How to publish research

Before Starting: Ethics

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GPP

ICMJE

MPIP

EMWA

COPE

WAME

ISMPP

GRP

GPP

All research involving human participants should include a statement about the Institutional Review Board and/or Independent Ethics Committee review and informed consent procedure. Publications of laboratory or other nonclinical (e.g., animal) research should also contain an ethics statement

GPP

Anonymized surveys and other research that were legally exempt from full review should be identified as such and the specific regulation cited

GPP

Patient confidentiality should be protected

ICMJE

Trials in humans should follow the Declaration of Helsinki (see https://www.wma.net/policies-post/wma-declaration-of-helsinki/) and authors should seek approval for trial conduct from an independent local, regional or national review body (e.g., ethics committee, institutional review board)

ICMJE

If informed consent has been obtained, this should be indicated in the published article

GPP

Trial registration numbers should be included on all publications, even if not required by the journal, to facilitate automatic linking to registry information

GPP

Some journals encourage preregistration of protocols as registered reports before data collection

ICMJE

To be considered for publication in ICMJE member journals, ICMJE recommends that all medical journal editors require clinical trials are registered in a World Health Organization (WHO) approved registry (see www.who.int/clinical-trials-registry-platform) at, or before, the time of first patient consent for enrolment

ICMJE

Authors are responsible for ensuring they have met the requirements of funding and regulatory agencies regarding the reporting of results in clinical trial registries

ICMJE

The clinical trial registration number should be included at the end of the article abstract

GPP

Study sponsors should describe their obligations, and those of the authors, to ensure awareness of and adherence to ethical practices, in a written agreement before work on a publication begins; this should include agreements regarding confidentiality and any data embargoes

GPP

The agreement should:
• Disclose the sponsor’s role in the review of the publication or presentation (e.g., for medical accuracy, intellectual property protection, or other legal or regulatory review), and provide a reasonable timeline for review to be completed (30 days is the recommended maximum)
• Describe what, if any, editorial and other support may be available for publication development
• Commit authors to take responsibility for the content, accuracy, and completeness of the publication

ICMJE

For sponsored research, author access to supporting data should be provided for any research agreements

ICMJE

Authors should avoid entering into agreements with sponsors that interfere with their access to the trial data or their ability to analyze, interpret and publish the data independently

GPP

The creation of a publication steering committee is recommended to provide outside advice to authors and other contributors on publication planning in situations where multiple peer-reviewed outputs will be generated, for example for clinical/research programs or large-scale clinical trials

GPP

The criteria for membership should consider the needs and complexities of the research, as well as inclusivity across geographies, demographics, and job roles

GPP

The steering committee should be formed before results are available and all members should receive a charter outlining their responsibilities

GPP

In the event of a collaborative alliance between two or more organizations, the steering committee should have representation from all alliance partners, unless otherwise specified

GPP

Patients, caregivers, and patient advocates may be appropriate members of a steering committee and may serve as consultants, authors or contributors to publications, depending on journal/conference requirements

GPP

All investigators should be informed of the steering committee’s membership and its responsibilities

GPP

Membership of the steering committee does not automatically confer authorship

GPP

Steering committees should meet at least annually and be formally disbanded once all relevant deliverables are complete

GPP

A publication working group may be formed to manage the authorship, discuss data interpretation and publication content, and oversee the submission of abstracts, presentations and publications from a study or predefined analysis, or group of related studies or datasets

GPP

The publication working group should be initiated before data availability. Eligible authors and other contributors should be invited, but are not obliged, to participate. Membership does not automatically confer authorship

GPP

A lead author should be selected, based on their expertise and existing contributions to the intellectual work of the research being reported. The lead author should meet ICMJE criterion 1 at time of selection

GPP

Authorship criteria should be applied consistently to all contributors, including patients and professional medical writers, regardless of their affiliation, professional role, or level of educational attainment

GPP

The authors should agree on the order in which they will be listed; using a contributorship model or checklist, such as CRediT (see 'Contributorship' for more detail), will help to build consensus around questions of authorship and byline order. The lead author may settle disputes; however, in cases of equal contributions, deferring to a neutral criterion, such as alphabetical or reverse alphabetical order, is recommended. Joint authorship is increasingly common and acceptable if all authors agree

