Publishing Policies

Policies

Article Policies

1. Originality
2. Publication criteria and authorship
3. Competing interests
4. Ethical Policies
5. Inappropriate image manipulation
6. Registration of trials and systematic reviews
   6.1 Trial registration
   6.2 Systematic reviews registration
7. Standards of reporting
8. Data availability
9. Licenses
10. Permanency of content
    10.1 Correction
    10.2 Retraction
    10.3 Editorial Note
    10.4 Expression of Concern
11. Allegations of misconduct
12. Policy for Comments on Articles
13. The peer review model
14. Advertising

Publication of any material in NIHR Open Research denotes that all its authors have agreed to its content and have ensured that NIHR Open Research's policies have been fully adhered to. Non-compliance with these policies may mean that an article cannot be published.

If an article is accepted for publication by NIHR Open Research, NIHR Open Research will publish your article on the NIHR Open Research website in advance of any peer review being performed on the article. We seek to ensure that the content we produce, publish and for which we provide a platform is responsible, and has been selected and produced without bias. We respect the intellectual property rights of our contributors and seek to avoid unethical publishing behaviors, which are not in line with our policies, including but not limited to, plagiarism, fabrication, defamation, and misinformation.

Our Publication Terms and Conditions set out the publishing standards by which we operate. We require that all work

• sets out to be fair and accurate
• clearly differentiates between fact and opinion
• is obtained by legitimate and ethical means
• is evidence-based
• and shall be promptly corrected (where appropriate) or withdrawn if it is subsequently found to be dangerous, inaccurate or misleading.

The acceptability of any article shall be decided by NIHR Open Research at its discretion, taking into account NIHR Open Research policies. NIHR Open Research reserves the right, at its discretion, to not proceed with publication at any time or to remove the Content following publication, including but not limited to, if there are legal or ethical concerns with the article.

1. Originality

All articles submitted to NIHR Open Research must be original; the work, or large parts of it, must not have been published previously or be currently under consideration or review elsewhere. If there is any significant overlap with another paper, this must be cited in the article and mentioned on submission. NIHR Open Research uses Crossref's similarity checker (iThenticate) to check for plagiarism in articles; if clear plagiarism (including self-plagiarism) is identified, the article will be rejected.

Articles previously posted on a preprint server, such as ArXiv, bioRxiv or PeerJ PrePrints can be submitted for publication in NIHR Open Research.

Submitted articles with content that infringes copyright may be rejected if the problematic sections cannot be removed.

Authors who wish to reproduce a figure or table from a previous copyrighted publication are responsible for obtaining the permission of copyright holders and for clearly referencing the original source. Figures that were previously published under a creative commons license may be reused under the condition of the specific license that applies to those figures.

2. Publication criteria and authorship

The NIHR Open Research platform is set up to make it easy for researchers supported by the NIHR to share their results and insights rapidly, and to facilitate a constructive scientific discussion.

NIHR Open Research does not have Editors who make an editorial judgement on whether research presented in a given article is 'valid'. Instead, the key criteria for publication are:

• Each publication must have at least one author whose contribution to the research described in the publication was supported by the NIHR through project funding, infrastructure funding or career development support.
• Current and past recipients of a NIHR funding are eligible to publish research supported by NIHR funding.

Authors must be aware that using AI-based tools and technologies for article content generation, e.g. large language models (LLMs), generative AI, and chatbots (e.g. ChatGPT), is not in line with our authorship criteria. All authors are wholly responsible for the originality, validity and integrity of the content of their submissions. Therefore, LLMs and other similar types of tools do not meet the criteria for authorship.

CRediT

All authors should have made a clear contribution to the published article. As a guide, authors should refer to the criteria for authorship that have been developed by The International Committee of Medical Journal Editors (ICMJE). Each author’s contribution must be detailed by selecting CRediT roles on the article submission form.

Anyone who has contributed but does not meet the criteria for authorship (for example, purely technical or writing assistance) should be listed in the ‘Acknowledgments’ section. The involvement of any professional scientific or medical writer assistance must be declared. Authors should obtain permission to include the name and affiliation, from all those mentioned in the Acknowledgments section.

Any assistance from AI tools for content generation (e.g. LLMs) and other similar types of technical tools which generate article content, must be clearly acknowledged within the article. It is the responsibility of authors to ensure the validity, originality and integrity of their article content. Authors are expected to use these types of tools responsibly and in accordance with our editorial policies on authorship and principles of publishing ethics.

Correspondence with authors: If an author requires a change to the article, the editorial office will require confirmation of the identification of the individual. Usually, this will be via sending an email using the email address that NIHR Open Research has stored on the system. If this is no longer possible, please contact the editorial team, who will be able to assist with confirmation of identification.

