BMJ Ethics Committee Meeting, 28 October 2002

Anonymised minutes

Present:

Richard Smith
Sandy McCall Smith
Tom Wilkie
Liz Wager
Ann Sommerville
Peter Singer (via telephone)
Rachel Fetches

Apologies

Jeff Tobias
Derick Wade

1. Minutes from the last meeting

The Committee accepted the minutes.

2. Guidelines on articles criticising doctors

Tony Delamothe joined the meeting for this part of the discussion. SMS invited TD to introduce the topic to the Committee. TD wanted the Committee to consider whether there was an uneven relationship between patients and doctors in respect to confidentiality. When patients publicly criticise care, doctors cannot respond to the allegations because of a duty of confidentiality. The latest example of this was a highly publicised incident at the Whittington Hospital in London where a patient’s family criticised their mother’s care in a national tabloid paper. There was extensive media coverage about the hospital’s response to those allegations. This particular case did not involve the BMJ in any way.

TD felt that the BMJ guidance appears to say that doctors cannot respond to any critical allegations of poor care. RS stated that the BMJ has the same requirements for patients and doctors in respect of the BMJ not wishing to engage in "trial by media". TD queried whether it would be permissible for a doctor to defend any allegations using the same amount of information that the patient has already voluntarily released? SMS pointed out that there is no imposition of a duty of confidentiality on the patient. The duty of confidentiality is a one-sided obligation on the doctor. Only in certain circumstances could a breach be sanctioned: (1) where the patient had waived his/her right to confidentiality. (2) On the grounds of public interest.

RS felt that one could distinguish between a story about a clearly identifiable doctor and a "story" to raise an issue where there was very little chance of identifying the individual(s) involved. TD pointed out that within the medical community, the identity of particular health care professionals could quite easily be deduced, giving rise to asymmetry. TD pointed out that an unnamed doctor may have another side of a story, or may wish to correct any factual errors. SMS assented that in regard to factual correctness, it was not simply the doctor’s reputation but public health that was affected.

TW pointed out that there was a tension in the nature of running a medical journal. Journalistic principles would demand that the journal offer a right of reply but this was in conflict with the ethical duty to protect confidentiality. Doctors are still bound by the rules of the GMC, BMA, and other guidelines. This is set within the broader context of reporting medical error, which is on a continuum from mistake through to wrongdoing. Many of the guidelines are framed in an adversarial manner, setting patients against doctors. A patient will sue a doctor for wrongdoing, though the actual doctor involved may be at the end of a chain of systemic failures. Would a change lead to the suppression of publication of an angry patient’s complaint? Because of the professional status of doctors, there is an imbalance and one could not expect a patient to seek consent from his/her doctor (who they are complaining about). It could be a way forward to have a policy that where a patient comes to the BMJ that we would tell the patient that the BMJ will go back to the doctor to give a right of reply. If a patient consents then there is no breach of duty.

AS stressed that the doctor-patient relationship is an inherently asymmetrical partnership and rights and duties on either side did not necessarily correspond. AS pointed out that in the example put before the Committee (Whittington) the patient’s relatives were making the allegations. If the BMJ where to go away from the official GMC line on the duty of confidentiality this would put doctors in a difficult position.

LW pointed out that the Department of Health’s guidance allowed for disclosure of minimal facts and is, in fact, directed more towards an institution making a statement rather than an individual doctor. SMS agreed that there was a fundamental difference in the institution and individual doctor’s position. RS queried how all of the guidance could be practically implemented? Most stories about doctors do not arise out of a patient complaining. Point (iv) of the BMJ guidelines for articles where doctors or other health care professionals are identified states that: "… we must aim for balance. This will almost always mean getting a quote from the ‘accused.’" There must be consent for the doctor to have right of reply. SMS queried whether the story would be published without the patient’s agreement to this? RS thought it would depend—for example, this may differ if the patient has been abused.

TD pointed out that if a doctor is being criticised then the patient’s account may be partial, the doctor may want to set the record straight. RS agreed that there were usually two sides to every story. Sometimes it was difficult to go to both sides. LW felt that there was a difference between allowing a right of reply versus actively seeking the other perspective. SMS queried whether journalists would practise the approach of actively contacting the "other side"? RS queried whether for an article on a general theme containing a "story" a journalist would check all the facts? TW stated that there would be a difference between anonymity versus making a general point. If one names an individual involved in wrongdoing then it would be advisable for a journalist to check. TW queried whether an important lesson type story would be of use without very specific details that could allow for identification? Is there a distinction between naming a person suspected of wrongdoing and anonymising a report of a mistake? Irrespective of whether one is discussing a general point versus a named wrongdoer, there are still two sides to the story. It would be as wrong to publish a general article based on partial information. All the versions of reality are relevant and necessary to a story. RS stated that there was a practical difference between a newspaper and a medical journal. Generally the journal trusts the authors and wouldn’t check everything. For example, a woman’s personal view on seeing six surgeons who, she felt, did not listen to her. RS agreed that it must be clear that the journal’s aim is not to expose those health care professionals.

