Minutes of ethics committee meeting, 26^th June 2001

Attending:

Sandy McCall Smith

Richard Smith

Derek Wade

Ann Sommerville

Liz Wager

Tom Wilkie

Sandy Goldbeck-Wood

Apologies: Jeffrey Tobias

• Extra item – Possible collaboration between bmj.com and another medical website: the need for disclosure of the fact that conference report authors may be nominated by pharmaceutical companies?

Background: TD explained the proposal that BMJ and the other website should co-host commissioned conference reports on their websites. The agreement is that pharmaceutical sponsors are entitled to nominate one, or in some cases more, members of the writing committee. BMJ has so far taken the view that such nomination should be declared explicitly. The potential partner is happy only with a general statement concerning the possibility of an individual having been nominated by a sponsor. This could be a deal-breaking issue.

Discussion: SMS felt we should hold out for explicit disclosure. LW took the view that "singling out" the issue of pharmaceutical company influence is unfair. Other conflicts of interest are likely to be equally important. She objected to the notion that industry sponsorship is the only form of "taint" relevant here. PS agreed that all bodies (nominators) might have vested interests. Why single out pharma industry? SGW suggested that since there is a serious possibility, at least theoretically, of a collusional relationship between a sponsor – favoured author, and the company, it would be in spirit of BMJ thinking to adopt a policy of maximum transparency. RS suggested we might debate the issue with readers, if the potential partner agrees.

Decision: The committee recommends continued insistence on individual disclosure of a pharma company nomination of writers. However, if RS wishes to consult the readership, and there should be evidence of substantial disagreement from readers with the ethics committee decision, the committee would be willing to revisit the decision at a future meeting.

• Item 2: Should we insist on ethics committee approval for audit studies?

Discussion: RS suggested that requiring ethics committee approval for audit studies would impose a paralysing bureaucratic block on continuous quality improvement – type activities, in which we should all be engaged. AS agreed that, where it is difficult to define the border line between audit and research, it is clear that ethics committees currently have too much else to do, to be assessing audit proposals. DW agreed that this is unrealistic, and unfulfillable. TW dissented, questioning what external scrutiny is, in any case, for. Procedural, pragmatic argument could also have been used to oppose the setting up of ethics committees per se, he argued. He suggested it is unhelpful to try and make a clear distinction between research and audit. PS agreed that the argument for exceptionalism over audit is not strong. DW felt this position was too extreme, and that it is often unclear where the boundary lies between careful patient care (trial of an individual drug in individual circumstances), and audit. AS suggested there may be a need for separate "audit monitoring mechanisms", but felt it is not a suitable activity for LRECs as currently construed. PS suggested this would be a suitable topic for a reader poll. RS argued that we at the BMJ are not the people to rule on this.

Decision: Set up a BMJ readers poll on the topic.

Item 3: Cases for discussion:

Consent

• General question with specific examples: are we getting OTT over consent?

Discussion: LW suggested this would be a good topic on which to ask readers. SMS suggested that there is a meaningful distinction to be made between the recent and the very distant past, in terms of the needs to gain consent. AS argued that minimisation of harm and maximisation of benefit, at a global level, should be the criterion. Some stories were just so important they needed telling, and that whereas consent ought to be sought, the story nonetheless ought to be published if consent were simply unobtainable.

Decision: The overall feeling was that the need for consent might be waived where the patient is absolutely untraceable AND the reason to publish the story is better than average AND suitable measures are taken to minimise the risk of identification AND we state, alongside the article, that this is what we have done. PS will write proposals for the next meeting. RS will consider polling readers.

In addition, the following cases relating to consent issues were considered, most of which will be revisited, in the light of the new policy, in a future meeting:

• Case a – a filler, and a personal view.

Decision: RS to write holding letter to author, pending the revised policy. Decision over this paper to be revisited at that stage.

• Case f "fillers transform lives:" how should a doctor/journalist handle confidentiality?

