1. The Rise (and Rise) of
Publication Ethics
Chris Graf, Associate Editorial Director
chris.graf@wiley.com
Publisher, International Journal of Clinical Practice
www.IJCP.org
Council Member, Committee on Publication Ethics (COPE)
www.publicationethics.org
Member at Large, ISMPP Board of Trustees
www.ISMPP.org
4. Office of Research Integrity
Paraphrased from NATURE, Vol 453, 19 June 2008
• Each year ORI investigates 24 cases of
misconduct
• The survey suggests 1.5 cases of misconduct per
100 scientists per year
• There are 155,000 NIH-supported scientists
• This would mean >2300 cases per year
• Survey says only 58% reported (would mean
1350 cases per year)
http://www.nature.com/nature/journal/v453/n7198/pdf/453980a.pdf
http://ori.dhhs.gov/research/intra/documents/Investigations1994-2003-2.pdf
http://ori.dhhs.gov/publications/reporting_suspected_research_misconduct.shtml
5. Office of Research Integrity
NATURE, Vol 453, 19 June 2008
• The authors conclude…
“falsified and fabricated research
records, publications, dissertations
and grant applications are much more
prevalent than has been suspected to
date”
• Me: 1350 is a lot more than 24
8. Pharma gets regulated, rules
• FDA Modernization Act, 1997
(registration, serious or life- threatening
diseases and conditions)
• ICMJE May 2004 (registration)
• FDAAA, preceded by State of Maine
(posting)
• ICMJE supports FDAAA schedule and
format (October 2008)
9. But do most editors worry?
Science journal editors views on publication ethics: An international survey
400 350
350 300
300
250
250
200
200
150
150
100
100
115
50
112
111
50 83
14 11
7 4
1 1
1
0 0
Healthcare Science Social Other Africa Australia China East Asia Europe Japan Middle North
sciences & NZ East America
Survey respondents Total population sent survey Survey respondents Total population sent survey
231 (44%) responses from 524
95% confidence with confidence interval +/- 4.8%
10. Do editors worry?
• In our survey, most editors were not very
concerned about publication ethics
• Believe problems occur only rarely, but
often unsure of frequency
• So if ORI is right, probably not enough…
http://www.nature.com/nature/journal/v453/n7198/pdf/453980a.pdf
12. We all subscribe to
“Good scientific practice embraces all
the procedures and practices that are
necessary for planning, conducting and
reporting research and scholarship
within a framework of scientific
integrity.”
Good Scientific Practice in Research and Scholarship. ESF Policy Briefing.
December 2000 http://www.esf.org/publications/policy-briefings.html Accessed
4 November 2008
13. … and something like …
“Transparent writing collaboration with
attribution between academic and
industry investigators, medical writers,
and/or technical experts is not
ghostwriting.”
AAMC Industry Funding of Medical Education Report of an AAMC Task Force,
June 2008.
https://services.aamc.org/Publications/index.cfm?fuseaction=Product.displayFo
rm&prd_id=232&prv_id=281
14. So what are we doing about it?
• Advising, assisting editors (authors,
and contributors) doing a tough job
• Ethics guidance from publishers
• Wiley-Blackwell first
http://www.blackwellpublishing.com/publicationethics/
• Others followed
www.elsevier.com/wps/find/editorshome.editors/Introduction
http://www.informaworld.com/smpp/authors_editorexisting_ethics~db=all
15. Leading guidance…
• … on posting clinical trial data
• Wiley-Blackwell does not consider
results databases to be inappropriate
prior publication
Graf C, Wager E, Bowman A et al. Best Practice Guidelines on Publication
Ethics: A Publisher's Perspective is reproduced with permission from. Int J
Clin Pract 2007; 61 (s152):1–26
• Now ICMJE says the same thing
(October 2008 update to „Uniform Requirements‟)
16. Sooooo many guidelines
• But … WMA trumps everything?
• New Helsinki (October)
• “Reports of research not in
accordance with the principles of this
Declaration should not be accepted
for publication”
http://www.wma.net/e/policy/b3.htm
17. New Helsinki
• Make results publicly available
• Emphasis on accountability,
completeness, accuracy
• Adherence to accepted guidelines for
ethical reporting
• Declaration of funding, institutional
affiliations, conflicts of interest
19. What does this mean for you?
1. The world of medical
publishing is complex
and fast-moving
Recommendations,
guidelines and legislation
evolve
2.
Ask publishers to help
Wiley Offices, New
York circa 1880