LW clarified that we would be asking the patient that if one of the doctors chooses to reply then this would not be considered a breach of confidentiality? LW thought that this would only work with a named doctor because any details provided about the patient would have to come from a specific attending doctor. RS felt that this would be up to the GMC. SMS stated that any named or identified patient details from the doctor would have to fall within an adequate and explicit consent from the patient.

AS stated that the patient would be authorising to a third party and such consent would be valid if the patient knows the general details. What if the patient doesn’t have to know? LW stated that the doctor would be able to correct factual errors relating to a patient’s treatment and would have to be relevant. SMS felt that the consent would not necessarily require precise details. RS wondered if the patient would set the boundaries of consent? No one could argue with this. AS stated that she had raised this because there was no redress with the GMC. RS pointed out that most complaints about doctors came from other doctors. RS wondered that if the patient weighs in with criticisms whether they are really "fair game"? The journal could modify the policy and where publishing articles from patients ask them to agree that if the doctor comes back then the "relevant" information could be published. TW stated that there was a danger that such a policy would diminish the willingness of people to speak up. SMS thought that this must be balanced against a potential injustice of an inaccurate record. RS didn’t feel that such a policy would reduce the number of stories received. RS was conscious about the web site and the need to debate the guidelines in existence and get a better feel for the reality of the situation on the "frontline" of health care. There was a possibility of writing something on the issue for the journal.

SMS queried what the position would be if the patient had gone to the popular press and the doctor wanted to then "correct the record" in the BMJ? RS felt that in such a situation then the patient’s consent would be required. LW agreed that this was the GMC’s line. TD stated that there was a real need for the GMC to address the situation of patients going to the popular press. SMS agreed and said that this issue was also prominent in political discussions where politicians would have to have reasons in the public interest to discuss particular patients. TW agreed and stated that much of the Whittington issue had political overtones. Furthermore, irrespective of what the BMJ decided, doctors are answerable to the GMC and GMC guidelines.

SMS queried whether the GMC would see the situation as a complicit confidence breach? RS stated that the GMC had no actual leverage over the BMJ but that there was a moral issue. RS felt that the discomfort and potential unfairness around this area should be broached with the GMC. RS suggested that the Committee was at liberty to write to the GMC to ask them to consider the issue. SMS agreed and thought that it was a broader issue to a popular press attack. RS felt that it was an issue for the press that they should allow for balance in reporting such stories. TW agreed but stated that the reality would be a potential loss of stories, which wouldn’t be tolerated by the popular press. There is an operational presumption that once Mrs X said … then there is tacit consent.

AS pointed out that there had been a BMA ARM resolution that doctors should be allowed to reply when the patient had initiated a break in the partnership. However, the prevailing view was that the doctor should remain above the fray.

SMS to have informal discussion with GMC
RS to consider highlighting the issue in the journal
Committee to look at guidelines (see item 7)

 

3. Update on current cases

3.1 Action points

Outstanding points

(a) Committee to discuss the issues of obtaining consent for genetic pedigree studies and the first series of cases in a new condition. Would be helpful to have a summary document to focus discussion.

(b) Case 02/001

A new surgical operation without evidence of either ethics committee approval or consent from the patients to be part of an experiment

Background: Authors from a developing country submitted a study in which they describe a new surgical operation using an established technique in a new context. They say in their paper that in the treatment of the particular disorder described "no operation stands out in comparison to the others". During subsequent correspondence the authors stated they had "taken an informed consent from all the patients undergoing the procedure. They were well informed before they were subjected to the procedure." The authors also stated that their country "did not have any ethical committee whose permission is needed to carry out any new procedure." The authors felt that their paper was about a new technique and not an experiment. The editorial committee felt that even though the technique was established, it had not been used in this context before and therefore the authors could not have known prior to treating the patients whether the technique would have been effective.

No response to date from the authors who have been sent the Committee’s discussion of 24/04/02 and the ICMR guidelines. Committee to consider the BMJ instructions to authors and whether it is made explicitly clear that an author can have his/her paper referred to the Committee and also that the editor may contact the head of his/her institution or even higher authorities.

