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What are Conflict of Interest Statements, Funding Source Declarations, Author Agreements/Declarations and Permission Notes?

Many Journals request that the Author(s) supply them with one or more of these items at initial submission stage.

Please note:  Most journals require a formal format for these items. A generic form can be found further down this page.

To create one of these items, you're required to:

• Have located a journal to submit to.
• Have checked the Guide for Authors for that journal (sometimes a sample form is provided for you to download and complete).

If these are part of journal requirements, it'll be listed at the 'Attach File/Upload Files' step during the submission process.

Journals may request one or more of the following be uploaded as part of your submission:

An  Author Agreement  is a statement to certify that all authors have seen and approved the final version of the manuscript being submitted. They warrant that the article is the authors' original work, hasn't received prior publication and isn't under consideration for publication elsewhere.

A  Conflict of Interest or Competing Interest  is defined as a set of conditions in which professional judgment concerning a primary interest, such as the validity of research, may be influenced by a secondary interest, such as financial gain. See the  Competing Interests Factsheet  for more information.

A  Declaration of Interest  (sometimes called a Disclosure Statement) is a notification from the author that there's no financial/personal interest or belief that could affect their objectivity, or if there is, stating the source and nature of that potential conflict. To prevent ambiguity, authors must state explicitly whether potential competing interests do or don't exist, so you may be asked to provide one, even if no competing interests exist.

• Many Elsevier journals use our Declaration Tool helps authors step-by-step through the process of preparing well-considered and ICMJE-compliant Please watch this short video on  how to use the Declaration Tool in Editorial Manager .
• Many medical journals follow  ICMJE Recommendations . For these titles, you can download the  ICMJE COI form , complete it and save it on your computer, then submit the completed form to the journal along with your manuscript.

Please refer to each journal’s guide for authors for information on how to provide a Declaration of Interest statement for that journal.

A  Funding Source Declaration  contains a declaration of any funding or research grants (and their source) received in the course of study, research or assembly of the manuscript.

A  Permission Note  is a statement that permission has been received to use any material in the manuscript such as figures etc. which isn't original content. See Elsevier's  Permission Guidelines  for more information.

When in doubt, always consult with your professor, advisor, or someone in a position of authority who can guide you to the right course of action.

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Competing Interests

Authors are requested to disclose interests that are directly or indirectly related to the work submitted for publication. Interests within the last 3 years of beginning the work (conducting the research and preparing the work for submission) should be reported. Interests outside the 3-year time frame must be disclosed if they could reasonably be perceived as influencing the submitted work. Disclosure of interests provides a complete and transparent process and helps readers form their own judgments of potential bias. This is not meant to imply that a financial relationship with an organization that sponsored the research or compensation received for consultancy work is inappropriate.

Interests that should be considered and disclosed include, but are not limited, to the following:

Funding:  Research grants from funding agencies (please give the research funder and the grant number) and/or research support (including salaries, equipment, supplies, reimbursement for attending symposia, and other expenses) by organizations that may gain or lose financially through publication of this manuscript.

Employment:  Recent (while engaged in the research project), present or anticipated employment by any organization that may gain or lose financially through publication of this manuscript. This includes multiple affiliations (if applicable).

Financial interests:  Stocks or shares in companies (including holdings of spouse and/or children) that may gain or lose financially through publication of this manuscript; consultation fees or other forms of remuneration from organizations that may gain or lose financially; patents or patent applications whose value may be affected by publication of this manuscript.

It is difficult to specify a threshold at which a financial interest becomes significant, any such figure is necessarily arbitrary, so one possible practical guideline is the following: "Any undeclared financial interest that could embarrass the author were it to become publicly known after the work was published."

Non-financial interests: In addition, authors are requested to disclose interests that go beyond financial interests that could impart bias on the work submitted for publication such as professional interests, personal relationships or personal beliefs (amongst others). Examples include, but are not limited to: position on editorial board, advisory board or board of directors or other type of management relationships; writing and/or consulting for educational purposes; expert witness; mentoring relations; and so forth. 

Primary research articles require a disclosure statement. Review articles present an expert synthesis of evidence and may be treated as an authoritative work on a subject. Review articles therefore require a disclosure statement.Other article types such as editorials, book reviews, comments (amongst others) may, dependent on their content, require a disclosure statement. If you are unclear whether your article type requires a disclosure statement, please contact the Editor-in-Chief.

Please note that, in addition to the above requirements, funding information (given that funding is a potential conflict of interest (as mentioned above)) needs to be disclosed upon submission of the manuscript in the peer review system. This information will automatically be added to the Record of CrossMark, however it is not added to the manuscript itself. Under ‘summary of requirements’ (see below) funding information should be included in the ‘ Declarations ’ section.

Summary of requirements

The above should be summarized in a statement and included in a section entitled “ Declarations ” before the reference list. Other declarations include Funding, Conflicts of interest/competing interests, Ethics approval, Consent, Data and/or Code availability and Authors’ contribution statements.

Should the information already be mentioned somewhere else in the manuscript, for example under Methods & Materials, please make sure to repeat that information on this page.

Please see the various examples of wording below and revise/customize the sample statements according to your own needs.

When all authors have the same (or no) conflicts and/or funding it is sufficient to use one blanket statement.

Authors are responsible for correctness of the statements provided in the manuscript. See also Authorship Principles. The Editor-in-Chief reserves the right to reject submissions that do not meet the guidelines described in this section.

