Research and publication ethics: can readers trust

your journal?

MedicReS World Congress 2012

Dr Trish GrovesDeputy editor, BMJ

& Editor-in-chief, BMJ Open

What I aim to cover

• research ethics– Declaration of Helsinki 2008– clinical trial registration– informed consent– patients’ confidentiality

• publication ethics– complete reporting of study design, data, and ethics– authorship– conflicts of interest– scientific misconduct: definition, prevention, detection,

action, retraction

Research ethics

http://www.wma.net/en/30publications/10policies/b3/index.html

2008 Declaration of Helsinki: editors take note!

Paragraph 30.

Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research.

Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports…

Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication.

… 2008 Declaration of Helsinki (continued)

19. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.

25. For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse.

Research ethics: editors’ role

Make it clear* that authors must:

• follow declaration of Helsinki 2008• prospectively register clinical trials• gain approval by an ethics committee or IRB• seek informed consent for participation,

publication, and sharing of identifiable data or materials

• protect participants’ identities• report all the above points in their papers

* in instructions to authors, in correspondence, during editing

Why trial registration matters Ottawa statement 2005Ethical

Respects investigator-participantcovenant to contribute to publicknowledge

Provides global open access

Reduces unnecessary duplication

Assures accountability

Enables monitoring of adherence to

ethical principles and processes

Scientific

Increases reliability/availability ofevidence for healthcare decisions

Improves trial participation

Increases collaboration

Transparent design and methods

Open review of protocols

Identifies/prevents biased reporting

Accelerates knowledge creation

http://www.icmje.org/publishing_10register.html

Publication ethics

Ensure complete reporting of studies

www.equator-network.org/resource-centre/library-of-health-research-reporting/

How authors and editors can protect patients’ confidentiality

• have a clear policy

• beware identifiers:

– age, sex, ethnicity, location

– clinical details, test results

– unusual history or context

– picture (incl. photo of a body part, clinical image)

Avoid guest- and ghost-authors

ICMJE policy: Authorship credit is based only onsubstantial contributions to: • conception and design, acquisition of data, or data

analysis and interpretation • drafting the article or revising it critically for important

intellectual content • and final approval of the version to be published All these conditions must be met Solely acquiring funding, collecting data, or supervising the research group does notjustify authorship  All authors included on a paper must fulfil the criteria No one who fulfils the criteria should be excludedEach author should have participated sufficiently in the work to take publicresponsibility for appropriate portions of the content

Consider using contributorship statements

Research articles in BMJ and some other journals list:

• contributors who took part in planning, conducting, and reporting the work, including professional medical writers

• guarantors (one or more) who accept full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish

Researchers must decide among themselves the precise nature of

each contribution

Competing interests (conflicts of interest)

A person has a competing interest when he or she has an attribute that is invisible to the reader or editor but which may affect his or her judgment

Always declare a competing interest, particularly one that would embarrass you if it came out afterwards

ICMJE statement

http://www.icmje.org/coi_disclosure.pdf

Misconduct

Fabrication: making up data or results and recording or reporting them

Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record

Plagiarism: the appropriation of another person's ideas, processes, results, or words without giving appropriate credit

Famous (probable) fraudsters

What can editors do to reduce misconduct?

Editors’ role in tackling misconduct

• optimise peer review

• enlist statistical peer reviewers

• help prevent misconduct through clear advice to authors

• detect and refer cases of misconduct, and act on them– ask authors for explanation/raw data– refer unresolved and proven cases to author’s

institution/licensing body/COPE/journal ethics committee– publish notices of concern and retractions

http://publicationethics.org/

When to retract an article

Thank you

Any questions?

tgroves@bmj.com

Twitter @trished