Ties in with action points for item 7

 

(c) Declaration of competing interests of the BMJ Ethics Committee members: not all have been received.

(d) Background: A submitted paper detailing a randomised controlled trial shows that a new treatment, which is a combination of familiar compounds, is highly beneficial in a common but largely untreatable problem. The authors come from several different countries and include people from the company that manufactures the treatment. It proved to be difficult to obtain reviewers for the paper and many returned the paper stating they could not produce an opinion. The reviewer who did eventually produce an opinion did not believe the results and suggested that there were signs that the data were fraudulent. A statistical review was then commissioned. The statistical reviewer felt the results were unlikely but was less convinced that the data had been manipulated. The statistical reviewer suggested the BMJ request the raw data.

The raw data is with statistical reviewer for examination. The Committee are waiting for the report.

 

(e) Background: A systematic review done originally for the UK’s National Institute for Clinical Effectiveness and submitted to the BMJ in abridged form. A previously published Cochrane review on the same subject was not mentioned, and five trials included in the Cochrane review and the NICE reviews were omitted from the review sent for publication. Was the omission deliberate or just incompetent? Did the advisory group for the NICE review peer review this version before submission, as claimed by the authors?

LW summarised the conclusions of her report on this paper, concluding that the paper was muddled but the authors had committed no outright research misconduct. RS felt that the report might have some important messages for NICE as well as the authors but the BMJ would not normally correspond with a third party without a compelling reason to do so.

The authors have not responded to the editor’s request about forwarding the report to NICE.

 

The Committee agreed to close this case

 

3.2 Investigation of possible research/publication fraud by a university in a developed country

Background: BMJ had strong suspicions that a paper was fabricated. This paper was a follow up on a paper published in another prominent journal in the 1990s. University investigation has found no evidence. The consensus was that we do not have sufficient reassurance that a proper investigation has been conducted, and there remains a significant possibility that the whole paper might be entirely fraudulent. RS had written a follow up letter to the University authorities expressing the concern of the committee that the raw data had not been examined during the investigation.

RS updated the Committee on developments with this case. After the last meeting, RS sent a follow up letter to the university Vice Chancellor. A senior university official had written back and informed RS that the author in question had been on leave without pay for the majority of the first half of 2002 and had not responded to the university’s queries. The author had then tendered his/her resignation. The university have made it clear that despite his resignation, they still expect a response to their inquiry. At this stage the university does not feel that it is in a position to "judge what might have transpired in the conduct of the research in question". RS also referred the paper back to the original editor who had raised questions about the validity of the data and queried whether the related paper, published in the other journal, was also fraudulent. The editor looked through the paper and highlighted areas of concern in the original paper though pointed out that the original journal would be in a much better position to undertake a full investigation of the paper. RS asked the Committee to consider whether he has a responsibility to alert any other journals?

PS queried whether the original paper in the other journal had ever been retracted? RS told the Committee that no doubts about the validity of the study had been raised to date. PS queried whether RS would be bound by the stricture of editor-author confidentiality? RS stated that he did consider correspondence with authors as confidential. PS queried whether this would be a serious enough situation to qualify as an exception? Effectively is there a limit on the editor-author relationship of confidentiality? LW queried whether breaking this confidentiality could be justified as being in the public interest? RS asked the Committee was it sufficient to write to the Vice Chancellor again and also to the other journal about the related paper? SMS felt that this course of action would discharge the editor’s moral obligation. PS queried whether the author’s consent was required for a retraction and whether the editor did have a moral obligation to alert other journals. RS explained the notion of "recall of aegis"—that is to withdraw the journal’s support of a paper where the research was considered to be fundamentally flawed. The inference being that if the journal had known at the time details that later came to light then publication would not have occurred. In this case, the editors have serious doubts about the validity of the research but the author has "disappeared". If the editor cannot prove the data is fraudulent then he or she can’t fully retract but can indicate that the journal now has a lack of confidence in the work.

TW agreed that this was a remarkable set of circumstances. LW wondered if the notion of confidentiality should be regarded as a whole package. TW accorded that indeed the specific details should be considered. Here the Committee was looking at a balance between confidentiality versus a correct scientific record. PS thought that it would be useful to publicise the precise delineation of the editor’s limits of confidentiality with prospective authors. RS agreed to draft and circulate a document on this topic. AS felt that the relationship of confidentiality between doctor-patient was actually quite different from the relationship of confidentiality between editor-author under discussion here. Once an author had submitted a paper for peer-review then the work was opened up for scrutiny. TW felt that authors had entered into a "conversation" with an editor. RS stated that the analogy had come into practice because doctors had adopted it wholesale. PS stated that there was a need to focus on the limits of the relationship.

