Consent to the publication of patient information
http://www.100md.com
《英国医生杂志》
1 University of Toronto Joint Centre for Bioethics, 88 College St, Toronto, Canada M5G 1L4 peter.singer@utoronto.ca
Sometimes valuable clinical information cannot be published because it is not possible to contact patients to obtain consent. The BMJ therefore asked its ethics committee to review the guidelines on consent
Introduction
The policy of the BMJ was stated in an editorial published in 1998.3 This set out a general requirement of consent, followed by a series of possible exceptions in which publication would be permitted without the patient's consent. The exceptions were:
The patient is long dead and has no living relatives
The interaction with the patient was long ago—perhaps more than 15 years
Because the interaction was long ago and the patient was elderly or terminally ill, the patient is likely to be dead
The piece is to be published without the authors' names attached, making it unlikely that anybody could identify the patient
All extraneous information that might help identification is excluded
Even if the patient were to identify him or herself, the events described are unlikely to cause offence.
In practice, these exceptions have not been invoked to allow publication, and several contributions have been rejected because the consent of the patient has not been obtained. Why? Perhaps because these conditions require some operational sharpening and it is unclear whether any or all must apply to justify publication without the patient's consent.
The BMJ Ethics Committee has considered the matter of publishing information from the doctor-patient relationship without consent. The situation commonly arises in "fillers," which are meant to provide thought provoking clinical anecdotes. The committee took the view that a strict application of the consent requirement was excessively restrictive, and we felt that the journal's policy should be re-examined. This view was largely prompted by several cases that came to our attention in which a strict application of the rule would exclude contributions that, on balance, deserved publication. These cases involved patients whose consent was impossible to obtain because they were untraceable.
In order to clarify the situation, the committee has considered the policy set out in the 1998 editorial and approved the revised policy set out in the box:
This policy was pilot tested by two BMJ editorial staff in September 2002 on nine cases that had been submitted for publication but that were not published because of lack of consent. Both editors agreed four of these cases met the criteria of the policy, and these were ultimately published:
A 56 year old case of meningococcal septicaemia in which the patient's life was saved but she ultimately had bilateral below knee amputations; the lesson is that a brilliant clinical diagnosis and prompt treatment does not always lead to ideal patient outcomes4
A 17 year old case in which an ophthalmologist in India put aside personal risk of being robbed to open the door of his residence to a patient5
A 20 year old case about a patient with palatal pyoclonus who was initially treated as a psychiatric patient because he complained of a clicking in his head, highlighting the importance of listening to patients6
A case of an appreciative homeless patient, who could not be tracked down, that showed the value of "a hospital providing sick people with a roof over their heads, three meals a day, warmth, and good medical care."7
In the other cases, the disagreement between the editors arose from judgments about how worth while was the message, how likely it was that anyone (including the patient) would recognise who it was about, and how likely it was to cause offence or upset if the patient was recognised. On the general experience of using the guidelines, one of the editors said, "I would say it remains a subjective process but it is useful to have rules to guide our subjectivity."
The committee recognised that publication without consent, using the above policy described, should remain the exception rather than the rule. For this reason, we requested that editors keep a log of the cases published under the policy so they could be reviewed periodically.
We also considered several situations that should be distinguished from publication of information from the doctor-patient relationship as detailed below. These include:
Publication of research results—These arise from the researcher-participant relationship, and are therefore regulated by research ethics committees. Qualitative studies may pose special challenges regarding whether a study participant is identifiable.
Fictional cases—These arise in the imagination of the author and not the doctor-patient relationship. Intentionally misleading the reader by presenting fiction as fact, as in a case about suicide among aboriginal peoples, is not permitted.8 9
Publication of information including photographs obtained from the public domain, including wire services and news archives—This information was obtained from the journalist-subject relationship. The information is in the public domain and it is ethical to republish it in the BMJ. Such publication may offend some readers, as in the case of a photo of a young boy with a learning disability published alongside an article on methylphenidate.10 Editors may want to exercise discretion in publishing such information, but this is a matter of etiquette, not ethics.
BMJ policy on consent to the publication of patient information
Publication of any personal information about a patient will normally require the consent of the patient. This will be so even if identifying details are removed.
Personal information about a patient will not be published over the patient's refusal, except in the most exceptional circumstance of over-riding importance to public health.
Publication without the consent of the patient will be permitted if all of the following conditions are met:
The patient who is the focus of the article is untraceable without an unduly burdensome effort and it is also impossible or unreasonable to expect consent to be obtained from the patient or the patient's next of kin.
The article contains a worthwhile clinical lesson or public health point which could not be as effectively made in any other way. (Worth while is intended to sit on a spectrum between "interesting," which is the publication threshold with patient consent, and "over-riding public health importance," which is the publication threshold over patient refusal.)