Changes in authorship: If the author list of an article changes following its publication, a new version of the article can be published with an explanation included in the ‘Amendments’ section at the top of the new version. Any changes in authorship must be confirmed by all authors. If the editorial team is unable to contact an author, the corresponding author is responsible for facilitating communication. In agreement with COPE guidelines, the editorial team cannot take responsibility for resolving any disputes over authorship; any disagreements amongst the authors must be settled by the authors’ institution(s).

Changes to author names: NIHR Open Research understands that authors, reviewers or commenters may wish to change their names for many reasons, including gender identity recognition, marriage, divorce and other personal reasons. Following a name change request, the editorial office will require confirmation of the identification of the individual, as per all communications with authors, as we will need to check you are requesting the name change on your own behalf. To avoid any distress this process may cause, NIHR Open Research is keen to work with researchers to enable them to provide identification on their own terms. We do not require legal or official proof of a name change.

Researchers should note that the corresponding author will be contacted to make them aware that a name change has taken place. Researchers may wish to inform their co-authors of the change, for example so that they use an updated offline copy or change the way they cite the publication. Or researchers can rely on a notification from us to the corresponding author alone and the updated online version. Please inform us if we should wait until a particular date to enact the name change to give researchers time to communicate with co-authors if desired. If there are any reasons that the corresponding researcher should not be contacted, please let us know.

For articles, any change of name will not require a new version of the article to be created; all existing versions will be edited to reflect the change and the DOI will remain the same. A Notice of Change will not be posted to articles unless requested by the researcher; if requested, the following standard text will be used: ‘A name change in the author list of this article was requested. The change was implemented on <date>’.

If an article is indexed, NIHR Open Research will exert all efforts to ensure that the change is propagated to indexer websites. However, please note that NIHR Open Research cannot control the use or appearance on third party websites.

Please note that NIHR Open Research considers it a violation of publishing and personal ethics to request to change the name of another individual without their explicit consent. If an author, reviewer or commenter requires a name change, please contact the editorial office. To protect the identify and personal data of the researcher requesting the name change, all correspondence will be treated in confidence, only team members that are required to implement the name change will be made aware, and the information will not be used for any use apart from name change implementation.

3. Competing interests

Authors must include a 'Competing interests' statement. A competing interest will not preclude publication, but it provides full transparency for the reviewers and readers. If there are no competing interests to declare, the following standard statement is added: ‘No competing interests were disclosed’.

A competing interest may be of non-financial or financial nature. Examples of competing interests include (but are not limited to):

• individuals receiving funding, salary or other forms of payment from an organization, or holding stocks or shares from a company, that might benefit (or lose) financially from the publication of the findings;
• individuals or their funding organization or employer holding (or applying for) related patents;
• official affiliations and memberships with interest groups relating to the content of the publication;
• political, religious, or ideological competing interests.

Authors from pharmaceutical companies, or other commercial organizations that sponsor clinical or field trials or other research studies, should declare these as competing interests on submission. The relationship of each author to such an organization should be explained in the ‘Competing interests’ section. Publications in NIHR Open Research must not contain advertising.

The International Society for Medical Publication Professionals provides good practice guidelines, which are aimed at ensuring that “clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner”.

Reviewers are also required to declare any competing interests in their reports, as are readers who contribute comments on the site.

If an undisclosed competing interest is brought to the attention of the editorial office after publication, NIHR Open Research will follow the COPE guidelines.

4. Ethical Policies

All studies involving humans (individuals, human data or material) must have been conducted according to the principles expressed in the Declaration of Helsinki. All research must have been conducted in accordance with the Health Research Authority guidance “UK Policy Framework For Health and Social Care Research”, with “The Concordat to support Research Integrity” and, if relevant, in accordance with the Health Research Authority guidance "Governance Arrangements for Research Ethics Committees” (GAfREC). Approval must have been obtained for all protocols to ensure that they meet national and international guidelines. Details of the relevant approval must be provided when submitting an article, including the institution, review board name, and permit number(s).

Human studies categorized by race/ethnicity, age, disease/disabilities, religion, sex/gender, sexual orientation, or other socially constructed groupings, should include a justification of the choice of definitions and categories, including whether any rules of human categorization were required by the relevant funding agencies. Appropriate non-stigmatizing language should be used when describing different groups.

Ethics approval must be obtained before the research is conducted; retrospective approval can usually not be obtained and it may not be possible to publish the study.

All studies must have been conducted in compliance with any applicable law relating to the processing, privacy, and use of Personal Data as applicable from time to time.

As stated in the Recommendations of the International Committee of Medical Journal Editors: “Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that the patient be shown the manuscript to be published. When informed consent has been obtained it should be indicated in the published article.”