RS to write to the other journal with the concerns raised with the subsequent paper
RS to write to the university to see enquire about progress
RS to draft document on limits of editor-author confidentiality

 

3.3 Background: Authors A, B, and C submitted a paper about the behaviour of a group of doctors. All authors come from one institution, and the behaviour studied was that of the doctors at the institution. Author A (the most junior author) did the data collection under the supervision of author B (who was responsible for the design of the study and acted as corresponding author and guarantor). Author C is an office holder of the institution’s work. This paper raises difficult and important ethical issues.

The journal accepted the paper after revision, edited it and sent proofs. All correspondence to date had been with author B. When the proofs arrived, author B was on leave, and author C raised serious concerns about the paper and stated that it needed to be rewritten. Author C, who is the most senior author, did not seem to have previously read the submitted paper in depth—author C disputes this. A few weeks later, author C sent in a revised paper. The general effect was to water down the negative aspects and increase the positive aspects. In particular, author C stated that the original version had misinterpreted one part of the results and the new paper includes a new interpretation but no further supporting evidence as to the new interpretation. In addition, a new author, author D, appeared on the paper and was now listed as both the corresponding author and guarantor. Author D had not even appeared in the acknowledgements in the original version. The editor wrote to author C asking for an explanation of the change of authorship, raising the possibility that poor authorship practices were evident. He asked for a written assurance from all authors that they were happy about the revision, and asked for a copy of the questionnaire used as well as evidence to support the new interpretation so that the journal could judge the changes for itself.

Author C has written two holding replies, refuting the suggestion that there has been any authorial misconduct, and asserting that he/she was involved in the research. Author C stated that the authors were currently debating the appropriate interpretation of the results of the study. RS reported that he had spoken with the original guarantor (author B) who had withdrawn from being guarantor on the revised version. Author B stated that he/she would withdraw as an author if the paper were to be published in the substantially revised form. However, author B is clearly the person who determined the methods of the study.

RS updated the Committee on this case. RS had spoken directly with Author A. Author A expressed that he/she had been under considerable pressure about the paper’s original interpretation. Author A had met with the Vice Chancellor who had been very supportive of publishing the original version of the paper without the new guarantor (Author D) present in the revised version of the paper. The main difficulty in revising the paper was that Author A was subject to considerable work time constraints. Author A was also apprehensive about the potential for a "media circus". The Committee suggested that the student could pass responsibility to the Dean/Vice Chancellor or that the press team for the BMJ could offer advice/support. RS stated that he would like to publish the case as soon as possible.

 

RS to chase student for finalised version for publication
RS to ensure press office provide support if appropriate

 

3.4 Background: An author who has several published papers in a particular area submitted a number of new papers which gave cause for concern due to a lack of reference to the earlier published papers, overlap and similarity to published papers, and questions about the reliability of data. The author was asked to clarify these issues. The author then submitted further papers that were rejected with suspicions on the validity of the data. Unsolicited revisions were then submitted. Two separate groups raised concerns of the validity of the author’s work. A further paper was submitted and the editor requested the raw data on all 3 papers. The author submitted the raw data in a format that was difficult to examine. Two of the papers under peer review were also submitted to other journals; reviewers alert the journals to this fact. Two further papers are submitted and one of the clinical referees raises the issue of potential fraudulent work. A statistician compiled a full report concluding that there is evidence that the data are fraudulent. After further papers are submitted the author demanded a decision on the outstanding papers. The editor rejects the papers and informs the author that a full report will be forthcoming. The allegations of fraud were relayed to the author. The author claim that the data has been destroyed by natural causes, blinding in the study was impossible, and the last available data for patients who died or were lost to follow up were used. The author denied the claim that the data were generated to fit the values in the tables. In further correspondence, the author claimed that the persons raising concerns had a personal axe to grind and are not credible. The editor contacted the country's human rights organisation and they in turn forward the editor's complaint to the country's national medical research council. The human rights organisation's report concludes that despite errors and inaccuracies, the lack of information about the data source collection makes it difficult to comment on the authors' work. Despite a follow up letter, no further communication was received from the national medical research council. The original published article has become a citation classic.