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Competing interests

On this page, application to authors, application to referees, application to editors, application to external editors, guest editors and editorial board members.

• Nature Portfolio journals' editorials

Application to publishing policy

In the interests of transparency and to help readers form their own judgements of potential bias, Nature Portfolio journals' require authors to declare any competing financial and/or non-financial interests in relation to the work described. The corresponding author is responsible for submitting a competing interests' statement on behalf of all authors of the paper.

For the purposes of this policy, competing interests are defined as financial and non-financial interests that could directly undermine, or be perceived to undermine the objectivity, integrity and value of a publication, through a potential influence on the judgements and actions of authors with regard to objective data presentation, analysis and interpretation.

Financial competing interests include any of the following:

Funding: Research support (including salaries, equipment, supplies, and other expenses) by organizations that may gain or lose financially through this publication. A specific role for the funder in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript, should be disclosed.

Employment: Recent (while engaged in the research project), present or anticipated employment by any organization that may gain or lose financially through this publication.

Personal financial interests: Stocks or shares in companies that may gain or lose financially through publication; consultation fees or other forms of remuneration (including reimbursements for attending symposia) from organizations that may gain or lose financially; patents or patent applications (awarded or pending) filed by the authors or their institutions whose value may be affected by publication. For patents and patent applications, disclosure of the following information is requested: patent applicant (whether author or institution), name of inventor(s), application number, status of application, specific aspect of manuscript covered in patent application.

It is difficult to specify a threshold at which a financial interest become significant, but note that many US universities require faculty members to disclose interests exceeding $10,000 or 5% equity in a company (see, for example, B. Lo et al. New Engl . J. Med . 343, 1616-1620; 2000). Any such figure is necessarily arbitrary, so we offer as one possible practical alternative guideline: "Any undeclared competing financial interests that could embarrass you were they to become publicly known after your work was published."

We do not consider diversified mutual funds or investment trusts to constitute a competing financial interest.

Non-financial competing interests:

Non-financial competing interests can take different forms, including personal or professional relations with organizations and individuals. We would encourage authors and referees to declare any unpaid roles or relationships that might have a bearing on the publication process. Examples of non-financial competing interests include (but are not limited to):

• Unpaid membership in a government or non-governmental organization
• Unpaid membership in an advocacy or lobbying organization
• Unpaid advisory position in a commercial organization
• Writing or consulting for an educational company
• Acting as an expert witness

Top of page ⤴

Authors must disclose and specify any competing interest during the submission process, via declarations in the manuscript submission system. For certain types of content, declarations may be collected via the Nature Portfolio disclosure form. The corresponding author is responsible for providing a declaration on behalf of all authors.

For peer reviewed contributions, authors' declarations are disclosed to peer reviewers in full. However, if authors have opted for double-anonymized peer review, during the peer review process reviewers will be provided with a minimal statement disclosing the existence of any financial or non-financial interest, to prevent the disclosure of authors' identities. Reviewers will be provided the full competing interests declarations at the time of acceptance. Authors opting for double-anonymized peer review should provide their minimal statement (either "The authors declare the existence of a financial/non-financial competing interest" OR "The authors declare no competing interests") in the submission system and a complete statement of disclosure in their cover letter.

In addition to any declarations in submission systems or forms,  all authors regardless of peer review model are required to include a statement at the end of their published article to declare whether or not they have any competing interests. The published article indicates the authors' response using one of the following standard sentences:

• The authors declare the following competing interests:
• The authors declare no competing interests.

We recognize that some authors may be bound by confidentiality agreements. In such cases, in place of itemized disclosures, we require authors to state: "The authors declare that they are bound by confidentiality agreements that prevent them from disclosing their competing interests in this work."

We do not require authors to state the monetary value of their financial interests.

The Nature Portfolio journals invite peer-reviewers to exclude themselves in cases where there is a significant conflict of interest, financial or otherwise. However, just as financial interests need not invalidate the conclusions of an article, nor do they automatically disqualify an individual from evaluating it. We ask peer-reviewers to inform the editors of any related interests, including financial interests as defined above, that might be perceived as relevant. Editors will consider these statements when weighing reviewers' recommendations.

All Nature Portfolio journal editorial staff are required to declare to their employer any interests — financial or otherwise — that might influence, or be perceived to influence, their editorial practices. Failure to do so is a disciplinary offence.

The following Nature Portfolio journals make editorial decisions in collaboration with external editors and editorial board members from within the scientific community: The Communications journals, npj journals , Scientific Reports , Scientific Data.

Editorial Board Members, Guest Editors and Editors are required to declare any competing interests and may be excluded from the peer review process if a competing interest exists. 

In addition, they should exclude themselves from handling manuscripts in cases where there is a competing interest. This may include – but is not limited to – having previously published with one or more of the authors, and sharing the same institution as one or more of the authors.

Where an Editor, Guest Editor or Editorial Board Member is on the author list we recommend they declare this in the competing interests section on the submitted manuscript. If they are an author or have any other competing interest regarding a specific manuscript, another Editor, Guest Editor or member of the Editorial Board will be assigned to assume responsibility for overseeing peer review. These submissions are subject to the exact same review process as any other manuscript.