Consent to participate: For all studies involving human participants, including personal genomics studies, case reports, clinical trials, questionnaires, observations etc, informed written consent to take part in the research must have been obtained, and this should be stated in the article in a section entitled ‘Consent’. You can use our consent form, or your own institution’s form as you prefer. If only oral consent was obtained (rather than written), the reasons need to be explained, confirmation of the relevant Authority approval that oral consent was adequate must be provided, and a statement of how it was documented included in the Consent section.

Consent for publication of identifiable data: For any articles that include information that could potentially identify an individual, please ensure that you have obtained written, informed consent from all patients or healthy participants (or their legal guardians for minors, or next of kin if the participant is deceased), confirming that the results and any accompanying images can be published. This includes large clinical datasets with direct or indirect identifiers (see this article for information), specific details about individuals, images and so on.

If your article contains any identifiable images of individuals, you must include a statement confirming that you have permission to publish these images. If your article contains any clinical images or identifiable data then you must include an explicit consent statement under a separate heading of the ‘Consent’ section (we suggest: “We confirm that we have obtained permission to use [images/data] from the participants/patients/individuals included in this presentation”). Please also state the conditions under which the permission was obtained.

Alternatively, if no consent for publication was required (e.g. the data has been anonymised), then this should be clearly stated and a note should be added confirming that such alterations have not distorted scientific meaning.

5. Inappropriate image manipulation

Photographic images published in NIHR Open Research should accurately reflect the original image. As such, we require that all images, whether submitted as figures or uploaded as data, are not manipulated so that readers are not misled about what the images indicate. We understand that it is standard practice to use software to modify images to make them clearer and easier to interpret. However, any modifications that are made to images should be minor and must be made uniformly to the whole image.

Modifications that alter the scientific meaning of the image, whether conducted on specific regions or the whole image, are not permitted. Where parts of the same gel are spliced together, this should be indicated on the figures with a dividing line, making it clear where the image has been joined. Areas from different gels should not be spliced together. Where loading controls are present, these should always be included in the image; if spliced together, any modifications to the loading control and area of interest must be identical.

Authors are required to include details of all modifications made to images published as figures or uploaded as data in the Methods section of an article, including the name of the software (with version number) used to make these modifications.

Examples of improper image manipulation are well described in an article in the Journal of Cell Biology (Rossner & Yamada, 2004), published by the Rockefeller University Press.

We also require the original, uncropped, unannotated and unprocessed versions of all gel and micrograph images, which we consider underlying data, to be deposited to an approved online repository (see our Data Guidelines for further details on depositing your data).

The Editorial Team will conduct checks of random selected figures and data using ImageTwin. In line with COPE guidelines, where images suspected of improper manipulation are detected, clarification with the authors will be sought. Where the reasons for these suspected manipulations are not explained satisfactorily, the article is likely to be rejected and the authors’ institution may be contacted.

6. Registration of trials and systematic reviews

6.1 Trial registration

Please see the NIHR policy on clinical trial registration and disclosure of results.

NIHR Open Research uses the WHO definition of a clinical trial to decide what constitutes a clinical trial:

“A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include (but are not restricted to) drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.”

Trials should be registered prospectively and the trial registration number and registration date must be included in the article. Further information can be found at the ICMJE FAQ on trial registration and the WHO provides a list of approved registries.

Although we expect trials to be registered before patient recruitment starts, several initiatives (such as the AllTrials campaign) have recognized that retrospective trial registration will encourage publication of both positive and negative results, and trials that were conducted before registration was possible. In line with these initiatives, NIHR Open Research will consider retrospectively registered trials, provided an explanation for the late registration is provided in the article. Again, the trial registration number and date of registration must be included in the Methods section of the article.

6.2 Systematic reviews registration

We encourage authors to register their systematic reviews in PROSPERO or another registry for systematic reviews. The registration number should be included in the article.

7. Standards of reporting

Standards of reporting guidelines help authors to ensure that they have provided a comprehensive description of their research, making it easier for others to assess and reproduce the work; for more detail and a comprehensive overview, see the FAIRSharing initiative. Comprehensive lists of available reporting guidelines can be found on the EQUATOR network website for health research.

Specifically, articles in NIHR Open Research that report clinical trials must adhere to the CONSORT reporting guidelines. We ask authors to include a copy of the original trial protocol and a completed CONSORT checklist and flow diagram as supporting files, which will be published alongside the article. The trial registration number and registration date must be included in the Methods section. Any deviation from the original trial protocol must be explained in the article.

Articles that report systematic reviews must adhere to the PRISMA guidelines, and authors should also include a completed PRISMA checklist and flow diagram as supporting files. Study protocols of systematic reviews must adhere to the PRISMA-P guidelines. We ask authors to include a completed PRISMA-P checklist.

8. Data availability

NIHR statement on the sharing of research data (see here for the full position).

