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Philip Morris

New Requirements for Authors: Signed Statements of Authorship Responsibility and Financial Disclosure

Date: 19891013/P
Length: 3 pages
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Flanagin, A.
Lundberg, G.D.
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PSCI, PUBLICATION SCIENTIFIC
BIBL, BIBLIOGRAPHY
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WORLDWIDE REG AFFAIRS/LIBRARY
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2048252468/2048252471
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N403
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Stmn/R1-048
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2048252198/2048252525/Bero Barnes (Ciar)
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2048252379/2524
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Jama
Litigation
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05 Jun 1998
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bjs65e00

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New Requirements for Authors: Signed Statements of Authorship Responsibility and Financial Disclosure Edit.*s of peer-reviewed journals, have relationships based on trust with authors, readers, owners, editorial board mem- bers, reviewers, funding agencies, institutions, students, ad- vertisers, the media, and the public at large. These trust relationships frequently come into conflict, the product of obvious differences in goals, values, and priorities. Other differences arise from faulty communications. Still others arise from ignorance of editorial and authorial ethics and publication laws, sloppiness of work, and sometimes deliber- ate attempts to deceive. See also p 2005. 'Ib educate authors and help them avoid the pitfalls of ignorance and to discourage a few from believing that the ethics and laws do not apply to them, peer-reviewed journals codify their policies and procedures in Instructions for Au- thors.i Many journals specify simi.iar instructiona such as the "Uniform Requirements for Manuscripts Submitted to Bio- medical Journals" produced and updated periodically by the International Committee of Medical Journal Editors (the Vancouver Group).Z In 1985, the Vancouver Group devised specific guide'anes for authors, requiring each author of each manuscript to have "participated sufficiently in the work to take public responsibility for the content.' These guidelines also required authors to include specific information in their cover letters about possible previous or simultaneous dupli- cate publication and financial or other involvement that may pose conflicts of interest as well as assurance that the manu- script had been read and approved by all authors. We have listed similar requirements in our Instructions for Authors for many years. However, pressures to publish, increased competition in the research and academic communi- ties, and inadequate education of researchers and authors have allowed naive authors to unknowingly transgress the ill- defined boundaries of publication and authorial ethics, and a lack of formal policies (or enforcement thereof) has allowed dishonest authors to intentionally deceive. The proliferation of papers with multiple authors that has charactEriZed medical and scientific writing for a number of decades has stretched the definition of authorship past rea- sonable belief in many instances. Without question honorary authorship has become a real problem and has been one of the factors that has promoted the publication of fraudulent arti- cles." Some academic institutions have attempted to de- crease the practice of honorary authorship by establishing criteria for authorship and by providing academic rewards for faculty based on importance of work rather than number of publications. Harvard Medical School's appointment and pro- motion guidelines now suggest a maximum number of publi- cations to be considered per candidate.' Leading medical journals have placed arbitrary limits on the number of authors per article, but have allowed exceptions with proper justifica- tion.l Since 1984, The Annals of Internal Medicine has re- quired all authors, including coauthors, to sign a "Conditions of Publication" form before final acceptance of a manuscript is issuei. This form lists four conditions: certification of author- ship; notification of previous or duplicate publication; agree- ment for publication in other forms, reprinting, and translat- ing; and agreement for public release of information. Stimulated by these examples, discussions at the Interna- tional Congress on Peer Review in Biomedical Publication,7 recent congressional hearings,' and a report of the Institute of Medicine that recommends that journals "develop policies to promote responsible authorship," we have developed a new statement of authorship responsibility and revised our state- ment of financial interest. Neither of these new statements represents policies that are fundamentally different from those we have routinely published in our Instructions for Authors. The major difference is that instead of simply rely- ing on authors to include the information in their cover letters accompanying submitted manuscripts, we now will require all authors to sign statements vouching for tt.. -_ authorship and identifying any relevant financial interests. Authorship Responsibility The statement of authorship responsibility require3 pro- spective authors to validate their authorship on five levels~ (1) to certify sufficient participation in the work to take pubiic responsibility for it; (2) to vouch for the validity of the work; JAMA, October 13, 1989-Vol 262, No. 14 Editorial 2003