Nature Portfolio journals' editorials

• Authors will now be asked to declare any interests that might cloud objectivity. Nature , Nature journals tighten rules on non-financial conflicts, January 2018.
• To promote transparency and honesty, it is important for corresponding authors to divulge any financial interests that may affect how their articles are perceived. Nature Photonics , Truth and transparency, June 2013.
• The US government has changed how biomedical scientists disclose their financial interests. The revised rules are welcome, but  internet access to the identified conflicts should be a requirement, Nature, Accountable and transparent, 6 September 2012.
• Claims of conflicts of interest highlight the difficulties facing regulators participating in collaborations with industry. Nature Biotechnology. Conflicts and collaborations , November 2010.
• A one-size-fits-all policy on disclosure of competing interests may not be the way forward. Nature Reviews Clinical Oncology. Conflict of interest disclosures, January 2010.
• Not all financial interests in drug discovery are detrimental, and many are essential for its success. But focusing on perceived conflicts of interest may cause true scientific corruption to go unnoticed. Nature Medicine. A really serious conflict, May 2009.
• The distinction between actual and perceived competing interests. Nature Medicine. The doors of perception , February 2008.
• Scientific endeavours benefit from transparency and open declarations of real or perceived conflicts of interest. Nature Chemical Biology . Keeping it real , April 2007.
• Declaring competing financial interests when publishing a methods paper is essential to maintaining credibility and transparency. Nature Methods. Nothing to declare? November 2006.
• Researchers's disclosures of competing financial interests are undergoing a dangerous transformation from instruments of transparency to evidence of wrongdoing. Nature Medicine. Dealing with disclosure , September 2006.
• A competing financial interests policy adds transparency to the increasingly elaborate net of financial interests in research. Nature Cell Biology . Nothing to declare? June 2004.
• The journal extends its conflicting financial interests policy to include review articles. Nature Neuroscience . Financial disclosure for review authors , October 2003.

Introducing a competing financial interests policy for authors, 2001:

• Nature Neuroscience. A new policy on financial disclosure
• Nature Immunology. Competing financial interests
• Nature. Declaration of financial interests

The Nature Portfolio journals thrive on their independence. Their strict policy is that editorial independence, decisions and content should not be compromised by commercial or financial interests, or by any specific arrangements with advertising clients or sponsors. Our policy is to disclose such arrangements where there is any risk of a perception of compromise.

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• Publication ethics and research integrity: policy guidelines for authors

We all want to ensure that the research you publish with us meets strict quality guidelines. Your reputation, and ours, depends on it. So does the reputation of your research institution on the global stage.  

Here you will find guidance on policies that help us achieve this, and what we ask of you to comply with them. We also recommend taking a look at the guidelines provided by The Committee on Publication Ethics (COPE)  

Declaration of conflicting interests

If you’ve received research funding, or been paid for attending a talk related to your work, these may be interpreted as competing interests. You should declare anything relevant, and we’re here to help you to do so easily by providing sample wording for typical scenarios.

What do authors need to declare? How should authors make this declaration? What do Editors need to declare?

Funding statements

All research articles need a funding statement, so here’s a quick guide to writing one.

Writing a funding statement Industry-funded articles

Ethics approval and informed consent statements

Guidance on preparing ethics statements in support of research findings, with multiple examples of scenarios and statements to get you started.

Studies involving humans Studies involving animals Studies not involving humans or animals Global research ethics and inclusion

Sage follows COPE and ICMJE guidance on the declaration of conflicts of interest by authors, reviewers, and editors. A conflict of interest is defined as any direct or indirect interest that my influence the reading, assessment of or conducting of the research reported in the submission. Any interests within a five-year period prior to beginning the research are considered relevant, although authors must disclose interests outside this time frame if they may have influenced the research. 

What do authors need to declare?

Authors are required to disclose any direct or indirect interests that relate to their submission to any Sage journal so that the editor, reviewers and readers may be able to make informed judgements about any potential bias in the research process, writing or publication. The following interests may present a conflict and should be declared upon submission: 

Financial Interests

• Grants from a funding agency, a commercial entity or any type of payment to authors from organisations that are likely to benefit financially from the research  
• Employment with or affiliation to an organisation that has an interest in the research and/or is likely to benefit from its publication and dissemination  
• Stocks, shares, patents or patent applications or other forms of financial holdings that are likely to benefit from the publication and dissemination of the research  
• Consulting fees, reimbursement or any other payments made to authors for conducting the research  
• Close relatives who may financially benefit from the publication and dissemination of the research  

Non-financial

• Affiliation to an organisation that will have an interest in the outcome such as members of a research advisory board, steering or advisory committees, associations or honorary affiliations  
• Membership of organisations or scientific societies that undertake advocacy work  
• Ideology, beliefs, thoughts, faith relevant to the research topic  
• Activism or other advocacy work related to the research   
• Political leanings or legal action relevant to the research or its potential outcome   
• Research competition, previous personal disagreements, close working relationships with editors, editorial board members  
• Editorial responsibilities or membership of the editorial board of the journal  

How should authors make this declaration?

If you are publishing in a journal that requires a declaration of conflicting interests it should be added under the heading ‘Declaration of conflicting interests’ after any Acknowledgments and before Funding, Notes and References. If there are no conflicting interests, we’ll publish this statement: ‘The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article’.

In your Contributor Agreement you will be asked to certify that:

• All financial support is acknowledged in your article.
• Any commercial or financial arrangements related to your article have been discussed with your Editor, who will advise whether details should be declared.
• You have not signed an agreement with any sponsor that might compromise the impartial reporting of data.

