Uniform manuscript submission formats: The need and challenges
Molly Mary Thabah1, Graeme Currie2
1 Department of Clinical Immunology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
2 Chest Clinic C, Aberdeen Royal Infirmary, Aberdeen, Scotland, UK; Editor in Chief, Journal of The Royal College of Physicians of Edinburgh
Correspondence Address:
Dr. Molly Mary Thabah
Department of Clinical Immunology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/0973-3698.364679
Uniform requirements for manuscript submission (URMs) are considered to be “recommendations on conduct, reporting, editing, and publication of scholarly work in medical journals.” They have gradually evolved from initial guidance describing how to prepare manuscripts into a full document defining the role and responsibilities for all key players involved with academic medical publishing and ethical considerations of publishing and editorial issues. Significant changes to URMs over the years include an update on criteria for authorship. Emphasis is also laid on mandatory disclosure of financial or relationships not only by the authors but also by editors, peer reviewers, and editorial staff alike. Since 2005, all International Committee of Medical Journal Editors (ICMJE) journals require that clinical trials are prospectively registered. Efforts and guidance by the ICMJE are primarily to ensure transparency in academic publishing and enhance the credibility of published data.
Keywords: Academic publishing, authorship, manuscript, peer review, uniform requirements for manuscript submission
Uniform requirements for manuscript submission (URMs) came into existence in an attempt to help authors, editors, and ultimately readers easily write, review/edit, and access, respectively, the results of biomedical studies. It is over four decades since the first URM was published,[1],[2] and guidelines have gradually evolved since then. A small group of general medical journal editors (steering committee of medical journal editors) who met in Vancouver, British Columbia, in 1978 agreed on a uniform format of manuscripts. This meant that authors would not have to re-format prior to re-submission to another journal.[1],[2] The steering committee of medical journal editors' name was then changed to the International Committee of Medical Journal Editors (ICMJE).[3]
These (initially basic) URMs – that initially focused on how to cite references – have now evolved into a full document/guide suggesting best practice describing how to carry out biomedical medical studies from inception to publication. They are now referred to as “recommendations on conduct, reporting, editing, and publication of scholarly work in medical journals.” An article published in the Science Editor 2004 provides an interesting account of how these recommendations came into place.[4],[5]
The Journey from Manuscript Formatting to Publishing IssuesOriginal URMs focused on how to prepare a manuscript and advised authors to “type manuscript double spaced, including title page, text, acknowledgments, references, tables, and legends.” It was also advised that each table and figure should be complete with title and footnotes.[1],[2],[3],[6]
As per accounts by Drs. Huth and Case, in the initial days of URM meetings, editors debated extensively on whether to follow Harvard style references or the style that the US National Library of Medicine designed (Vancouver style).[4] However, nowadays reference styles are conveniently and easily altered depending on journal styles due to the availability of reference manager software systems. It is important to note that authors should try to reference key original articles, and not promote their own published work.
Major revisions to the URMs came about in 1997[6],[7] and 2004.[8] The scope of URMs expanded from just a uniform formatting of manuscript to also involve major ethical issues relating to publishing [Table 1].[8],[9] These included statements on duplicate publications, prior publications, redundant publication, policy on advertising in the journal, authorship, and patient's rights to privacy.
Table 1: Revisions to the URMs from its inception in 1979 up to the year 2005*Between 2004 and 2022, URMs underwent a further change [Table 2].[10] Indeed, a considerable amount of the document is now devoted to defining the role and responsibilities for all key players involved with academic medical writing and publishing (including authors, peer reviewers, editors, publishers, and owners of journals), and ethical considerations. Tables 1 and 2 highlight revisions of URMs from when they were first published in 1979 to the latest 2022 update are highlighted.[2],[3],[4],[5],[6],[7],[8],[10],[11]
Needs and Challenges of the RecommendationsAuthors are advised to read the recommendations of particular journals carefully before embarking on preparing a manuscript. All sections of the recommendations are important and should be adhered to, or manuscripts are likely to be returned (unread).
