Anonymised minutes of the ethics committee meeting, 24 April 2002

Attending:

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

Apologies:

Derick Wade

Rachel Fetches has taken over from Sandy Goldbeck-Wood as Committee Secretary. RF is a technical editor with the BMJ Publishing Group and has a MA in Health Care Ethics.

Background: The BMJ is trying to finalise a deal with another medical web site to post conference reports compiled by the other web site on bmj.com. The issue before the ethics committee was transparency over the nomination of authors by pharmaceutical companies who had financially sponsored the conference being reported. The potential partner felt that identifying that a financial sponsor had nominated an author implied taint. The author may have no knowledge that he/she had been nominated by the financial sponsor. The author may have been suggested by a variety of sources and the web site's editorial team makes the ultimate decision. The potential partner was concerned that the reports were being held to a higher standard than the print BMJ.

Discussion: The Committee was joined by teleconference by a senior editorial representative of the potential partner who presented their view. Nominations for authors are taken from a variety of sources—would the BMJ require the whole list of sources or just any financial sponsors? What was the position on nominations from a financial sponsor of another conference would that also be explicitly stated? The web site was willing to compromise on the issue for reports published jointly with BMJ.

The potential partner stated their editorial policy is to select the best people to write up conferences. The author's name could come from a variety of sources and the web site did not feel it was beneficial to exclude those authors nominated by financial sponsors. There are graded levels of sponsorship and those purchasing a higher level have a right to nominate an author(s). There is no guarantee that this nominated author would be used and editorial policy prevails.

Decision: The BMJ would disclose the financial sponsor's nomination AND also make it clear that the author was unaware of the nomination. This would only be the case where the financial sponsor of the conference being written up had made the nomination for that conference. This issue would also be debated in the BMJ.

The members of the Ethics Committee agreed to declare any competing interests. They will also declare any competing interest about an agenda item and not take part in the discussion.

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 review 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.

Decision: RS to send the report to authors and request consent to send report to NICE.

Case k (26 June 2001 minutes)

Background: BMJ had strong suspicions that a paper was fabricated. 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.

Discussion: PS raised the point that there was concern over the fact that the University felt that reviewing the raw data from the study was unnecessary. This was at odds with the Committee's concern about the integrity of the research. Should RS continue correspondence with the University or go to a higher authority?

Decision: RS to contact the University again and request a more substantive response. If there is no further response then the Committee agreed that the issue could be escalated to a higher authority.

Case x

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 authors were asked to clarify these issues. The authors 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 authors' work. A further paper was submitted and the editor requested the raw data on all 3 papers. The authors 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 compiles a full report concluding that there is evidence that the data are fraudulent. After further papers are submitted the authors demand a decision on the outstanding papers. The editor rejects the papers and informs the authors that a full report will be forthcoming. The allegations of fraud were relayed to the authors. The authors' 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 authors deny the claim that the data were generated to fit the values in the tables. In further correspondence, the authors claim that the persons raising concerns have a personal axe to grind and are not credible. The editor contacts 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 authors' national medical research council. The original published article has become a citation classic.

Discussion: The Committee discussed that the issue of possible fraudulent work has never been publicised despite several papers of the authors being published.

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.

Discussion: SMS expressed the belief that it appeared that the author did not think that consent was required for this new surgical treatment. AS pointed out that there simply was not enough information to determine whether the patients were mislead about the procedure. RS expressed concern that patients might be substantially harmed by this procedure. JT stated that without evidence it was difficult to estimate the harm to patients. PS stated that the authors' country had recently enacted ethical guidelines. The key issue would be whether surgical innovations would fall within the guidelines' remit. The Committee was unclear as to whom to approach as a higher authority as the authors appeared to be working at their own organisation. SMS suggested that if there is no ethics committee with locus standi, then RS should consider writing to the relevant licensing body.

Decision: RS to send the authors the new guidelines adopted in their country and invite a reply. The Committee also agreed to review the case in light of the authors' reply and also the BMJ's instructions to authors. The Committee would look at whether it was made clear that authors' studies could be submitted to the Committee for scrutiny based on UK standards.

Case 02/002

Background: The article presented two anonymised case reports where the female partner of an at-risk father requested prenatal testing that would jeopardise his own decision about whether to know his gene status. Consent had not been obtained from either the women described or their partners.

Discussion: Several of the Committee members felt that there was a real risk of identification by the patient or third parties. TW pointed out that there were a small number of individuals in the area of the research, who were of child bearing age and at risk from the disorder. JT felt that even when the cases were anonymised consent was required. The Committee felt that the case did not fall into any of the exceptions for consent under the consent guidelines. The Committee discussed to what extent was consent required and consensus was achieved that other relatives' consent was not required.

Decision: The committee felt that if the article were to use the real cases then the consent of all parties, including partners, was required. The consent of other relatives was not required. Alternatively the article could be framed around hypothetical cases.

Case 02/003

Background: The authors describe the errors in treatment of the particular patient but stated that he 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).

Discussion: Does the case fell within one of the exceptions of the consent policy? Is the patient's family untraceable? Would publication of the piece serve a greater good in encouraging openness about medical error? The Committee discussed whether the consent of other members of the medical team as well as the patient's relatives should be. RS stated that there was a policy that patients were different from colleagues. However, the BMJ would not pursue the policy of trial by media. The point of publishing would not to nail the medical team but to stimulate discussion. PS raised the issue that all discussion of the reporting of medical error was in the context of error in developed countries not developing countries.

Decision: The Committee felt that the paper could not be published without the consent of the patient's relatives. The Committee would review the case in light of the authors' reply and also the BMJ guidelines on criticising doctors.

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.

Discussion: The Committee felt that it would not be hard to identify the individuals concerned. The authors had not provided enough information to say whether the other attendees knew about the illness of one attendee leading to the death of another. Was the function a family do, business related, did the people know each other? PS queried whether the information arose out of a doctor-patient relationship or was concerned with an epidemiological investigation. Was there a difference between the scenarios when deciding about consent? The committee felt it needed to get more information about the case from the authors and also about epidemiological standards of consent.

Decision: To ask the authors whether they were using any epidemiological guidelines on consent and discuss the case again in light of this.

Item 5

Deferred to the next meeting

Committee to look at the instructions to authors and the revised consent policy at the next meeting. A discussion on developing a strategy in reviewing policy deferred to the next meeting.

The committee agreed that policy items should be higher on the agenda as time constraints often meant these items were deferred.

The committee agreed that it should bring out an annual report (as per original remit) on cases and policies considered.