Not all Sage journals require a declaration of conflicting interests to be published alongside your article, but authors are strongly encouraged to declare these upon submission by including these in a cover letter or by writing to the Editor.

Submissions will be evaluated fairly and will not necessarily be rejected when any conflicting interests are declared. If a relevant conflict that was not declared by authors becomes apparent at any time during the peer review or publishing process, the Editor reserves the right to reject the submission. Sage will follow COPE guidelines for any conflicts that come to light post-publication.  

What do Editors need to declare?

All Editors are required to declare any conflicts of interest that may impact the peer review and decision-making process. If a conflict arises, an alternative member of the Editorial board must be appointed and the Editor with the conflict must recuse themselves from the decision-making process. These conflicts include financial and non-financial interests listed above.

• If the Editor is based at the same institution as the authors or has previously conducted research with them in the last three years, they should recuse themselves from the peer review and decision-making process.  
• Journal Editors or members of the editorial board submitting their research to their own journals may do so and must declare their involvement with the journal as a conflict of interest. Where applicable, the Journal Editor or Editorial Board member must recuse themselves from the peer review process. The Journal Editor must appoint another member of the Editorial board who will invite two or more subject experts to evaluate the manuscript.   
• Guest Editors may submit their research to a special issue or special collection they are leading and must declare a conflict of interest upon submission. Where Guest Editors are involved in peer review and final decisions, their submissions will be handled by an alternate member of the editorial board or the Journal Editor.   

Sage Editorial Staff 

All Sage editorial staff are required to declare their employment at Sage as a conflict of interest in any submission they send to a Sage journal. These submissions are treated as any other submissions within the journal.

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All research articles need a funding statement, so here’s a quick guide to writing one. It should appear under the heading ‘Funding’ after any Acknowledgments and Declaration of conflicting interests, and before Notes and References.

This should comprise the text in bold in the example below, followed by the full name of the funding agency, and the grant number in square brackets:

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Medical Research Council [grant number xxx].

Multiple grant numbers should be separated by commas, multiple agencies by semicolons.

What if your research was supported indirectly by grants available to your institution, but not to you personally? In this case, simply include this statement:

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Note: If you have any concerns that the information you give may compromise your anonymity prior to the peer review process, you can choose to wait until you submit your final accepted manuscript.

Industry-funded articles

We can only consider industry-funded articles if funding is fully declared within the manuscript, together with any role in the design of the study or in the analysis and interpretation of data played by the funder.

Both direct and indirect funding must be declared, whether funding is in full or in part. Indirect funding includes organisations associated with the research and/or authors receiving funding from one of the industries below, or any industry where the funder could be seen to have a vested interest in the results of a study.

Industries include but are not limited to:

• Pharmaceuticals
• E-cigarettes

Failure to declare industry-specific funding can lead to the rejection of your article at submission, or retraction of the whole article if the oversight comes to light after publication.

How do we make sure that we maintain high ethical standards in publishing? By including clear statements in support of results reported in articles. Here is guidance, with examples of sample statements, for:

Studies involving humans

All studies involving humans, for example including patients, their samples, data or any other study involving human participants must be evaluated by a suitably qualified research ethics committee prior to undertaking the research in line with the Declaration of Helsinki .

All studies involving people, whether patients or research participants, must be evaluated by a qualified research ethics committee prior to undertaking the research in line with the Declaration of Helsinki .

Ethics statements should be included in the methods section of all relevant submissions (unless the journal you’re submitting to publishes them under a separate heading – the journal’s submission guidelines will make this clear) and must include the name and location of the review board, approval number and date, as in the examples below.

Ethics approval statements

These examples can be used If ethics approval was obtained:

This study was approved by the XXXX Research Ethics Committee (approval no. XYZ123) on Month DD, YYYY.

This study received ethical approval from the XXXX IRB (approval #XYZ123) on Month DD, YYYY.

Examples of ethics approval statements suitable for different scenarios:

The XXXX Ethics Review Committee at XXXX University approved our interviews (approval: XYZ123) on Month DD, YYYY. Respondents gave written consent for review and signature before starting interviews.

This study received ethical approval from the XXXX IRB (approval #XYZ123) on Month DD, YYYY. This is an IRB-approved retrospective study, all patient information was de-identified and patient consent was not required. Patient data will not be shared with third parties.

The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of XXXX (no. XYZ123) on Month DD, YYYY, with the need for  written informed consent waived. 

This study was conducted in accordance with the Declaration of Helsinki. Approval was granted on Month DD, YYYY. The Institutional Review Board (IRB) at XXXX acted as the central IRB, whose review was accepted by all participating institutions’ IRBs (Ref. XYZ123). The central IRB determined that this research involved minimal risk and approved a waiver for informed consent.

This study was approved by the Ethics Committee of XXXX University (Ethics Code: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to enrolment in the study. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

The ethics review committee of the XXXX University approved this study on Month DD, YYYY. Number: XYZ123. Date: Month DD, YYYY. Written informed consent for inclusion in this research was obtained from the patients prior to surgery.

The experimental protocols were approved by the Institutional Review Board (IRB) of the XXX University (No. XYZ123) on Month DD, YYYY. All research activities complied with ethical regulations and were performed in accordance with regulations of each hospital. Informed consent to use histopathological samples and pathological diagnostic reports for research purposes was obtained from all patients prior to surgery. They were given the option to refuse to participate by opting out.

