Parents' understanding of a randomised double-blind controlled trial.

Abstract

Recent reports in the media about the NHS inquiry at a North Staffordshire hospital have highlighted concerns about clinical trials involving children, especially about informed consent and the information given to parents. An inquiry led by Professor Griffiths has recommended that the Department of Health produce guidelines for the conduct of clinical trials (Boseley 2000, Rumbelow and Johnstone 2000). The UKCC Code of Professional Conduct (1992) requires that nurses must ‘act always in such a manner to promote and safeguard the interests and well being of patients and clients’. Polit and Hungler (1991) summarise informed consent as meaning ‘subjects have adequate information regarding the research; are capable of comprehending the information and have the power of free choice, enabling them to voluntarily consent to participate in the research or decline participation’. While actively recruiting pre-school children for a randomised controlled trial, the research team became aware that despite adhering to the consent procedure and regular contacts with parents, 14 of the 54 participants failed to complete the trial as requested. Albert and Chadwick (1992) suggest that effective communication can only take place if a message is successfully and completely transferred from one person to another. It was important that the research team (two nurses, a registrar and a consultant) were able to identify and understand any potential communication problems with the information given about the trial. A retrospective postal audit of all 54 participants was carried out to address the question of why some parents failed to complete the trial and if information given to parents should be adapted. The results of this audit will be presented in this article.