and Psychiatry, 5(3-4): 319-329.
4. Bamberg, M., and Budwig, N. (1992) Therapeutic misconceptions: when the voices of caring and research are misconstrued as the voice of curing. Ethics and Behavior, 2(3): 165-184.
5. Belkin, G.S. (2006) Misconceived bioethics? The misconception of the "therapeutic misconception". International Journal of Law and Psychiatry, 29(2): 75-85.
6. Ben-Bashat, D., Ben-Sira, L., Graif, M., Pianka, P., Hendler, T., Cohen, Y., and Assaf, Y. (2005) Normal white matter development from infancy to adulthood: Comparing diffusion tensor and high b value diffusion weighted MR images. Journal of Magnetic Resonance Imaging, 21(5): 503-511.
7. Brett, M., Johnsrude, I.S., and Owen, A.M. (2002) The problem of functional localization in the human brain. Nature Reviews Neuroscience, 3: 243-249.
8. Bush, G., Valera, E.M., and Seidman, L.J. (2005) Functional neuroimaging of attention-deficit/hyperactivity disorder: A review and suggested future directions. Biological Psychiatry 57(11): 1273-84.
9. Coleman, C. (2003) Rationalizing risk assessment in human subject research. Arizona Law Review, 45(897): 1137-1187.
10. Dresser, R. (2002) The ubiquity and utility of the therapeutic misconception. Social Philosophy & Policy, 19(2): 271-294.
11. Durston, S., and Casey, B.J. (2006) What have we learned about cognitive development from neuroimaging? Neuropsychologia, 44(11): 2149-2157.
12. Fried, E. (2001) The therapeutic misconception, beneficence and respect. Accountability in Research 8(4): 331-348.
13. Glannon, W. (2006) Phase I oncology trials: why the therapeutic misconception will not go away. Journal of Medical Ethics 32(5): 252-255.
14. Hadskis, M. (2007a) The regulation of biomedical research in Canada. In Downie, J., Caulfield, T., and Flood, C. (eds.) Canadian Health Law and Policy, 3rd ed. Toronto: Butterworths.
15. Hadskis, M. (2007b) Giving voice to research participants: should IRBs hear from research participant representatives? Accountability in Research 14(3): 155-177.
16. Henderson, G. E., Easter, M. M., Zimmer, C., King, N. M. P., Davis, A. M., Rothschild, B. B., Churchill, L. R., Wilfond, B. S., and Nelson, D. K. (2006) Therapeutic misconception in early phase gene transfer trials. Social Science & Medicine 62: 239-253.
17. Hinton, V.J. (2002) Ethics of neuroimaging in pediatric development. Brain & Cognition 50(3): 455-468.
18. Hochhauser, M. (2002) "Therapeutic misconception" and "recruiting doublespeak" in the informed consent process. IRB: Ethics & Human Research 24: 11-12.
19. Kimmelman J., and Levenstadt, A. (2005) Elements of style: consent form language and the therapeutic misconception in Phase 1 gene transfer trials. Human Gene Therapy 16(4): 502-508.
20. King N.M., Henderson, G.E., Churchill, L.R., Davis, A.M., Hull, S.C., Nelson, D.K., Parham-Vetter, P.C., Rothschild, B.B., Easter, M.M., and Wilfond, B.S. (2005) Consent forms and the therapeutic misconception: the example of gene transfer research. IRB: Ethics & Human Research 27(1): 1-8.
21. Kodish E., Eder, M., Noll, R.B., Ruccione, K., Lange, B., Angiolillo, A., Pentz R., Zyzanski, S., Siminoff, L.A., and Drotar, D. (2004) Communication of randomization in childhood leukemia trials. Journal of the American Medical Association 291(4): 470-475.
22. Lidz, C.W., and Appelbaum, P.S. (2002) The therapeutic misconception - problems and solutions. Medical Care 40(9): 55-63.
23. Mahncke, H.W., Bronstone, A., Merzenich, M.M. (2006) Brain plasticity and scientific losses in the aged: scientific basis for intervention. Progress in Brain Reseach 57: 81-109.
24. Mamourian, A. (2004) Incidental findings on research functional MR images: should we look? Americal Journal of Neuroradiology 25(4): 520-522.
25. McNeill, P.M. (1993) The Ethics and Politics of Human Experimentation. New York: Cambridge University Press.
26. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada (1998) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Ottawa: Public Works and Government Services Canada.
27. Miller F.G., and Joffe, S. (2006) Evaluating the therapeutic misconception. Kennedy Institute of Ethics Journal 16(4): 353-366.
28. Racine, E., Bar-Ilan, O., and Illes, J. (2005) fMRI in the public eye. Nature Reviews Neuroscience 6(2): 159-164.
29. Racine E., Bar-Ilan, O., and Illes, J. (2006) Brain imaging - A decade of coverage in the print media. Science Communication 28(1): 122-143.
30. Racine E., and Illes, J. (2006) Neuroethical responsibilities. Canadian Journal of Neurological Sciences 33: 269-277.
31. Rorden, C., and Karnath, H. (2004) Using human brain lesions to infer function: A relic from a past era in the fMRI age? Nature Reviews Neuroscience 5: 813-819.
32. Shaywitz, B.A., Lyon, G.R., and Shaywitz, S.E. (2006) The role of functional magnetic resonance imaging in understanding reading and dyslexia. Developmental Neuropsychology 30(1): 613-632.
33. Steinke, E.E. (2004) Research ethics, informed consent, and participant recruitment. Clinical Nurse Specialist 18(2): 88-95.
34. Stevens, P. E., and Pletsch, P. K. (2002) Ethical issues of informed consent: mothers' experiences enrolling their children in bone marrow transplantation research. Cancer Nursing 25: 81-87.
35. Title 45, Code of Federal Regulations, Part 46, Subpart A ("Common Rule").
36. Vanderpool, H.Y., and Weiss, G.B. (1987) 2 urgent problems in research ethics - false data and last hopes - enrolling ineligible patients in clinical-trials. Hastings Center Report 17(2): 16-19.
37. Vitiello, B., Aman, M. G., Scahill, L., McCracken, J. T., McDougle, C. J., Tierney, E., Davies, M., and Arnold, L. E. (2005) Research knowledge among parents of children participating in a randomized clinical trial. Journal of the American Academy of Child and Adolescent Psychiatry 44: 145-149.
38. Weinfurt, K.P., Sulmasy, D.P., Schulman, K.A., and Meropol, N.J. (2003) Patient expectations of benefit from Phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theoretical Medicine Bioethics 24(4): 329-344.
39. Wilke, M., Schmithorst, V.J., Holland, S.K. (2003) Normative pediatric brain data for spatial normalization and segmentation differs from standard adult data. Magnetic Resonance in Medicine 50(4): 749-757.