Ethics & Integrity in Scholarly Publishing

EURAXESS

25th September 2020

Sarah Robbie

Head of Research Integrity & Ethics

Sarah.Robbie@tandf.co.uk

1

Outline

• Ethics in the scholarly system• Research ethics – key considerations• Clinical trial registration and informed consent• Publication ethics – who guides this? • Publication ethics – common issues which arise• The responsibility of authorship• Purpose of Correction, Expression of Concern and Retraction notices• Tips on avoiding problems• Q&A

Ethics

Research Publication

• Declaration of Helsinki• Declaration of Belem• Societies code of ethics• Institutional ethics

committee• Local laws

• International Committee of Medical Journal Editors (ICMJE)

• Committee on Publication Ethics (COPE)

• Good Publication Practice (GPP3)

Research ethics - humans

• To protect human participants

• To ensure research is conducted to serve interests of individuals, groups and/or society

• Management of risk, protection of confidentiality and informed consent

• Respect for cultures and heritage

Guidance:WHO Research EthicsDual Use Research of ConcernDeclaration of Helsinki Declaration of Belem

Research involving human subjects, human material, or human data, must have been performed in accordance with the Declaration of Helsinki and must have been approved by an appropriate ethics committee.

Experimental research on vertebrates or any regulated invertebrates must comply with institutional, national, or international guidelines, and where available should have been approved by an appropriate ethics committee.

Study design and conduct according to 3R’s principles (Replace, Reduce, Refine)

Guidance:

Basel Declaration: basel-declaration.org/basel-declaration/

International Council for Laboratory Animal Science:iclas.org/committees/ethics-and-animal-welfare-committee

ARRIVE: https://www.nc3rs.org.uk/arrive-guidelines

Research ethics - animals

Research ethics - plants

Experimental research on plants (either cultivated or wild), including collection of plant material, must comply with institutional, national, or international guidelines. Field studies should be conducted in accordance with local legislation.

Guidance:• Convention in international trade in endangered species of wild fauna

and flora (CITES)• IUCN Policy Statement on Research Involving Species at Risk of

Extinction

Study designs & ethics

Many different study designs, therefore many ethical considerations:

• Retrospective studies: permission must be obtained to use participant details, prior to starting the study. Participants should be kept anonymous. Permission acquired to use a dataset for research.

• Prospective cohort studies and RCTs: informed consent; participants kept safe at all times; patients/study participants know they can leave the study at any time with no repercussions.

• Animal models: must comply with institutional, national, or international guidelines. 3R’s principles (Replace, Reduce, Refine).

• Endangered species: where ethical approval has been obtained, in some cases it is necessary to redact information about the location.

• Biosafety and biosecurity: consider all possible dual-use of research and take steps to mitigate misuse of information provided via the research.

Informed consent

• Informed consent should be documented in studies involving human participants

• This includes:

– Prospective studies

– Interviews

– Focus groups

– Parental/guardian consent for children <16-18 (determined by national laws)

– Guardian consent for incapacitated or vulnerable people

• If ethics committee waived the need for consent, this should be explained

• Typically, this will be documented as written informed consent, but in some

cases verbal consent is more appropriate (e.g. if participants are illiterate)

Informed consent: major elements

• Disclosure of information (including explanation of any risks)

• Competency of the participant (or parent/guardian)

• Voluntary participation and freedom to leave the study at any time

https://authorservices.taylorandfrancis.com/editorial-policies/

What is publication ethics?• Based on consensus about

standards and best practice

• Ensures the integrity of the scholarly record

• Ensures that readers can trust what they read

• Ensures scholars and researchers can build upon published work

Societies

Who guides publication ethics?

The ICMJE recommendations are a set of guidelines produced by the ICMJE for standardizing the ethics, preparation, formatting, reporting and publication of content in medical journals. Launched 1978

COPE is a forum for editors and publishers, providing education and resources on all aspects of publication ethics. It also advises editors on how to handle cases of research and publication misconduct. Launched in 1997

WAME is an association of editors representing medical journals globally. The aims of the group include fostering cooperation and improving editorial standards in medical editing. Launched in 1995

Good Publication Practice guidelines (GPP3) updated in 2015 was developed to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. First version published in 2003

Analysis by Science and Retraction Watch on 10,500 retracted journal articles showed that majority of retractions are due to fraud (fabrication, falsification, plagiarism) and other misconduct (fake peer review)

Brainard J, You J: What a massive database of retracted papers reveals about science publishing’s ‘death penalty’ ; Science Oct 25, 2018

Publication ethics- issues that can arise

• Authorship (disputes; ghost; gift; ’for sale’)

