Skip to main content
SpringerLink
Log in

Therapeutic Misconception: Hope, Trust and Misconception in Paediatric Research

  • Original Article
  • Published:
Health Care Analysis Aims and scope Submit manuscript

Abstract

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Abresch, R. T., Seyden, N. K., et al. (1998). Quality of life. Issues for persons with neuromuscular diseases. Physical Medicine and Rehabilitation Clinics of North America, 9(1), 233–248.

    CAS  PubMed  Google Scholar 

  2. Action Duchenne: http://www.actionduchenne.org/. Accessed at 25 Nov 2011.

  3. Ahlstrom, G., & Sjoden, P. O. (1996). Coping with illness-related problems and quality of life in adult individuals with muscular dystrophy. Journal of Psychosomatic Research, 41(4), 365–376.

    Article  CAS  PubMed  Google Scholar 

  4. Allied Control Council. (1949). Trials of war criminals before the Nuremberg military tribunals under control council law no. 10 (pp. 181–182) Washington, DC: US Government Printing Office.

  5. Appelbaum, P. S., & Lidz, C. W. (2006). Re-evaluating the therapeutic misconception: Response to Miller and Joffe. Kennedy Institute of Ethics Journal, 16(4), 367–373.

    Article  PubMed  Google Scholar 

  6. Appelbaum, P. S., Roth, L. H., et al. (1982). The therapeutic misconception—Informed consent in psychiatric research. International Journal of Law and Psychiatry, 5(3–4), 319–329.

    Article  CAS  PubMed  Google Scholar 

  7. Appelbaum, P. S., Roth, L. H., et al. (1987). False hopes and best data—Consent to research and the therapeutic misconception. Hastings Center Report, 17(2), 20–24.

    Article  CAS  PubMed  Google Scholar 

  8. Appelbaum, P. S., Lidz, C. W., & Grisso, T. (2004). Therapeutic misconception in clinical research: Frequency and risk factors. IRB: Ethics and Human Research, 26(2), 1–8.

    Article  PubMed  Google Scholar 

  9. Bamberg, M., & 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.

    Article  PubMed  Google Scholar 

  10. Bostrom, K., & Ahlstrom, G. (2004). Living with a chronic deteriorating disease: The trajectory with muscular dystrophy over ten years. Disability and Rehabilitation, 26(23), 1388–1398.

    Article  PubMed  Google Scholar 

  11. Bothwell, J. E., Dooley, J. M., et al. (2002). Duchenne muscular dystrophy—Parental perceptions. Clinical Pediatrics, 41(2), 105–109.

    Article  CAS  PubMed  Google Scholar 

  12. Boyer, F., Drame, M., et al. (2006). Factors relating to carer burden for families of persons with muscular dystrophy. Journal of Rehabilitation Medicine, 38(5), 309–315.

    Article  PubMed  Google Scholar 

  13. Braude, P., Minger, S. L., & Warwick, R. M. (2005). Stem cell therapy: Hope or hype? British Medical Journal, 330(7501), 1159–1160.

    Article  PubMed  Google Scholar 

  14. Buxton, J. (2007). Animal egg stem cell research plans in jeopardy. BioNews, 390. Website. Retrieved 9 February 2012, from http://www.bionews.org.uk/page_12949.asp.

  15. Cave, E. (2010). Seen but not heard: Children in clinical trials. Medical Law Review, 18(1), 1–27.

    Article  PubMed  Google Scholar 

  16. de Melo-Martın, I., & Ho, A. (2008). Beyond informed consent: The therapeutic misconception and trust. Journal of Medical Ethics, 34, 202–205.

    Article  PubMed  Google Scholar 

  17. Department of Health. (2000). Stem cell research: Medical progress with responsibility. London, Crown Copyright.

  18. Dixon-Woods, M., Ashcroft, R. E., et al. (2007). Beyond ‘misunderstanding’: Written information and decisions about taking part in a genetic epidemiology study. Social Science and Medicine, 65(2007), 2212–2222.

    Article  PubMed  Google Scholar 

  19. Doyal, L., & Tobias, J. (Eds.). (2000). Informed consent in medical research (pp. 286–292). London: BMJ Books.

    Google Scholar 

  20. Dresser, R. (2001). When science offers salvation: Patient advocacy and research ethics. New York: Oxford University Press.

    Google Scholar 

  21. Dresser, R. (2002). The ubiquity and utility of the therapeutic misconception. Social Philosophy & Policy, 19, 271–294.