GPP

Paid employment related to trial conduct, analysis or publication development does not disqualify a person from authorship

GPP

Authors should provide their ORCiD number, if they have one, to ensure transparency in their identity

ICMJE

Authorship should be based on:
1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; AND
2. Drafting the work or reviewing it critically for important intellectual content; AND
3. Final approval of the version to be published; AND
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved

ICMJE

It is the collective responsibility of the authors to determine that all people named as authors meet all four criteria; this is not the role of journal editors

ICMJE

All individuals who meet the first criterion should have the opportunity to participate in the review, drafting, and final approval of the manuscript

ICMJE

Local investigators or researchers from low- and middle-income countries who qualify for authorship should be included to ensure that the authorship reflects the fairness, context and implications of the research

ICMJE

Authors should be accountable for their own work and be able to identify which co-authors are responsible for other parts

ICMJE

Authors should be able to take public responsibility for the work and should have confidence in the accuracy and integrity of the contributions of their co-authors

ICMJE

When a large multi-author group has conducted the work, the group should ideally decide who will be an author before the publication is initiated, and reconfirm prior to submission

ICMJE

AI or AI-assisted technologies, including chatbots such as ChatGPT, should not be listed as authors or co-authors

MPIP

A 5-step framework can be followed to determine authorship: (1) establish an authorship working group of core contributors before patient enrolment begins; (2) determine which authorship contributions will be deemed substantial; (3) implement a process to track progress towards substantial contributions; (4) assess the documented contributions to invite those with substantial contributions to be authors; and (5) ensure invited authors meet ICMJE criteria throughout the process

EMWA

Authors should be identified at an early stage

COPE

AI tools cannot be listed as an author of an article

WAME

Only humans can be authors; chatbots cannot be authors

GPP

Payment should never be made (or offered) simply to attract someone to be an author or influence an author’s opinion

GPP

Companies may reimburse reasonable out-of-pocket, publication-related expenses (e.g., travel and accommodation)

GPP

Reimbursement of patients, patient advocates and/or steering committee members for their time throughout publication development is permitted

GPP

Companies may pay for publication activities (e.g., statistical analysis, medical writing, editing); any payments should reflect the services provided and be at fair market value

GPP

The corresponding author is responsible for overseeing the submission process and managing communications with the journal

ICMJE

The corresponding author takes primary responsibility for communication with the journal during submission, review, and publication but duties may be delegated to one or more co-authors

ICMJE

The corresponding author should be available to respond to editorial queries in a timely way

ICMJE

The corresponding author typically ensures that all the journal’s administrative requirements, such as providing details of authorship, ethics committee approval, clinical trial registration documentation, and disclosures of relationships and activities, are properly completed and reported

MPIP

The corresponding author should function as the primary contact between the journal and the other authors

MPIP

The corresponding author does not need to be the lead author, but should be selected for their ability to help coordinate the review and revision process

GPP

Professional medical writers should have a good understanding of publication ethics and current publication guidelines

GPP

Professional medical writers should be in frequent contact with the authors during the development of the article

GPP

Documentation (e.g., author agreements, meeting minutes, drafts, comments, approvals) should be retained in an auditable format, in line with sponsor policies

EMWA

A professional medical writer facilitates the development of articles

EMWA

Unless they have made a substantial contribution to the analysis or interpretation of the data and feel able to take public responsibility for the work, professional medical writers generally do not meet authorship criteria

WAME

Professional medical writers are considered to be legitimate contributors to articles

ISMPP

Professional medical writers must follow GPP guidelines and ICMJE recommendations, consult appropriate reporting guidelines (e.g., CONSORT), ensure authors/sponsors are aware of their obligations, and keep up to date with advances in best practice

GPP

Sponsors must provide authors and other contributors with relevant aggregated study data, consistent with patient confidentiality, before work on a publication begins or as soon as data becomes available during publication development

GPP

Information necessary to appraise the quality and robustness of the findings (e.g., study protocol, statistical analysis plan, statistical report, and validated data tables, figures, listings) should be provided if needed

GPP

Authors and sponsors should establish a process based on honest scientific debate to resolve differences in interpretation of findings or data presentation

