Independent ethical review of studies involving personal medical records. Report of a working group to the Royal College of Physicians Committee on Ethical Issues in Medicine.

There is a duty to use available information for the general good where this can be done without detriment. It is, in principle, ethically acceptable to use personal medical records without approaching or involving the patients concerned, provided that confidentiality and anonymity are preserved; such use does not require independent ethical approval provided that confidentiality is assured and subject to safeguards described below. Epidemiologists have a special interest in the use of personal medical records in their work (in this context the use of health-related registers and existing biological samples may be included), though access to such data involves professional staff in all medical specialties, not only those in epidemiology. The following guidance is based on a report of a working group (which included non-medical members) to the Royal College of Physicians Committee on Ethical Issues in Medicine. Activities such as medical audit, epidemiological surveillance, inquiries designed to establish indices of morbidity and mortality and outbreak investigations all constitute medical practice and as such do not require independent ethical review. Research involving access to medical records, health-related registers, or existing biological samples only, without direct patient involvement, requires neither explicit individual patient consent nor independent ethical review provided that: a) explicit consent to access a person's records is obtained either from official custodians of the records (who have a duty to satisfy themselves as to the bona fides and competence of the investigator) or from the patient's clinician: the decision to access personal medical information should not be left to the sole discretion of the investigator.(ABSTRACT TRUNCATED AT 250 WORDS)