    Article  Google Scholar 

  22. Edsall, G. (1971). Experiments at Willowbrook. Lancet, 298(7715), 95.

    Article  Google Scholar 

  23. Eggers, S., & Zatz, M. (1998). Social adjustment in adult males affected with progressive muscular dystrophy. American Journal of Medical Genetics, 81(1), 4–12.

    Article  CAS  PubMed  Google Scholar 

  24. Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent. Oxford: Oxford University Press.

    Google Scholar 

  25. Gagliardi, B. A. (1991). The impact of Duchenne muscular dystrophy on families. Orthopaedic Nursing, 10(5), 41–49.

    Article  CAS  PubMed  Google Scholar 

  26. Geesink, I., Prainsack, B., & Franklin, S. (2008). Stem cell stories 1998–2008. Science as Culture, 17(1), 1–11.

    Article  Google Scholar 

  27. General Medical Council. (2002). The role and responsibility of doctors. London: General Medical Council.

    Google Scholar 

  28. General Medical Council. (2007). 0–18 years: Guidance for doctors. London: General Medical Council.

    Google Scholar 

  29. General Medical Council. (2010). Good practice in research. London: General Medical Council.

    Google Scholar 

  30. Gibson, B. E., Young, N. L., et al. (2007). Men on the margin: A Bourdieusian examination of living into adulthood with muscular dystrophy. Social Science and Medicine, 65(3), 505–517.

    Article  PubMed  Google Scholar 

  31. Goldby, S. (1971). Experiments at the Willowbrook state school. Lancet, 297(7702), 749.

    Article  Google Scholar 

  32. Hadskis, M., Kenny, N., Downie, J., Schmidt, M., & D’Arcy, R. (2008). The therapeutic misconception: A threat to valid parental consent for paediatric neuroimaging research. Accountability in Research, 15(3), 133–151.

    Article  PubMed  Google Scholar 

  33. Hagger, L. (2009). The child as vulnerable patient: Protection and empowerment. Aldershot: Ashgate Publishing.

    Google Scholar 

  34. Hagger, L., & Woods, S. (2005). Children in research: A risk of double jeopardy. International Journal of Children’s Rights, 13, 47–68.

    Article  Google Scholar 

  35. Harris, J. (2003). Consent and end of life decisions. Journal of Medical Ethics, 29, 10–15.

    Article  PubMed  Google Scholar 

  36. Henderson, G. E., Easter, M. M., Zimmer, C., et al. (2006). Therapeutic misconception in early phase gene transfer trials. Social Science and Medicine, 62, 239–253.

    Article  PubMed  Google Scholar 

  37. Henderson, G. E., Churchill, L. R., Davis, M. R., Easter, M. M., Grady, C., Joffe, S., et al. (2007). Clinical trials and medical care: Defining the therapeutic misconception. PLoS Medicine, 4(11), 1735–1738.

    Article  Google Scholar 

  38. Henderson, R. A. (2008) Consent, choice and children in research: Exploring decision-making by parents of children with Duchenne Muscular Dystrophy considering participation in genetic research projects. Unpublished PhD thesis, University of Newcastle UK.

  39. Horng, S., & Grady, C. (2003). Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB, 25(1), 11–16.

    Article  PubMed  Google Scholar 

  40. Horrobin, D. F. (2003). Modern biomedical research: An internally self-consistent universe with little contact with medical reality?. February: Nature Reviews Drug Discovery.

    Google Scholar 

  41. James, A. (2008). Responsibility, children and childhood. In J. Bridgeman, H. Keating, & C. Lind (Eds.), Responsibility, law and the family (pp. 145–165). Aldershot: Ashgate Publishing.

    Google Scholar 

  42. Jansen, L. A. (2006). The problem with optimism in clinical trials. IRB, 28, 13–19.

    PubMed  Google Scholar 

  43. Jansen, L. A. (2011). Two concepts of therapeutic optimism. Journal of Medical Ethics, 37, 563–566.

    Article  PubMed Central  PubMed  Google Scholar 

  44. Joffe, S., Cook, E. F., Cleary, P. D., Clark, J. W., & Weeks, J. C. (2001). Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet, 358, 1772–1777.

    Article  CAS  PubMed  Google Scholar 

  45. Joffe, S., & Miller, F. G. (2006). Rethinking risk benefit assessment for phase I cancer trials. Journal of Clinical Oncology, 24, 2987–2990.