GPP

Authors should agree as to who will perform final checks for data accuracy. Authors should fulfil this responsibility as regards data; a professional medical writer, if not a byline author, should not perform the final data check

ICMJE

Manuscripts reporting clinical trial results, and that are to be submitted to ICMJE journals (see list of journals here, https://www.icmje.org/about-icmje/faqs/icmje-membership/), must contain a data sharing statement

GPP

Authors and sponsors should discuss practical issues such as the choice of journal and conferences, with suggestions from publication professionals, but recognize that the authors have the final decision

GPP

Open-access or free-to-access options for publications should be used whenever possible and funds for this purpose considered when planning budgets

GPP

Pre-submission enquiries to journal editors about specific datasets or publications should only be done with the agreement of the authors

ICMJE

Predatory or pseudo journals generally accept and publish almost all submissions; they may charge article processing fees and claim to perform peer review even if they do not

ICMJE

Authors must be aware that predatory journals exist and avoid submitting their work to them by evaluating the integrity of the journals they seek to publish in. Resources from associations such as WAME (https://wame.org/identifying-predatory-or-pseudo-journals) and the ThinkCheckSubmit website (https://thinkchecksubmit.org/journals/) can be used by authors to help identify trusted journals and publishers

MPIP

The journal choice should reflect the most appropriate means of disseminating the findings to the target audience

GPP

Author lists should remain consistent for a specific dataset, and encore presentations should list the same authors as the original presentation

GPP

If a colleague served as an author for a conference presentation and opts out of the byline for a subsequent manuscript, this earlier authorship should be either noted in an acknowledgement or cited

GPP

Care must be taken to avoid the appearance of duplicate or redundant publications

GPP

Encore publications and translations should be considered only to meet specific scientific needs and/or reach audiences who would otherwise lack access

ICMJE

Secondary analyses should cite any primary publication and clearly state that they contain secondary analyses

ICMJE

Secondary publication of materials already available in other journals or online may be justifiable when intended to disseminate important information to a wider audience, e.g., guidelines in a different language

MPIP

The primary article should always be accepted for publication before other articles reporting secondary analyses

GPP

Any publication might be augmented by enhanced content, including a plain language summary (PLS) or lay summary; these can be in text, video, audio, podcast, or infographic format

GPP

It is recommended that a text-based PLS be prepared for any clinical trial publication that follows CONSORT guidance, or any other publication of clinically relevant information about a currently marketed product; review by a lay person, patient or plain language expert may be helpful

GPP

A PLS follows plain language principles and may serve many audiences, while lay summaries of publications are intended for nonexperts. A well-designed PLS may serve both functions

ISMPP

A standalone PLS (or PLS of a publication [PLSP]) is regarded as a secondary publication as per the ICMJE guidelines and requires approval from the publisher of the original article, for courtesy and to avoid copyright issues

GPP

Results should be submitted for publication within 18 months of trial end for licensed products; for investigational products, results should be submitted within 12 months of product approval or 18 months of product discontinuation

GPP

Publications should follow established reporting standards for specific study types (e.g., those found on the EQUATOR Network, see https://www.equator-network.org/)

GPP

The manuscript should follow established reporting guidelines (e.g., CONSORT for randomized trials, PRISMA for systematic reviews, STROBE for observational trials, as found on the EQUATOR network)

ICMJE

Authors should consult guidelines for the reporting of specific trial types, e.g., CONSORT for randomized trials; this helps to describe trials in enough detail for effective evaluation

GPP

The authors control and direct the publication content. The professional medical writer must receive direction from the authors before they undertake any writing, including an outline

GPP

The authors should be fully involved at all stages of publication and comments should be documented and made available to all authors

GPP

If conflicting comments are received, consensus should be reached through discussion with all authors/contributors

GPP

The sponsor should have the right to review drafts in a timely manner to ensure accuracy, adherence to regulatory requirements, and protection of intellectual property

ISMPP

Authors remain responsible and accountable for the content of any publication that includes AI-powered outputs and for ensuring ethical use of AI

EMWA

Authors should have sufficient time to comment on the drafts of an article

GPP

Authors are responsible for the content, accuracy, and completeness of the manuscript and its final approval

