texte original publié dans : THE LANCET Oncology, 2004, 5:592

Professional skills and shared consent in pediatric clinical research.

Jean-Louis BERNARD

Paediatric Oncology Department, La Timone Children’s Hospital and Consultative Committee of Protection of the People in Biomedical Research Marseille 2, Marseille, France.

In a recent essay [1], Massimo and coauthors stressed that informed consent in paediatric research should be managed as a negotiated process of shared consent. They also advocated a role for appropriate training of future paediatricians to preserve and promote the child’s best interest. As a paediatric oncologist, paediatrics teacher, and chair of an ethics committee in France, I offer another perspective.

The French academic curriculum has two obvious deficiencies : first, the paediatric curriculum is centred mainly on pathology and therapeutics, with very little consideration of communicative skills, relational behaviour, or reflection on ethics ; and second, paediatric trainees who aim to reach an academic position, which is determined mainly by the production of research papers, follow an additional research curriculum that is supposed to give them an adequate investigative ability. In fact, this training is focused on fundamental research with very little attention to clinical research and the special requirements associated with paediatric studies. As a result, competence to design and manage a clinical research programme involving children is often self-acquired. I would advocate that paediatric trainees need to be provided with a coherent curriculum, based on activities actually needed in their future profession and practice. In other words, paediatricians need to be better prepared to do clinical research in children.

The ethics committee that I chair is often concerned about the wide range of abilities between investigators to write adequate patient information and consent documents. This concern highlights a major role for ethics committees in protection of patients and volunteers enrolled in trials. As a general rule, ethics committees have a mix of members from different backgrounds, such as care-givers, ethicists, social workers, lawyers, and patients. This diversity is an important asset and gives the committee a rich depth of experience and knowledge. But, this particularity is often misunderstood by investigators. Teachers and trainees should be made aware that ethics committees can be a potentially useful educational resource. Most paediatric study groups run activities under the auspices of paediatric societies [2] or organisations [Gill D. Ethical principles and operational guidelines for good clinical practice in paediatric research : recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 2004 ; 163 : 53-57.] and are often involved in the formulation of guidelines for good clinical practice in paediatric research. However, although these guidelines increase awareness of important issues within the paediatric community, their implementation is not well assesse [3].

Finally, in 2001, the European Union produced a directive [4] applicable to each member state from May, 2004, that detailed new rules on good clinical practice for all trials involving children and for investigation of medicinal products. In particular the directive stated several key points related to informed consent. First, “consent must represent the minor’s presumed will” ; second, “the minor has received information, according to its capacity of understanding, from staff with experience with minors, regarding the trial, the risks, and the benefits” ; third, “the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator” ; fourth, “the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical, and psychosocial problems inthe field of paediatrics, has endorsed the protocol” ; and fifth, “the interests of the patient always prevail over those of science and society”. This directive constitutes major progress in paediatric research in European countries and it will be important to ensure that trainees are made fully aware of their responsibilities in view of this new law.

The paediatric community now needs to find a way to balance the promotion and preservation of a child’s best interests with the training and professional activities of paediatricians. The notion of shared consent proposed by Massimo and co-authors1 will undoubtedly contribute to this challenge.