Therapeutic and Other Misconceptions in Clinical Trials for Paediatric Genetic Disorders

Abstract

Paediatric research is ethically complex because it involves subjects unable to consent for themselves. As some conditions only affect children, it is necessary to involve children in research so that treatments can be developed. Paediatric genomic research requires parental consent for children with serious, often progressive and frequently life‐threatening conditions. A body of evidence identifies the various vulnerabilities associated with the process of informed consent. Commonly misconceptions about the nature of research, especially those that mistake research for treatment, the ‘therapeutic misconception’, can occur. Serious misconceptions about research potentially undermine the validity of consent. Various factors increase the likelihood of therapeutic and other serious misconceptions, which include the complexity of the research, the timing and context of decisions. Researchers may also contribute to misconceptions, for example by being too optimistic about the benefits of research. Wider factors such as the ‘promissory’ hyperbole that accompanies public discussion of bioscience research also encourage inflated expectations of research. Researchers ought to be conscious of these factors but should not deny parents the opportunity to exercise parental responsibility in giving consent nor deny them the capacity for hope alongside a realistic understanding of the aims and limitations of research.

Key Concepts

  • Informed consent for clinical research is an important ethico‐legal concept, but it is vulnerable to several serious flaws which may undermine the validity of the consent.
  • In research ethics, the ‘therapeutic misconception’ is commonly observed in which research participants falsely believe that the aim of the research is to provide beneficial treatment.
  • Paediatric genomics research is a complex area of research in which appropriate support for parental decisions is needed to help them to navigate complex information and to understand the aims of the research.
  • Clinicians who are also active in paediatric research ought to be aware of the influence they can exert over parents invited to participate in genomics research.
  • A disposition to hope for benefit from research may be an important coping mechanism, for parents and researchers should distinguish between a disposition to hope and a serious therapeutic misconception.
  • Researchers and policymakers should attend to the language they use in the public discussion of developing areas of biomedicine, avoiding ‘promissory’ claims which may encourage a therapeutic misconception.

Keywords: parental consent; therapeutic misconception; therapeutic optimism; hope; paediatric genomics; patient activism; research ethics; informed consent

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Woods, Simon(Jul 2018) Therapeutic and Other Misconceptions in Clinical Trials for Paediatric Genetic Disorders. In: eLS. John Wiley & Sons Ltd, Chichester. http://www.els.net [doi: 10.1002/9780470015902.a0028016]