Symposium on Governance of Medical Research Databases

Seligman Theatre
Royal College of Physicians, London
Wednesday 27th October 2004

Background to meeting | Programme and presentations | Summary Report of Meeting

Background

Apart from clinical trials, which have different considerations, past epidemiological research has often been limited by the difficulty of accessing paper-based records, restricting studies to local investigations. By and large, these studies were vetted locally and researchers (often clinical staff) were allowed access to patients' medical records by Research Ethics Committees, with information being painstakingly transcribed to computers for statistical analysis.

With increasing use of IT in the NHS, it is becoming more viable to gain access to electronic medical information to support epidemiological studies and other research. This reduces costs and may enable a much wider (and hence more statistically relevant) population to be assessed.

At the same time, attitudes have been changing about patient rights, particularly in respect to confidentiality. NHS staff, who may once have shared patient data without great consideration, now look for clear authorisation and legal approval.

The Data Protection Act 1998 spelled out clearly minimum requirements and identified general principles to be considered - a flexible and effective approach (as against the American HIPAA regulations which have been highly prescriptive). However, peculiarities of English Common Law in respect of confidentiality together with recent Guidance from the BMA and GMC created concerns within the NHS requiring the creation of the Section 60 (Health & Social Care Act 2001) process to create exemption from the common law for approved uses of patient data.

The question of patient consent for the use of their medical records, either in research or more generally in new NHS systems, has come to the fore, and is still unresolved in its practical application. Current developments in the fields of medical informatics and medical research are being held up by inconsistent and partial judgements on what is appropriate practice.

Issues Discussed:

• Can we develop a consistent and acceptable policy for all parties to avoid inconsistent decisions? What are the steps we need to take to create such a policy?
• What is the correct balance between individual rights and public good?
• Does everyone want their say, and can we afford it? Where do we draw the line between risk and cost?
• How 'anonymous' must 'anonymised' information be without it becoming useless?
• Can we develop realistic and pragmatic guidelines for developers, data suppliers, users, and regulatory bodies to support proper use of medical records?

The symposium was kindly sponsored by the Medical Research Council, NTRAC, and the Galton Institute of Genetic Medicine