    Article  PubMed  Google Scholar 

  46. Kodish, E., Eder, M., Noll, R. B., Ruccione, K., et al. (2004). Communication of randomization in childhood leukemia trials. Journal of the American Medical Association, 291(4), 470–475.

    Article  CAS  PubMed  Google Scholar 

  47. Lidz, C. W. (2006). The therapeutic misconception and our models of competency and informed consent. Behavioral Sciences and the Law, 24, 535–546.

    Article  PubMed  Google Scholar 

  48. Manson, N. C., & O’Neill, O. (2007). Rethinking informed consent in bioethics. Cambridge: Cambridge University Press.

    Book  Google Scholar 

  49. Marcel, G. (1995). The philosophy of existentialism (trans: Manya Harari.) New York, NY: Carol Publishing Group.

  50. Martin, P., & Nightingale, P. (2004). The myth of the biotech revolution. Trends in Biotechnology, 22(11), 564–569.

    Article  PubMed  Google Scholar 

  51. Meisel, A., Roth, L., & Lidz, C. (1977). Towards a model of the legal doctrine of informed consent. American Journal of Psychiatry, 134(3), 285–289.

    CAS  PubMed  Google Scholar 

  52. Miller, M. (2000). Phase I cancer trials. A collusion of misunderstanding. Hastings Cent Rep, 30, 34–43.

    Article  CAS  PubMed  Google Scholar 

  53. Muscular Dystrophy Association: http://quest.mda.org/news/research-briefs-dmd-bmd-trials-update. Accessed at 25 Nov 2011.

  54. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC.

  55. Natterlund, B., Sjoden, P. O., et al. (2001). The illness experience of adult persons with muscular dystrophy. Disability and Rehabilitation, 23(17), 788–798.

    Article  CAS  PubMed  Google Scholar 

  56. NHS Executive. (2003). West midlands regional office report of a Review of the research framework in north staffordshire hospital NHS trust http://www.doh.gov.uk/wmro/nrthstaffs.htm. Accessed 25 Nov 2011.

  57. O’Neill, O. (2002). Autonomy and trust in bioethics. Cambridge: Cambridge University Press.

    Book  Google Scholar 

  58. Parent Project Muscular Dystrophy: http://www.parentprojectmd.org/site/PageServer?pagename=nws_index. Accessed at 25 Nov 2011.

  59. Pattinson, S. D. (2011). Medical law and ethics. London: Sweet and Maxwell.

    Google Scholar 

  60. Pohlschmidt, M., & Meadowcroft, R., (2010). Muscle disease: The impact. Incidence and prevalence of neuromuscular conditions in the UK (p. 15) London, Muscular Dystrophy Campaign.

  61. Reeve, C. (2005). CRF position statement on human embryonic stem cell research. Christopher and Dana Reeve Foundation: 2005.

  62. Reynolds, W. W., & Nelson, R. M. (2007). Risk perception and decision processes underlying informed consent to research participation. Social Science & Medicine, 65, 2105–2115.

    Article  Google Scholar 

  63. Sammons, H. (2009). (2009) Ethical issues of clinical trials in children: A European perspective. Archives of Disease in Childhood, 94, 474–477.

    Article  CAS  PubMed  Google Scholar 

  64. Samson, A., Tomiak, E., et al. (2009). The lived experience of hope among parents of a child with Duchenne muscular dystrophy: Perceiving the human being beyond the illness. Chronic Illness, 5, 103–114.

    Article  PubMed  Google Scholar 

  65. Saver, R. S. (2006). Medical research and intangible harm. University of Cincinnati Law Review, 74, 941–1012.

    Google Scholar 

  66. Shilling, V., Young, B. (2009). How do parents experience being asked to enter a child in a randomised controlled trial? BMC Medical Ethics, 10, 1. doi:10.1186/1472-6939-10-1. http://www.biomedcentral.com/1472-6939/10/1.

  67. Siminoff, L., & Simon, C. (2004). A comparison of the informed consent process in paediatric and adult oncology. Philadelphia, PA: American Society of Bioethics and the Humanities.

    Google Scholar 

  68. Smith, R. (2000). Babies and consent: Yet another NHS scandal. British Medical Journal, 299, 1253.

    Google Scholar 

  69. Sorapop, K., & Douglas, S. (2009). Monitoring and regulating offshore stem cell clinics. Science, 323(5921), 1564–1565.

    Article  Google Scholar 

  70. Stephenson, T. (2005). How children’s responses to drugs differ from adults. British Journal of Clinical Pharmacology, 59(6), 670–673.

