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

We interviewed 64 parents by questionnaire after completion of a clinial trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realised that drug trials are designed to assess not only efficacy but safety as well. More...

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Bibliographic Details
Published in:Social science & medicine (1982) 1995-06, Vol.40 (11), p.1573-1577
Main Authors: Harth, S.C., Thong, Y.H.
Format: Article
Language:English
Subjects:
Access to information
Adult
Asthma - drug therapy
Attitude to Health
Australia
Biological and medical sciences
Child health
Child, Preschool
Children
Children & youth
Clinical interviews
Clinical research
Clinical trial. Drug monitoring
Clinical trials
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - psychology
Double-Blind Method
Female
General pharmacology
Health Knowledge, Attitudes, Practice
Humans
Infant
Informed consent
Informed Consent - legislation & jurisprudence
informed consent proxy consent minors clinical research
Ketotifen - adverse effects
Ketotifen - therapeutic use
Legal Guardians - psychology
Male
Medical research
Medical sciences
minors
Parents
Parents & parenting
Parents - psychology
Patient Education as Topic - legislation & jurisprudence
Perceptions
Pharmacology
Pharmacology. Drug treatments
proxy consent
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Summary:We interviewed 64 parents by questionnaire after completion of a clinial trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realised 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 realised 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.
ISSN:0277-9536
1873-5347
DOI:10.1016/0277-9536(94)00412-M