Data protection legislation: interpretation and barriers to research
- 7 October 2000
- Vol. 321 (7265), 890-892
- https://doi.org/10.1136/bmj.321.7265.890
Abstract
Research has been described as “a powerful means of achieving” the objectives of the Department of Health, namely “to improve the health and well-being of the population and to secure high quality care.”1 There is, however, a need to find a balance between facilitating important research and protecting the confidentiality of patients. As the capabilities of information technology grow, legal frameworks and professional guidance need to be created or refined to safeguard the rights of patients. Some areas of the common law duty of confidentiality and the new Data Protection Act 1998 (box, p 891), which constitutes the United Kingdom's implementation of the relevant European Union directive,2 are causing difficulties of interpretation within the NHS. With few exceptions, broad debate about the implications of the new act is lacking, particularly in the context of epidemiological research that uses patients' records.6-8 Questions of consent, anonymisation of data for research, and access to medical notes for research purposes (rather than audit) have been addressed in a range of literature.9-13 Some of these documents are being updated; this may indicate that there are uncertainties about the legal issues involved in implementing the act. Local variations in interpretation may cause particular difficulties for researchers conducting multicentre epidemiological studies, as the case study that will be described in this article shows. In the meantime, those who must make decisions about confidentiality are still confused. This confusion exists for several reasons. Firstly, there is the interpretation of the act (and to an extent the common law duty of confidentiality). The interpretation is subject to debate, and no case law exists which might clarify the interpretation. Secondly, there is a dearth of up to date and clear policy guidance. Thirdly, the new system of “Caldicott guardians” (box) is untried, and guardians as well …Keywords
This publication has 8 references indexed in Scilit:
- Storage of human organs prompts three inquiriesBMJ, 2000
- Bristol inquiry into baby deaths to move into new phaseBMJ, 2000
- Doctors suspended in child health inquiry2000
- Injury surveillance programmes, ethics, and the data protection Act1999
- Injury surveillance programmes, ethics, and the Data Protection Act Sharing data to prevent injuries Potential problems for tenants The legal position Ethical viewpointBMJ, 1999
- Research Based on Archived Information and Samples1999
- Informed consent: edging forwards (and backwards)BMJ, 1998
- Ethical debate: Informed consent in medical research Informed consent---a response to recent correspondence Changing the BMJ's position on informed consent would be counterproductive Informed consent---a publisher's duty Trial subjects must be fully involved in design and approval of trials Studies that do not have informed consent from participants should not be publishedBMJ, 1998