    Article  PubMed Central  PubMed  Google Scholar 

  71. Treanor, B. (2010). In G. (-Honore) Marcel, E. N. Zalta (Ed.), The stanford encyclopaedia of philosophy (Fall 2010 Edition) http://plato.stanford.edu/archives/fall2010/entries/marcel/.

  72. TREAT-NMD. (2009). Therapeutic Misconception. TREAT-NMD International Conference: Bringing down the barriers in translational medicine in neuromuscular disorders. Brussels. Website. Retrieved 21 September 2011, from http://www.treat-nmd-conference.org/brussels-2009/2009-questions-received/2009-questions-the-therapeutic-misconception.

  73. TREAT-NMD. (2010). Website. Retrieved 21 September 2010, from http://www.treat-nmd.eu/home.php.

  74. Williams-Jones, B., & Corrigan, O. (2003). Rhetoric or hype: Where’s the ‘ethics’ in pharmacogenomics? American Journal of Pharmacogenomics, 3(6), 375–383.

    Article  PubMed  Google Scholar 

  75. Woods, S. (2008). Stem cell stories: From bedside to bench. Journal of Medical Ethics, 34(12), 845–848.

    Article  CAS  PubMed  Google Scholar 

  76. Woods, S., & McCormack, P. (2011). Disputing the ethics of research: The challenge from bioethics and patient activism to the interpretation of the Declaration of Helsinki in clinical trials. Bioethics (in press).

European Union Legislation

  1. Regulation (EEC) No 1768/92.

  2. Regulation (EC) No 1901/2006 (Medicinal products for paediatric use).

  3. Directive 2001/83/EC.

  4. Directive 2001/20/EC (Clinical trials directive).

  5. Regulation (EC) No 726/2004.

UK Legislation

  1. Children’s Act 1989.

  2. Medicines for Human Use (Clinical Trials) Regulations 2004.

  3. Mental Capacity Act 2005.

  4. Mental Capacity Act 2005 Code of Practice.

Cases

  1. Bolam v Friern Management Committee (1957) 1 WLR 582.

  2. S v S (1972) AC 24.

  3. Chatterton v Gerson (1981) QB 432.

  4. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital (1985) AC 871.

  5. Gillick v West Norfolk and Wisbech Area Health Authority (1986) AC 112.

  6. In Re Cincinnati Radiation Litig 874 F Supp 796 (SD Ohio 1995).

  7. Re Y (1997) 2 WLR 556.

  8. Bolitho (Deceased) v City and Hackney Health Authority (1998) AC 232.

  9. Pearce v United Bristol Healthcare Trust (1999) PIQR 53.

  10. Pretty v United Kingdom (2002) 35 EHRR 1.

  11. R v Portsmouth NHS Trust ex p. Glass (1999) 2 FLR 905.

  12. Re A (Male Sterilisation) (2000) 1 FLR 549.

  13. Chester v Afshar (2005) 1 AC 134.

  14. Mabon v Mabon et al. (2005) 3 WLR 460.

  15. Re B (Adult, refusal of medical treatment) (2002) 2 All ER 449.

Reports

  1. European Commission. (2008). Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. ftp://ftp.cordis.europa.eu/pub/fp7/docs/ethical-considerations-paediatrics_en.pdf. Accessed 12 Nov 2011.

  2. Parliamentary Office of Science and Technology. (2006). Postnote No. 266. Children’s medicines. http://www.parliament.uk/documents/post/postpn266.pdf. Accessed 14 Nov 2011.

Download references

Acknowledgments

TREAT-NMD is funded by the EU via FP6 under contract number LSHM-CT-2006-036825.

Author information

Authors and Affiliations

  1. Policy Ethics and Life Sciences Research Centre (PEALS), Newcastle University, 4th Floor Claremont Bridge, Newcastle upon Tyne, NE1 7RU, UK

    Simon Woods & Pauline McCormack

  2. School of Law, University of Sheffield, Sheffield, UK

    Lynn E. Hagger

Authors
  1. Simon Woods
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lynn E. Hagger
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Pauline McCormack
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Simon Woods.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Woods, S., Hagger, L.E. & McCormack, P. Therapeutic Misconception: Hope, Trust and Misconception in Paediatric Research. Health Care Anal 22, 3–21 (2014). https://doi.org/10.1007/s10728-012-0201-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10728-012-0201-8

Keywords

Search

Navigation