Data protection and patients' consentBMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7285.549 (Published 03 March 2001) Cite this as: BMJ 2001;322:549
Informed consent should be sought before data are used by registries
- James I Morrow, consultant neurologist
- Department of Neurology, Royal Victoria Hospital, Belfast BT12 6BA
- North Staffordshire Local Research Ethics Committee, North Staffordshire Health, Staffordshire ST4 4LX
- Robert Graham Center for Policy Studies in Family Practice and Primary Care, American Academy of Family Physicians, 2023 Massachusetts Ave NW, Washington, DC 20036, USA
- Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin, New Zealand
EDITOR—The news story on the possibility that cancer registries might collapse as a result of new guidance on patient confidentiality issued by the General Medical Council highlighted the difficulties faced by doctors who must deal with increasing bureaucracy.1 In conjunction with a multidisciplinary team from different parts of the United Kingdom I was involved in establishing a prospective register of pregnant women with epilepsy. Pregnancy in women with epilepsy is associated with an increased risk of fetal malformation.
As with cancer, there are variations in the routine treatment of epilepsy in pregnancy. It would be considered unethical to carry out a clinical trial of treatment, but because many pregnancies occur in women already taking a variety of anti-epileptic drugs (for many of which no reliable data on teratogenicity in humans exists) valuable information could become available if only it was collated. It was on this premise that the UK Epilepsy and Pregnancy Register was established.
From the outset we identified the need for confidentiality, and all patients included in the register give informed consent. Few patients have refused or withdrawn consent, and indeed most are delighted that some research is being carried out on this subject. Although case ascertainment would probably be higher if informed consent was not necessary, this is an inevitable trade off made to maintain patients' trust.
A further difficulty faced by registries is that of formal ethical …