patients confidentiality and data privacy
We welcome recent editorials [1-3] calling for further
debate on the matter of data privacy and access to patient records. We
wish to raise a related concern, about recent GMC guidelines on
confidentiality  and their effect on research. Academic clinical
research, and the evaluation of new therapies, is likely to remain a
crucial element in providing high quality cost-effective patient care for
the foreseeable future. This requires the co-operation and good
will of patient volunteers. This process is externally regulated and
monitored by both local and regional ethical committees to ensure that
patients who contribute in this way are well protected.
The recent GMC document  focuses on the patients' right to
confidentiality and the protection of personal information. We agree that
guidance in this area is important, for the protection of both patients
and doctors, and recognise the value of consent to the sharing of
confidential information about patients. In relation to
clinical research, there is clear guidance that the physician with
responsibility for patient care within a health care team "must be
satisfied that patients have been told, or have had access to written
material informing them, that their records may be disclosed to persons
outside the team which provided their care" and "that they
have the right to object". The only exception to this is where obtaining
consent is not practicable or "where the benefits to an individual or to
society of the disclosure outweigh the public and the patient's interest
in keeping the information confidential". We presume that for most
conditions the public interest would not outweigh patient rights. In
addition, we are not aware that health
authorities have instituted generic systems to inform patients of these
rights so that they can 'opt-out' of research. Until such systems are in
place it would seem to be the responsibility of individual investigators
and practitioners to ensure compliance with the guidance.
difficulties are likely to arise at the
interface between health care teams within the hospital system, and
between health care teams in hospital and general practice. As a
hypothetical example, let us assume that a hospital-based research team
was interested in investigating the effects of a new treatment to prevent
atherosclerosis in patients with different degrees of
other risk factors for vascular disease, where the patients are mainly
managed in general practice. In the past, one of the research team would
often identify suitable patients from practice records and the general
practitioner then sign a letter to the patient asking whether they would
be willing to participate. This now contravenes GMC guidance and could not
be approved by an ethics committee without
invoking 'the public interest' approach. The alternatives are that general
practitioners, or their administrative staff, do this work directly.
However, this has important resource implications. For a general practice
with a number of links to hospital-based projects it might be simpler to
ask all patients whether they would be willing to be approached, but this
would even more costly.
We recognise that these issues can and will be addressed in time, if the
NHS remains committed to such research, and believe this is in the best
long term interest of both patients and doctors. Nevertheless, we are
concerned that there has been little response to the GMC's document as
yet, and that the current position may inhibit progress with clinical
studies that might improve patient care.
Stephen J Leslie
BHF Research Fellow
David J Webb
Professor of Clinical Pharmacology
Clinical Pharmacology Unit and Research Centre, The University of
Edinburgh, Western General Hospital, Edinburgh. EH4 2XU.
1. Strobl J, Cave E, Walley T. Data protection legislation:
interpretation and barriers to research. BMJ 2000;321:890-2.
2. Al-Shahi R, Warlow C. Using patient-identifiable data for
observational research and audit. BMJ 2000;321:1031-2.
3. Anderson R. Undermining data privacy in health information.
4. General Medical Council. Confidentiality: protecting and
providing information. September 2000.
Competing interests: No competing interests