• Affiliation misrepresentation

• Inappropriate references/poor attribution

• Competing interests (under-reporting; personal CI’s)

• Consent to publish (includes Acknowledgements)

• Inadequate/selective reporting of research (irreproducible research and bias)

• Data sharing (should adhere to FAIR principles; sensitive data)

• Duplicate submission/publication

• Data or image fabrication/falsification

• Plagiarism/ text recycling

• Peer review manipulation

• Citation manipulation

• Breaches of copyright

• Unethical research

• Hoax submissions

• Papermills

Publication ethics- issues that can arise

• Authorship (disputes; ghost; gift; ’for sale’)

• Affiliation misrepresentation

• Inappropriate references/poor attribution

• Competing interests (under-reporting; personal CI’s)

• Consent to publish (includes Acknowledgements)

• Inadequate/selective reporting of research (irreproducible research and bias)

• Data sharing (should adhere to FAIR principles; sensitive data)

• Duplicate submission/publication

• Data or image fabrication/falsification

• Plagiarism/ text recycling

• Peer review manipulation

• Citation manipulation

• Breaches of copyright

• Unethical research

• Hoax submissions

• Papermills

Authorship

Authorship: who qualifies?

• Made a significant contribution to the work reported, whether that’s in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas.

• Have drafted or written, or substantially revised or critically reviewed the article.

• Have agreed on the journal to which the article will be submitted.

• Reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage.

• Agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Any listed author is a representative of the published paper and agrees to share accountability.

Authorship comes with legal responsibilities.

Authorship dispute: what are the issues?

• Can’t be resolved by us

• If manuscript has not been published yet, all processes should be halted while the dispute is ongoing (authors should be notified)

• Typically the institution needs to get involved

• Once consensus is reached between all authors (including any added or removed), then we can proceed

• Best practice is to ask all authors to confirm they agree to the new author list and authorship order (corresponding author should coordinate)

• Article reviewed and accepted by Editor• Once received by the production team, the corresponding author

contacted the Production Editor and asked for their co-author to be removed from the authorship list

• Co-author was contacted for confirmation, but a dispute ensued• This was escalated to the Editor and upon query it transpired that

personal issues had led to a relationship breakdown between the corresponding author and the co-author

• We refused the removal of the co-author, as their contributions met the authorship criteria. The article was published with the original full author list

Case: authorship dispute

Policy on changes to authorship: Anyone who meets the authorship criteria should be listed as an author, and can only be removed at their own request. This needs to be confirmed by all remaining authors who should also confirm they agree to any changes in authorship order

Gift Authorship: what are the issues?

• Dishonest representation of who was involved in the work

• Listed authors must be accountable for the published work

• Encourages dishonest scholarly behaviour

• Sometimes occurs without the knowledge of whomever has been “gifted” the authorship

Authorship ‘for sale’

Agency led paper-mills sell authorship to papers, often containing faked data, manipulated or stock images, high levels of plagiarism, etc

Some prominent authorship spots (e.g. first or last author) are sold directly in exchange for hefty sums of money

Leads to publication of dishonest and unreliable work, duplicate submissions/publications (with different author lists), salami slicing, researchers being listed as authors on topics outside their area of expertise and reputational damage for authors.

Ghost Authorship: what are the issues?

• Differs from “craftmanship” (e.g. medical/scientific writers)

• Lack of credit for those who have contributed to the work

• Conceals involvement of those who have influenced the research, data analysis, conclusions etc

• Conceals relevant competing interests

Competing interests

To ensure transparency, any associations which can be perceived by others as a competing interest must

also be declared.

Examples of financial competing interests include (but are not limited to):

• Employment or voluntary involvement• Collaborations with advocacy groups relating to the content of the article• Grants from an entity paid to the author or organisation• Personal fees received by the author/s as honoraria, royalties, consulting fees, lecture fees,

testimonies, etc• Patents held or pending by the authors, their institutions or funding organizations, or licenced to an

entity whether earning royalties or not• Royalties being received by the authors or their institutions• Stock or share ownership• Benefits related to the development of products as an outcome of the workExamples of non-financial competing interests include (but are not limited to):

• Receipt of drugs, specialist equipment, tools, computer programmes, digital applications, etc or access to data repositories, archival resources, museum collections, etc by an entity that might benefit or be at a disadvantage financially or reputationally from the published findings.

• Holding a position on the boards of industry bodies or private companies that might benefit or be at a disadvantage financially or reputationally from the published findings.

• Writing assistance or administrative support from a person or organisation that might benefit or be at a disadvantage from the published findings.

