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GMC issues new guidance on research ethics
In its guidance "Research: the role and responsibilities of doctors", the General Medical Council sets out the duties of doctors involved in research in the NHS, or in the academic or private sectors. The guidance covers not just clinical trials, but "genetic studies, epidemiological research including analyses of medical records, and other collections and analyses of data about health and illness, whether anonymised or not". In addition to advice on protecting the interests and dignity of patients, the document includes detailed guidance on seeking consent and protecting confidentiality. In seeking a patient's consent, a doctor should ensure that s/he provides information about the aims of the research and why the patient has been asked to participate, the patient's legal rights and protections, the nature of the research itself, the patient's right to withdraw at any stage, how the information arising from the research will be stored and used, and whether (and in what form) information about the outcome will be given to the participant. Guidance is also given on seeking consent to obtain organs, tissues or body fluids for research purposes, from a living patient or at post-mortem.
In the area of confidentiality of medical information, some controversy about the doctor's ethical duties has arisen. In the past it has been common practice for doctors to release identifiable medical data for use in epidemiological research projects approved by research ethics committees, without the consent of those to whom the data applied. However, the implementation of the Data Protection Act of 1998 has highlighted potential legal difficulties with this practice, which could be held to contravene the doctor's common law duty of confidentiality to the patient. The GMC's guidance recommends a cautious approach, saying that the doctor "must be satisfied that express consent has been sought from the participant, wherever that is practicable". Some situations are set out in which it may not be practicable to obtain consent to disclosure of the information, for example if very large numbers of records are to be used and/or if the records are very old, and/or if disclosure of the information is deemed to be in the public interest, but the guidance seems to place on the doctor the responsibility for deciding if such conditions are fulfilled, and it appears likely that many will feel it safer to deny researchers access to any records they hold. Clarification of this area will be needed if research is not to be unnecessarily hindered, while ensuring that patients' interests are protected.