RS updated the Committee on this case. After he chased up his letter to the national medical research council in summer 2002, he received a reply stating that the country’s human rights organisation had referred the case to them and that they had made a report and that further action now rested with the human rights organisation. The national medical research council also stated that the author did not come under their jurisdiction. The national medical research council stated that they were bringing the matter to the notice of the appropriate authorities (but did not elaborate on who they were). RS wrote back to the national medical research council asking for a copy of the report (which was not enclosed) and asking which authorities were to be notified. RS indicated to the national medical research council that he was considering publishing an account of the story in the BMJ if no assurances were made that a responsible body was taking steps to rectify matters.

RF pointed out that in the Committee member’s pack on this case, there was an earlier letter in 2000 from the human rights organisation stating that the original complaint had been referred to the national medical research council and that the editor was to direct all further communication to the national medical research council directly and that "The case is closed."

LW queried whether the national medical research council was the correct body to approach? RS referred the members to the fact that he got nowhere with either organisation. SMS felt that RS had made a significant effort despite the failure to get anywhere. SMS wondered if RS should write an editorial on the absence of mechanisms to deal with such cases in this particular country. RS felt that there was a duty to publish some of the story. RS has been attempting to get some form of action on the papers for some years. TW queried whether RS had ever got any communication from the author? RS stated that the author had never responded to the substance of the allegations and that a statistician had spent 2.5 years sorting through the raw data.

SMS felt the Committee should consider the appropriateness of the BMJ publishing on this matter. First, the BMJ had published earlier work of the author and felt that this was likely to be fraudulent. This gave the BMJ standing to publicly address the matter. Second, under the rules of natural justice, the BMJ wanted to set the academic record straight. Third, the BMJ had approached the appropriate bodies in the author’s country. SMS postulated, and the Committee agreed, that to publish an account of the matter would be ethically defensible. SMS then turned to the implications for a legal case of defamation being brought against the journal in the author’s country. SMS suggested that RS should take advice from solicitors as to the consequences of a defamation action being raised in the author’s country. PS also stated that the journal’s insurers should be consulted. PS felt that publishing an account needed to strike a balance between the "commercial point of view" and the "scientific & journalistic view". The BMJ is a prestigious journal and needs to maintain an accurate scientific record. To not do so would be unjust and there is an ethical obligation on the journal. LW agreed with this and that the credibility of the BMJ needs to be maintained by the withdrawal of the paper. This is the duty of the editor. TW pointed out that setting the record straight was also important from a public interest point of view. AS agreed that if the editor has substantial doubts then they should be pursued.

RS asked the Committee if they would back a decision to publish an account of the matter in the BMJ? The Committee offered its support and SMS summarised that the Committee felt it was the ethically sensible course of action and that the Committee encouraged this course of action with the provisos listed below.

RS to publish an account of the matter after

1. consulting with the journal’s insurers

2. consulting with solicitors about an action for libel

 

3.5 Consent cases and the revised consent guidelines

As requested, the editorial team (Roger Robinson and Jane Smith) had looked at the outstanding (nine) "consent cases" in light of the Committee’s new guidelines and had reported back their decisions. The Committee were provided with a short summary of the reasoning behind each decision and a copy of each piece where a decision to publish without consent had been agreed. The editorial team thought they could publish four and couldn’t publish four pieces, with one case being undecided. RS explained that a decision to publish without consent would only be taken if both editors felt that the case fell within the guidelines’ exception category. If there were a strong disagreement then they would bring the case to the Committee. PS enquired whether the editorial teams found the new guidelines useful. RS stated that the editorial team did find the revised version and additional guidance useful. PS queried how to take the revised guidelines forwards in terms of accountability and letting the authors and readership know about them? RS stated that he planned on mentioning the draft guidelines (currently available at the ethics committee part of bmj.com). RS also felt that it would be useful to let the readership know about the process of deriving the guidelines from principles and illustrating with cases. The guidelines were currently on the web for a trial period but RS would eventually like to publish them in print and hoped that this would prompt debate and increased awareness. PS felt that it would be useful to describe the overall experience, including the use of the guidelines. RS agreed that it would be good to do this and illustrate with cases. PS pointed out that the draft guidelines are actually set out in an expanded, explanatory paper. SMS stated that the Committee would aim to finalise the draft guidelines. LW thought that it would be good to have comments from RR & JS on the application of the guidelines. TW felt that it would also be a good idea to review the application of the guidelines later on in 2003 to see if they are being interpreted in the same way as the Committee interpreted them.

