The quality of parental consent for research with children: a prospective repeated measure self-report survey.
BACKGROUND
Researchers have ethical and legal responsibilities to ensure that individuals give informed consent to participate in research. The few studies of parental consent for paediatric research suggest there may be inadequate competence, information, understanding, or voluntariness for valid consent to occur.


OBJECTIVE
To determine parents' level of understanding of the research study requirements and satisfaction with the informed consent process.


METHODS
English literate parents of children actively involved in research studies.


METHODS
A repeated measures self-report survey was conducted to measure parent understanding (actual and perceived) of the study consented for and satisfaction with the informed consent process. Relationships between parents understanding of the research and their satisfaction with the consent process were explored and changes in parent understanding or satisfaction over time were described.


RESULTS
Questionnaires from 109 parents were returned, representing 25 different studies. Parents demonstrated a high level of knowledge of information essential for informed consent, such as the purpose, benefits, and participant rights. Nervousness or inability to concentrate, and reading ease of the information sheet were found to relate to parents' knowledge and their perceptions of the adequacy of the consent. Parents overall reported high satisfaction with the consent process.


CONCLUSIONS
These findings support and extend previous research on parental consent for research with children. They suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents. Current practices of obtaining informed consent for research lack supporting research evidence and may not be ethically justifiable.
Franck
Linda S
LS
lnstitute of Child Health, London, UK. l.franck@ich.ucl.ac.uk
Winter
Ira
I
Oulton
Kate
K
D000293:Adolescent; D000328:Adult; D001007:Anxiety / Q000523:psychology; D001294:Attitude to Health; D002648:Child; D002651:Child Advocacy / Q000193:education / Q000523:psychology*; D032882:Comprehension; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006776:Hospitals, Pediatric; D006805:Human Experimentation; D006801:Humans; D008131:London; D008297:Male; D024802:Nurse's Role; D015404:Nursing Methodology Research; D033282:Parental Consent / Q000523:psychology*; D010290:Parents / Q000193:education / Q000523:psychology*; D010371:Pediatric Nursing; D011446:Prospective Studies; D012107:Research Design; D011795:Surveys and Questionnaires; D013664:Teaching Materials