The NIHR promotes openness and transparency in research through a number of its policies, guidance and platforms including NIHR Open Research.

The NIHR strongly supports the sharing of data in the most appropriate way, to help deliver research that maximises benefits to patients and the wider public, the health and care system and which contributes to economic growth in the UK.

The NIHR recognises that the sharing of research data must: protect the confidentiality and privacy of individuals; respect the terms of consent by individuals who are involved in research; be consistent with relevant legal, ethical and regulatory frameworks; and guard against unreasonable costs. Where sharing of data is not limited by ethical, security, data protection, or similar issues, articles in NIHR Open Research that report original results should include citations to repositories that host the data underlying the results, together with details of any software used to process the results. It is essential that others can see the underlying data in order to be able to replicate the study and analyse the data, as well as in some circumstances, reuse it.

The NIHR Open Research data guidelines provide detailed instructions on how to: (a) prepare data for sharing, (b) select a repository, (c) write a data availability statement, and (d) link datasets to articles.

We recognize that there may be cases where openly sharing data may not be feasible (because of ethical or security considerations, or data protection issues). If you think that this applies to your article, please let the editorial team know at the submission stage, as we have policies in place to allow the publication of papers associated with such data, whilst maintaining the appropriate level of security.

Exceptions may be made for:

If data access is restricted for ethical or security reasons, the manuscript must include:

• a description of the restrictions on the data; and
• all necessary information required for a reader or reviewer to apply for access to the data and the conditions under which access will be granted.

Where human data cannot be effectively de-identified, data must not be shared in order to protect patient/participant privacy unless the individuals have given explicit written consent that their identifiable data can be made publicly available.

In instances where the data cannot be made available, the manuscript must include:

• an explanation of the data protection concern;
• any intermediary data that can be de-identified without compromising anonymity;
• what, if anything, the relevant Institutional Review Board (IRB) or equivalent said about data sharing; and,
• where applicable, all necessary information required for a reader or reviewer to apply for access to the data and the conditions under which access will be granted.

Where data has been obtained from social media sites, we ask that authors do not share this data due to ethical and copyright restrictions. This includes reproductions of the data in the manuscript, e.g. images of representative posts, unless you have explicit written informed consent to publish from the author of the social media post. The manuscript should include:

• a Methods section containing a detailed description of the methodology to allow replication by others, including sources, search dates, full search strategies/terms, eligibility criteria, and data selection processes; and
• a description of the data in the Data Availability section, including any variables assessed; and
• the following disclaimer in the Data Availability section: The underlying data to this research cannot be shared due to the ethical and copyright restrictions surrounding social media data. The Methods section contains detailed information to allow replication of the study. Any queries about the methodology should be directed to the corresponding author.

If you are using data from Twitter, you are permitted to share the Tweet IDs or User IDs in a dataset. This allows others to ‘hydrate’ (get complete details of) these IDs using Twitter’s API. Datasets containing Tweet/User IDs should be uploaded as per our data guidelines under a CC0 license.

It is not always feasible to share large data sets. In these cases, authors should include a description of the data, including the file types and sizes, when submitting their manuscript. The editorial team can then advise on hosting.

Where data is too large to be feasibly hosted by a recommended repository, the manuscript should include:

• any intermediary data that can be easily shared; and
• all necessary information required for a reader or reviewer to access the data alongside a description of this process.

In cases where data has been obtained from a third party and restrictions apply to the availability of the data, the manuscript must include:

• all necessary information required for a reader or reviewer to access the data by the same means as the authors;
• any intermediary data that can be shared legally; and
• publicly available data that is representative of the analysed dataset and can be used to apply the methodology described in the manuscript.

In cases where data from human studies has been obtained from government level organisations (e.g. the Ministry of Health), and strict restrictions regarding availability of the data apply, the authors must include a clear explanation about the restrictions, and all the necessary information required for a reader or reviewer to request access from the data owners.

9. Licenses

NIHR Open Research provides immediate open access to its content on the principle that making research freely available to the public supports a greater global exchange of knowledge. Articles are published under a CC BY license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited, and leaves the copyright of the article with the current copyright holder (usually the author or his/her institution).

Other equivalent licensing options are available when an author determines that the terms of the research funding contract, or contracts, which supported the work described in the paper require the publication under an alternative license (e.g. Open Government Licence, OGL).

Data associated with NIHR Open Research articles are made available, where possible, under the terms of a Creative Commons Public Domain Dedication (CC0 license). This facilitates and encourages re-use and helps prevent the problems of attribution stacking when combining multiple datasets each authored by multiple authors that use multiple different licenses.

Peer review reports that are published with a given article are also available under the CC BY license.

10. Permanency of content

All articles published in NIHR Open Research receive a DOI and are permanently published. This applies regardless of the outcome of the peer review that follows after publication.

