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 (75%) 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.