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Parental opinions about biomedical research in children in Tours, France

E Autret1, J P Dutertre, P Barbier

  • 1Department of Clinical Pharmacology, Hôpital Bretonneau, Tours, France.

Developmental Pharmacology and Therapeutics
|January 1, 1993
PubMed

Insights

Most parents are unaware of France's clinical trial law (Loi Huriet). While few would consent to their children participating in trials, physicians should improve direct communication to enhance parental understanding and informed decisions.

Area of Science:

  • Medical Law
  • Bioethics
  • Pediatric Clinical Trials

Background:

  • Parental awareness of laws governing clinical trials is crucial for ethical research.
  • The Loi Huriet in France specifically addresses patient rights in clinical research.

Purpose of the Study:

  • To assess parental awareness of the Loi Huriet in France.
  • To understand parental attitudes towards child participation in clinical trials.
  • To identify factors influencing parental consent decisions.

Main Methods:

  • A questionnaire-based study was conducted in a French maternity unit from February to April 1991.
  • The study targeted parents in the immediate postpartum period.
  • A response rate of 59% was achieved.

Main Results:

  • 59% of parents were informed about the Loi Huriet, primarily through media (75%) and general practitioners (12%).
  • Only 21% of parents would consent to their child's participation in a clinical trial, while 74% would refuse.
  • Reasons for acceptance included benefiting others and medical progress; refusal reasons cited side effect risks and unproven efficacy.
  • Parents with higher education were more likely to accept participation.

Conclusions:

  • Parental awareness of the Loi Huriet is limited.
  • Significant parental apprehension exists regarding child participation in clinical trials.
  • Physicians should enhance direct communication with parents about clinical trials and relevant legislation.

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