A reasonable person in the patient's position would not be expected to object to the publication of the case. (This requires an assessment of the intrusiveness of the disclosure and the potential that it has for causing the patient, or the patient's family, embarrassment or distress. Particular attention must be paid to differences of cultural and social attitudes. It must not be assumed that what is a matter of indifference in one society will have the same status in another.)
The risk of identification of the patient is minimised by measures designed to prevent the identity of the patient being revealed either to others or to the patient himself or herself. (These measures will include anonymisation of the case or the author, or both. The publication without consent of photographs will require particularly scrupulous attention to anonymisation.)
Data relating to aggregate anonymised tissue and other samples—These will not normally be considered to be personal information relating to a particular patient, and publication of research findings connected with such samples does not require patient consent.
Genetic pedigrees—These represent a special problem. The committee is preparing a paper on this.
Medical error—One particularly intriguing type of case is medical error. Consider, for example, a recent published case report on "wrong side" surgery.11 The surgeon is at greater risk than the patient in relation to publication of this information. Publications about error should be encouraged as they are core to improvements in patient safety in both relation to analysis of root causes and engendering a culture of openness about error. If a patient refused consent to publish, perhaps because of anger at the physician, should that preclude publication? If you might publish even if the patient refused, should you even ask permission?
Conclusions
International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Privacy and confidentiality. www.icmje.org/index.html#privacy (accessed 30 Mar 2004).
General Medical Council. Confidentiality: protecting and providing information. Publishing case studies. www.gmc-uk.org/standards/confidentiality_faq.htm (accessed 21 May 2004).
Smith R. Informed consent: edging forwards (and backwards). BMJ 1998;316: 949-51.
Kerr D. A pyrrhic victory. BMJ 2002;325: 1011.
Palimar P. Strangers in the night. BMJ 2002;325: 1104.
Andrade C. Straight from the patient's mouth. BMJ 2002;325: 1169.
Collins I. But the greatest of these is charity. BMJ 2002;325: 1358.
Shah S. A piece of my mind: five miles from tomorrow. JAMA 2000;284: 1897-8.
Josefson D. JAMA falls foul of fabricated suicide story. BMJ 2001;323: 472.
Gottlieb S. Methylphenidate works by increasing dopamine levels. BMJ 2001;322: 259.
Bernstein M. Wrong side surgery: systems for prevention. Can J Surg 2003;46: 144-6.(Peter A Singer, Sun Life )
Sometimes valuable clinical information cannot be published because it is not possible to contact patients to obtain consent. The BMJ therefore asked its ethics committee to review the guidelines on consent
Introduction
The policy of the BMJ was stated in an editorial published in 1998.3 This set out a general requirement of consent, followed by a series of possible exceptions in which publication would be permitted without the patient's consent. The exceptions were:
The patient is long dead and has no living relatives
The interaction with the patient was long ago—perhaps more than 15 years
Because the interaction was long ago and the patient was elderly or terminally ill, the patient is likely to be dead
The piece is to be published without the authors' names attached, making it unlikely that anybody could identify the patient
All extraneous information that might help identification is excluded
Even if the patient were to identify him or herself, the events described are unlikely to cause offence.
In practice, these exceptions have not been invoked to allow publication, and several contributions have been rejected because the consent of the patient has not been obtained. Why? Perhaps because these conditions require some operational sharpening and it is unclear whether any or all must apply to justify publication without the patient's consent.
The BMJ Ethics Committee has considered the matter of publishing information from the doctor-patient relationship without consent. The situation commonly arises in "fillers," which are meant to provide thought provoking clinical anecdotes. The committee took the view that a strict application of the consent requirement was excessively restrictive, and we felt that the journal's policy should be re-examined. This view was largely prompted by several cases that came to our attention in which a strict application of the rule would exclude contributions that, on balance, deserved publication. These cases involved patients whose consent was impossible to obtain because they were untraceable.
In order to clarify the situation, the committee has considered the policy set out in the 1998 editorial and approved the revised policy set out in the box:
This policy was pilot tested by two BMJ editorial staff in September 2002 on nine cases that had been submitted for publication but that were not published because of lack of consent. Both editors agreed four of these cases met the criteria of the policy, and these were ultimately published:
A 56 year old case of meningococcal septicaemia in which the patient's life was saved but she ultimately had bilateral below knee amputations; the lesson is that a brilliant clinical diagnosis and prompt treatment does not always lead to ideal patient outcomes4
A 17 year old case in which an ophthalmologist in India put aside personal risk of being robbed to open the door of his residence to a patient5
A 20 year old case about a patient with palatal pyoclonus who was initially treated as a psychiatric patient because he complained of a clicking in his head, highlighting the importance of listening to patients6
A case of an appreciative homeless patient, who could not be tracked down, that showed the value of "a hospital providing sick people with a roof over their heads, three meals a day, warmth, and good medical care."7
In the other cases, the disagreement between the editors arose from judgments about how worth while was the message, how likely it was that anyone (including the patient) would recognise who it was about, and how likely it was to cause offence or upset if the patient was recognised. On the general experience of using the guidelines, one of the editors said, "I would say it remains a subjective process but it is useful to have rules to guide our subjectivity."