All content, including articles that have not (yet) passed peer review, is permanently archived in Portico. Once the platform has been formally approved by bibliographic databases, articles that have passed peer review will be archived there.

Authors can revise, change and update their articles by publishing new versions, which are added to the article’s history; however, the individual versions, once published, cannot be altered or withdrawn and are permanently available on the NIHR Open Research website. NIHR Open Research participates in the CrossMark scheme, a multi-publisher initiative that has developed a standard way for readers to locate the current version of an article. By applying the CrossMark policies, NIHR Open Research is committed to maintaining the content it publishes and to alerting readers to changes if and when they occur.

Clicking on the CrossMark logo (at the top of each NIHR Open Research article) will give you the current status of an article and direct you to the latest published version; it may also give you additional information such as new peer review reports.

In order to maintain the integrity and completeness of the scholarly record, the following policies will be applied when published content needs to be corrected; these policies take into account current best practice in the scholarly publishing and library communities.

10.1 Correction to an Article

In traditional journals, where articles are peer reviewed before publication, Corrections (or Errata) are published to alert readers to errors in the article that became apparent following the publication of the final article.

By contrast, articles in NIHR Open Research undergo peer review post publication and publication is not ‘final’ as new versions can be added at any stage. Possible mistakes that come to light during the peer review process may be highlighted in the published peer review reports, which are part of the article. Authors can publish revised versions, and any errors that become apparent during peer review or later can be corrected through the publication of new versions. Corrections and changes relative to the previous version are always summarized in the ‘Amendments’ section at the start of a new version.

10.2 Retraction

Articles may be retracted for several reasons, including:

• honest errors reported by the authors (for example, errors due to the mixing up of samples or use of a scientific tool or equipment that is found subsequently to be faulty)
• research misconduct (data fabrication)
• duplicate or overlapping publication
• fraudulent use of data
• clear plagiarism
• unethical research

For any retracted article, the reason for retraction and who is instigating the retraction will be clearly stated in the Retraction notice. The retraction notice will be linked to the retracted article (which usually remains on the site) and the article will be clearly marked as retracted (including the PDF).

An article is usually only retracted at the authors’ request or by the publisher in response to an institutional investigation. It is important to note in the context of NIHR Open Research's publication model, that - as in traditional journals - a retracted article is not ‘unpublished’ or ‘withdrawn’ in order for it to be published elsewhere. The reasons for retraction are usually so serious that the whole study, or large parts of it, are not appropriate for inclusion in the scientific literature anywhere.

The content of a retracted article would only be removed where legal limitations have been placed upon the publisher, copyright holder or author(s), for example, if the article is clearly defamatory or infringes others’ legal rights, or if the article is the subject of a court order. In such cases, the bibliographic information for the article will be retained on the site along with information regarding the circumstances that led to the removal of the content.

Under rare circumstances, for example, if false or inaccurate data have been published that, if acted upon, pose a serious health risk, the original incorrect version(s) may be removed and a corrected version published. The reason for this partial removal would be clearly stated on the latest version.

10.3 Editorial Note

If there is a potential, not yet resolved, problem with an article, it may be appropriate to alert readers with an Editorial Note. Such an Editorial Note may be added, for example, if NIHR Open Research receives information that research or publication misconduct might have taken place, or that there is a serious dispute between authors or between the authors and third parties. The Editorial Note will usually be posted while further investigations take place and until a more permanent solution has been found (e.g. the publication of a revised ‘corrected’ version, or a Retraction).

10.4 Expression of Concern

In rare cases, NIHR Open Research may decide to publish an Expression of Concern, which is linked to the problematic article, if there are serious concerns about an article but no conclusive evidence can be obtained that would unequivocally justify a Retraction. This may include:

• if there is inconclusive evidence of research or publication misconduct
• there is evidence that there are problems with the article, but the authors’ institution will not investigate the case
• an investigation into alleged misconduct has not been impartial or conclusive

11. Allegations of misconduct

NIHR Open Research is a member of the Committee on Publication Ethics (COPE) and provides an ethical publishing framework in accordance with COPE’s codes of conduct for editors and publishers.

If a case of suspected research or publication misconduct is brought to our attention, we will follow the guidance and workflows recommended by COPE. In the first instance this will usually involve contacting the person/persons about whom the allegations have been raised to request an explanation. We may also need to contact the involved party's research institution, an ethics committee or other third parties.

Research misconduct includes data fabrication or falsification, or cases where research involving animals or humans has not been carried out within an appropriate ethical framework. Publication misconduct includes duplicate publication of articles or clear plagiarism. Honest errors or differences of opinion are not considered ‘misconduct’.