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(3) to have reviewed and approved of the final version of the manuscript; (4) to ensure that the information has not been previously and will not be subsequently published elsewhere without permission of the editors; and (5) to be able to produce the data on which the manuscript is based for examination if requested by the editors.' This last level fulfills the Institute of Medicine's reconunen- dation that journal policies "include procedures for respond- ing to allegations or indications of miscrTlduct,s6 and will be useful if any type of audit, as proposed by Rennie,' is to be performed to identify the prevalence of scientific misconduct. Rarely have we needed to request access to the actual data on which reports are based, but this statement will provide us the option of such access as a precondition for publication. The authorship responsibility statement will appear in our routine Instructions for Authors, and all authors are expect- ed to submit it signed with their manuscript for consideration. If such a statement does not accompany a submitted manu- script, we will secure all signatures after provisional accep- tance of the manuscript as a condition of publication. It is our hope that this step will, by education and honor, serve to validate actual authorship, diminish the practice of honorary authorship, decrease the likelihood of receiving fraudulent work, and help us reverse the trend toward duplicate, "sala- mi," and redundant publication. Financial Disclosure Since 1985, our Instructions for Authors has asked authors to identify in writing any financial interests they may have in relation to their manuscripts. Many knowledgeable and hon- orable authors have provided such statements with their submitted manuscripts. When they have not, our editors have made a judgment as to whether the content of the aianuscript seems subject to financial conflicts of interest and, if so, we have requested financial disclosure statements from the authors. Such information is held in confidence during the review process so as not to adversely influence the reviewers. If publication is likely, the editors, in consultation with the authors, then determine the extent to which disclo- e sure of the information would be important for our readers. When appropriate, notices of financial disclosure are pub- lished as a part of the article so that readers may be aware of possible biases the authors may have. In response to a question asked during the congressional hearings on federally funded medical research last June, we have added "honoraria" to our list of finaneiai interests that require disclosure. Because of our heightened sensitivity to the subject of authors' financial interest that was created by the hearings and the International Congress on Peer Review in Biomedical Publication, we decided to elevate financial disclosure to a more formal level. Effective today, we will require that authors of manuscripts submitted to JAMA sign a statement of financial disclosure, l which identifies any affili- ation or financial involvement that may be considered a con- flict of interest. We hope that such a statement will be includ- ed with the manuscript on receipt. If it is not, we will secure it after provisional acceptance and before publication. Honesty and Tlrust Just as authors rely on editors' integrity to keep the infor- mation in their manuscripts confidential and to deal with them in a competent, fair, and honest manner, editors must rely on the integrity and honestj of authors. Unfortunately, there are now enough examples of the published consequences of scientific misconduct by those who transgress the ethics of authorship-either because of ignorance or actual intent to deceive-that we feel required to escalate our approach to educate authors and prevent these problems. We recognize the inconvenience of this procedure, but we do not believe honorable authors will protest this small additional bother that is designed to protect all of us from the shadow that has fallen over the scientific and medical communities. We hope that the visibility of this process will serve a useful purpose toward maintaining the credibility of our publications and our scientific enterprise. George D. Lundberg, MD Annette Flanagin, RN, MA 1. Instructions for authors. JAMA.1989;262:2005. 2. International Committee of MedicalJournal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Ann Intern Med. 1988;108:258-265. 3. International Committee of Medical Journal Editors. Guidelines on author- ship. BrMed J.1985;291:722. 4. KaatorJA. Authorship and the Darsee case. Int JCardio1.1984;5:7-11. 5. Locke R. Another damned by publications. Nature.1986;324:401. 6. Institute of Medicine Committee on the Responsible Conduct of Research. T.`u Reaponaible Conduct of Reaearch in the Health Sei.,nuee. Washington, DC: National Academy Press;1989. 7. Sun M. Peer review comes under peer review. Science.1989;244:910-912 8. Hearings Before the Subcommittee on Human Resources and Interyovern- mental Relations of the Houae Governmental Operations Committee, 101st Cong,lst Sess(1989) (testimony of George D. Lundberg, MD). 9. Rennie D. Editors and auditors. JAbMA.1989;261:2543-2545. 2004 JAMA, October 13, 1989-Yo! 262, No. 14 Editorial I
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Instructions for Authors Manuscript Cr!teria and Information Send manuscripts to the Editor, George D. Lundberg, MD, JAMA, 535 N Dearborn St, Chicago, IL 60610. Manuscripts are considered with the understanding that they have not been published previously and are not under consideration by another publication. A complete report following presentation or publication of prelimirary findings elsewhere (eg, in an abstract) can be considered. IncludE copies of possibly duplicative material that has been previously published or is currently being considered elsewhere. Cover Letter.-Designate one author as correspondent and pro- vide a complete address and telephone number. Manuscripts should have no more than six authors; a greater number will require justifi,tation. In the cover letterinclude (1) one of the two followingstatements on copyright or federal employment; and (2) statement on authorship responsibility; and (3) statement on financial disclosure. Each of these three statements must be signed by all authors. Copyright Transfer -"In consideration of the action of the American Medical Association (AMA) in reviewing and editing this submission, the author(s) taadersigned hereby transfer(s), assign(s), or otherwise convey(s) all copyright ownership to the AMA in the event that such work is published by the AMA." Fsdwal Employmant= I was an employee of the US federal gov- ernment when this work was investigated and prepared for publica- tion; therefore, it is not protected by the Copyright Act and there is no copyright of which the ownership can be transferred." Avthorshfp RtspontlbJJltyc= I certify that I have participated suffi- cientlyin the conception and design of this work and the analysis of the data (when applicable), as well as the writing of the manuscript, to take public responsibility for it. I believe the manuscript represents valid work. I have reviewed the final version of the manuscript and approve it for publication. Neither this manuscript nor one with substantially eimilar content under my authorship has been pablished or is being considered for publication elsewhere, except as described in an attachment. Furthermore, I attest that I shall produce the data uponwhich the *nanuscript is based for examination by the editors or their assignees if requested." Financial D/aolosun.