Parental Opinions about Biomedical Research in Children in Tours, France

Abstract

In order to evaluate parental awareness of the law governing clinical trials in France (Loi Huriet), a study was performed by questionnaire between February and April 1991 in a maternity unit during the days following delivery. The response rate was 59%. 59% of the parents (319/541) were informed of the existence of the law by the media (7 5 %) or their general practitioners (12%). Twenty-one percent (116/541) of the parents would accept the participation of their children in a clinical trial and 74% would refuse. The principal reasons for acceptance were: for the benefit of other children, contribution to medical progress and confidence in physicians. The reasons for refusal were: risk of side effects and unproven efficacy. Parents who would accept had more often received higher education (44%) than parents who would refuse (30%), the latter being less influenced by the explanations of physicians and less willing to accept that a physician should decide for them. Physicians should consider transmitting information directly to parents and indirectly via the media.

Parents’ Perspectives on Research Involving Children

“…For example, socially disadvantaged parents have been more likely to volunteer their children in some studies (16,17), but not in others (18,19). Parents with less education have been found to be more negative to research than college educated parents (20).…”

Preference Assessment of Recruitment into a Randomized Trial for Adolescent Idiopathic Scoliosis

“…The role of the physician has been shown to influence decisions concerning trial participation. Confidence in the doctor who recommended the trial was a principal reason for parents to allow their children to be randomized to a hypothetical drug trial 69 . In general, patients who perceive their physicians to have affiliative communication styles are more likely to be satisfied with their care, and they are more likely to comply with physician recommendations, including participation in clinical trials 70 .…”

Information du public sur les essais cliniques et la recherche

“…Les résultats qui en ressortent sont : 1. Les essais chez l'homme sont perçus comme une nécessité (90 % des patients [enquête réalisée auprès de la patientèle de médecins investigateurs ; Giacomino A, données non publiées]), y participer est une bonne action (73 % du grand public), [9] et ceux réalisés dans le cadre de la médecine libérale sont [10] 72 % de la clientèle de médecins investigateurs (enquête réalisée auprès de la patientèle de médecins investigateurs ; Giacomino A, données non publiées) se déclarent plutôt favorables à participer (13 % ont de fait déjà participé à des essais) [9] et 25 % des adultes toutvenant participeraient (taux de participation effective de 4 %). Autrement dit, en l'absence d'information de proximité, telle qu'une personne de l'entourage ou un médecin traitant lui-même impliqué dans les essais, le niveau de motivation est faible.…”