• Linda S Franck, Ira Winter, and Kate Oulton.
• lnstitute of Child Health, London, UK. l.franck@ich.ucl.ac.uk
• Int J Nurs Stud. 2007 May 1;44(4):525-33.

BackgroundResearchers 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.ObjectivesTo determine parents' level of understanding of the research study requirements and satisfaction with the informed consent process.ParticipantsEnglish literate parents of children actively involved in research studies.MethodsA 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.ResultsQuestionnaires 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.ConclusionsThese 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.

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