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J Med Ethics 32:229-234 doi:10.1136/jme.2004.011114
  • Research ethics

Assent in paediatric research: theoretical and practical considerations

  1. D S Wendler
  1. Correspondence to:
 D S Wendler
 Department of Clinical Bioethics, The NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD USA 20892; dwendler{at}nih.gov
  • Received 11 November 2004
  • Accepted 25 May 2005
  • Revised 9 May 2005

Abstract

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children’s sustained dissent should be respected in all cases.

Footnotes

  • i Section 111 of Title I of the Food and Drug Administration Modernization Act 1997, signed into law by President Clinton on 21 November 1997, created the Federal Food, Drug and Cosmetic Act.8

  • The opinions expressed are the author’s own. They do not represent any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services.