The committee recognised that publication without consent, using the above policy described, should remain the exception rather than the rule. For this reason, we requested that editors keep a log of the cases published under the policy so they could be reviewed periodically.
We also considered several situations that should be distinguished from publication of information from the doctor-patient relationship as detailed below. These include:
Publication of research results—These arise from the researcher-participant relationship, and are therefore regulated by research ethics committees. Qualitative studies may pose special challenges regarding whether a study participant is identifiable.
Fictional cases—These arise in the imagination of the author and not the doctor-patient relationship. Intentionally misleading the reader by presenting fiction as fact, as in a case about suicide among aboriginal peoples, is not permitted.8 9
Publication of information including photographs obtained from the public domain, including wire services and news archives—This information was obtained from the journalist-subject relationship. The information is in the public domain and it is ethical to republish it in the BMJ. Such publication may offend some readers, as in the case of a photo of a young boy with a learning disability published alongside an article on methylphenidate.10 Editors may want to exercise discretion in publishing such information, but this is a matter of etiquette, not ethics.
BMJ policy on consent to the publication of patient information
Publication of any personal information about a patient will normally require the consent of the patient. This will be so even if identifying details are removed.
Personal information about a patient will not be published over the patient's refusal, except in the most exceptional circumstance of over-riding importance to public health.
Publication without the consent of the patient will be permitted if all of the following conditions are met:
The patient who is the focus of the article is untraceable without an unduly burdensome effort and it is also impossible or unreasonable to expect consent to be obtained from the patient or the patient's next of kin.
The article contains a worthwhile clinical lesson or public health point which could not be as effectively made in any other way. (Worth while is intended to sit on a spectrum between "interesting," which is the publication threshold with patient consent, and "over-riding public health importance," which is the publication threshold over patient refusal.)
A reasonable person in the patient's position would not be expected to object to the publication of the case. (This requires an assessment of the intrusiveness of the disclosure and the potential that it has for causing the patient, or the patient's family, embarrassment or distress. Particular attention must be paid to differences of cultural and social attitudes. It must not be assumed that what is a matter of indifference in one society will have the same status in another.)
The risk of identification of the patient is minimised by measures designed to prevent the identity of the patient being revealed either to others or to the patient himself or herself. (These measures will include anonymisation of the case or the author, or both. The publication without consent of photographs will require particularly scrupulous attention to anonymisation.)
Data relating to aggregate anonymised tissue and other samples—These will not normally be considered to be personal information relating to a particular patient, and publication of research findings connected with such samples does not require patient consent.
Genetic pedigrees—These represent a special problem. The committee is preparing a paper on this.
Medical error—One particularly intriguing type of case is medical error. Consider, for example, a recent published case report on "wrong side" surgery.11 The surgeon is at greater risk than the patient in relation to publication of this information. Publications about error should be encouraged as they are core to improvements in patient safety in both relation to analysis of root causes and engendering a culture of openness about error. If a patient refused consent to publish, perhaps because of anger at the physician, should that preclude publication? If you might publish even if the patient refused, should you even ask permission?
Conclusions
International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Privacy and confidentiality. www.icmje.org/index.html#privacy (accessed 30 Mar 2004).
General Medical Council. Confidentiality: protecting and providing information. Publishing case studies. www.gmc-uk.org/standards/confidentiality_faq.htm (accessed 21 May 2004).
Smith R. Informed consent: edging forwards (and backwards). BMJ 1998;316: 949-51.
Kerr D. A pyrrhic victory. BMJ 2002;325: 1011.
Palimar P. Strangers in the night. BMJ 2002;325: 1104.
Andrade C. Straight from the patient's mouth. BMJ 2002;325: 1169.
Collins I. But the greatest of these is charity. BMJ 2002;325: 1358.
Shah S. A piece of my mind: five miles from tomorrow. JAMA 2000;284: 1897-8.
Josefson D. JAMA falls foul of fabricated suicide story. BMJ 2001;323: 472.
Gottlieb S. Methylphenidate works by increasing dopamine levels. BMJ 2001;322: 259.
Bernstein M. Wrong side surgery: systems for prevention. Can J Surg 2003;46: 144-6.(Peter A Singer, Sun Life )