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Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia
  1. H Chappuy1,2,
  2. A Baruchel3,
  3. G Leverger4,
  4. C Oudot3,
  5. B Brethon3,
  6. S Haouy4,
  7. A Auvrignon4,
  8. D Davous5,
  9. F Doz6,
  10. J M Tréluyer7,8
  1. 1Service d'Urgences Pédiatriques, Assistance Publique Hôpitaux de Paris, Hôpital Necker Enfants Malades, Faculté et Université de Médecine Paris Descartes, Paris, France
  2. 2Laboratoire d'Ethique Médicale, Université Paris Descartes, Paris, France
  3. 3Hématologie Pédiatrique, Assistance Publique Hôpitaux de Paris, Hôpital Robert Debré, Université Paris 7, Paris, France
  4. 4Hématologie-Immunologie-Oncologie Pédiatrique, Assistance Publique Hôpitaux de Paris, Hôpital A. Trousseau, Université Paris 6, Paris, France
  5. 5Association Apprivoiser l'Absence, Cent pour Sang la Vie, Paris, France
  6. 6Département d'Oncologie Pédiatrique, Institut Curie, Université Paris Descartes, Paris, France
  7. 7Unité de Recherche Clinique Paris Centre, Paris, France
  8. 8Pharmacologie, Assistance Publique Hôpitaux de Paris, Hôpital Cochin Saint Vincent de Paul, Faculté et Université Paris Descartes, Paris, France
  1. Correspondence to Hélène Chappuy, Service d'Urgences Pédiatriques, Hôpital Necker Enfants Malades, 149 rue de Sèvres, 75743 Paris Cedex 15, France; helene.chappuy{at}


Objective To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision.

Patients and method The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought.

Results 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team.

Conclusions The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk.

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  • Funding This work received financial support in the form of a Contrat d'Initiation à la Recherche Clinique (Assistance Publique Hôpitaux de Paris).

  • Competing interests None.

  • Ethics approval This study was approved by the ethics committee of the Hôpital Tarnier-Cochin, France.

  • Provenance and peer review Not commissioned; externally peer reviewed.