GPP

Once authors are satisfied with the manuscript draft, the professional medical writer should manage the review and approval process through the sponsor, following applicable processes

GPP

Nonauthor contributors should not be expected to approve the final manuscript, but a courtesy copy may be provided before submission

GPP

Sponsor employees with commercial roles should not be involved in manuscript review or approval

ICMJE

At submission, the journal should require authors to disclose whether they used AI-assisted technology

ICMJE

Authors who use AI or AI-assisted technology should describe, in both the cover letter and in the appropriate section of the submitted work, how they used it

ICMJE

Use of AI for writing assistance should be reported in the acknowledgements

ICMJE

Nondisclosure of AI use may require corrective action and may be construed as misconduct in some circumstances

COPE

AI use in writing, analysis, or figures should be fully disclosed

ISMPP

Authors and medical publication professionals should disclose the active use of generative AI in the creation of content or assistance with writing or editing of publications, per the journal guidelines

GPP

Copyright permissions for the reproduction of previously published materials should be retained in accordance with sponsor policies

ICMJE

Written permission should be obtained from the copyright holder to reproduce any previously published figures or tables; permission is required irrespective of authorship or publisher, except for documents in the public domain

ICMJE

AI tools may incorporate information from sources without proper attribution (including copyright material). Humans are responsible for citing appropriate sources, obtaining permissions where needed, and ensuring that plagiarism has not occurred when using AI tools

ICMJE

Referencing AI-generated material as the primary source is not acceptable. Authors are responsible for citing references accurately and should be able to attest that the references cited support the associated statement

ISMPP

Be aware that copyright rules apply to those who are using AI to generate content. The use of copyrighted information in training datasets for AI models or in any material created by AI models can lead to copyright infringement unless permissions are obtained

GPP

Nonauthor contributors who provided technical expertise, trial investigators or participants (often as a group), should be included in an acknowledgement statement. People who reviewed the publication and provided helpful advice may also be acknowledged

GPP

Each person named in the acknowledgements should review the wording and provide written permission to be included

GPP

The authors will disclose, at a minimum, the professional medical writer’s name, professional qualifications, affiliation, funding source, and any other information required by the journal or conference

ICMJE

Nonauthor contributors who are acknowledged must provide their written permission, as acknowledgement may imply endorsement of a trial’s data and conclusions

WAME

The precise roles and affiliations of professional medical writers must be disclosed

ISMPP

Authors should acknowledge professional medical writing support, including its nature; the names, highest relevant qualification, and affiliation of the writer accountable; and the funding source for the writing support

GPP

Authors and sponsors should disclose all sources of funding and other sources of support, as well as relevant financial and nonfinancial relationships that could be perceived to bias their work or influence professional judgement

GPP

If no time frame for disclosure is specified by the journal or conference, it is recommended to follow the ICMJE disclosure form and use a 36-month disclosure window

ICMJE

Articles should be published with statements declaring authors’ conflicts of interest, and sources of support for the work and details of the role of the sponsor in the trial design, the collection, analysis and interpretation of data, writing the report, and the decision to publish

ICMJE

Perceptions of conflicts of interest are as important as actual conflicts of interest; an author’s complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the process

ICMJE

The ICMJE has developed a disclosure form (https://www.icmje.org/disclosure-of-interest/) to facilitate and standardize authors’ disclosures

ICMJE

Authors should declare whether they had access to the trial data

GPP

Clear, concise descriptions of the roles and affiliations of each author and any listed nonauthor contributors should be included within each publication or presentation

GPP

Authors should use a contributorship model, such as CRediT (https://credit.niso.org/), to describe each person’s role

ICMJE

Some journals request and publish information relating to the contributions of each named participant in the research

ICMJE

Individuals whose contributions do not justify authorship may be acknowledged individually or as part of a group (e.g., “Participating investigators”), and their contributions should be specified

GPP

Urgent public health needs may necessitate the use of preprints for clinical trial data in limited circumstances to collect feedback or share critical information

GPP

Since preprints generally are not peer reviewed, they should not be a routine element of publication planning or data dissemination for company-sponsored trial data