These examples can be used if ethics approval and patient consent were waived:

The Ethics Committee of the XXXX waived the need for ethics approval and patient consent for the collection, analysis and publication of the retrospectively obtained and anonymised data for this non-interventional study.

The study was approved by the Danish Data Protection Agency. According to Danish legislation, neither ethics  approval nor patient consent is required for registry linkage studies [23].

Case reports

Ethical approval to report this case (or case series) was obtained from *name of ethics committee or institutional review board (approval number/ID)*.  

Our institution does not require ethical approval for reporting individual cases or case series.

Patient or participant consent

In all cases, it’s important to state that consent has been granted to use any personal information, and how that consent has been gathered. Informed consent includes three key components:  

• Communication of information  
• Comprehension of information  
• Voluntary participation

For research articles, you need to state in the methods section whether the participants provided written or verbal informed consent. This statement should include whether the participants provided consent to conduct the study, publish the study, and have their photos or other images used . If information has been anonymized, that should be clearly stated too. If you are publishing on an open access basis, patients or participants must be aware that the article will be available to anyone with an internet connection.

The American Psychological Association (APA) recommends that for those who are legally incapable of giving informed consent, researchers should:  

• Provide an appropriate explanation  
• Seek the individual's assent  
• Consider the person’s preferences and best interests  
• Obtain appropriate permission from a legally authorized person, if such a substitute consent is permitted or required by law  

If the law doesn’t permit or require a legally authorized person to provide consent, you’ll need to show that you’ve taken reasonable steps to protect the individual's rights and welfare.   Participants should be informed about:  

• The purpose, duration, and procedure of the research  
• Their right to decline to participate and how to withdraw from the research along with the possible consequences  
• Factors that may be expected to influence their willingness to participate, such as potential risks, discomfort, or adverse effects  
• Prospective research benefits and incentives for participation  
• Limits of confidentiality  
• Whom to contact for questions about the research and research participants’ rights.  

You can access Sage’s Participant Consent Form here . Authors should not submit completed consent forms alongside the manuscript files unless specifically requested to do so, owing to potential legal/privacy issues with sending and receiving confidential information. Instead, they should confirm in the relevant section of the – e.g. manuscript – text that the individual(s) or their proxy has provided written informed consent for the publication of this information in the present work.

Informed consent for ethnographic research  

Ethnographic research requires similar ethics approvals from an International Review Board or independent local, regional, or national review body as well as participant consent to conduct and publish the research. Consent should obtained before the research is conducted and it should be part of the project design, implementation, and other parts of the research process. Consultation with groups or communities affected by the studies and consideration of their input on the study design should happen throughout the entire research period. If consent is not obtained before the study perhaps because of the research context, process, or researcher/participant relations, you can seek to obtain it retroactively if necessary.  

Participants should also understand that there is a possibility that confidentiality might be compromised, despite best efforts. This is especially important to note for small communities where participants may be more easily identifiable.

Examples below if consent was obtained:

1.      Written informed consent

The study was approved by the XXXX (Ethical Clearance Reference Number: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to participating.

Written informed consent was obtained from a legally authorised representative for anonymised patient information to be published in this article.

2.      Verbal informed consent

Informed consent was obtained verbally before participation. The consent was audio-recorded in the presence of an independent witness.

3.      Patient consent for studies involving minors

Written informed consent to participate in this study was provided by the participants’ legal guardians/next of kin.  

4.     Patient or participant consent for use of images including faces

Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.

If patient consent was not obtained:

Informed consent for information published in this article was not obtained because [please state the reason].

Studies involving animals

All studies involving animals, particularly vertebrate animals, must be evaluated by a qualified animal ethics or welfare committee. Ethics statements should include the name and location of the reviewing committee, approval number and date, as in these examples:

Protocols for animal experiments were approved by the Animal Experimental Ethics Committee of the XXXX University (Approval no. XYZ123) on Month DD, YYYY, in compliance with the National Institutes of Health guidelines for the care and use of laboratory animals.

All animals were cared for in strict accordance with the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 85-23, revised 1996), and the experimental design was approved by the Ethics Committee of XXXX (Approval no. XYZ123) on Month DD, YYYY.

If IACUC approval was obtained you can use the example below:

The XXX Institutional Animal Care and Use Committee approved the experimental procedures used in this study (approval no. XYZ123) on Month DD, YYYY.

An example on animal welfare:

All animal housing and experiments were conducted in strict accordance with the institutional Guidelines for Care and Use of Laboratory Animals at [insert name of institution where the research was conducted and/or where the author is based].

Studies not involving humans or animals

These statements can be used in situations where a study did not involve human or animal participants as well as non-research articles such as reviews:

This article does not contain any studies with human or animal participants.

There are no human participants in this article and informed consent is not required.

