Select Committee on Science and Technology Written Evidence


Memorandum from the Lancet

1.   (i) How do you ensure the integrity of the peer-review process?

  The Lancet has an in-house team of 12 physicians and scientists who read around 8,000 submitted papers each year. About 30% of papers are sent for external peer review. The remaining 70% are rejected because they fail on grounds of suitability for our readership (international and clinical), topicality, originality, or validity. The Lancet's editors select reviewers based on their knowledge of the subject. Each editor has specialty area knowledge, which he or she uses to select reviewers who are able to evaluate critically each manuscript, or part of each manuscript. If an editor perceives that he or she has a conflict of interest with either the subject or authors of a paper, that article is reallocated to another editor. Editors select at least three clinical/scientific reviewers for each manuscript. The manuscript is then presented to colleagues at a once-weekly manuscript meeting. All editors collectively make the decision whether to proceed to statistical review by statistical experts who regularly review for the journal, to seek a revised paper from the authors, to seek further reviews, or to reject the paper. Specialist reviewers in economics and genetics are drawn from a separate database of reviewers, if required. The process of review and revision is continued until a final decision about acceptance or rejection is made. This group decision-making process helps to eliminate the risk of individual editorial bias. Editors submit a conflict of interest statement annually to senior editorial staff.

  Reviewers are usually contacted by e-mail and asked if they are able to review the paper (they are given the title and name of main author) within 1-2 weeks. Reviewers are asked at this stage, and then again when they receive the manuscript, whether they have a conflict of interest. If so, it is left to individual reviewers to decline to review on the basis of a substantial conflict, or to discuss their conflict with the editor, or simply to declare any conflict on the reviewer's form. All reviewers are asked to complete a form declaring that they either do or do not have a conflict of interest, and to give details. Editors then judge whether to exclude the review and choose another reviewer or to use it. Every original research manuscript published in The Lancet has at least three clinical reviews and one statistical review.

  Authors are asked to declare to us in their submission letters that their manuscript is not under consideration at another journal (to prevent duplicate publication). They are asked to state what the contributions of each author are to the manuscript (to ensure that all authors take responsibility for some aspect of the work). Authors are asked to declare all conflicts of interest at the end of the text of their manuscript. They are also asked to explain the role of each source of funding for the study (to ensure that all potential sources of bias are evident to readers and reviewers). They are asked to prepare original research manuscripts according to standard guidelines to ensure that all necessary information to judge the methods used is present. These processes help to ensure the integrity of the peer-review process

  In addition to these standard reviewing procedures, The Lancet offers two additional services. First, fast-track of clinically important work using the identical peer-review process described above. By means of email, pre-contacting reviewers, overnight editing (if necessary), accelerated production scheduling, and early-online publication, we can take a paper from receipt to publication in 4-5 weeks. Second, we offer a formal appeals procedure for all rejected manuscripts. Appealed articles are read by the original editor who dealt with the article plus myself. If the appeal is accepted, it enters the usual process of peer review once again, as described above.

  A further important, and sometimes neglected, aspect of peer review is the work conducted by our seven technical editors. Once a paper has been accepted for publication, it undergoes line-byline editing. Errors are often found and corrected at this stage. Clarity is always improved. Ambiguities are removed. Manuscript editing at this level of detail is a declining art in traditional publishing. We recognise it as one of the key strengths of The Lancet.

  In summary, by involving 12 editors, at least four specialist reviewers, and the relevant authors in decisions to publish all original research in The Lancet, together with the input of a team of technical editors, we minimise the likelihood of bias, error, dishonesty, fraud, and misconduct. These processes rely on the integrity of the individuals involved, and we rely on trust between editors, reviewers, and authors.

(ii)  Do you review your reviewers and, if so, by what process?

  Reviewers have to fill in a 3-page form for each manuscript. Those who give poor reviews are less likely to be approached again by the same editor. Evidence of poor reviewing is entered into a computer database of all peer reviewers used by the journal. At the weekly meeting where manuscripts and their reviews are discussed, all editors can see the reviews and judge for themselves the level of critique given. This gives editors the opportunity to assess a reviewer's area of expertise and modify our database accordingly.