RS to mention draft guidelines in Editor’s choice
RF to collate all decided cases for review by Committee in 2003
RF to canvass opinion of RR/JS for Jan meeting
SMS/PS to table paper summarising revised guidelines "experience"

3.6 Case 02/003

A case reporting multiple errors in treatment where the patient died

Background: The authors describe the errors in treatment of the particular patient but stated that they did not have consent of the relatives to publish the case. It appears that the relatives and the "authorities" do not know about the errors that occurred with this patient. The authors write that there is no non-punitive voluntary reporting system in place in their country (a developing country).

The Committee was very impressed with the lengths to which the author had gone to locate the family of the patient described in the submitted case report. The author had then contacted the editorial office asking for advice on the exact nature of the consent he should seek from the family. Whether he/she should show the family the entire text of the report, should it be translated word for word into the family’s language, or would a general consent suffice—for example, "I am writing a report on the treatment of your relative, would you give consent?" The authors flagged an additional problem in that the deceased patient and family were part of a minority community and the author feared initiating communal ill will.

 

LW expressed the view that the consent required the author to provide the patient’s family with more information about the nature of the report and where the author was submitting it for publication. SMS felt that the issue of communal ill will did raise an additional difficulty if the authors were to provide that additional information. RS agreed that there might be some difficulty if the family were to see the case published, especially since the full text is free on the world wide web. LW still felt that as the case report raises the possibilities of mistakes in the care of the patient that the consent would have to involve more information to be adequate.

LW also felt that the author might have a duty to other colleagues who would be implicated in the case report. The author states that there is no blame free culture in his country and the health care staff implicated could be in danger (of both losing their jobs but also from violence in a volatile situation). AS stated that in the country in question, the triggers for violence in the region are often quite small. TW highlighted that it would be difficult as the doctors were from the majority and the patient from the minority. SMS agreed that the minority might feel that the patient was "deliberately disposed" of. LW pointed out that in reality the Committee had no way of knowing that information. TW stated that if the patient’s family were alerted, there was a risk of escalation from the mere process of seeking consent for publication. The Committee agreed that this was a very unusual complication of seeking consent.

In the light of the danger, SMS queried whether the benefit of the truth being published outweighed the risk of sparking violence. SMS felt that the decision about seeking consent was not entirely up to the author as the attending health care staff could also be targeted. AS queried how accurately the author could anticipate or measure the likelihood of sparking violence. Violence in the region had previously been grotesque and barbaric. RS thought that, if in fact, there had been abuse of a patient then highlighting the faults in the system would be positive. AS backed up the author’s assertion that there was no blame free method of investigating mistakes in this particular country’s system.

SMS felt that there were many questions raised, and that the author may not have considered all the implications. RS queried could the case be published if all inessential details were stripped from the report? AS/RS suggested several measures designed at anonymising the report. RF queried whether the consent should still be sought for an anonymous case report? The Committee went through the new consent guidelines (section 3). TW pointed out that the patient was unable to give consent and that it could be considered unreasonable to obtain the next of kin’s permission. The "lesson" in the article was worthwhile, and that the identifying details could be stripped from the article. However, on point 3(c) there was considerable risk of intrusiveness and distress for the family, especially when taking into account the cultural aspects of the particular case. SMS stated that the Committee felt that §3(c) precluded publication without consent. RS additionally felt that it would be unwise to urge the author to obtain a fuller consent.

LW queried whether if the Committee had decided on requested consent to be sought whether a full translation of the case would be necessary? SMS stated that the author would have had to tell the family that the care of their relative had been poorly handled. LW felt that the author would be in a better position to judge the likely reaction to informing the parents. SMS pointed out that the author may wish to avoid communal ill feeling and that SMS was unhappy with the notion of leaving such a risk up to the author. TW agreed that there was a risk of the family taking umbrage at the revelations and that looking at the guidelines the reasonable person would object to the revelations being published. TW felt that any consent would not have to be word for word but more telling the family the facts. LW qualified that statement to the author telling the family the substantial facts. SMS still felt that obtaining consent from the family could leave other staff vulnerable. AS said that really it was juggling harms but in this case a backlash against the hospital staff could be horrendous. LW queried whether there were other ways of raising the issue of the difficulties of not having a blame free culture?

RS to relay the Committee discussion to the author
RS to consider raising the issues around a blame culture in medicine

 

3.7 Case 02/004

The case of airborne transmission of a virus at a function leading to the death of one of the attendees

Background: A public health incident where an attendee at a function infected many others and the illness lead to death in one other person. The authors wished to publicise the case as a means of highlighting the risks of airborne transmission of this virus but did not have the consent of any of the attendees of the function.