Global research ethics and inclusion

If your article reports on global research, you should follow the TRUST Code . We recommend including a statement in your methods section describing how your work adheres to the Articles in the Code. Some journals may require a statement under the separate heading ‘Global research ethics and inclusion’ at the end of your article. This should cover the following:

• Confirm that the research has local relevance and has been designed and conducted in collaboration with local communities. Note that contributors meeting the requirements of authorship as per the ICMJE Guidelines must be listed as authors. Sometimes research is conducted in low- and middle-income countries in partnership with researchers from higher income countries. In these cases it is expected that local researchers are listed in first and/or last authorship positions to reflect the significant contribution they will have made. Joint first and/or joint senior authorship is an option here.
• Confirm that local ethics review was sought and if not, explain the reasons why.
• Where research involvement presented any kind of risk to participants e.g. discrimination, incrimination or risk to personal health and safety, describe the special measures taken to ensure their safety and wellbeing that were agreed with local partners.
• Explain how communication was tailored to the requirements of local participants to ensure that informed consent was freely given, and any feedback on findings was comprehensible to local communities. Describe how any potential cultural sensitivities were explored in advance.
• Confirm that all research was conducted to the highest possible ethical standards, regardless of the requirements of the local setting.

We also recommend the guidance provided by Consensus statement on measures to promote equitable authorship in the publication of research from international partnerships (Morton, B. et al, 2022) .

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Conflict of interest.

The authors should reveal to the editor any potential conflict of interest. Conflicts of interest include affiliation or involvement in an organization or entity with a financial or non-financial interest in the subject matter or materials discussed in this manuscript (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) that might be affected by publication of the results contained in a manuscript. The authors should ensure that no contractual relations or proprietary considerations exist that would affect the publication of information in a submitted manuscript.

Please select one of the following:

There are no conflicts of interest.

Conflicts of interest have been declared to the Editor and will be included in a Conflict of Interest Declaration section of the final paper.

Statement on Human Research

Research involving human participants must have been conducted according to the Common Rule . Authors must adhere to all research ethics guidelines of their discipline, and institution particularly where human participants are involved. Studies that involve human participants must include a statement that the study has been approved by the appropriate research ethics committee and were performed in accordance with the ethical standards stated in the 1964 Declaration of Helsinki and its later amendments. If guidelines are not available in the country where the research is being performed, we recommend following the guidelines described by the National Institutes of Health, USA.

This article does not include research in which human participants were involved.

All procedures performed for studies involving human participants were in accordance with the ethical standards stated in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all participants. Documentation provided upon request.

Policy on Informed Consent

Informed consent is a voluntary agreement to participate in research. Informed consent protects the rights, safety, wellbeing and interest of all participants. The Belmont Report and the Nuremberg Code both address voluntary informed consent as a requirement for the ethical conduct of all types research on human participants. All participants must give their informed consent in writing prior to inclusion in a study.

Authors must declare: Informed consent was obtained from all participants included in the study or informed consent not applicable.  Informed consent not applicable. Informed consent was obtained for all individuals. Documentation provided upon request.

Statement on Animal Research

Authors must adhere to all research ethics guidelines of their discipline, and institution particularly in cases when animal participants are involved. Authors must indicate that international, national, and institutional guidelines for the care and use of animals have been followed and that the studies were approved by a research ethics committee. If guidelines are not available in the country where the research is being performed, we recommend following the guidelines described by the National Institutes of Health, USA.

Please select one of the following: This article does not include any research in which animal participants were involved. This article includes research with animal participants were involved. All the applicable international, national, and institutional guidelines for the care and use of animals were followed. Documentation provided upon request.

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html https://olaw.nih.gov/policies-laws/phs-policy.htm 1964 Declaration of Helsinki Belmont Report Nuremberg Code

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Authors are required to declare what support they received to carry out their research. ASME offers the option to include funding sources in a standardized way. Authors may choose their funder from a given list. If funding information is not available from the list it may be added manually upon final paper submission.

Funding information will be published as searchable meta-data for the accepted article. It will be made publicly available through Crossref's funding data search .

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Improving researchers’ conflict of interest declarations

Commercial influence in health: from transparency to independence, click here to read the complete collection, please sign our call to action, your opportunity to support greater independence from commercial interests in healthcare and share your thoughts and ideas about how this can be achieved..

• Related content
• Peer review
• Quinn Grundy , assistant professor 1 2 ,
• Adam G Dunn , associate professor 3 4 ,
• Lisa Bero , professor 2
• 1 Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
• 2 Charles Perkins Centre, School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia
• 3 Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia
• 4 Discipline of Biomedical Informatics and Digital Health, School of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
• Correspondence to: Q Grundy quinn.grundy{at}utoronto.ca or @QuinnGrundy on Twitter

Enforced, structured reporting and processes to assess relevance are required to make conflict of interest disclosures fit for purpose, argue Quinn Grundy , Adam Dunn , and Lisa Bero

Transparency of financial interests is expected in medical research, but our ability to assess bias is limited because disclosures are incomplete, inconsistent, and difficult to access at scale. True transparency involves more than just making conflict of interest disclosures available; they also need to be accessible, accurate, complete, and clear about relevance. There have been several calls for standardising the reporting of conflict of interests 1 2 since the Institute of Medicine first recommended it 10 years ago. 3 The International Committee of Medical Journal Editors (ICMJE) and Committee on Publication Ethics (COPE) recommend that journal editors require published statements declaring authors’ conflicts of interest. 4 5

Despite the apparent policy consensus, disclosure practices are plagued by recurring problems with non-disclosure and inconsistent reporting. The result is that the policy conversation is fixated on the shortcomings of the disclosure system rather than on how to deal with relationships that threaten research integrity. The ICMJE is consulting on updating its declaration form to improve transparency, completeness, and consistency of disclosures. We also need to enforce accessible, accurate reporting and develop processes to assess relevance so that we can move the debate forward, from being about greater transparency to being about greater independence from commercial influence.

