Experiences of the BMJ ethics committee
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《英国医生杂志》
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The BMJ established its ethics committee nearly four years ago. What has it achieved and has it changed the journal's practice?
Introduction
Like many ethical issues, the confidentiality of the doctor-patient relationship sounds straightforward until you are confronted with difficult cases. As part of our review of journal policies with ethical implications, we considered the BMJ's guidelines on publishing information on individual patients. These stated that information should not be published without the patient's consent. That sounds fine, until Minerva wants to publish a picture of an Egyptian mummy2 3 or someone submits a piece with an important message describing a patient who died decades ago in a remote part of the world. The committee has therefore revised the guidelines to describe the situations in which publication of individual information without consent might be appropriate.4
We also considered whether rules about consent to publish individual data still applied after a patient had complained about a doctor to the media. Does the patient's public allegation constitute an implicit consent to have the case discussed? If not, is it fair that the doctor(s) concerned cannot respond to the allegations or attempt to set the record straight? Should the BMJ ask patients who write criticisms of doctors to sign a waiver permitting the doctor to respond? Discussions with the General Medical Council and the BMA's ethics committee are still underway, but we hope the outcome will be new recommendations that satisfy natural justice, publication ethics, and the GMC's guidelines (which currently curtail the doctors' right of reply).
Journal's wider duty of care
The committee's longest running cases have concerned suspected research malpractice. The individual cases are still under investigation so we cannot report them in detail, but they have raised questions such as whether the editor should inform other journals when a BMJ investigation casts serious doubt about papers that they have published and, if so, when? One case has lasted more than four years and shows no signs of resolving. It has involved authorities on several continents and threats of legal action. It might seem fairer to wait until an inquiry has reached a conclusion before alerting other journals, but the committee felt that this would increase the risk that further potentially fraudulent research might be published.
Like many journals, the BMJ requires authors to show that research has been approved by appropriate bodies and conducted to relevant ethical standards. In most cases, research ethics committees or institutional review boards approve research proposals, but several grey areas have exercised our committee. For instance, we learnt that there was no provision for ethical review for research conducted in private practice in the United Kingdom. Similarly, it is not always clear how innovative surgical techniques should be studied, and whether variations from standard practice require ethical review and explicit patient consent. We have also discussed reports describing the use of dietary supplements or of licensed drugs at unusual doses that raised concerns about whether patients were fully informed that they were receiving unorthodox treatment.
Perhaps the greyest of areas, and one that the committee has yet to resolve, is the borderline between audit and research. Legislation and guidelines about the use of patient records are in a state of flux,5 6 and doctors may not realise that they need to seek approval. We plan to discuss this further at future meetings and to draw up guidelines (or at least point authors in the direction of some helpful resources), since we know readers are concerned about it.7
What else has the committee done?
McCall Smith A, Tonks A, Smith R. An ethics committee for the BMJ. BMJ 2000;321: 720.
Minerva. BMJ 1996;313: 240.
Meux CJ, Stegen G. Getting a mummy's consent. BMJ 1996;313: 1265.
Draft guidelines on consent to the publication of patient information. http://bmj.bmjjournals.com/cgi/content/full/322/7297/1263/DC1/5 (accessed 8 July 2004).
Stroble J, Cave E, Walley T. Data protection legislation: interpretation and barriers to research. BMJ 2000;321: 890-2.
Al-Shahi R, Warlow C. Using patient identifiable data for observational research and audit. BMJ 2000;321: 1031-2.
Venters G. Lack of ethical approval is a disgrace. BMJ 2001;322:7281 http://bmj.bmjjournals.com/cgi/eletters/322/7281/276#12825 (Accessed 14 Oct 2003.)(Elizabeth Wager, freelanc)
The BMJ established its ethics committee nearly four years ago. What has it achieved and has it changed the journal's practice?
Introduction
Like many ethical issues, the confidentiality of the doctor-patient relationship sounds straightforward until you are confronted with difficult cases. As part of our review of journal policies with ethical implications, we considered the BMJ's guidelines on publishing information on individual patients. These stated that information should not be published without the patient's consent. That sounds fine, until Minerva wants to publish a picture of an Egyptian mummy2 3 or someone submits a piece with an important message describing a patient who died decades ago in a remote part of the world. The committee has therefore revised the guidelines to describe the situations in which publication of individual information without consent might be appropriate.4
We also considered whether rules about consent to publish individual data still applied after a patient had complained about a doctor to the media. Does the patient's public allegation constitute an implicit consent to have the case discussed? If not, is it fair that the doctor(s) concerned cannot respond to the allegations or attempt to set the record straight? Should the BMJ ask patients who write criticisms of doctors to sign a waiver permitting the doctor to respond? Discussions with the General Medical Council and the BMA's ethics committee are still underway, but we hope the outcome will be new recommendations that satisfy natural justice, publication ethics, and the GMC's guidelines (which currently curtail the doctors' right of reply).
Journal's wider duty of care
The committee's longest running cases have concerned suspected research malpractice. The individual cases are still under investigation so we cannot report them in detail, but they have raised questions such as whether the editor should inform other journals when a BMJ investigation casts serious doubt about papers that they have published and, if so, when? One case has lasted more than four years and shows no signs of resolving. It has involved authorities on several continents and threats of legal action. It might seem fairer to wait until an inquiry has reached a conclusion before alerting other journals, but the committee felt that this would increase the risk that further potentially fraudulent research might be published.
Like many journals, the BMJ requires authors to show that research has been approved by appropriate bodies and conducted to relevant ethical standards. In most cases, research ethics committees or institutional review boards approve research proposals, but several grey areas have exercised our committee. For instance, we learnt that there was no provision for ethical review for research conducted in private practice in the United Kingdom. Similarly, it is not always clear how innovative surgical techniques should be studied, and whether variations from standard practice require ethical review and explicit patient consent. We have also discussed reports describing the use of dietary supplements or of licensed drugs at unusual doses that raised concerns about whether patients were fully informed that they were receiving unorthodox treatment.
Perhaps the greyest of areas, and one that the committee has yet to resolve, is the borderline between audit and research. Legislation and guidelines about the use of patient records are in a state of flux,5 6 and doctors may not realise that they need to seek approval. We plan to discuss this further at future meetings and to draw up guidelines (or at least point authors in the direction of some helpful resources), since we know readers are concerned about it.7
What else has the committee done?
McCall Smith A, Tonks A, Smith R. An ethics committee for the BMJ. BMJ 2000;321: 720.
Minerva. BMJ 1996;313: 240.
Meux CJ, Stegen G. Getting a mummy's consent. BMJ 1996;313: 1265.
Draft guidelines on consent to the publication of patient information. http://bmj.bmjjournals.com/cgi/content/full/322/7297/1263/DC1/5 (accessed 8 July 2004).
Stroble J, Cave E, Walley T. Data protection legislation: interpretation and barriers to research. BMJ 2000;321: 890-2.
Al-Shahi R, Warlow C. Using patient identifiable data for observational research and audit. BMJ 2000;321: 1031-2.
Venters G. Lack of ethical approval is a disgrace. BMJ 2001;322:7281 http://bmj.bmjjournals.com/cgi/eletters/322/7281/276#12825 (Accessed 14 Oct 2003.)(Elizabeth Wager, freelanc)