Authorship
In 1988, the ICMJE advised that an author must have a role in ALL of the following:
Conception and design, and/or analysis and interpretation of dataDrafting the article or revising itFinal approval of the final version.[12]In 2013, a fourth prerequisite stating that the author must agree to be accountable for all aspects of the work was added. Individuals not fulfilling all criteria should not be listed as an author, but instead, acknowledged in a footnote at the end of the manuscript (with permission of the individual). The order of authorship should be jointly decided by the authors. In the case of work performed by multi-author groups, the ICMJE recommends that such a group decides beforehand who will comprise authors (including corresponding author) and nonauthor contributors, in order to avoid disputes. A nonauthor contributor is one who fulfills three or fewer authorship criteria.
It is pertinent to point out that the ICMJE states that “acquisition of funding, collection of data, or general supervision of the research group alone, do not justify authorship.” Many researchers are not fully aware of the ICMJE's authorship criteria.[13],[14] For example, in a questionnaire-based survey of 218 faculty members across Pakistan, almost 51% were not aware of authorship criteria,[14] 19% stated they were listed as authors without their knowledge, and another 40% felt they were not included as authors despite feeling it was merited.
A study from Croatia evaluated 4 groups: 152 medical students who received instructions on authorship criteria, 85 medical students without prior instructions on the criteria, 112 medical teachers, and 125 doctors with regard to perceptions of research contribution which qualified for authorship.[13] It was found that all the groups rated conception and design, as the most important criteria for authorship, while students without prior education on ICMJE criteria rated these significantly lower than doctors and medical teachers. Drafting of manuscript, analysis, and interpretation of data were considered to be moderately important by all groups. Revising, final approval, and critical revision were rated least important by all groups except students who had received prior instruction on ICMJE criteria. Contributions regarded as not qualifying for authorship by the ICMJE such as provision of study material, acquisition of funding, and statistical analysis were rated as important qualifiers for authorship by all participants. It, therefore, stands to reason that widespread dissemination and understanding of authorship criteria are essential to avoid disagreements, honorary authorship, and ghostwriting.[14]
The terms “honorary,” “gift,” “guest,” or “courtesy” authorship are all essentially same and describe a situation whereby authorship is bestowed upon an individual who has not worked or contributed substantially to a manuscript. The prevalence of honorary authorship varies is difficult to quantify and is likely to vary widely, although in a survey of 218 faculty members across Pakistan, it was found to be 17%.[14] In an electronic survey of 227 corresponding authors of major ophthalmology journals, 115 (51%) indicated the presence of honorary authorship and 16% ghost authors in their papers.[15] This study also showed that residents and fellows in training (as corresponding authors) were more likely to confer honorary authorship on someone else. One typical example of an honorary authorship is when a junior researcher “obliges” a senior colleague or head of department by simply adding their name to a paper as an author.[16] Another reason for honorary authors is the perception, usually by a junior researcher, that the presence of an “established” leading name in the particular field is likely to increase the likelihood of a manuscript being accepted for publication and/or create greater impact following publication. On the other hand, a ghost author is someone who has substantially contributed to the writing/drafting of manuscript work but is not acknowledged as an author. A ghost author may or may not fulfill all the ICMJE criteria, and a typical example is a professional writer employed by a pharmaceutical company.[17]
Disclosure of all activities or relationships
In 1994, the ICMJE advised that authors declare any relationship and activities (financial or otherwise) that would in any way serve to influence the handling of manuscripts and interpretation of data up to its publication. The list of activities was further expanded,[18] and included a declaration of the source of funding, support, sponsors, stocks, consulting fees, etc. Moreover, a declaration of conflict of interest and transparency during the entire study planning, execution, and publication process is likely to improve the credibility of scientific articles. A uniform format of disclosure[18] was developed by the ICMJE and is freely available for authors (https://www.icmje.org/disclosure-of-interest/). It is preferable that not only authors but also peer reviewers and editors disclose relationships or activities that might in any way potentially bias or influence decisions made about any given manuscript.