If you suspect potential misconduct in an article published on NIHR Open Research, please contact the F1000 editorial office (editorial@openresearch.nihr.ac.uk) - a member of the editorial team will contact you within 10 working days to confirm the details that you have provided and ask any additional questions needed for us to investigate. Please be aware that it may not be possible to keep you updated throughout the process, however we will endeavour to let you know the outcome where appropriate.

12. Policy for Comments on Articles

While peer reviewers are formally invited, we encourage unsolicited open scientific discussion on all articles. Such contributions are published through our Comment system. To ensure that comments contribute to, and focus on, the scholarly debate, we usually only allow comments from readers who have a formal affiliation with a research institution, or other organisation clearly related to NIHR Open Research’s scope. Alternatively, we may also allow comments from readers who have demonstrable expertise in a relevant area of research. Consistent with our commitment to full transparency, the reader’s full name and affiliation appear on their public comment.

Comments should focus on the scholarly content presented in the articles with which they are associated.

Comments that appear to be advertising, are potentially libellous or legally problematic (including comments revealing patient information) are not permitted. We will not accept Comments that are offensive, indecent or contain negative comments of a personal, racial, ethnic, sexual orientation, or religious character.

All Comments must be written in good English; a Comment may be rejected if it is deemed unintelligible.

Readers who wish to comment on an article are asked to declare any competing interests. Competing interests can be of a financial nature (e.g. holding a patent or receiving fees from a company that may lose or gain financially from the publication of the Comment), or they can be personal, religious, political or other non-financial interests. When completing your declaration, please consider the issues summarized in the Declaration of Competing Interests.

While we welcome open scientific debate and discussion, we will not tolerate abusive behaviour towards our authors and reviewers via our Comment system or via social media. In extreme cases we will consider contacting the affiliated institution to report the abusive behaviour of individuals.

13. The peer review model

Peer review of articles on NIHR Open Research takes place after publication; once the article is published, expert reviewers are formally invited to review under our open and transparent peer review model. To improve the consistency of definitions and terminology in peer review, NIHR Open Research uses the NISO standard terminology for peer review to summarise our peer review process as:

• Identity transparency: All identities visible
• Reviewer interacts with: Editor, other reviewers, authors
• Review information published: Review reports, submitted manuscript, reviewer identities
• Post publication commenting: Open

More information is available on Peer review process for articles section of the How it Works page.

Revisions and updates are published as new versions, with clear explanations (in an “Amendments” section) of the changes the authors made.

Usually, an article receives 2 or 3 peer review reports. The reviewers choose an approval status, which contributes to determining whether the article has ‘passed peer review’ and is indexed in bibliographic databases.

14. Advertising

NIHR Open Research does not publish advertorial articles. Advertisers have no influence on the editorial publication process. Any advertisements, such as online banner adverts, must be clearly distinguished from published content. The publisher reserves the right to place the word “Advertisement” in any material that may - in the publisher’s opinion - be potentially confused with peer-reviewed research content.

Document Policies

1. Originality
2. Publication criteria and authorship
3. Competing interests
4. Ethical Policies
5. Registration of trials and systematic reviews
   5.1 Trial registration
   5.2 Systematic reviews registration
6. Standards of reporting
7. Licenses
8. Permanency of content
   8.1 Correction
   8.2 Retraction
   8.3 Removal
9. Allegations of misconduct
10. Policy for Comments
11. Advertising

Publication of any material in NIHR Open Research denotes that all its authors have agreed to its content and have ensured that NIHR Open Research’s policies have been fully adhered to; adherence to sections 1-3 is compulsory for documents, as is section 4 if any research is presented. Sections 5 and 6 (where applicable) are optional but strongly encouraged as they present good scientific practice and publishing standards.

We seek to ensure that the documents we publish and for which we provide a platform are responsible and have been selected and produced without bias. We respect the intellectual property rights of our contributors and seek to avoid unethical publishing behaviors, which are not in line with our policies, including but not limited to, plagiarism, fabrication, defamation, and misinformation.

Our Publication Terms and Conditions set out the publishing standards by which we operate. We require that all work sets out to be fair and accurate, clearly differentiates between fact and opinion, is obtained by legitimate and ethical means, is evidence-based, and shall be promptly corrected (where appropriate) or withdrawn if it is subsequently found to be dangerous, inaccurate or misleading.

The acceptability of any document shall be decided by NIHR Open Research at its discretion. NIHR Open Research reserves the right, at its discretion, to not proceed with publication at any time or to remove the document following publication, including but not limited to, if there are legal or ethical concerns.

1. Originality

Authors of documents must ensure that they do not breach copyright with any content they post. Authors who wish to reproduce a figure or table from a previous copyrighted publication are responsible for obtaining the permission of copyright holders and for clearly referencing the original source. Figures that were previously published under a creative commons license may be reused under the condition of the specific license that applies to those figures.