The author had come back to RS’s letter querying whether the author was aware of any epidemiological guidelines giving guidance on consent in public health incidents. The author was unaware of any such guidelines.

LW pointed out that the Committee still did not know how much of the incident was in the public domain. RS felt that those present at the function would probably know of the incident. AS felt that those who were at the function should be given a reasonable chance of knowing before publication. TW stated that if the incident was in the public domain then publication was unproblematic. LW felt that the editor needed to go back to the author to find out.

RS to ask author whether incident is in the public domain

4. New items

4.1 Research projects in the BMJ—getting ethics approval

RS asked the Committee’s views on the competing interest research among readers that he had tabled before the Committee. RS had asked three questions in regards to the research: (1) Is it necessary to have research ethics committee approval for this study? (2) Can it be acceptable for the BMJ Ethics Committee to give approval for such a study? (3) If approval is needed for such a study, and the BMJ Ethics Committee can grant it, then would the Committee feel able to give retrospective approval for such a study?

SMS started from the premise that the research did involve human subjects. LW wondered if the research wasn’t more akin to marketing research, surveys, and gathering peoples’ (readers) views? RS stated that where the reviewers were the subjects of the research, there was no coercion but that there was the element of time given by reviewers to do the work. TW queried whether the research should come under a social science researchers’ code of conduct? Guidelines for social psychologists might be more useful to refer to and might be more rigorous. RS stated that there was a statement to authors that they might be included in research. In the randomised trial of reviewers, they were sent spoof papers containing deliberate errors. TW felt that there was a different issue of deception of the reviewers in order to carry out the research. In the discussions about deception in research it was an agreed principle that the researchers should tell participants the full nature of the research afterwards. PS agreed that where deception was necessary to carry out the research and that the harmful effects of the deception were balanced by the usefulness of the research this would be okay. A full debrief of participants would be necessary afterwards.

SMS felt that such research projects should only come to the Committee if there was a difficult issue to be resolved. PS thought that research on patients or not it would have to be reviewed. There was a contextual issue here about whether even the apparent audit purposes of the research could still be construed as research because the researchers had submitted for publication. PS felt that in order to exhaust due diligence, the researchers should see if this type of research on human subjects were covered by any research guidelines. SMS stated that there was an EC Directive concerning research committees and research involving human subjects though they are framed in a medical context. The UK framework focuses on the use of medical subjects and patient data. LW pointed out that the low response rate indicated that those who were "participants" considered the research optional.

SMS stated that the scope of research ethics committees was being extended—for example, in New Zealand a university was allegedly involved in research connected to holocaust denial prompting the government to impose stricter controls on research, which diminished academic freedom. PS stated that if the research had been carried out in Canada (under Canadian guidelines), it would probably have been sent to a research ethics committee because it was a systematic analysis in an area of editorial research. PS queried whether there were any relevant UK guidelines that the research could be examined against? RS said he would distribute a full list of research projects that the BMJ was undertaking at the next meeting. SMS agreed that the Committee would look at the projects at the January meeting and check the codes of practice that might be relevant. PS felt that the projects should be looked at prior to the research being carried out. RS felt this issue dovetailed with the difficulties that there is no clear guidance on audit as research.

RS to bring all existing research projects to January meeting
PS to send Canadian guidelines to RF/RS
ALL to look at relevant UK research guidelines

4.2 Ad complaint

In BMJ Careers there was an advert posted on the doctors’ notice board for the sale of a "real half skeleton". A complainant called to say that the GMC said that such advertisements were "illegal". The complainant found out that the ads were "illegal" after calling the GMC Legal department and asking for more information. The legal staff told her that since its illegal to own a person and profit from that ownership, it therefore follows that it is illegal to own a person's body parts.

BMJ Careers tried to verify this with the GMC legal department but no such department exists. A contact at the GMC thought that a government body recommended that the sale of skeletons be illegal. The GMC publication, GMC News, no longer accepts ads for skeleton sales and recommends that attempted advertisers call Her Majesty's Inspectorate of Anatomy to arrange ethical disposal. Her Majesty's Inspectorate of Anatomy had a much more complicated story. The inspectorate has no remit for bodies originating or skeletalised outside the UK: the Anatomy Act only applies to the UK. As most skeletons offered for sale originated in Asia pre-1985, the inspectorate cannot advise on their disposal. Callers referred by the GMC are advised to offer the skeletons to medical schools. There is currently no law against importation of body parts and apparently skeletons are still being imported but now mostly from the Far East. There may however be a stipulation in the Convention on Human Rights and Biomedicine that no profit may be made from the sale of a body or its parts, although the process of skeletalisation may be charged for. The Convention may not be enshrined in UK law for some years and the Inspectorate is aware of a number of companies who sell skulls at various grades who have not been stopped. The Inspectorate thought that BMJ Careers could possibly get more information from the Retained Organs Commission.