Author responsibilities during the submission process
In view of the recent rise of pseudo or predatory journals, the ICMJE recommends authors identify the integrity of a journal before submission.[10] There are many characteristics of a pseudo-journal,[19] some of which include rapid publication without peer review, acceptance of all submissions, and charge of publication fees after acceptance. They are also characterized by the use of “aggressive and indiscriminate solicitation practices” such as frequently contacting potential authors soliciting manuscripts and invitations to become an editorial board member (often in journals that are unrelated to the interests/expertise of a researcher).[20] A reliable authentic scientific medical journal will always follow the best editorial (including peer review) and publication practices.
Journal responsibility during the submission process
Throughout the submission process, a journal must ensure the confidentiality of submitted manuscripts and ensure timeliness in processing manuscripts up to publication. If there is no intention to accept a manuscript, journals should notify authors of rejection as soon as possible.[11]
Peer review
ICMJE states that journals are responsible for having a system in place for selecting suitable reviewers.[11] They have a responsibility to publish peer review policy clearly, including whether it is single- or double-blind or open review; this ensures that authors are aware of what to expect. Critical, unbiased review by an expert helps editors decide the suitability of a manuscript for a journal and helps authors improve the quality of reporting. However, a journal is under no obligation to send manuscripts for review, or follow reviewer recommendations.
A reviewer is expected to respond promptly to peer review invitations (whether agree or decline), and respond in a timely manner. They are ethically bound to keep manuscripts under review strictly confidential, and provide polite, honest, and constructive comments. Ultimately the editor decides the final content of the journal, but such an editorial decision is usually based on many criteria including merit, novelty, and relevance of the manuscript to the journal plus reviewer comments.
Publication process: Corrections and retractions and re-publication
Since genuine errors can happen in research and publication, the ICMJE recommends that corrections are published in the electronic format or print as soon as they are detected. These should be included in the table of contents which means that corrections can be indexed.[10] Subsequent debates, questions, and queries by readers can be handled as letters to the editor. However, when the error is serious enough to alter the entire paper's results and conclusion, it should lead to a retraction.[21] However, if an error is genuine (such as due to miscalculation or statistical error), it can lead to re-publication after retraction of the erroneous paper. Retractions due to fake peer review are also of particular concern.[22],[23]
Preprints
A preprint is a non peer-reviewed article published in an online archive. Increasing number of authors post manuscripts to a preprint server to improve visibility and highlight data to help gain citations.[24],[25] However, authors must choose a preprint server that requires them to state funding and disclosures. There must be a clear statement that the article has not been peer reviewed. Authors must inform journal editors at the time of submission if the manuscript is in a preprint server. A published article must not be posted in a preprint archive nor can an author post in preprint, versions of a manuscript undergoing peer review. It is the responsibility of the author to post in the preprint server that the manuscript has been published. A preprint article can be cited in the references, under certain conditions.[10] Authors should refrain from citing preprints that subsequently fail to be published in a peer-reviewed journal.
Registration of clinical trials
The ICMJE defines a clinical trial as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause and effect relationship between a medical intervention and a health outcome.”[10]
The ICMJE mandates prospective registration for clinical trials starting enrollment after July 1, 2005.[26] Generally, sponsors and investigators (and journal editors) lean heavily toward publication of studies with positive results, especially those with large-margin effects. In contrast, studies with negative results are often not published, especially when financial (or reputation) risk is possible. To help overcome this, ICMJE member journals require that registration of clinical trials is a prerequisite to manuscript submission. Prospective registration, therefore, helps ensure transparency in research for all stakeholders, and the promotion of publication of trials with negative results.
