Competing interests, appeals and trial registration in the Bulletin
The Bulletin of the World Health Organization
Editors of biomedical journals are meeting at the Fifth International Congress on Peer Review and Biomedical Publication in Chicago this month to discuss their working practices and the highlights and pitfalls of peer review and publication. There are few journals that have the resources to investigate every aspect of the way they work and measure the impact of changing the way they do things. This is why such an international congress is invaluable; everyone learns from the experiments of others, and publishing practices improve overall. In the spirit of such efforts to examine and harmonize editorial policies, we are updating the Bulletin’s “Guidelines for Contributors”. We would like to make our guidelines clearer and more helpful to authors and reviewers, and clarify our position on three particular topics: competing interests, appeals, and trial registration.
Competing interests. As anyone who has tried to submit a paper to the Bulletin knows, our online manuscript submission system provides a box that asks for competing interests. What should go into this box? Basically, anything that could be interpreted as a personal, commercial, political, academic or financial interest with the potential to influence the authors’ interpretation or use of their paper’s content. Reviewers are asked to fill out a similar box, and decline to review papers if they feel that they have competing interests that would impede their objectivity. The editors and editorial advisers of the Bulletin are obliged to declare any competing interests to WHO, and preclude themselves from handling papers in which any such interests collide. The Bulletin’s usual time-span on competing interests is the preceding three years, but we ask authors, reviewers and editors to declare also any competing interests that they feel are still relevant outside of this limit.
Appeals. The Bulletin’s “Information for contributors” on the web site now includes a list of the most frequent reasons why papers are rejected without external review. When papers have passed the first hurdle of in-house selection, and have been sent for external review, the reviewers’ reports are always passed on to the authors in the event of rejection. In addition, authors often receive the comments of editorial advisers who have considered the entire file before the final decision was made. In each of these cases, some authors may still wish to appeal the decision to reject their paper, and we would like to standardize this process. We ask authors who feel that their paper has been unfairly rejected to send us a detailed letter explaining why this decision should be re-examined, with a point-by-point rebuttal of the reviewers’ criticisms provided. Authors who wish to submit appeals of manuscripts that have been rejected without external review should first consult this list of reasons for rejection (http://www.who.int/bulletin/ contributors/en/) to make sure that they have a good case for appealing. The editor who originally handled the paper will present the appeal at an editorial meeting, and a decision will be made at that meeting to either seek further review, or uphold the original decision to reject the paper. If we decide to seek further review, we will ask the authors to provide a revised manuscript that accounts for the first round of reviewers’ comments. If the meeting decides to uphold the original decision to reject the paper, the editor concerned will write to the authors, explaining the reasons for this decision. We aim to let authors know whether their appeal will be upheld or not within four weeks of receiving their initial request.
Trial registration. The idea behind trial registration is to make a publicly available, comprehensive database that answers the question — who is studying what? This question should be asked, and answered, by everyone designing, funding, running, or participating in clinical research to ensure that the right trial is being done at the right time. The ultimate aim is to increase the transparency of clinical research, avoid duplication, reduce publication bias, and restore public trust by guiding the research back to its objective, well intentioned origins. One step towards achieving this aim is to have a public record of all trials; including those that in the past, may not have been published on completion. Without such a registry, trials that are not published because the desired results were not obtained, or because a concurrent study was bigger, or better run, are lost to other researchers and interested people. WHO has recently established an International Clinical Trials Registry Platform to link individual registers, set registration standards, promote compliance and help countries to strengthen their capacity to monitor research. The Bulletin will now be asking authors of all clinical trials whether, and where, their trials have been registered, and henceforth, trials that started recruitment after 1 July 2005 must have been registered at inception to be accepted for publication. Ongoing trials that started recruitment before this date must be registered in retrospect, but before submission. If you have any doubts as to whether your paper falls within the International Committee of Medical Journal Editors’ (ICMJE) definition of a clinical trial, need help identifying a suitable registry, or have any other questions on our editorial policies and guidelines, please contact us at firstname.lastname@example.org.
The Bulletin is a member of the Committee on Publication Ethics (COPE), the European Association of Science Editors (EASE), and the World Association of Medical Editors (WAME), and is listed by the International Committee of Medical Journal Editors (ICMJE) as a publication that follows its guidelines. We participate in the work of these groups to improve the way the Bulletin is edited and published, but the Bulletin’s content is largely up to you, our contributors. With your papers — research, debate and reviews — and the resources and expertise of WHO, we aim to produce a journal of international public health that is freely accessible and relevant to all.