GMC's guidance may inhibit research

Editor—Academic clinical research, including the evaluation of new treatments, is central to providing high quality, cost effective care to patients, and it requires the cooperation and goodwill of the patients who volunteer to participate. The research process is externally regulated and monitored by ethics committees to ensure that patients are protected.

We welcome the debate on the Data Protection Act and access to patients' records,^1–3 and wish to raise a related concern about the General Medical Council's recent guidelines on confidentiality and their effect on research.⁴ The GMC's document focuses on patients' rights to confidentiality and the protection of personal information. Guidance is important to protect both patients and doctors, and we recognise the value of consent in sharing confidential information.

In clinical research it is now clear that the physician within a healthcare team who is responsible for a patient's care “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” and “that they have the right to object.”⁴ The only exception is where obtaining consent is not practicable or “where the benefits to an individual or to society . . . outweigh the public and the patient's interest.”⁴

Presumably the public interest will rarely outweigh a patient's rights and it will, therefore, be the responsibility of individual investigators and practitioners to ensure that compliance with guidance occurs. Because of the new guidance, difficulties may arise between healthcare teams within hospitals and between hospitals and general practices. Previously, for instance, a hospital team interested in investigating a new treatment for a condition that was mainly seen by general practitioners might have used records from the practice to identify patients to whom the general practitioner could then write. However, this would contravene the GMC's current guidance, and alternative strategies have major implications for resources. In a general practice with links to several hospital research projects it might be sensible to ask all patients whether they would be willing to be approached, but this would be costly and take time.

These issues will need to be addressed if the NHS is to remain committed to such research, and we believe that addressing these issues 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 and that the current position inhibits clinical studies that might improve patient care.