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- W2907683375 abstract "Fifty years ago, The New England Journal of Medicine (NEJM) clarified a policy about what we now would call redundant or duplicate publication. The Editor-in-Chief of NEJM at the time, Franz J. Ingelfinger, made it clear that (apart from a few exceptions) his journal would not publish research that had been submitted to any other journal or published in the media.1 What has since come to be known at NEJM and elsewhere as the “Ingelfinger rule” has endured, largely unchanged,2, 3 to this day. It also has been the explicit policy of The Bone & Joint Journal (BJJ), Clinical Orthopaedics and Related Research (CORR), The Journal of Bone and Joint Surgery (JBJS), and the Journal of Orthopaedic Research (JOR) not to accept research papers submitted or published elsewhere either as a whole or in part. We are not alone in this regard. The leading international bodies whose standards of scholarly publishing we seek to adhere to, including the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE), both consider (again, with a few exceptions) prior submission or publication of work sent to a journal for review to be an ethical and practical problem; according to COPE, it is grounds for retraction of a published paper,4 and the ICMJE lists numerous harms that it can cause, including, but not limited to, “inadvertent double-counting of data or inappropriate weighting of the results of a single study, which distorts the available evidence.”5 But science and changes within the world of scholarly publication march on, and perhaps restrictions on prior publication are no longer necessary or even reasonable. Certainly, that is the viewpoint of those who espouse the development of medical preprint servers,6-8 although we do not agree with them for reasons that we will explain. For those who are unfamiliar, a preprint server allows authors to make public full-length versions of complete manuscripts that have not yet passed peer review. Preprint servers offer the benefits of durability, speed of posting, and easy access by the public. Other potential advantages include the ability for authors to establish precedent (“we are the first to report…”), to receive feedback on the work from other scientists, and to disseminate results without barriers such as journals’ subscription paywalls or the delays associated with peer review. Advocates of preprint servers feel that they can help mitigate positive-outcome bias and that they increase transparency and data sharing,7, 8 the latter being a requirement of important funding bodies such as the National Institutes of Health9 and the Wellcome Trust.10 Perhaps for these reasons, several major funding bodies have expressed public support for the development of preprint servers.11 Preprint servers have been an accepted part of the scholarly publishing landscape in the physical sciences and mathematics for many years, and a preprint server in the biological sciences—bioRχiv (the last four letters being a typical preprint server naming convention; pronounce them “archive”)—has posted year-over-year increases in usage and now publishes clinical research,12, 13 including some on orthopaedic topics. A preprint server specifically for medical research, medRχiv, now is being developed by a partnership consisting of the Yale University Open Data Access (YODA) Project, Cold Spring Harbor Laboratory, and BMJ.14 Others may be on the way.15 While some well-respected journals, including JAMA, are staying on the sidelines or actively discouraging authors from posting to preprint servers,16 dozens of other publishers and journals (including The Lancet17 and of course BMJ) are on board with the concept of preprint servers. Despite the high-octane support already behind the unproven concept of medical preprint servers, we believe that there are fundamental differences between the communities served by the existing preprint servers in mathematics, physics, and biology and the patients whose lives may depend on high-quality, peer-reviewed biomedical research. We believe that the benefits proposed by advocates of medical preprint servers can be better achieved in other ways, and that medical preprint servers pose serious health and safety dangers to the patients for whom are supposed to be caring. One of us (S.S.L.) visited at length with one of the developers of medRχiv.19 Another of us (M.S.) was on the board of directors of one of the three organizations that are sponsoring a medical preprint server.21 We have tried diligently to see their point of view, but after