Minutes of the BMJ Ethics Committee Meeting

2.00–5.00pm, Tuesday 19^th October 2004

Old Editorial Room,

BMA House, Tavistock Square, London WC1H 9JR

 

Anonymised Web Minutes

 

Present:

 

Iona Heath (Chair)

Sam Knottenbelt (Secretary)

Kamran Abbasi

Jane Smith

Liz Wager

Derick Wade

Jeffrey Tobias

Apologies: Andrew Lawson, Peter Singer

Minutes: The minutes of the last meeting were accepted. It was noted that there had been a problem with the previous secretary providing anonymised Web Minutes and they have not been posted on the BMJ website.

2.1 – Notifying authors of referral to the Ethics Committee – ground rules.

JS noted that there were currently no consistent ground rules for when an author’s paper is referred to the Ethics Committee. KA suggested this should be consistent – authors should be told when papers are referred to the ethics committee. JT asked how to ensure consistency with a large staff. KA noted there are not many papers and some arise from mini-hang meetings. It was suggested that SvK should check to see if the authors are notified. Letters should always be copied to the secretary with a summary, benchpress number and the notice to the author. JT asked if the correspondence would be marked confidential, since this is sensitive information. KA said that the rules would be put on the EdStat agenda. DW pointed out there should also be a closing letter with feedback, notification that the case has been discussed. It is the editor’s responsibility and the Secretary to the Ethics Committee should be cc’d in to letters to the author.

Action: KA to ensure that authors are notified that papers are being referred to the ethics committee and cc in SvK to correspondence.

2.2 - Pedigree Privacy Editorial

It was asked if this was a recent article. The Committee noted that patient information is changing dramatically and it was asked if doctors can be custodians of confidential information at all. Patient groups are very keen for an NHS electronic record. AS commented that GPs’ and the GMC’s guidelines are out of sync with every day practice. IH commented that the old certainties are disappearing and confidentiality is becoming impossible to defend from a practical perspective. Possible authors for the piece could include Jonathan Montgomery, John Williams (health informatics) or possible a patient voice from the mental health arena.

Action: KA should commission a pair of articles on the pros and cons of electronic records and balancing access vs confidentiality. JT suggested a busy, senior hospital based doctor frequently on emergency call would be best for the access case.

3.1  Case 04/001

Summary

This paper has been submitted as an example of when the BMJ editorial thought that the ethical statement was acceptable.

The ethics statement:

Ethical approval: This was not deemed necessary as the surveillance was part of the hospital audit programme.

Does the ethics committee agree?

Discussion

JS brought this case for guidance on the level of sensitivity the BMJ should have on the line between audit and research especially in light of DWs paper. JS thought that this paper was acceptable as it was part of the audit process and described the data collection methods – it sounded reasonable to monitor the procedure in the paper.

DW asked if the data collection techniques were routine and noted that it was difficult to believe that they were routine. KA noted that they seemed to go beyond information that would be routinely collected. IH wondered if it was the decision of the ethics committee or the authors that the paper was audit, and that perhaps there should be an analysis along the lines of DWs paper. JS asked if on the face of it the paper was acceptable. KA noted that the process the authors went through was not clear and needed to be clarified and rather than fudging what had happened. JT commented that it looked like this paper was on the interface between research and audit, that the authors had never dreamed that ethics approval was needed and added a post hoc disclaimer and that maybe it was something more than audit as normal audit would rely on patient notes. IH pointed out that you could equally argue that it was audit, that a way forward was needed and the paper should be published. IH pointed out that editors need to think for themselves. JS noted editors have a tendency to defer to ethics committees rather than thinking for themselves. KA suggested there needed to be more transparency around who takes responsibility, is it the ethics committee? This raised a practical problem that if every paper was stopped it would clog up the system, on the other hand it is only a marginal area and there should be some scrutiny on the editorial side where there was no ethics committee approval. KA also pointed out that there should also be scrutiny of papers with ethics approval. JS said there needed to be extra operational steps for editors.

Action: DW’s paper should be transformed into an editorial policy.  DW will prepare a policy for the BMJ and KA will publish an editorial on Derick’s paper.

3.2 Case 04/002

Summary:

This interactive case report describes a real patient with symptoms that are still unresolved and who may have a poor prognosis. It has been written up and submitted by the patient's doctor. If we publish the report, we will present it as an unfolding story in three parts over five weeks, inviting responses on bmj.com from readers to questions about diagnosis and management, and about what to say to the patient. We will also commission several expert commentaries to publish with the third part of the case history.

