Parental perceptions and attitudes about informed consent in clinical research involving children

Soc Sci Med. 1995 Dec;41(12):1647-51. doi: 10.1016/0277-9536(95)00058-f.


We interviewed 64 parents by questionnaire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realized that drug trials are designed to assess not only efficacy but safety as well. More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks. Moreover, a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised. Even more worrisome was the small percentage of parents who realized that a signed consent form was primarily meant to protect their rights, and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time. These findings suggest that there may be significant attitudinal barriers to parental understanding of the informed consent process.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Anti-Allergic Agents / adverse effects
  • Anti-Allergic Agents / therapeutic use
  • Asthma / drug therapy
  • Asthma / psychology
  • Attitude*
  • Australia
  • Child
  • Child, Preschool
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Clinical Trials as Topic / psychology
  • Double-Blind Method
  • Drug Approval / legislation & jurisprudence
  • Female
  • Humans
  • Infant
  • Informed Consent / legislation & jurisprudence*
  • Ketotifen / adverse effects
  • Ketotifen / therapeutic use
  • Legal Guardians / psychology*
  • Male
  • Parents / psychology*
  • Safety / legislation & jurisprudence
  • Treatment Outcome


  • Anti-Allergic Agents
  • Ketotifen