# Presentation: 702615

## Authorship Ethics Requirements in Medical Journals 

**William Gardner, PhD**

**Center for Innovation in Pediatric Practice**
**Columbus Children’s 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

## 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.

## 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?

## Journals Publishing Clinical Trials (CTs) in 2005

- Median = 2.5 articles.

- We retrieved 13,184 references to CTs, published in 2,056 journals.

- We used Haynes et al.’s ‘conservative’ strategy to retrieve CTs from PubMed.

- Average journal published 6.4 articles.

- Top 25% of journals publish 74% of articles.

## Journals by CT Count: Log-Log Plot

- 80/20 laws: Web site hits, crime, income, journal citations.

- Matthew effect: “Unto him that hath, shall be given.”

- The distribution of journal CT counts falls somewhere between a Power Law (dashed line) and Log-Normal (curved line).

## 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 < 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.

## 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

## 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, Cronbach’s  = .87.

## Journal Requirements

*N* = 289 journals, weighted analysis.

## Estimated Population Density: Authorship Ethics Requirements

*N* = 289 journals, weighted analysis.

## 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.

## What Journal Factors Are Associated with AE?

| Variable | b | z | p |
| --- | --- | --- | --- |
| Journal Age | .002 | 1.77 | .077 |
| Pediatrics | .26 | 2.47 | .014 |
| Pharmacology | -1.04 | -6.54 | <.0001 |
| Surgery | .22 | 2.55 | .011 |
| Electronic Journal | 1.17 | 8.26 | <.0001 |
| CTs Published | .016 | 7.29 | <.0001 |

- Where the journal is published does not matter. Only statistically significant ‘discipline’ factors are shown.

- Journal age is associated with AE (older have higher AE), but not when you control for CTs Published.

## Authorship Ethics Score & Number of CTs Published in 2005

*N* = 289 journals, weighted analysis.

## 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.

## 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.
- Don’t just look at the high volume journals. There is also a ‘long tail’ of small journals
- How will E-publishing affect AE policies?