2.   What are your views on the impact that a "pay-to-publish" business model would have on your peer-review process?

  If one assumes that all editorial decisions are hermetically sealed from the publishing environment in which those decisions are made, one could safely consider that a "pay-to publish" business model would have no impact on our peer-review process. This assumption is at best naive, at worst flawed.

  The reality is that editors face—and sometimes try to resist—many indirect pressures on their decision making. Take, for example, the desire to win higher subscription and web-usage numbers. For a medical journal such as The Lancet, our readership is mostly clinical—that is, it consists of individuals qualified to practice medicine. That audience drives us to select material for publication that is likely to influence clinical thinking, clinical research, or clinical practice. This seems to us a valuable pressure—it provides an incentive for us to produce a journal designed to best suit the needs of our readers. There is also pressure to produce a journal that meets the needs of authors. In part, this requirement means an efficient and effective peer-review process. It also means ensuring that the journal's Impact Factor is competitive.

  There are less benign pressures that increasingly press themselves on editors. It is important to appreciate these adverse pressures if one is to understand the potential impact of a "pay-to publish" business model on editorial decision making. One of the most difficult areas for The Lancet is research sponsored by the pharmaceutical industry. In a traditional publishing environment, especially one that is more commercially oriented, the pressure to publish research that will earn revenues from, for example, the sale of reprints is intense. The pharmaceutical industry is seen as an important partner for publishers—in revenue-generating research papers, supplements etc. Any criticism of industry by editors is also a matter of particular sensitivity. Although these pressures are not direct on The Lancet's editorial team, we are increasingly made aware of their existence an environment that can, at times, be uncomfortable and could be, if it were not resisted, damaging to the journal's independence.

  In exactly the same way, a "pay-to-publish" business model would inevitably create an environment in which editors perceived a pressure, especially where profit margins were tight, to accept more papers (and so generate more revenue). The publication of more papers, in our daily experience, would be bound to lower the overall quality of The Lancet a severely damaging result. If editors tried to resist this pressure, as I am sure we would, our quality would be preserved at the expense of our financial viability—an extremely unwelcome balance of forces. Furthermore, in a "pay-to-publish" model, there would likely be a perverse shift in the type of submission sent to us. We would receive fewer papers from authors who might find it hard to pay a submission or publication fee. We would, instead, receive papers from those who could pay. I would be concerned that research sponsored by industry would have no access barrier to publication, whereas those authors not backed by a wealthy sponsor could face serious difficulties. Such "pay-to-publish" journals may therefore receive and publish more industry-driven research, thus compromising their independence and neutrality. One of the vital safeguards of scientific integrity would have been erased.

3.   (i) Does The Lancet take responsibility for the papers that it publishes after publication?

  Yes, 100%, and forever. That responsibility transfers, across time, from one group of editors to another. If an error is discovered, and if it is serious enough to need correcting, then a correction will be printed. The Lancet's website and MEDLINE link that correction to the original published article.

(ii)  For example, in deciding to publish a paper, what weight is attached to the possibility that certain campaigners are likely to attach an exaggerated significance to certain papers which support their view?

  Editors always consider the way in which articles may be used or interpreted once published, not only by "campaigners" but also by doctors, scientists, the media, and members of the public. The possibility of a paper being misused would never stop the journal working on an article; it becomes just one of many factors taken into consideration before a final decision is made. If a controversial paper is accepted, we weigh very carefully indeed the claims made in the article (ensuring that they are properly qualified where necessary), we frame the work in a responsible clinical or public health context by commissioning a linked commentary to be published in the same issue, and we consider if and how to present the article to the media in an accompanying press release. In more recent years, we have seen a trend for authors and their institutions/sponsors to press release and publicise their own work, separately from the journal. While understandable, this process carries its own risks since different messages can be transmitted, confusing media and public alike. We try to work with all parties to ensure that the same and appropriate scientific or clinical message is published.

(iii)  What steps do you take to respond to the distortion or misrepresentation of papers published in your journal in cases of great public interest?