We always ask patients to give signed consent to publication. This consent is informed: we ask the authors to explain to the patient that their case will be discussed "live" on bmj.com Indeed, we ask authors to invite the patient to read the rapid responses and to write a commentary about their health and their experience of having their story discussed in this way. To date, we have used the patient's real first and family names in these case reports, with their consent.

Until now, interactive case reports have described patients whose problems have been resolved. Will it be ethical to publish this unresolved case, given that the patient may be exposed to all sorts of opinions on their health, some of which may be very frightening? Can consent in this situation be truly informed?

Discussion

LW – No! This is not ethical. This is treatment by Journal, you just don’t know what the repercussions will be. This case should only be used once the diagnosis is discovered. DW & JT agreed and added that there was no message. It was noted that sometimes it is possible to be to paternalistic, but what is gained from this story? If a person understands the risks and the risks are weighed, then the answer must be NO, this should not be published. KA noted that the case does not need to occur in real time, once the diagnosis is finalised the case can be presented, really otherwise this is only titillation.

A general point was made by the committee that there should be some sort of resolution before a case like this is published and that it is impossible to obtain informed consent without such resolution.

4.1 – Update on past/going cases

Case Summary:

An editor received a paper and intended to referee it, after requesting details of ethical approval from the authors. The authors replied that they approached the ethics committee about carrying out a more extensive study than the submitted study, for which ethical approval was denied.

When almost at the end of the interviews for the study they received the decision from the ethics committee that the more extensive study would not be granted approval. The authors were happy to refrain from their more extensive plans, and realised that the interviews they had carried out so far yielded much interesting information anyway, and would make a good research paper. They informed the ethics committee that they were not carrying out the original study, and they have not specifically received approval for the current study.

The authors summarise the situation by saying that approval from the ethics committee was denied for a study that was not carried out.

What should the editor do?

Actions:

• Editor to request ethics committee correspondence sent to the authors
• Editor to also write to the research ethics committee directly  

 Update: 

• The author has finally provided the contact details of the ethics committee (last week), but has now resubmitted his paper again despite the whole issue not being resolved.
• The editor will now write to the ethics committee directly and the paper is on hold.

Action: KA to write to Ethics Committee directly

4.2 update

Case Summary:

Obtaining consent for a study of people with severe learning disabilities

A paper was submitted which reported a study of people with severe learning disabilities and their interactions with staff. The journal was keen to consider the paper further, but had concerns about ethical approval. The authors stated in their cover letter that ‘Ethical approval was sought from the Research Ethics Committee, but the Committee deemed that the research 'can go ahead without the need for Ethical approval'. The editor presumed this was because the research was being done for operational/service reasons. The editor’s main ethical concern was that consent from the individual patients had not been obtained, to which the authors responded that it was not possible to obtain consent as the participants’ learning difficulties were too severe. Instead they had assumed ‘process consent’, whereby the participants made it clear if they did not wish to be interviewed. The editor was not reassured by this response. The paper was reviewed by an expert in research ethics who stated that, in such circumstances, consent should be obtained by proxy (ie from next of kin), and that ‘process consent’ is not a substitute for written informed consent by proxy.

Committee decision:

Ultimately the committee felt that the paper should be rejected on ethical grounds. Consent should have been gained from the patients’ next of kin or from a patient advocate and this was a significant defect. The risk of harm to the patients through publication outweighed any further benefits the patients could gain. (see minutes for more detailed discussion)     

Actions:

• Editor, to write to the authors outlining the committee’s discussion

Update:

• Editor wrote to author that the paper had been rejected and outlined the committee’s decision. The paper was also sent to COPE. The pieces could also perhaps be written up as an educational piece and be published for debate.

Action: KA to ensure the case is written up as educational piece and published for debate.

Plagiarism by Medical Journalism student - update

Case summary:

RS had previously updated the committee that he had just received a new letter from the student’s course leader. The student’s course leader had written back to the editor’s queries. The letter stated that the university considered that as this was an assessment matter and the external examiner had been informed. The institution felt that this was a serious matter but not a disciplinary matter and cited their rules and it would only be serious if over 30% of the coursework were plagiarised.

IH summed up that the committee was most concerned about the institution’s standards especially since it was likely that future students would be referred to the BMJ. The majority of the committee was advising the editor against notifying the medical school but that the decision was ultimately up to the editor. 

Action:

• Editor to write to the institution about concerns over standards

Update:

• RS had had discussions on phone with a more senior academic and was reassured that they do take plagiarism seriously and they had considered this case properly. He was satisfied we need take no more action. The case is now closed.

4.4

Committee minute 23/6/04:

The committee received the letter from the author. The committee reiterated its previous conclusion that publication of this paper did require the patient’s consent. The committee noted that as written the author’s stance was in breach of the GMC’s guidelines.