GPP

Preprints should meet the same standards for rigour, completeness, and ethics as peer-reviewed publications. All authors must agree to posting on a preprint server

GPP

Journal policies regarding preprints vary; some do not permit preprints as citations

ICMJE

Preprint servers should clearly identify preprints as not peer reviewed; require author disclosures and funding sources; have clear processes for users’ concerns; and document preprint withdrawals and publication in a peer-reviewed journal

ICMJE

It is the authors’ responsibility to ensure that preprints are amended to point readers to subsequent, peer-reviewed versions of the work

ISMPP

Preprints should be clearly distinguished from peer-reviewed publications, i.e., watermarked, and should clearly disclose the lack of formal peer review in the article

ISMPP

Pre-publication checks of preprints should be extensive, using a comprehensive checklist

ISMPP

Articles on preprint servers that have been subsequently fully published should be marked as such and linked via the DOI to the final published version

ISMPP

It is suggested that preprints are not used as references unless these are cited in the manner of a personal communication, as an in-text reference (using the preprint link, DOI, or both) rather than as bibliographic references. It should be clearly disclosed that the source is a preprint

GPP

Authors should approve the publication version to be submitted and state a commitment to take public responsibility for the work, which may be done via email

ICMJE

Authors should not submit the same manuscript, in the same or different languages, simultaneously to more than one journal

ICMJE

If the manuscript has been submitted previously to another journal, it is helpful to include the previous editor’s and reviewers’ comments with the submitted manuscript, along with the authors’ responses to those comments

MPIP

Articles should comply with the target journal’s requirements regarding:
• Format, style, language, length/word limit, graphic sizes, document format, etc.
• Cover letters
• Copyright transfer forms/licence agreements, and disclosures

GPP

Authors should evaluate peer-review comments before a professional medical writer undertakes any revisions; if applicable, a sponsor employee should be responsible for obtaining any necessary reviews (e.g., intellectual property) of the updated materials

GPP

Substantial revisions as a result of peer review may warrant the addition of new authors and/or acknowledgements, and should be approached in accordance with journal guidelines

ICMJE

A peer-reviewed journal is under no obligation to follow reviewer recommendations; the journal editor is ultimately responsible for the selection of all content

MPIP

All reviewer and journal editor comments should be addressed before the article is resubmitted

GRP

The journal editor should be advised if it is not possible to meet the original deadline for responding to reviewers’ comments (e.g., if extra analysis is required)

ISMPP

In the event of rejection comments, authors may consider submitting to a second-choice journal with itemized rebuttals and relevant updates (portable peer review)

MPIP

It is worthwhile addressing the suggestions of the peer reviewers if the article is rejected but will be resubmitted to a different journal

ICMJE

Articles that have been accepted but not yet published (and therefore, not yet available in its final form) should be designated as “in press” or “forthcoming”

GPP

The corresponding author should communicate with all authors before sending a correction (erratum) to the journal

ICMJE

Authors have a responsibility to respond appropriately and cooperate with any requests from the journal for data or additional information should questions about the article arise after publication

ICMJE

Authors also have a responsibility to respond to any substantial criticism of their work through a correspondence section or online forum, according to the journal’s preferred practice

COPE

Editors can decide to retract a publication if they no longer have confidence in the results and conclusions reported in the paper, due to:
• Clear evidence of major errors, irregularities in the data or images, or any form of misrepresentation (eg, fraud, identity theft or fictitious authorship)
• Findings published elsewhere without proper attribution, permission, or justification, or material or data have been used without proper authorisation
• Unethical research practices, compromised peer review, or undisclosed conflicts of interest

GPP

Social media postings about publications of company-sponsored research data are available to the general public and can therefore be perceived as promotional. In the context of regulated research, compliance must be maintained regarding label indications and pharmacovigilance obligations

GPP

Individual employees of sponsors, companies, or medical communications agencies should not use personal social media accounts to post information about specific products, company-sponsored research about those products, or biomedical publications of such research; requests regarding social media posts should be managed by the corresponding author, who should consult/inform the other authors

GPP

Embargoes must be respected, i.e. authors, sponsors, and institutions should not issue press releases about accepted articles without consulting the journal

ICMJE

Many journals embargo content before publication