workshop part 2: publication ethics for biomedical researchers (biomed central brazil 2015)

Publication ethics for biomedical researchersMaria KowalczukBiology EditorBioMed Central

• Team of in-house Editors

• Responsible for:

• Editorial policies

• Instructions for authors

• Best practice in peer review

• Publication and research ethics

• Training and support for editors.

Research Integrity Group

• Research ethics- Consent to participate and to publish- Animal and field studies- Trial registration- Standards of reporting

• Publishing ethics and misconduct- Data fabrication- Image manipulation- Plagiarism and text recycling- Duplicate submission and publication- Gift and ghost authorship- Undeclared conflicts of interest

• How BioMed Central supports its Authors, Reviewers and Editors in dealing with ethical issues

Outline

Ethics

Research Publication

• Declaration of Helsinki• Institutional ethics

committee• Local laws

• International Committee of Medical Journal Editors (ICMJE)

• Committee on Publication Ethics (COPE)• Journal editorial policies

Many different study designs, therefore many ethical considerations:

• Retrospective studies: permission has been sought to use patient details, participants will be kept anonymous

• Prospective cohort studies and RCTs: informed consent; participants kept safe at all times; patients know they can leave the study at any time, but still receive treatment

• Animal models: must comply with institutional, national, or international guidelines

Improper use of human subjects and animals can never be justified

Research Ethics

Declaration of HelsinkiEthical principles for medical

research involving human subjects.

“The health of the patient will be my first consideration”

Research Ethics

Editorial policies:

“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.”

• Researchers recruit patients to a trial to test a new drug for rheumatoid arthritis

• Patients are divided into two groups:• Group 1: receive standard treatment plus the new drug• Group 2: receive standard treatment plus placebo

• Patients are not told they are part of a trial

Case 1 – Research Ethics

Any ethical concerns?

• Researchers want to test a new, untested drug for treating Helicobacter pylori

• Patients provide informed consent

• Patients are divided into three groups:• Group 1 are treated with standard therapy plus new drug• Group 2 are treated with standard therapy plus placebo• Group 3 are treated with the new drug only

Any ethical concerns?

Case 2 – Research Ethics

Research Ethics

• All studies involving human subjects, human material, human data or animals must have:

– A statement on ethics in the manuscript, including:• The name of the ethics committee• The reference number where appropriate

Exemptions (granted by ethics committees) should also be detailed in the manuscript

Studies requiring ethics statements:

• Prospective studies (including observational)• Retrospective studies (e.g. medical records, imaging)• Cross sectional surveys (online or paper)• Focus groups/interviews• Patients, volunteers, health professionals, students• Samples (blood, sputum, wound swabs, urine, tissue etc.)

Research ethics

Consent to Participate

• Informed consent must be documented in all studies involving human participants

• Includes:– All prospective studies– Interviews (including of health

professionals)– Focus groups– Samples taken prospectively– Parental consent for children <16

• If ethics committee waived, should be documented.

Consent to Publish

• Required for:

– Identifiable patient information in manuscript

– Patient images (including photos, scans)

– Not required for completely anonymous images with no patient identifiable information in manuscript

– Cannot be waive by the ethics committee

Research Ethics – Animal Studies

The principles of the 3Rs

• Replace

• Reduce

• Refine

• Compliance with institutional, national, or international guidelines

• Ethics approval if committee exists

• Client-owned animals: document informed client consent and adherence to best practice of veterinary care

• Reporting guidelines: ARRIVE, REFLECT

• Should be conducted in accordance with institutional, national, or international guidelines

• Ethics approval if committee exists

• Manuscript should include a statement specifying the appropriate permissions and/or licences (usually local)

Recommend that authors comply with• IUCN Policy Statement on Research Involving Species at Risk of Extinction• Convention on the Trade in Endangered Species of Wild Fauna and Flora

Research Ethics - Field Studies

Required for all clinical trials• Prevents duplication of efforts and reduces publication bias

Clinical trialWHO: “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”

• There are a number of different registries; these need to be publicly accessible; most are free to register

• Register before you recruit participants.

Trial registration

http://www.equator-network.org/

Standards of reporting

Help editors, reviewers and readers understand what

you did

• Research ethics- Consent to participate and to publish- Animal and field studies- Trial registration- Standards of reporting

• Publishing ethics and misconduct- Data fabrication- Image manipulation- Plagiarism and text recycling- Duplicate submission and publication- Gift and ghost authorship- Undeclared conflicts of interest

• How BioMed Central supports its Authors, Reviewers and Editors in dealing with ethical issues

Outline

• Systematic Review and meta-analysis on fabrication and falsification of results (Fanelli 2009)– 2% admitted to fabrication, falsification or manipulation of results– 14% reported witnessing this behaviour in a colleague

• 67.4% of retractions due to misconduct (Fang et al. 2012)– Fraud 43.3%, duplicate publication 14.2%, plagiarism 9.8%

• Estimates on prevalence of plagiarism in submitted manuscripts vary– One Chinese journal found ‘unreasonable degrees of copying’ in

22.8% of submitted manuscripts (Zhang 2010)

Fanelli D. PLoS ONE. 2009 4(5):e5738Fang F, Steen R, Casadevall A. PNAS. 2012 109:42Zhang H. Learned Publishing. 2010 23:9-14

How common is misconduct?

Images in manuscripts

Is this acceptable?

• Editor sends a manuscript containing these images to reviewers.

• Reviewer: the images are not new!