Action:

• RS to write back to the author and point out the GMC’s guidance

Update:

• Letter written
• Case closed

5 Report on meeting with Standards Committee of the GMC

The meeting with the GMC discussed publishing articles where patients are critical of specific doctors and whether there is any way they can have a right of reply without breaching patient confidentiality.

KA asked how convinced IH and RS had been by the compromise position. IH replied that it was better as it made it more possible to give consent. LW was concerned that this position was a doctor ban on displaying anything from the record and was not protecting the patient. It was suggested that the balance in the compromise position was not quite right. JT was uncomfortable that the patient has the first and last say - most doctors do their best and this is too much in favour of the patient. JS pointed out that doctors have no ability to respond or defend themselves. KA pointed out that in attacks on professionals someone always has the last word, but if pitched in the right way it can protect the patient.

The process was discussed, JT suggested a joint article by the patient and doctor, LW pointed out that a patient might comment, but would then change their mind when they see the doctor’s response. There were problems with this. JS mentioned that if the patient said no you would have to live by it. KA suggested that when a doctor replies the patient can object to personal information being published, it could be explained that this is the process and also they have a right of reply. DW asked what is a personal detail? It could be anything. This becomes an effective power of veto and you do need a right of reply. JS pointed out that currently if you decide to publish a doctor may or may not respond. If there is criticism the doctors do not have the right do defend themselves and this is potentially unfair. JT pointed out in some ways this is fair, you can’t be fair to both, you could have a joint paper written between them both. KA pointed out this would be incredibly difficult to arrive at something that they were both happy with. IH thought that ultimate the duty to the patient outweighs the right to fair play.

KA suggested the piece could go the doctor saying that it will be published and asking for a response, this process creates a right of veto from the patient (since you need permission for their details) but it also provides a right of reply for the doctor.

IH summarised, that the committee had come back to starting position and the same old process is actually the best. The article should be published and the doctor can respond if they want to, combined with editorial discretion.

6. Strengthening Patient Voice

The role of the BMJ Patient Advisory Group (PAG) was clarified. It advises on patient related matters, meets twice a year and its aim and span are currently up in the air and it is currently not used properly. LW suggested that perhaps there could be a link to, or a representative from the PAG. KA stated that a patient voice should be part of the committee. DW was worried we could get stuck in bureaucracy and we should advertise in the street. It was also suggested that KA could invite the PAG to elect a member as a representative on the ethics committee. IH was inclined to do this.

Action: KA to organise the PAG to vote in a member representative, who will not be mandated or representative of the PAG. They need to be an individual not a representative.

7 Proactive Ethics Coverage

‘Physician practitioners’

IH raised the issue of ‘physician practitioners’. Why? Who are they? They seem to be pretending to be doctors when they are not. They seem to wear the kit but not have the knowledge – they can prescribe and there seems to be some sort of patient deception occurring. This seems to be designed to delude, they only have a science degree and two years training compared to an SHO with 8 years training.

For instance if you have a referral you will be sent to an orthopaedic ‘practitioner’ rather than an orthopaedic surgeon – patients may not know what the difference is. JT commented that this seemed to be status deception.

Action: KA to commission a piece and IH will suggest an author.

Guidelines and the influence of pressure groups.

Pro-life groups on the fringes that are well resourced are having a significant negative impact through seeking judicial review of guidance. They are attacking guidance through having it judicially reviewed.

The GMC and BMA will issue less and less advice if it is put up for judicial review and doctors will have less and less guidance. This is also problematic because there is no previous tradition of resolving ethical issues through the courts.  It is also difficult because doctors by treating to the last moment – right up to death - they risk nothing, but by acting ethically they risk everything.

Action: KA will consider an editorial on this issue

 

8 Draft BMJ Complaints procedure

The draft BMJ internal complaints procedure was discussed. IH concluded that it looked robust.

9 Paper on editorial independence

KA outlined the current status of the paper on editorial independence. Option 1 is reactive with a small panel. With an unresolved complaint the panel may resolve the complaint or make recommendations on what to do. Also if the editor feels that their editorial independence is compromised, the panel can deal with this. The panel is made up of 3 people, is independent and has no BMA representative.

The panel is in waiting if the mechanism is triggered. Who decides if it is triggered? The BMA, the Chief Executive, or others, this is difficult to resolve now and once the new editor is appointed the fine detail will be resolved.

Option 2 is more proactive with an element of oversight.

JT pointed out that there needs to be a balancing of needs, the journal needs to have sparkle and be racy, so the panel needs to have a light touch and that last thing that is needed is oversight, also there is an advantage of a small group as it will be fleet of foot.

IH summarised that the committee supported the decision to go with option 1 and asked KA to please supply more information.

Meeting closed.