Jp. Dutertre et al., PARENTAL CONSENT FOR CHILDREN TO BE INVOL VED IN BIOMEDICAL-RESEARCH - A SURVEY OF 541 PARENTS, Archives francaises de pediatrie, 50(6), 1993, pp. 533-538
Background. We have interviewed the parents of children born at two ma
ternity hospitals to evaluate the knowledge of parents concerning the
French Huriet law and their consent to the participation of their chil
d in a randomized therapeutic trial. Methods. The inquiry was conducte
d between 15 February and 30 April 1991. Each couple of parents of who
m the mother had given birth in one of the hospitals was sent an expla
natory letter and a questionnaire on the second day after delivery. Pa
rents who were unable to read adequately and those whose baby was ill
were excluded from the study. The main questions were: age of parents,
country of origin, education, profession, social insurance, frequency
of medical consulting, their knowledge of the Huriet law, the source
of that knowledge, their attitude to giving parental consent for their
child to participate in a trial, the reasons for their consent or ref
usal. Results. Five hundred and eighty two questionnaires were distrib
uted but only 541 were used. 73% of the parents said they knew that dr
ugs were tested on volunteers. 59% claimed to know of the Huriet law,
through the media (75%), their practitionist (12%), their environment
(8%). 21% of the parents would consent to one of their children partic
ipating in such trial; 74 % would refuse. Both parents were in agreeme
nt in 79% of cases, 12% of them for consent. The main reasons for refu
sal were the risk for side-effects of the drug (75%), lack of proof fo
r efficacy.(49%), disagreement in principle (19%). The mothers who con
sented were older than those who refused. The members of the << consen
t >> group were more highly educated. Conclusions. Law Huriet is still
inadequately understood in France. Pediatricians should consider how
best to provide parents and the media with better information before t
yring to obtain parental consent.