• Editor checks and agrees.

• Editor asks the authors to explain.

• The authors respond to say this is true – they run many gels and have only used these images to be representative of their results.

Case 3

• Original data, such as gels, should not be used as illustrations, without an explanation.

• Original source must be cited and can only be re-used if the copyright holder gives permission.

• Editors need to ensure their journal policies are clear about how images should be described within manuscripts.

If you misrepresent your data, you are deceiving your colleagues, who expect and assume basic scientific honesty—that is, that each image you present is an accurate representation of what you actually observed. In addition, an image usually carries information beyond the specific point being made. The quality of an image has implications about the care with which it was obtained, and a frequent assumption (though not necessarily true) is that in order to obtain a presentation-quality image, you had to carefully repeat an experiment multiple times.

Manipulating images to make figures more simple and more convincing may also deprive you and your colleagues of seeing other information that is often hidden in a picture or other primary data. Well-known examples include evidence of low quantities of other molecules, variations in the pattern of localization, and interactions or cooperativity.

Rossner and Yamada; Journal of Cell Biology 2004;166:11–15

What is the consensus?

Plagiarism

Duplication of text (or figures) from someone else’s work

How much overlap with someone else’s work is acceptable?

A. 30%B. 10%C. None

Plagiarism

Duplication of text (or figures) from someone else’s work

How much overlap with someone else’s work is acceptable?

A. 30%B. 10%C. None

Not just previously published articles - websites, books etc.

Text Recycling

• Also called ‘self-plagiarism’

• Duplication of text from authors’ own previous publication

• Usually without attribution

• Acceptability depends on journals’ policy.

Text Recycling - example

Researchers have published an article reporting the primary outcomes of a large RCT. They now want to publish another article reporting the secondary outcomes. The methods used are the same.

How can they report the methods in their new paper? Original published article methods:This study was a randomised controlled trial (RCT) conducted in four teaching hospitals in London. Patients were recruited between January 2007 and December 2008. Patients were eligible for inclusion in the study if they were over the age of 18 and had undergone an elective laparoscopic cholecystectomy….. (the methods would then be described in detail)

Case 4

Text Recycling - example

Transparently! Methods (new article):The full methods of this study have already been reported in our previous article [6]. Briefly, we conducted a randomised controlled trial involving patients over the age of 18 who had undergone and elective laparoscopic cholecystectomy in 2007/8 in one of four London teaching hospitals.

There is no need to repeat the description of the methods as the authors provide a citation for the details. This clarifies that the results reported in the new article are secondary outcomes from the previous study rather than misleading the reader into believing this was another study.

How do Editors deal with plagiarism?

Follow COPE guidelinesUse plagiarism detection software

Before publication• Ask authors for explanation • Authors may be allowed to re-write • Manuscript may be rejected • Editor may contact authors’ institution

After publication • May publish retraction or correction.

Duplicate Submission

Is it ok to submit to more than one journal at once?

Consequences of duplicate submission:

• Rejection of both manuscripts

• Editor may contact the authors’ institution

• Duplicate publication

• May lead to retraction (14.2% of all retractions)

• Biases the literature

• Wastes editors’ and reviewers’ time.

Authorship

According to ICMJE guidelines:

An 'author' is generally considered to be someone who has made substantive intellectual contributions to a published study.

Authorship criteria:

1) substantial contributions

2) draft the manuscript

3) final approval

4) agree to be accountable

Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship.

• Gift authorship

• Ghost authorship

• Authorship disputes

Authorship problems

@#!!!!!!

Competing Interests

Competing interests (CI) can be financial or non-financial

Importance of declaring CI on submission• Editor is aware during manuscript assessment• Editor will not invite reviewers with the same CI• Reviewers are aware when assessing manuscript• Readers are aware once published• Editors/reviewers/readers are able to judge whether they are

relevant

Declaring a CI does not mean that an article will not be published

Who can have competing interests?

• Authors, reviewers, editors

Competing Interests

Which of the following could be considered competing interests?

• Being employed by the manufacturer of a drug described in an article

• Applying for a patent for a device described in an article• Owning shares in a company that manufactures a drug

described in the article• Receiving travel cost reimbursements from a company who

manufacture a drug described in an article• Being a member of a religious organisation opposed to

stem cell research when reviewing an article involving stem cell research

• Being a member of a lobby group opposed to the topic described in the article

• And many more examples…

Undisclosed Competing Interests

More problematic

May be identified by:• Editor• Reviewer• Reader

Potential consequences• Delays to review process• Rejection• Publication of a correction article• Retraction of an article

• Register trials

• Get ethics approval

• Follow reporting guidelines

• Agree authors contributions at the start

• Acknowledge writing/editorial support

• Declare all conflicts of interest

• Make sure all authors see manuscripts before submission (and resubmission).

How to avoid problems

• Research ethics- Consent to participate and to publish- Animal and field studies- Trial registration- Standards of reporting

• Publishing ethics and misconduct- Data fabrication- Image manipulation- Plagiarism and text recycling- Duplicate submission and publication- Gift and ghost authorship- Undeclared conflicts of interest

• How BioMed Central supports its Authors, Reviewers and Editors in dealing with ethical issues

Outline

Editorial Policies

Author Academy

Resources for Editors

Online distance learning course

Anti-plagiarism software

COPE membership

OASPA membership

Any Questions?

Maria KowalczukBiology Editor

Research Integrity GroupBioMed Central

Maria.Kowalczuk@biomedcentral.com

Thank you!