• Personal, political, religious, ideological, academic and intellectual competing interests which are perceived to be relevant to the published content.

• Involvement in legal action related to the work.

Competing interests – editorial policies

To ensure transparency, any associations which can be perceived by others as a competing interest must

also be declared.

Examples of financial competing interests include (but are not limited to):

• Employment or voluntary involvement• Collaborations with advocacy groups relating to the content of the article• Grants from an entity paid to the author or organisation• Personal fees received by the author/s as honoraria, royalties, consulting fees, lecture fees,

testimonies, etc• Patents held or pending by the authors, their institutions or funding organizations, or licenced to an

entity whether earning royalties or not• Royalties being received by the authors or their institutions• Stock or share ownership• Benefits related to the development of products as an outcome of the workExamples of non-financial competing interests include (but are not limited to):

• Receipt of drugs, specialist equipment, tools, computer programmes, digital applications, etc or access to data repositories, archival resources, museum collections, etc by an entity that might benefit or be at a disadvantage financially or reputationally from the published findings.

• Holding a position on the boards of industry bodies or private companies that might benefit or be at a disadvantage financially or reputationally from the published findings.

• Writing assistance or administrative support from a person or organisation that might benefit or be at a disadvantage from the published findings.

• Personal, political, religious, ideological, academic and intellectual competing interests which are perceived to be relevant to the published content.

• Involvement in legal action related to the work.

Competing interests – editorial policies

Consent to publish

Consent to publish

Required for:

• Identifiable patient, study participant information e.g. age, gender, diagnosis, treatment, occupation, etc

• Patient/participant images (including photos, scans), videos, audio recordings, etc

• Authors should include a statement within the manuscript to confirm they have obtained consent to publish from the participants (or guardians, next of kin, etc)

T&F Consent to Publish form

If we request a copy, it must be stored securely and destroyed when no longer needed

• Authors must notify and obtain permission from anyone named within the Acknowledgments section

• Gives them the option to not be named (personal reasons, political reasons etc)

• Person being acknowledged may think they should be an author rather than just be acknowledged

• Authors should declare at submission they have obtained agreement from those being named

Acknowledgments

Duplicate submissions and publications

• Cannot submit to more than one journal at the same time

• Authors must declare at submission that the manuscript has not been submitted elsewhere

• Prior to publication authors sign a legally binding publishing agreement

• Corresponding author signs on behalf on all co-authors. All listed co-authors are collectively accountable.

Duplicate submission

• Article was published in another language (considered at Editors discretion). Must be made clear which version is a translation. Best practice is to state it is a translation in the Abstract and main text and to cite the original article. Authors must check any copyright restrictions or permission requirements.

• Data presented at conferences (shortabstracts)

• Early version posted in a repository or a pre-print server

Duplicate submission or publication- when is it ok?

Transparency is key. Any previous full versions should be referenced within the main text to ensure the Editor is aware of it, as well as readers if published.

Plagiarism and text-recycling

• The appropriation of another person’s/groups ideas, processes, results, figures or words without giving appropriate credit

• Includes content from books and websites (blogs)

• Text plagiarism can be detected by plagiarism detection software (e.g. iThenticate)

• Any alleged plagiarism will be investigated, and the authors will be asked for an explanation.

Plagiarism

• The excessive repeated use of own work (text, figures, data, ideas, etc)

• Leads to redundant publication

• Distorts the scholarly record

• Any alleged text-recycling will be investigated, and authors will be asked for an explanation.

Self Plagiarism/Text recycling

Flickr: Shannon Kringen “Magical File”

Image or data integrity

https://mbio.asm.org/content/7/3/e00809-16

Analysis of 20,000 papers from 40 journals:(i) figures containing inappropriately duplicated images can be readily identified in published papers

through visual inspection without the need for special forensic software methods or tools(ii) approximately 1 of every 25 published papers contains inappropriately duplicated images(iii) the prevalence of papers with inappropriate image duplication rose sharply after 2002 and has since remained at increased levels (iv) the prevalence of inappropriate image duplication varies among journals and correlates inversely with journal impact factor (v) papers containing inappropriately duplicated images originated more frequently from China and India and less frequently from the United States, United Kingdom, Germany, Japan, or Australia(vi) other papers by authors of papers containing inappropriately duplicated images often contained duplicated images as well.

Science, technology and medicine: specific considerations

Experimental photographic images including microscopy, immunohistochemical

staining, immunofluorescence staining, electrophoretic gels and immunoblots

should accurately reflect the results of the original image. Where images have

been modified or enhanced in any way this must be stated with a full explanation

within the manuscript as well as in the figure legend so as not to mislead readers

about what the images show. Authors should be prepared to share the original,

uncropped and unprocessed images with the journal editorial office upon request.