The committee took the view that no doctor patient relationship issues arise in relation to this case, because the material discussed in the article did not arise out of the doctor-patient relationship itself (case closed).

• Case d

This case is suspended until we have our revised policy guidelines.

• Case b: double standards over soundings and fillers

This case is suspended until we have our revised policy guidelines.

• Case e: should we adopt a new policy over pictures and consent?

This case is suspended until we have our revised policy guidelines.

Cases a, d, b and e all to be revisited for final decisions at the next meeting.

Case c: ought we to allow self-styled titles like "XYZ advisory group?

Discussion: It was generally felt that readers are unlikely to be mislead by these titles, and that authors simply risk looking a little foolish in using them

Decision: On the matter of self styled titles, the committee felt we should allow people to use whatever titles they like for themselves.

 

 

Ageism:

• Case h: paper 1530 Rapid responses allege ageism. This case was discussed at a previous meeting and is now closed.

 

 

Others:

• Case i: The BMJ published a paper relating to unethical behaviour in a medical population. Individuals studied were never told by the paper's authors that the paper was to be published, and complained, anonymously.

Discussion: Two main arguments arose to inform the debate on this case: PS argued that the journal has an important duty to protect and support researchers (especially junior researchers) who find themselves in a "whistle blowing" situation, and having to raise a matter of serious public interest or professional concern. He felt it very important that technicalities over consent etc ought not to be allowed to sabotage such an attempt. TW invoked the "honest mistake" principle, which he believed to be the case over the publication of this paper without the participants' consent.

Decision: We would invite the authors to write an account of the anonymous complaint received, and to respond, which we would publish. RS to consider writing an editorial on the issue of free speech versus ethics/consent related issues. In view of the "free speech" and the "honest mistake" arguments, the committee would not be in favour of pursuing the matter any further than this.

• Case m: Rapid response to a short report focussing on ethical dilemmas, which argues that some activities described therein are also illegal. Does the BMJ have any duty to take further action over this?

PS stated a conflict of interest in relation to this case and did not participate in the discussion, but remained present.

Decision: It was felt that this was not an issue for this ethics committee, and that the BMJ had no duty to report this as a criminal offence.

•  
• Case j An otherwise robust paper on a common clinical condition underwent substantial changes at the proof stage, reflecting significant inaccuracies in the paper as originally submitted. It became clear that the senior author had not been fully aware of the way the material had been presented in the first place.

Discussion: It was accepted that this seemed likely to have been an oversight, of a kind which while unacceptable, may well nonetheless be common.

 

Decision: The paper should be published, but the author(s) encouraged to write an accompanying piece for the journal explaining what has happened. SGW to write to author.

• Case k: Investigation of possible research/publication fraud by a university in a developed country.

Discussion: BMJ had strong suspicions that a paper was fabricated. University investigation has found no evidence. We remain concerned. 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.

Decision: RS to seek reassurance from the university on two matters: 1 that the university has a proper process for dealing with allegations of research misconduct, and 2 that this process has been followed satisfactorily, with satisfactory answers. If the response to this is not satisfactory, RS should then approach the appropriate medical regulatory authorities.

• Case n: Pornography links to BMJ website – should they be removed?

Decision: The link should be removed immediately. This does not imply a duty constantly to comb the website for such links. However, since this has been brought to our attention, we should remove it.

• Case o: Undeclared competing interests

Decision: Deferred to next meeting.

• Case l: retrospective ethics committee approval

Decision: Now acceptable for publication, case closed.

• Case p: Complaint against Richard Smith

Decision: Complaints against the editor are not a matter for this committee, but should be sent to the chairman of the journal Committee. If the chairman of the journal committee sees fit, he may choose to consult the chairman of the ethics committee in an advisory capacity. AS will write to complainant.

 

Item 5, AOB:

The committee would like to record formal congratulations to Alison Tonks on her new daughter, and send warm greetings.