2. Publication criteria and authorship

The NIHR Open Research platform is set up to make it easy for researchers supported by the NIHR to share their results and insights rapidly, and to facilitate a constructive scientific discussion.

Documents (e.g. a non-standard manuscript that should not be peer reviewed) are associated with a gateway or collection on NIHR Open Research and may only be submitted by invitation or agreement by the gateway and collection advisors. Documents usually relate to specific National Institute for Health and Care Research funding schemes and are invited directly from past or present award holders. Authors wishing to submit such content who have not been invited to do so, should contact the editorial team.

The key criteria for publication of Documents are:

• Each publication must have at least one author whose contribution to the research described in the Document was supported by the NIHR through project funding, infrastructure funding or career development support.
• Current and past recipients of NIHR funding are eligible to publish Documents based on research supported by NIHR funding.

On submission, authors will be asked for the award ID number.

3. Competing interests

Authors must include a Competing interests' statement. A competing interest will not preclude publication, but it provides full transparency for readers. If there are no competing interests to declare, the following standard statement is added: ‘No competing interests were disclosed’.

A competing interest may be of non-financial or financial nature. Examples of competing interests include (but are not limited to):

• individuals receiving funding, salary or other forms of payment from an organization, or holding stocks or shares from a company, that might benefit (or lose) financially from the publication of the findings;
• individuals or their funding organization or employer holding (or applying for) related patents;
• official affiliations and memberships with interest groups relating to the content of the publication;
• political, religious, or ideological competing interests.

Authors from pharmaceutical companies, or other commercial organizations that sponsor clinical trials, should declare these as competing interests on submission. The relationship of each author to such an organization should be explained in the ‘Competing interests’ section. Publications in NIHR Open Research must not contain advertising.

The International Society for Medical Publication Professionals provides good practice guidelines, which are aimed at ensuring that “clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner”.

Readers who contribute comments on documents are also required to declare any competing interests.

If an undisclosed competing interest is brought to the attention of the editorial office after publication, NIHR Open Research will follow the COPE guidelines.

4. Ethical Policies

NIHR Open Research adheres to the COPE guidelines relating to ethical oversight.

All studies involving humans (individuals, human data or material) must have been conducted according to the principles expressed in the Declaration of Helsinki. All research must have been conducted in accordance with the Health Research Authority guidance “UK Policy Framework For Health and Social Care Research”, with “The Concordat to support Research Integrity” and, if relevant, in accordance with the Health Research Authority guidance "Governance Arrangements for Research Ethics Committees” (GAfREC). Approval must have been obtained for all protocols to ensure that they meet national and international guidelines. Details of the relevant approval must be provided when submitting an article, including the institution, review board name, and permit number(s).

Ethics approval must be obtained before the research is conducted; retrospective approval can usually not be obtained and it may not be possible to publish the study.

All studies must have been conducted in compliance with any applicable law relating to the processing, privacy, and use of Personal Data as applicable from time to time.

As stated in the Uniform Requirements of the International Committee of Medical Journal Editors: “Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that the patient be shown the manuscript to be published. When informed consent has been obtained it should be indicated in the published article.”

Consent to participate: For all studies involving human participants, informed written consent to take part in the research must have been obtained, and this should be stated in the document in a section entitled ‘Consent’. You can use our consent form, or your own institution’s form as you prefer. If only oral consent was obtained (rather than written), the reasons need to be explained, confirmation of the relevant Authority approval that oral consent was adequate must be provided, and a statement of how it was documented included in the Consent section.

Consent for publication of identifiable data: For any documents that include information that could potentially identify an individual, please ensure that you have obtained written, informed consent from all patients or healthy participants (or their legal guardians for minors, or next of kin if the participant is deceased), confirming that the results and any images can be published. This includes large clinical datasets with direct or indirect identifiers (see this article for information), specific details about individuals, images and so on.

If your document contains any identifiable images of individuals, you must include a statement confirming that you have permission to publish these images. If your document contains any clinical images or identifiable data then you must include an explicit consent statement under a separate heading of the ‘Consent’ section (we suggest: “We confirm we have permission to use [images/data] from the participants/patients/individuals included in this presentation [conditions under which the permission was obtained]”).

Alternatively, if no consent for publication was required (e.g. the data has been anonymised), then this should be clearly stated and a note should be added confirming that such alterations have not distorted scientific meaning.

5. Registration of trials and systematic reviews

5.1 Trial registration

Please see the NIHR policy on clinical trial registration and disclosure of results.

NIHR Open Research uses the WHO definition of a clinical trial to decide what constitutes a clinical trial:

“A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include (but are not restricted to) drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc”.

Trials should be registered prospectively and the trial registration number and registration date should be included in the document. Further information can be found at the ICMJE faq on trial registration and the WHO provides a list of approved registries.