  There are two parts to our procedures: one before and one after publication. Before publication, editors ensure that the interpretation sections of the discussion and summary do not go farther than the results allow. Statistical reviewers can be helpful here. Sometimes the authors will be asked to alter their interpretation, especially to tone it down. Editors may ask authors to list any limitations of their study. The Lancet has a comprehensive set of guidelines for authors on conflict of interest, as already discussed. The role of the funding source is also made clear. For clinical trials, the CONSORT checklist is used by editors to ensure that all the CONSORT points have been described in the paper (eg, an effect size as well as relative risks). CONSORT now insists that authors list major side-effects in the paper in absolute and percentage terms, and The Lancet ensures that the main or any unexpected side-effects are also reported in the summary. As already mentioned, we invariably commission an expert to write a signed commentary on controversial papers, to put the study and its findings, together with any general implications, into context. A study may be included in a press release, written by a dedicated press officer and checked by an editor with a clinical qualification, and it will include the main results and any adverse events in simpler language than the journal might use. It would highlight, where appropriate, any limitations of the study. A commentary linked with the paper would also be mentioned in the press release, with a quote from the author of the commentary. The press release includes contact details for the main author of the paper and of any commentary. If appropriate, one of the senior editors will be available for interview by a journalist.

  After publication, the journal has a correspondence column that acts as a forum for critical debate about the work we publish. We will also, in cases of substantial clinical or public health interest, consider papers that report contrary findings—that is, we position ourselves as a place where the self-correcting nature of science can be played out transparently and accountably. In occasional instances, we might refer to distortions and misrepresentations in editorials, which are written by the editors, and signal major errors or new material facts relating to work we have published by notifying the press, for example, by means of a news release.

4.   How does The Lancet implement the COPE guidelines on good publishing practice?

  As one of the founding members of COPE in 1997, I, together with other Lancet editors, have been actively involved in devising the COPE guidelines, which were first published in 1999. COPE started out as a sounding board for editors. The committee meets bi-monthly and gives advice to editors about how to handle suspected cases of publication and research misconduct. In 2001, COPE matured into a more formal body with a COPE Council committee, an elected chair and vice-chair, and subcommittees for research into misconduct and for education about good research practice. Two Lancet editors are members of the COPE Council and are joint chairs of the education subcommittee. The Lancet fully endorses the COPE Guidelines on Good Publication Practice (it took part in their drafting) and we have been actively involved in devising a basic Code of Conduct for Editors, which will become binding for all COPE members shortly. In addition, one Lancet editor will be working on a gold-standard Code of Conduct for Editors. The Guidelines on Good Publication Practice are divided into 11 major points:

    (a)   Study design and ethical approval

  The Lancet requires statements by authors on ethics approval where appropriate. However, editors and peer reviewers will, in addition, judge the ethical conduct of a study independent of such a statement. For all randomised controlled trials, we require the submission of the protocol of the study to scrutinise the planned design and to compare this with the submitted paper. We expect all other studies to state a rationale for the research undertaken. All case reports, clinical pictures, or other easily identifiable material will only be published afier The Lancet has seen an appropriate signed informed consent form.

    (b)   Data analysis

  The Lancet sends every paper with data analyses (and the protocol in the case of clinical trials) to statistical advisors who have specific guidelines to assess methods, analysis, reporting and interpretation of data. In addition, a CONSORT table and figure is normally required for all randomised controlled trials.

    (c)   Authorship

  All authors are required to sign an authorship and contributor statement explaining their role in the planning, design, analysis, and reporting of a study. A summary of the contribution of each author is published at the end of the paper. The corresponding author signs a statement taking responsibility that all authors have seen and agree with a final version of the paper before acceptance. Should authorship disputes arise, a paper will not be published before these are resolved satisfactorily.

    (d)   Conflicts of interest

  All authors have to sign a conflict of interest statement explaining whether they have any financial and personal relationships with other persons or organisations that could inappropriately influence their work. Examples of financial conflicts include -employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications, and travel grants, all within three years of beginning the work submitted. If there are no conflicts of interest, authors should state that there are none. These conflict of interest statements are published under a separate heading at the end of the paper. All reviewers have to state their conflict of interest on the reviewer form and are advised to speak to the editor handling a paper if they have a conflict of interest before proceeding with the review. All editors declare any conflict of interest to the Editor and Deputy Editor and will take themselves out of the peer-review process if a conflict would bias their decision-making in relation to a particular paper.