-"I certify that I have no affiliation with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the manuscript (eg, employment, consultancies, stock ownership, hono- raria) except as disclosed in an attachment." Note: Research or project support should be listed in an aclmowl- edgement. All other information pertaining to fiaancial interests will be held in confidence during the review proceas. Should the manu- script be accepted, the editor will discuss with the author the extent of discloetxre appropriate for publication. Informed Consent.-If the manuscript reports the results of an experimental investigation of human subjects, state formally that an appropriate institutional review board approved the project and/or that informed consent was obtained from the subjects after the nature of the procedure(s) had been explained. Include a signed statement of consent from the patient (or, if the patient is a minor, from both parents or the legal guardian) with all identifiable photographs. Consent forms must contain a statement that photographs and infor- mation about a case may be published separately or together and that the patientb name will not be disclosed. Editing.-Accepted manuscripts are copy edited according to AMA style and returned to the author for approval. Authors are responaible for all statements made in their work, including changes made by the copy editor and authorized by the corresponding author. Reprinta.-Reprint order forms are included with the edited type- script sent for approval. Reprints are shipped 6 to 8 weeks after publication. All accepted manuscripts become the permanent property of the AMA and may not be published Asewhere without written permis- eion from both the author(s) and the AMA. Manuscript Proparetiont4 • Submit the original manuscript and three photocopies, typed on one side only of standard-sized white bond paper. Use ample margins. • Double-space throughout, including title page, abstract, text, ac- knowledgments, references, legends for illustrations, and tables. Start each of these sections on a new page, numbered consecutively in the upper right-hand corner, beginning with the title page. • Provide copy that can be scanned by an optical character reader: no smudges or pencil or pen marks. If prepared on a word processor, do not use proportional apacing; use unjuatified (ragged) right margins and letter-quality printing. • On the title page type the full names, highest academic degrees, and affiliations of all authors. If an author's affiliation has changed since the work was done, list the new affiliation as well. Also state the name and affiliation of any statistical reviewer consulted. • Include an abstract of 150 words or fewer, stating the problem considered, methods, results, and conclusions. • Use SystPme International (SI) meaFurements.` • Use generic names of drugs, unless the specific trade name of a drug used is directly relevant to the discussion. • Do not use abbreviations in the title or abstract and limit their use in the text. References. -Number references in the order they are mentioned in the text; do not alphabetize. In text, tables, and legends, identify references with superscript arabic numerals. In listing references, i,,aow AMA style, abbreviating names of journals according to Index Medicua. Note: List all authors and/or editors up to six; if more than six, list the first three and "et al." Exampls: 1. DuBois RN, Lazenby AJ, YardleyJH, Hendrix TR, Bayless TM, Giardiello FM. Lymphocytic enterocolitis in patients with `refractory eprue: JAMA. 1989;262:935-937. 2. Ritchie JM, Greene NM. Local anesthetics. In: Gilman AG, Goodman LS, Rall TW, Murad F, eds. The Pharmacoloyical Baaia of Thempcuties. 7th ed. New York, NY: Macmillan Publishing Co Inc;198b:309,410. Thblea.-Double-space on separate sheets of atandard-aized white bond paper. T'itle all tables and number them in order of their citation in the text. If a table must be continued, repeat the title on a second :3heet, followed by "(cont)." Illuatrationa.-Submit, in triplicate, (1) 5 x 7-in glossy photo- gmphs for all graphs and black-and-white photographs; (2) high- contrast prints for roentgenographic photographs; (3) color slides for color illustrations. Number illustrations according to order in the text. Affix figure number, name of senior author, short form of the manuscript title, and an arrow indicating "top" to the back of the print. Never mark on the print or the transparency itself. • Double-space legends (maximum length, 40 words) on separate pages. Indicate magnification and stain used for photomicrographs. • Acknowledge all illustrations and tables taken from other publica- ticns and submit written permission to reprint from the original publishers. RN.reclo» 1. Iverson CI, Dan BB, Glitman P, et al. American Medical Association Manual qf StylA. 8th ed. Baltimore, Md: Willisma & Willdne;1988. 2. International Committee of Medical Journal Editors. Uniform require- mentU for manuscripts submitted to biomedical journals. Ann Intern Med. 1988;108268-265. 3. Lundberg GD, Flanagin A. New requirements for authors: signed state- menta of authorship reaponaibility and financial disclosure. JAAfA 1889; 262:2003-2004. 4. Lundberg GD. SI unit implementation-the next atep. JWA.1988;2C0:73-76. Manuscript Checklist 1. Include original manuscript and three photocopies. 2. Leave right margins ur~justiSed (ragged). 3. Put references in proper format in numerical order, making sure each is cited in the text. 4. Send three sets of all illustrations. 5. Provide and label an abstract. 6. Include complete consent forms for patient photographs. 7. Include consent forms for previously published illustra- tions and tables. 8. Include in the cover letter statements-aigned by each author-on (a) copyright OR federal employment, (b) authorship responsibility, and (c) financial disclosare. 9. Designate a corresponding author and provide a telephone number and adl-ess. JAMA, October 13, 1989-Vol262, No. 14 Instructions for Authors 2005 I

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