Authorship Ethics Requirements in Medical Journals

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Authorship Ethics Requirements in Medical
Journals

• William Gardner, PhD

Center for Innovation in Pediatric
Practice Columbus Childrens Research Institute
Departments of Pediatrics, Psychology,
Psychiatry The Ohio State University
Thanks to Kendra Heck, MPH, and Ling Fan, MD.
Supported by NIH/ORI RO1 NS49591
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Journals Statements of Ethical Requirements for
Authors

• Requirements for publications of clinical trials
  cover human subjects protection, disclosure of
  conflicts of interest, and authorship ethics.
• Journals publish statements detailing norms.
• Authors affirm their compliance with the norms.
• The content of these statements are evidence of
  professional ethical expectations for authors.

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Prior Literature on Requirements for Authors

• Previous studies focused on human subjects
  protection.
• They used convenience samples and did not explore
  variation across journals.
• In the population of journals publishing RCTs,
  what are expectations for human subjects
  protection, conflict of interest, and authorship
  ethics?
• What explains variation across journals in
  requirements?

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Journals Publishing Clinical Trials (CTs) in 2005
We used Haynes et al.s conservative strategy
to retrieve CTs from PubMed.
We retrieved 13,184 references to CTs, published
in 2,056 journals.
Average journal published 6.4 articles.
Median 2.5 articles.
Top 25 of journals publish 74 of articles.
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Journals by CT Count Log-Log Plot
The distribution of journal CT counts falls
somewhere between a Power Law (dashed line) and
Log-Normal (curved line).
80/20 laws Web site hits, crime, income, journal
citations.
Matthew effect Unto him that hath, shall be
given.
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Sampling Journals the Distribution of CTs
Looking just at high impact / high prestige
journals would just give us data on a very select
set of journals.
So, we sampled all journals that published 50 or
more CTs in 2005, and randomly chose journals
from the rest.
This meant that journals that published lt 50 CTs
were undersampled. So we weighted them in the
analyses to correct for the undersampling.
However simple random sampling of journals would
give us very few of the journals that matter to
the most readers and that publish a
disproportionate share of articles.
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Scientific Ethical Quality Control

• We retrieved instructions to authors from the web
  or sent a request to the journal editor.
• We coded the instructions for the following
• Journal Self-Interest e.g, no previous
  publication.
• Human Subjects Informed Consent IRB review.
• CT Standards CONSORT Registration

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Components of Authorship Ethics (AE) Score

• Disclosures Source of funding, COIs.
• Authorship Author Contributions, Components of
  Authorship as defined by Vancouver.
• Affirmations of Responsibility For scientific
  work and data integrity.
• 10 elements in total, Cronbachs ? .87.

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Journal Requirements
N 289 journals, weighted analysis.
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Estimated Population Density Authorship Ethics
Requirements
N 289 journals, weighted analysis.
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What Journal Factors Affect Authorship Ethics?

• Negative binomial regression predicting number of
  AE elements present (with weights).
• Model includes journal age, CT count, US or
  European publication, journal discipline, and
  whether the journal was electronic.
• Important methods problem Journals are not
  independent observations.

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What Journal Factors Are Associated with AE?
Where the journal is published does not matter.
Only statistically significant discipline
factors are shown.
Variable b z p
Journal Age .002 1.77 .077
Pediatrics .26 2.47 .014
Pharmacology -1.04 -6.54 lt.0001
Surgery .22 2.55 .011
Electronic Journal 1.17 8.26 lt.0001
CTs Published .016 7.29 lt.0001
Journal age is associated with AE (older have
higher AE), but not when you control for CTs
Published.
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Authorship Ethics Score Number of CTs Published
in 2005
N 289 journals, weighted analysis.
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Conclusions

• CTs are published in a long tail of journals
  Many appear in lesser known journals that
  previous studies have ignored.
• AE requirements vary across journals.
• Journals publishing many CTs have stiffer
  requirements.
• AE requirements may vary by discipline pure
  electronic journals had high AE requirements.

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Implications for Ethics Research on Scientific
Journals

• Studies of journal population should use
  epidemiological rather than convenience designs.
• Studies should look for journal factors
  associated with variation in ethical
  requirements.
• Dont just look at the high volume journals.
  There is also a long tail of small journals
• How will E-publishing affect AE policies?