The ICMJE recommends a registry that is freely accessible to the public and registrants, electronically searchable, with a mechanism to ensure the validity of registration data, and managed by a not-for-profit organization. An acceptable registry is one that includes a minimum set of criteria specified by the World Health Organization in 2005.[27] Examples of registries are the US ClinicalTrial.gov, Health Canada Clinical Trials Database, Clinical Trials Registry-India, and the UK's International Standard Registered Clinical/soCial sTudy Number.[28] Authors should not confuse clinical trials registration with approval with the local ethics or institutional regulatory board.
Data sharing
“Sharing data” describes the practice of passing data collected during research with other researchers after study findings are published. Nowadays because of digitization, data can be stored in a repository, and the ICMJE recommends that it is stored for 10 years after a study is published. Funders of clinical trials such as the Wellcome Trust, and the Medical Research Council UK among others, and participants of clinical trials, also encourage authors to share data with other researchers so that findings can be validated (or otherwise) further research promoted.[29] All ICMJE journals advocate that data-sharing statements are made at the time that manuscripts report clinical results.[30] A data-sharing plan also needs to be included during clinical trial registration for all trials enrolling participants after 2019. Authors using shared data for secondary analyses[31] must explain how this will differ from the primary study, and are encouraged to collaborate with those who shared data. Although authors state their willingness to share data, very few actually do. For example, in a study of 1792 manuscripts where authors stated data were available on reasonable request, 93% failed to respond or declined to share, and only 7% actually shared data.[32]
Manuscript preparation: What is advised in the format of manuscript preparation?
The abstract is arguably the section of a manuscript likely to be read (and accessible free of charge!) and needs to reflect the pertinent features of a study accurately and succinctly. When writing a research paper, following the Introduction, Methods, Results, and Discussion format is advised (in both the abstract and main text), as doing so facilitates a logical sequence and flow.[10] Authors should adhere to standard reporting guidelines, such as the Consolidated Standards of Reporting Trials guideline for randomized trials and the Strengthening the Reporting of Observational Studies in Epidemiology guideline for observational studies. Adherence to such guidelines ensures that reporting is as complete and transparent as possible; this applies not only to randomized clinical trials, systematic reviews, and meta-analyses but also to observational studies and case reports.
In the introduction, authors should briefly describe what is known about the particular subject matter, and why further investigation is required. It can often be helpful to state the primary (and any secondary) research question(s) which in turn focuses the mind of the reader. In the methodology section, in addition to describing the type of study, it is vital to describe participants clearly. The terms “sex” and “gender” should be used appropriately: sex refers to a biological variable while gender is an identity and psychosocial parameter. Authors should also define race and ethnicity, and interpret results accordingly. In statistical analysis, relying solely on p value to ascribe significance should be avoided, and instead, confidence intervals to measure the certainty of measurements. Authors are advised also to justify the sample size and give reference for the basis of sample size calculation.
Results should be presented logically with the main findings first, followed by data pertaining to primary and secondary outcomes. When presenting results, absolute numbers in addition to percentages should be used. Duplicating data in both the main text and tables and/or figures should be avoided. When large data sets are generated, some journals permit results to be shown and/or illustrated in online supplements to help avoid excessive and unwieldy amounts of information.
In the discussion, main findings should be briefly outlined, followed by secondary findings. It is then preferable to discuss how such findings of a particular study relate (similarities and/or differences) to existing published data. Strengths and limitations to studies are important to highlight, which should then be followed by a description of what further research should lead on from findings. A short final summary paragraph should conclude a manuscript. Authors should reference original articles as much as possible and avoid using manuscripts from predatory journals. Preprints can be cited, although it must be clearly stated that this is the case. References should not be a platform to promote an author's own published works.
ConclusionWe have provided a brief description of URMs and how they have evolved into recommendations for conducting biomedical research and presenting findings. Such guidance is as helpful to editors, editorial staff, and peer reviewers as they are to authors/researchers. Widespread dissemination of URM guidance is required across the globe irrespective of experience levels, followed by careful application in all stages of the research process and during its inception. Scrupulous adoption must surely enhance the entire research process and in turn improve the quality and accessibility of data generated and its extrapolation beyond.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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