Trouble with existing declarations

In our study of the prevalence of conflict of interest disclosures in a random sample of 1002 biomedical articles, authors disclosed a conflict of interest in 23% of articles and said they had no conflict in 64%; 14% of articles did not include a disclosure statement. 6 Though the included journals stated that they follow ICMJE recommendations, we found it hard to arrive at these figures because disclosure statements were often inaccessible, inconsistent, or missing key information necessary to judge relevance.

Poor accessibility

Most articles contain conflict of interest statements in the online and PDF version. In others, however, the statements are only available online, as supplementary files, or on separate web pages, or are unavailable because links to disclosure statements are broken or missing. Some journals provide links to a PDF of the authors’ uploaded ICMJE forms instead of providing complete summaries and some include only the links with no disclosure in the article at all. The longest supplementary PDF we found totalled 94 pages (for 31 authors). 7 Occasionally, articles have more than one conflict of interest disclosure statement published in different locations, and these statements may be inconsistent. 8 9

Inconsistency

Journals use diverse headings to identify conflict of interest statements ( box 1 ), suggesting that they have not implemented a clear and consistent definition. This makes it challenging to automate extraction of disclosures for analysis, even from well structured web pages. Since March 2017, some publishers have included conflicts of interest in the metadata used by PubMed. 10 This could be a way to improve accessibility by centralising where disclosures are recorded.

Headings and keywords that journals use to indicate conflict of interest statements

Acknowledgments

Commercial relationships

Competing interests

Competing conflict of interest

Conflict of interest

Declaration of interest

Disclosures

Disclosure statement

Duality of interest

Financial conflict of interest

Financial interest

Potential conflict of interest

Proprietary or commercial interest

Receipt of benefits

Sources of funding

Conflict of interest statements are often conflated with statements about the funding of the research presented, making it difficult to assess individual authors’ conflicts of interest and study sponsorship separately. We argue that these disclosures should be reported separately because some evidence suggests that funding source and author conflict of interest are independently associated with risk of bias, 11 12 though the likelihood of confounding is high. 13

When conflict of interest disclosures are identified, substantial variability in the language used to make disclosures makes it difficult to interpret the meaning. We identified 130 different ways of stating “no conflicts of interest” across the 637 articles whose authors declared no conflict of interest, 6 ranging from one word (“nil” or “none”) to a 62 word statement:

“The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.”

Some of the variants change the meaning of the statement, suggesting that conflicts of interest might exist but are not disclosed ( table 1 ).

Categories of statements indicating no conflict of interest

• View inline

Missing information

Compounding the problems of accessibility and semantics is the problem of relevance and who should judge this. Current reporting practices rely on authors to judge the relevance of any interests to the work under consideration, though journal policies and procedures and editorial discretion may also influence what gets reported. For example, the ICMJE form asks authors to “disclose interactions with any entity that could be considered broadly relevant to the work.”

Journal editors, peer reviewers, and readers should be able to judge the relevance of disclosed interests to the work to evaluate whether a conflict of interest exists. However, the necessary contextual information is typically lacking in statements and forms. The result is that although conflict of interest disclosure is widespread, disclosures are not meaningful.

Obfuscation

Authors sometimes seek to define relevance in disclosure statements using adjectives such as “potential,” “relevant,” and “financial” to modify “conflict of interest” or contextualising statements by stating that disclosures pertained to “this work” or “this manuscript.” In some cases, authors disclose seemingly relevant financial ties but make statements that obfuscate whether the disclosed relationship constitutes a conflict of interest. 9 For example, in an angiography clinical trial, the authors reported receiving speakers’ fees and unrestricted grants from multiple medical device manufacturers with related products under the heading “Sources of funding” but included nothing under “Disclosures.” 14

In other cases, authors provide disclosures that include personal and professional biographical information, funding information that should be in another section of the article, or ambiguous descriptors that may obscure key signals of risk of bias such as financial relationships with industry. For example, one article with 17 authors had a 706 word disclosure statement that was located only in the 63 pages of supplementary ICMJE forms; it included numerous conflicts of interest, as defined by the ICMJE, among disclosures of receipt of public funding and honorariums from not-for-profit organisations (eg, public universities, hospitals); one of the authors disclosed receipt of personal fees from 42 bodies outside of the submitted work, including 23 drug and medical device companies. 15 Designations such as “unpaid consultancy” may mask the nature of the relationship with industry and fail to make transparent other transfers of value such as paid travel. 16

What should happen next?

To strengthen transparency while minimising burden on authors and editors, the biomedical research community should develop a public, comprehensive, structured, author centric database of financial interests. 2 3 17 The Institute of Medicine has proposed a detailed taxonomy for conflicts of interest, 17 which could serve as a standardised digital template for disclosure while providing adequate detail about the nature of the relationship or interest.

Table 2 sets our recommendations to help authors, editors, and peer reviewers identify, evaluate, and report conflicts of interest, drawing from the work of the ICMJE, 4 Institute of Medicine, 1 and the US Open Payments system. 18

Policy recommendations for identification, evaluation, and reporting of conflicts of interest and how they compare with ICMJE recommendations

The Open Payments database, created through the US Physicians Payments Sunshine Act, is a notable model in achieving transparency, though it applies only to prescribing clinicians and certain manufacturers in the US. Access to these detailed, accurate, structured data has enabled researchers to understand the extent and the impact of physicians’ relationships with drug and device companies. 19 20 21 The success of the Open Payments database argues for other countries to establish their own open payment databases and for any registry to be publicly funded and coupled with enforcement mechanisms.

