The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research

References

• Ackerman , R.H. 1995 . Neuroimaging looks to the future . Journal of the Neurological Sciences , 128 ( 2 ) : 117 – 121 .
   Google Scholar
• 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 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMedGoogle Scholar
• Belkin , G.S. 2006 . Misconceived bioethics? The misconception of the “therapeutic misconception” . International Journal of Law and Psychiatry , 29 ( 2 ) : 75 – 85 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Coleman , C. 2003 . Rationalizing risk assessment in human subject research . Arizona Law Review , 45 ( 897 ) : 1137 – 1187 .
   Google Scholar
• Dresser , R. 2002 . The ubiquity and utility of the therapeutic misconception . Social Philosophy & Policy , 19 ( 2 ) : 271 – 294 .
   PubMed Web of Science ®Google Scholar
• Durston , S. and Casey , B.J. 2006 . What have we learned about cognitive development from neuroimaging? . Neuropsychologia , 44 ( 11 ) : 2149 – 2157 .
   PubMed Web of Science ®Google Scholar
• Fried , E. 2001 . The therapeutic misconception, beneficence and respect . Accountability in Research , 8 ( 4 ) : 331 – 348 .
   PubMedGoogle Scholar
• Glannon , W. 2006 . Phase I oncology trials: why the therapeutic misconception will not go away . Journal of Medical Ethics , 32 ( 5 ) : 252 – 255 .
   PubMed Web of Science ®Google Scholar
• Hadskis , M. 2007a . “ The regulation of biomedical research in Canada ” . In Canadian Health Law and Policy , 3rd , Edited by: Downie , J. , Caulfield , T. and Flood , C. Toronto : Butterworths .
   Google Scholar
• Hadskis , M. 2007b . Giving voice to research participants: should IRBs hear from research participant representatives? . Accountability in Research , 14 ( 3 ) : 155 – 177 .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Hinton , V.J. 2002 . Ethics of neuroimaging in pediatric development . Brain & Cognition , 50 ( 3 ) : 455 – 468 .
   PubMed Web of Science ®Google Scholar
• Hochhauser , M. 2002 . “Therapeutic misconception” and “recruiting doublespeak” in the informed consent process . IRB: Ethics & Human Research , 24 : 11 – 12 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMedGoogle Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Lidz , C.W. and Appelbaum , P.S. 2002 . The therapeutic misconception - problems and solutions . Medical Care , 40 ( 9 ) : 55 – 63 .
   Google Scholar
• Mahncke , H.W. , Bronstone , A. and Merzenich , M.M. 2006 . Brain plasticity and scientific losses in the aged: scientific basis for intervention . Progress in Brain Reseach , 57 : 81 – 109 .
   Google Scholar
• Mamourian , A. 2004 . Incidental findings on research functional MR images: should we look? . Americal Journal of Neuroradiology , 25 ( 4 ) : 520 – 522 .
   Google Scholar
• McNeill , P.M. 1993 . The Ethics and Politics of Human Experimentation , New York : Cambridge University Press .
   Google Scholar
• 1998 . “ Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada ” . In Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans , Ottawa : Public Works and Government Services Canada .
   Google Scholar
• Miller , F.G. and Joffe , S. 2006 . Evaluating the therapeutic misconception . Kennedy Institute of Ethics Journal , 16 ( 4 ) : 353 – 366 .
   PubMedGoogle Scholar
• Racine , E. , Bar-Ilan , O. and Illes , J. 2005 . fMRI in the public eye . Nature Reviews Neuroscience , 6 ( 2 ) : 159 – 164 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Racine , E. and Illes , J. 2006 . Neuroethical responsibilities . Canadian Journal of Neurological Sciences , 33 : 269 – 277 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Steinke , E.E. 2004 . Research ethics, informed consent, and participant recruitment . Clinical Nurse Specialist , 18 ( 2 ) : 88 – 95 .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Title 45, Code of Federal Regulations, Part 46, Subpart A (“Common Rule”).
   Google Scholar
• 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 .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• Wilke , M. , Schmithorst , V.J. and 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 .
   Web of Science ®Google Scholar