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Evidence-based medicines for children: ethical aspects

Danish Paediatric Asthma Centre, Copenhagen University Hospital, Gentofte, Hellerup, Denmark.

To the Editors:

In an editorial in the December issue of the European Respiratory Journal, Bush 1 describes and welcomes newly proposed legislation from the European Commission requiring testing of all new medicine in children. We certainly agree that this new proposal is a step forward in terms of developing evidence-based therapies for children. We also agree that the creation of a new Paediatric Committee is an opportunity for the scientific community to influence the direction of research. This Committee could increase the collaboration between industry, researchers, paediatric societies and clinicians to the benefit of diseased children. By granting companies an extended period of patent and data protection, the new proposal reduces some of the economic barriers that have hampered clinical research in the paediatric population.

However, the cost of paediatric trials is not the only barrier that needs to be addressed. Paediatric research is ripe with ethical dilemmas that need to be discussed as an integral part of the implementation of the new legislation. There is a growing body of literature discussing specific ethical dilemmas in relation to paediatric research, such as the inclusion of healthy children in nontherapeutic research 2, 3 and the role of children’s assent and dissent in decision making 4, 5. A recent paper discussed the role of altruistic considerations in the informed consent process of paediatric research 6. While several studies report that altruistic considerations are among the motives that parents often cite when they explain their decision to enrol their child 7–10, it is still debatable whether or not investigators should include the subject of altruism in discussions with parents about participation. An empirical study of 140 audiotaped paediatric informed consent sessions shows that the enrolment rate of children was not higher among children whose parents were involved in discussions of altruism compared with those parents who were not 6. This is good news in so far as such discussions ought to be nonoppressive but it leaves one wondering what really motivates parents to let their children participate in research. In our opinion, more empirical studies are needed to reveal how parents and children perceive their participation in research and to highlight their needs and concerns. This will help us improve clinical research and hopefully motivate more families to participate.

REFERENCES

1. Bush A. Evidence-based medicines for children: important implications for new therapies at all ages. Eur Respir J 2006;28:1069–1072.[Free Full Text]
2. Koren G, Kearns GL, Reed M, Pons G. Use of healthy children as volunteers in drug studies: The ethical debate. Clin Pharmacol Ther 2003;73:147–152.[CrossRef][ISI][Medline] [Order article via Infotrieve]
3. Ross LF. Do healthy children deserve greater protection in medical research? J Pediatr 2003;142:108–112.[CrossRef][ISI][Medline] [Order article via Infotrieve]
4. Rossi WC, Reynolds W, Nelson RM. Child assent and parental permission in pediatric research. Theor Med Bioeth 2003;24:131–148.[CrossRef][ISI][Medline] [Order article via Infotrieve]
5. Wendler D, Shah S. Should children decide whether they are enrolled in nonbeneficial research? Am J Bioeth 2003;3:1–7.[ISI][Medline] [Order article via Infotrieve]
6. Simon C, Eder M, Kodish E, Siminoff L. Altruistic discourse in the informed consent process for childhood cancer clinical trials. Am J Bioeth 2006;6:40–47.[ISI][Medline] [Order article via Infotrieve]
7. Gammelgaard A, Knudsen LE, Bisgaard H. Perceptions of parents on the participation of their infants in clinical research. Arch Dis Child 2006;91:977–980.[Abstract/Free Full Text]
8. Rothmier JD, Lasley MV, Shapiro GG. Factors influencing parental consent in pediatric clinical research. Pediatrics 2003;111:1037–1041.[Abstract/Free Full Text]
9. Harth SC, Thong YH. Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study. BMJ 1990;300:1372–1375.[ISI][Medline] [Order article via Infotrieve]
10. Hayman RM, Taylor BJ, Peart NS, Galland BC, Sayers RM. Participation in research: informed consent, motivation and influence. J Paediatr Child Health 2001;37:51–54.[CrossRef][ISI][Medline] [Order article via Infotrieve]

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