extensive deliberation with our respective boards, we have been unable to convince ourselves that the benefits of preprint servers in clinical orthopaedic research outweigh the potential harm to patients and scientific integrity. For those reasons and others, Clinical Orthopaedics and Related Research, The Bone & Joint Journal, the Journal of Orthopaedic Research, and The Journal of Bone and Joint Surgery will not accept clinical research manuscript submissions—which we define as research involving human subjects or their medical records—that have been posted to preprint servers prior to submission, and we will withdraw from consideration any papers posted to those servers prior to publication. We exempt from this policy all laboratory research that does not involve human subjects, and we recommit ourselves to offering fast-track publication to those papers that share time-sensitive messages pertaining to patient health or safety. The authors thank the Senior Editor panel of CORR (Matthew B. Dobbs, MD; Mark C. Gebhardt, MD; Terence J. Gioe, MD; Paul A. Manner, MD; Raphaël Porcher, PhD; Clare M. Rimnac, PhD; and Montri D. Wongworawat, MD) as well as its Managing Director, Lee Beadling, BA, and its Associate Editor, Anthony Calabro, MA, all of whom participated in researching this topic and deliberating on this policy. They also thank Joseph Ross from the YODA Project for visiting with CORR's Senior Editor panel and engaging in extended dialogue by e-mail and telephone with its Editor-in-Chief to help us better understand his team's goals with respect to preprint servers. In addition, the authors extend their appreciation to the Research Methods Group at BJJ (Matthew Costa, PhD, FRCS[Tr&Orth]; Richard Carey Smith, BSc[Hons], MBBS, MRCS, FRCS[Tr&Orth]; Melinda Dritsaki, PhD; Xavier Griffin, PhD, FRCS[Tr&Orth]; David Metcalfe, MRCP, MRCS, MRCEM; Nicholas Parsons, BSc, MSc, PhD; Daniel Perry, MBChB[Hons], MRCS, PhD, FRCS[Orth]; and Dirk Stengel, MSc, PhD) as well as its Head of Editorial Publishing Services, Emma Vodden. The authors also thank Edward Schwarz, PhD, Chair, Editorial Advisor Board, Orthopaedic Research Society, and Mia Ricci, Executive Editor, John Wiley & Sons JOR. Finally, the authors acknowledge with gratitude the Editorial Board of JBJS (Jean-Noël A. Argenson, MD, PhD; Thomas W. Bauer, MD, PhD; Joan E. Bechtold, PhD; Charles R. Clark, MD; Charles M. Court-Brown, MD, FRCSCEd[Orth]; Lars Engebretsen, MD, PhD; Andrew Green, MD; Wei Guo, MD, PhD; Shepard R. Hurwitz, MD, FACHE; Anil K. Jain, MS, FAMS, FRCS; Michelle A. James, MD; Bernhard Jost, MD; Jeffrey N. Katz, MD, MSc; Patricia Katz, PhD; Eng Hin Lee, MD, FRCSC; Elena Losina, PhD; Stephen Lyman, PhD; Konstantinos N. Malizos, MD, PhD; Robert G. Marx, MD, MSc, FRCSC; Anna N. Miller, MD; Robin R. Richards, MD, FRCSC; Sanjeev Sabharwal, MD, MPH; Bruce Sangeorzan, MD; Andrew J. Schoenfeld, MD, MSc; Christoph J. Siepe, MD; Paul D. Sponseller, MD; Stephen R. Thompson, MD, MEd, FRCSC; Daisuke Togawa, MD, PhD; James P. Waddell, MD, FRCSC; Rick W. Wright, MD; Charles Carroll IV, MD; and Chad A. Krueger, MD) and its Editor Emeritus (Vernon T. Tolo, MD). All ICMJE Disclosure of Potential Conflicts of Interest forms for Clinical Orthopaedics and Related Research Editors are on file with the publication and can be viewed on request; the Editors’ disclosure statements also appear each month in print on the masthead of Clinical Orthopaedics and Related Research. The ICMJE Disclosure form for the Editor of The Bone & Joint Journal is available with the BJJ online version of this article. The ICMJE Disclosure form for the Editor of the Journal of Orthopaedic Research is available from the Orthopaedic Research Society. The ICMJE Disclosure form for the Editor of The Journal of Bone and Joint Surgery is provided with the JBJS online version of this article. Seth S. Leopold, MD Editor-in-Chief, Clinical Orthopaedics and Related Research Fares S. Haddad, FRCS(Orth) Editor-in-Chief, The Bone & Joint Journal Linda J. Sandell, PhD Editor-in-Chief, Journal of Orthopaedic Research Marc Swiontkowski, MD Editor-in-Chief, The Journal of Bone and Joint Surgery Correspondence Editor in Chief, Linda Sandell E-mail: sandelll@wustl.edu" @default.
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- W2907683375 title "Clinical Orthopaedics and Related Research, The Bone & Joint Journal, The Journal of Orthopaedic Research, and The Journal of Bone and Joint Surgery will not accept clinical research manuscripts previously posted to preprint servers" @default.
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