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Obtaining patient consent for clinical audit is unworkable without extra resources

A feasibility study of signed consent for the collection of patient identifiable information for a national paediatric clinical audit database BMJ Online First


Obtaining signed patient consent for audit purposes is difficult and is unlikely to be successful unless extra resources are made available, finds a study published online by the BMJ today.

The 1998 Data Protection Act strengthened controls on the use of personal data, but the Health and Social Care Act 2001 allows patient identifiable information to be made available in certain circumstances, including medical audit and research.

Researchers studied the feasibility of obtaining signed consent for submission of patient identifiable information to a national clinical audit database (PICANet).

Their analysis involved patients admitted to five paediatric intensive care units in England during May and July 2003. Parents and guardians were given a short explanation and an information sheet. Then 24 hours later (or before discharge) they were asked for signed consent. Factors that might influence the chance of consent being given, such as age, illness severity, and length of hospital stay, were also assessed.

Consent was obtained for 43% of admissions, only one refusal was received. Gaining consent for all admissions was difficult and varied widely across units.

The gaining of consent was unrelated to ethnicity or level of deprivation but was better for those who had a longer hospital stays and was worse for older children. The extremely low refusal rate suggested that parents were willing to share personal data.

These results reinforce the view that the logistics of obtaining consent for sharing information presents substantial challenges requiring new approaches to the issue, say the authors. Obtaining such consent is unlikely to be successful unless extra resources are allocated to training, staff time, and administrative support.


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