    (e)   Peer review

  All original research and all review material is peer reviewed. Original research papers are seen by three clinical and one statistical reviewer before publication. The Lancet peer review is largely confidential but if the reviewer wishes to disclose his or her name to the authors we will do so. Reviewers are pre-contacted and reminded if necessary to ensure a speedy review process. Descriptions of our peer review, selection, and appeals processes are published in our information-for-author section once a month in print and continuously on our website. We regularly monitor our acceptance rates and publication times and strive to keep delays to a minimum without compromising the quality of peer review.

    (f)   Redundant publication

  We do allow re-publication of a paper in a foreign language with disclosure of the original English-language publication. Any other form of redundant publication is unacceptable and a note of duplicate publication would be published if this has indeed been confirmed.

    (g)   Plagiarism

  Permissions for any previously published figures, illustrations, or tables are required. Any undisclosed plagiarism would be pursued by the editors.

    (h)   Duties of editors

  All action points under this subheading are observed by Lancet editors. In particular, we base our decision to accept or reject a paper on its importance, originality, and validity without stifling innovation or preliminary observations, provided their significance is not overstated. We do consider studies that challenge previous work published in the journal carefully. We do not exclude studies reporting negative results if they are clinically important. All published original studies are peer reviewed. We treat all submitted papers as confidential. We do correct the record if a published paper is subsequently found to contain major flaws. We follow due process when misconduct is suspected and contact the authors first before taking the matter further if needed. Our instructions to authors make it clear that authors must take informed consent from patients included in their research.

    (i)   Media relations

  We state our policy on presentation of results in meetings in our instructions for authors. Presentation of data at a scientific meeting has no conflict with submission to The Lancet. We have a dedicated press officer, who chooses 3-5 papers from each issue, writes summaries of their findings, which are then checked by the authors and an editor, and he sends those out under embargo 36 hours before publication.

    (j)   Advertising

  Editorial decision-making is not influenced by reprint value. Information on upcoming publications is confidential and known by non-editorial departments of The Lancet only up to eight days before publication (when journalists will be given this information also). We have a stringent advertising policy that does not allow unsubstantiated claims to be made or juxtaposition next to related research material. All advertisements are checked and approved by an editor. Reprints are published as they appear in the journal unless a correction has had to be added.

    (k)   Dealing with misconduct

  When misconduct is suspected, we follow due process as recommended by COPE, in that we seek clarification or explanation from the authors first. If that is either not satisfactory or not forthcoming, we take the matter further and write to the employer, the institution, or any other relevant bodies (such as licensing authorities) to request that they investigate the claim. If serious misconduct is proven, we would take appropriate steps, such as retraction of a paper or notification of duplicate publication. If there are serious concerns that cannot be proven, we would consider publishing an expression of concern. We aim to present all such cases at COPE for the record and for further advice.

5.   Can you outline your policy on retraction? What is a partial retraction, and how is this covered by the COPE guidelines?

  The Lancet's policy on retraction follows the guidance provided by COPE in its Guidelines on Good Publication Practice, Sections 3 (Serious Misconduct) and 5 (Sanctions).

  A partial retraction is simply the retraction of a very specific part of a previously published paper. Neither COPE nor the International Committee of Medical Journal Editors (nor, for that matter, the World Association of Medical Editors) has a separate policy on partial retraction. Rather like the difference between statute law and case law, partial retraction is, nevertheless, a well-described procedure in the scientific literature. For example,

    —    Retraction of part of a dataset

See Herman TS. Int J Radiat OncolBiol Phys 1995; 32: 897-98.

    —    Retraction of a figure

See Thompson JA et al. Proc Natl Acad Sci USA 1992; 89: 7849.

    —    Retraction of an interpretation

Zhang L et al. Science 2004; 303: 467.

  In the case of the 1998 paper by Dr Wakefield and colleagues, we noted that the press coverage of the partial retraction distinguished clearly between the differing elements of the work.

March 2004

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