If trial registration was missed before the start of the trial, NIHR Open Research encourages retrospective trial registration in line with several initiatives (such as the AllTrials campaign) have recognized that retrospective trial registration will encourage publication of both positive and negative results.

5.2 Systematic reviews registration

We encourage authors to register their systematic reviews in PROSPERO or another registry for systematic reviews. The registration number should be included in the document.

6. Standards of reporting

Standards of reporting guidelines help authors to ensure that they have provided a comprehensive description of their research, making it easier for others to assess and reproduce the work; for more detail and a comprehensive overview, see the FAIRSharing initiative. Comprehensive lists of available reporting guidelines can be found on the EQUATOR network website for health research.

7. Licenses

NIHR Open Research documents are published under a CC BY license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited, and leaves the copyright of the document with the current copyright holder (usually the author or his/her institution).

8. Permanency of content

All documents published in NIHR Open Research receive a DOI and are permanently published; this means they cannot be withdrawn or removed once they have been published.

In order to maintain the integrity and completeness of the scholarly record, the following policies will be applied when published content needs to be corrected; these policies take into account current best practice in the scholarly publishing and library communities.

8.1 Correction to a Document

Documents may contain errors; authors and readers can point out such mistakes via the Comment system. In the rare instance that a document needs to be formally corrected, for example, if a change needs to be made to the author list, a Correction statement will be added.

8.2 Retraction

This action is reserved for documents that are seriously flawed. They may be retracted for several reasons, including:

• honest errors reported by the authors (for example, errors due to the mixing up of samples or use of a scientific tool or equipment that is found subsequently to be faulty)
• research misconduct (data fabrication)
• duplicate or overlapping publication
• fraudulent use of data
• clear plagiarism
• unethical research

For any retracted document, the reason for retraction and who is instigating the retraction will be clearly stated in the Retraction notice. A publication is usually only retracted at the authors’ request or by the publisher because serious misconduct has been brought to our attention.

8.3 Removal

The removal of a document would only be undertaken where legal limitations have been placed upon the publisher, copyright holder or author(s), for example, if the document is clearly defamatory or infringes others’ legal rights. The bibliographic information for a removed document will be retained on the site along with information regarding the circumstances that led to its removal.

9. Allegations of misconduct

NIHR Open Research is a member of the Committee on Publication Ethics (COPE) and provides an ethical publishing framework in accordance with COPE’s codes of conduct for editors and publishers.

Documents are not peer reviewed and receive only a basic check in house before being posted on NIHR Open Research; publication of documents does not imply endorsement of its content, methods or ethical standards.

If a case of suspected research or publication misconduct is brought to our attention, we will follow COPE guidelines. This may involve contacting the authors’ research institution, an ethics committee or other third parties.

Research misconduct includes data fabrication or falsification, or cases where research involving humans has not been carried out within an appropriate ethical framework. Publication misconduct includes duplicate publication of articles or clear plagiarism. Honest errors or differences of opinion are not considered ‘misconduct’.

10. Policy for Comments

We encourage unsolicited open scientific discussion on all publications. Such contributions are published through our Comment system. To ensure that comments contribute to, and focus on, the scholarly debate, we usually only allow comments from readers who have a formal affiliation with a research institution, or other organisation clearly related to NIHR Open Research‘s scope. Alternatively, we may also allow comments from readers who have demonstrable expertise in a relevant area of research. Consistent with our commitment to full transparency, the reader’s full name and affiliation appear on their public comment.

Comments should focus on the scholarly content presented in the document with which they are associated.

Comments that appear to be advertising, are potentially libelous or legally problematic (including comments revealing patient information) are not permitted. We will not accept Comments that are offensive, indecent or contain negative comments of a personal, racial, ethnic, sexual orientation, or religious character.

All Comments must be written in good English; a Comment may be rejected if it is deemed unintelligible.

Readers who wish to comment are asked to declare any competing interests. Competing interests can be of a financial nature (e.g. holding a patent or receiving fees from a company that may lose or gain financially from the publication of the Comment), or they can be personal, religious, political or other non-financial interests. When completing your declaration, please consider the issues summarized in the Declaration of Competing Interests.

While we welcome open scientific debate and discussion, we will not tolerate abusive behaviour towards our authors and reviewers via our Comment system or via social media. In extreme cases we will consider contacting the affiliated institution to report the abusive behaviour of individuals.

11. Advertising

NIHR Open Research does not publish advertorial documents. Advertisers have no influence on the editorial publication process. Any advertisements, such as online banner adverts, must be clearly distinguished from published content. The publisher reserves the right to place the word “Advertisement” in any material that may - in the publisher’s opinion - be potentially confused with NIHR Open Research publications.