ORCID would be well placed to act as a repository for information on conflict of interests given its international scope and strong uptake among biomedical journals. ORCID is a not-for-profit organisation, funded through member contributions, that provides researchers with a unique, persistent digital identifier and infrastructure to support automated linkages across their professional activities. 22 With leadership from organisations such as ICMJE and COPE, the manuscript submission software used by journals could, for example, include an interface to allow authors to automatically export relevant disclosures from a registry such as ORCID. 2

Enforcement

The variability in how conflicts of interest are reported is probably related to journals having differing requirements for statements rather than a consequence of author intentions. Currently, the onus is on authors to disclose, which makes a breach of this honour system a serious violation of trust. Journal editors often do not have the information or resources needed to identify or verify authors’ conflicts of interest. 23 The ICMJE recently revised its policy to include purposeful non-disclosure of conflicts of interest as a form of scientific misconduct. 4

However, 14% of articles published in journals claiming to adhere to the ICMJE recommendations still do not routinely include conflict of interest statements. 6 ICMJE has limited ability to enforce its guidance but, at minimum, organisations such as COPE should not permit membership to journals that do not conform to these standards.

Assessment of relevance

Though the ICMJE recommends that authors report details on the funding source and the specific role of the sponsor in the design, conduct, and publication of the research, there is no equivalent requirement for authors to provide such structured detail in their declarations of conflicts of interest. 4 For example, when an author discloses personal fees from multiple entities, there is rarely information about the scope or extent of the relationships, how the scientific work relates to a company’s products, or the specific reason for the receipt of payment.

We propose that authors make use of public databases, where these exist, to report and maintain a structured and comprehensive list of their disclosures, and that these complete disclosures are made publicly available through a link in the article. Separately, we suggest that authors state which interests are relevant to the manuscript and why, that this statement is peer reviewed and adjudicated by editors and is visibly and succinctly included in all forms of the manuscript under the standard heading “conflicts of interest.” Box 2 provides a sample statement.

Sample conflict of interest disclosure statement including relevance

Conflicts of interest: DD holds a leadership position in an advocacy organisation (National Sexual Health Association) and is a clinical specialist, deriving income from diagnosing and treating sexual health conditions. DD is engaged as a consultant (BioX Company) and receives research funding from companies (GlaxoSmithKline and Merck). The intervention tested in this study is made by BioX, and all of the companies mentioned above market vaccines related to sexual health. DD holds a patent for a diagnostic test for tuberculosis, unrelated to this study.

[Link to full disclosure statement]

Enforced and structured reporting of conflicts of interest would enable large scale retrospective studies of the association between conflicts of interest and research methods, results, and conclusions. Future work should also consider randomised trials of structured reporting systems to assess author, editor, peer reviewer, and consumer usability and acceptability, and the effect on assessment of risk of bias in published work.

Conflict of interest disclosures should help us to evaluate risk of bias in biomedical research, but currently they only muddy the waters. Instead of providing an obvious and clear signal to readers of biomedical research, current practices obfuscate the underlying relationships or flood the signal with noise. To improve consistency, and as a necessary step towards achieving greater independence for healthcare research, we need consensus around the definition of conflict of interest and harmonisation of practices across journals and publishers.

Key messages

Disclosures of conflicts of interest in published biomedical articles vary widely in terms of location, format, wording, and content

Inconsistency creates problems with accessibility, semantics, and assessment of relevance

To assess research integrity, disclosures must be accessible, complete, accurate, and meaningful

A central database and standardised reporting are needed to improve transparency

Contributors and sources: The authors conduct qualitative and quantitative meta-research related to bias and conflicts of interest in biomedical research. All authors contributed to the planning, writing, and editing of this article. QG conducted the descriptive analyses of conflict of interest reporting and is the guarantor.

Competing interests: We have read and understood BMJ policy on declaration of interests and declare support from the Canadian Institutes of Health Research and National Health and Medical Research Council.

Provenance and peer review: Not commissioned; externally peer reviewed.

This article is part of a collection on commercial interests, transparency, and independence, based on ideas generated by BMJ editors in collaboration with external advisers Ray Moynihan (Bond University) and Lisa Bero (University of Sydney).

• Lichter AS ,
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Conflict of Interest Principles and Examples

Information for departments and individuals.

Staff, students and others working in the University are encouraged to discuss issues related to conflicts of interest with Heads of Department, colleagues, mentors, supervisors, tutors, or others as appropriate.

Additional information

See the quick links for further guidance and training.

Use the contact details on this page if you have questions about how to apply the policy and procedures in a particular situation.

Conflict of Interest Principles

Roles and activities outside the university, student supervision and teaching, other university activities (committee work, procurement, recruitment, admissions, contract negotiation), illustrative examples of conflicts of interest, examples for academics, examples for researchers, examples for members of staff and committee attendees.

COI Committee Secretary:  [email protected]

For further information contact the Risk, Compliance and Assurance Team:

[email protected]

Quick links

• How to seek approval to hold consultancies and other external appointments
• Conflict of Interest Policy
• Guidance and templates