SMS expressed surprise at the claim that there was any illegality in the sale of skeletons for medical uses. With the setting up of the Retained Organs Commission, the question of sensitivity should be taken into account—that is, the skeleton should not be advertised for cavalier purposes. LW queried whether there was an issue of profiting from the sale of "body parts"? SMS stated that there are restrictions on research on embryos and fetuses but that the UK government had not signed up to the European Convention on Human Rights and Biomedicine. TW stated that a skeleton would not be a human body as such. AS queried whether there wasn’t knowledge and skill applied. SMS felt that under the law of property to steal a skeleton would be theft. TW said that if there were any problems with the skeleton being identifiable as—for example, aboriginal remains or pre-1985 Asian skeletons. AS stated that the law was unclear about the import and export of "dry bones."

TW felt that any impropriety would be related to pubic offence v legality and it would depend on the purpose—for example, used for witchcraft. AS stated that it would become clearer what you can and can’t do with law changes. LW felt that it would be ethical to advertise for medical use so long as not wrongfully obtained. TW felt that any ad would be at the editor’s discretion.

RS brought up the debate that had been going on about the scope of the Committee. The Committee currently deals with editorial issues but ethical issues also arise under the "enterprise" side of the journal. This particular issue is on the edge of the commercial side of the business (classified advertising). Should the Committee expand the scope of issues to include the enterprise side? SMS felt that the Committee wouldn’t suggest an increase in scope but that the Committee would be willing to consider any issues that the executive felt should be brought to it. PS agreed that a case referral would be the best way of moving forward. RS queried whether it would be worthwhile enlisting a member with business ethics background. PS stated that with the emergence of small biotech start ups, bioethics and business ethics were converging and that it should be possible to find a new member with relevant experience. RS said that he would bring the issue up with the management executive committee.

RS to feed back discussion to classified advertising
RS to raise issue with management exec

5. Ethics committee approval for audit

DW was unable to attend the meeting. RS thought that he had some information on this subject that might be useful to focus this discussion.

 

RF to contact DW to see if he is too busy to provide report

6. Publications from the Committee

RS stated that he would like the Committee to produce a report on its work that can be "signed" by the Committee members. SMS enquired about the extent of the report? RS thought that as the minutes are up on the web, an editorial or education & debate piece setting out where the Committee was at and where it wanted to go would be appropriate. This would hopefully draw people into the part of bmj.com that housed the information on the BMJ Ethics Committee. RS thought a deadline of the end of the year would be appropriate. SMS will draft something for circulation and it will be finalised at the January meeting.

 

SMS to write piece on Committee’s work for end of 2002

7. Ongoing programme for reviewing the existing policies of the BMJ

RS felt that the Committee had traditionally acted in a reactive way to policy issues brought before it. RS asked the Committee if they would be willing to proactively review the editorial policies of the BMJ to see if there were any holes. Additionally the Committee would review existing policies to see if there were any deficiencies or difficulties with those policies. LW suggested one area that had been previously discussed about the lack of clarity with telling authors that they would be judged on UK standards and that there paper could be referred to the Ethics Committee, and where appropriate to other authorities. RS felt that the issue of how this impinged on the editor-author relationship of confidentiality had not been explored. RS asked PS if there might be a student who would be willing to work on a project like this? PS said that he would review the journal policies to identify areas that the Committee might like to review. LW expressed interest in also being involved in this and also thought it would be a good idea to look at other medical journals’ policies.

 

LW/PS to report back to the Committee about developing policy

 

 

SMS also thought it would be useful to review the policies in the Jan/Apr meetings. SMS suggested that it would be useful at some stage in 2003 to have a "working weekend" to go through BMJ policy. RS stated that the budget for the Ethics Committee could tolerate this.

RF to follow up weekend workshop

8. Any other business

PS asked if SMS/RS had made a decision on whether to invite his suggestion on a new member from a developing country. After a brief discussion of the individual’s curriculum vitae the Committee decided that RS would approach this individual.

 

RS to approach this individual

9. Dates for the next meeting

The next meeting is Tuesday 21 January 2003, 2.00–5.00pm at BMA House.

Other confirmed 2003 dates:

Monday 7 April 2003, 2.00–5.00pm at BMA House.

Monday 14 July 2003, 2.00–5.00pm at BMA House.