Please note that any modifications are only acceptable if these are minor in nature and have been applied to the whole image. Authors are required to include details of image gathering methods and details of processes for any modifications made to images, including the name of the software (with version number) used. Any modifications which can alter the scientific interpretation of the image are not allowed.

Clinical images such as X-rays and other types of medical imaging scans, should not include any identifying information about the patient. Details such as the patient name, ID number etc should be blurred or cropped out prior to submission.

Policy: Images and data

Case: Image manipulation

• A reader notified the journal of potential image manipulation in a paper

• Corresponding author was emailed asking for an explanation (other authors cc’d)

• Received an email from 1st author (not corresponding) explaining there was no manipulation

• Some time later we received an email from the corresponding author acknowledging there might be an issue

• The corresponding author advised they would investigate, and a departmental investigation was conducted

• Investigation determined the manipulation was intentional and the 1st author had acted alone

• Co-authors acknowledged they were also accountable

• Article was retracted

Ensuring the integrity of the scholarly record

Post-publication notices – when, what and whyhttps://authorservices.taylorandfrancis.com/corrections-to-published-articles/

Permanent notices attached to the original article. The purpose of these are to correct the scholarly record and ensure its integrity:

Correction

• No serious breach of publication or research ethics

• To correct minor errors, which do not affect the conclusions

Expression of concern (COPE discussion)

• Investigation is inconclusive or taking a long time, but a public expression of concern is still necessary

• Careful consideration required to determine when these are appropriate

• Author(s) will be informed

Retraction (COPE guidelines)

• Serious breach of publication or research ethics : i.e. where findings are unreliable due to misconduct; duplicate publication; plagiarism; unethical research, etc

• Where honest error is the cause (e.g. problem with data analysis), authors can instigate the retraction. This is good scholarly behaviour

• Where authors or institutions are non-responsive we can still take action

• Original article remains online with a “Retracted” watermark across it

We have a responsibility towards permanency of content once published, and so problematic articles can’t silently disappear

Removal, rather than a retraction, will only be considered in specific circumstances, e.g.:

• Defamation or other legal concerns• Content is subject to a court order• High risk of harm if acted upon• Breach of privacy

The record of the article does not disappear. A removal notice, outlining the reasons for removal will be issued in place of the article.

Removal vs retraction– what is the guidance?

Publication ethics : who is responsible?

All involved in the publishing process are responsible and accountable:

• Authors

• Institutions

• Editors

• Reviewers

• Publishers

Collectively we must work together to ensure that the content published is

accurate and reliable, and that any ethics issues which arise before or after

publication are investigated thoroughly, and any corrective measures taken

as appropriate.

Tips on avoiding problems

Tip 1

Authorship• Agree on authorship early on, based on criteria

and responsibilities

• Ensure anyone who meets authorship criteria has been included

• Be aware of the role and responsibilities of the corresponding author

• Ensure all authors agree on which journal to submit to

• Ensure all authors agree on any changes to the manuscript, including any changes to the authorship list

• Ensure all relevant declarations on funding and competing interests have been stated by co-authors

Tip 2

Securely store original data• Ensure all original data (including images) are

clearly labelled and stored

• Be ready to share the files with the journal editorial office upon request. This can happen even after publication

• Ensure anonymity of participants in any datasets which need to be shared

Tip 3

• Journal homepage list of requirements

• Confirmation about originality

• Clinical trial registration in a publicly accessible database, and inclusion of the registration number

• Mandatory data sharing policies

• Mandatory deposition policies

Check mandatory requirements

Tip 4

Include declarations on ethical conduct of the study• Statement on ethical approval for the study

from the appropriate ethics board (or reasons for a waiver)

• Ethics for animal research, stem cell research, technologies which can impact privacy, etc.

• Considerations for dual-use research of concern

• Informed consent from subjects to participate

• Consent for publication from anyone who can potentially be identified (keep copies of forms)

Tip 5

Cite all relevant sources and previous versions, and obtain permissions for re-use• Prior to submission check your manuscript for

unintended text re-use via a Plagiarism checker (e.g. iThenticate, Turnitin, etc.)

• Cite appropriate, balanced and relevant sources (evidence-based, peer reviewed content)

• If any previous full versions exist online or other citable form (e.g. preprints) then ensure these have been cited.

• Ensure permissions have been obtained from the copyright/license holder for any images, models, etc. from third parties.

sarah.robbie@tandf.co.uk