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Legal aspects of records based medical research
  1. S E Parkes
  1. Correspondence to:
    S E Parkes
    WMRCTR, Birmingham Children’s Hospital NHS Trust, Steelhouse Lane, Birmingham, B4 6NH, UK; sheila.parkes{at}bch.nhs.uk

https://doi.org/10.1136/adc.2003.045666

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    Ethical medical research must continue despite the legal problems of records based medical research

    All that may come to my knowledge in the exercise of my profession… which ought not to be spread abroad, I will keep secret and will never reveal (Hippocratic Oath)

    Patient confidentiality is a fundamental component of medicine, but as late as 1994 the Royal College of Physicians determined that there was a duty to use available information for the general good where that could be done without detriment to individuals.1 The British Medical Association Ethical Committee in 1988 said that information could be used without consent as long as a local research ethics committee had approved the study.2 In 1997, Doyal3 proposed that epidemiological research, involving only access to medical records, should be an exception to the requirement for informed patient consent.

    SO WHAT’S THE (LEGISLATIVE) PROBLEM?

    Data Protection Act 1998

    The situation was radically modified in March 2000, when the Data Protection Act 1998 (DPA)4 came into force in the UK, thus curtailing the relative freedom which had previously been enjoyed by medical researchers. The DPA was designed to protect the rights of individuals with regard to the confidentiality of their information and its implication was that no identifiable data on living individuals should be handled or disclosed without the explicit consent of the subject. Although the Data Commissioner said that the DPA should not be seen as an obstacle to medical research, that is the present situation.

    Subsequent legislation and the Patient Information Advisory Group

    The cancer registration establishment was the first body to voice concerns over the implications of the DPA, after the General Medical Council (GMC) issued its own guidance in September 2000. Their interpretation effectively prohibited the automatic reporting of cancer cases to the local registry without the patient’s consent. The system had been in effect for over 50 years, with no adverse …

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