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Kuklo case
Orthopedic surgeon in Army
Research on bone-growth product Recombinant human bone morphogenic
protein-2 Claimed benefit in soldiers with severe leg
injuries
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Kuklo allegations
Data fabricated Reported more cases than in Army records
Co-authors had not seen manuscript
prior to publication
Forged signatures of co-authors
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Kuklo allegations
Paid by manufacturer as consultant Almost $800,000 for two years Spoke on company’s behalf Taught other physicians Manufacturer did not sponsor study
• Denied knowledge of misconduct
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Kuklo case
Paid by manufacturer as consultant Did not get permission from Army Did not disclose payments to Army or
Washington University
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Reuben case
Peri-op analgesia with COX-2, NSAIDs Reduce opioid use, improve function Pre-emptive pre-op administration reduces
post-op and chronic pain Use for regional anesthesia or for intra-
articular injection Celecoxib + pregabalin superior to opioids
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Reuben case
Fabricated data in 21 / 72 articles Pleaded guilty to fraud charges Co-authors exonerated
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Editorial on impact of misconduct
Retraction does not correct problems
with meta-analyses, reviews, CME
Confirmatory studies unlikely to be
published
“We might be heading in wrong
direction or toward blind ends”
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Darsee case
109 papers as a fellow
Fabricated data in view of colleagues
Patients and collaborators did not exist
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Slutsky case
137 papers while a resident and fellow One paper every ten days
Two studies had same mean and SD for
different populations
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Why is research misconduct problematic?
Data and conclusions not valid Harm to science, other researchers Harm to patients
Wasted resources
Unmerited rewards
Undermines public trust and support
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Congressman Dingle
“Every time a researcher takes
taxpayer money and publishes
fabricated, falsified, or plagiarized
findings, the taxpayer has in effect
been swindled. Furthermore, given our
budget deficit, there is never enough
money to go around.”
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Consequences
When self-regulation fails, government
will step in NIH requires ethics training Conflict of interest disclosures when submit
grant
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How you will encounter misconduct?
Review manuscript or grant
As PI of large project
Serve on selection committee
Challenges to your work by others
Serve on investigation panel
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What would you do?
You review paper on prevention trial
for cancer. Accrual extremely rapid. Point estimate not vary across sites. Confidence interval very narrow.
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What would you do?
You decided to call the editor about
concerns but did put them in writing.
One month later you are sent a revised
manuscript for re-review Your concerns not raised with authors None of your concerns addressed.
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What would you do?
Decline to review the article
Recommend biostatistical review of the
article
Describe your concerns in a written
review
Other?
Why not?
Not your job
Don’t look for trouble
Don’t be a snitch or tattletale
Don’t ruin a career if you’re not sure
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Encounter misconduct as PI?
Progress too good to be true Enrollment at site >> other sites Phenomenal productivity
Data are too good to be true Discrepancy from other sites Variation too small
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Encounter misconduct on selection committee?
Plagiarism of personal essay 5.2% of resident essays match Internet
pages, previous essays, printed resources
Falsification of publication record 4.9% of residency and fellowship
applicants
Falsification of publication record
Article not in journal
Not an author
Change order of authors
List abstract as article
Change journal
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Federal definition of research misconduct
Fabrication
Falsification
Plagiarism
Must be intentional
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Research misconduct excludes
Unintentional “honest” error
Sloppiness, incompetence, laziness
Differences of opinion or interpretation
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Research misconduct excludes other ethical problems
Lack of IRB approval
Lack of informed consent
Financial mismanagement
Discrimination
Poor mentoring
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Federal definition of misconduct
Legal requirements set a minimum
standard
Ethical and professional standards
may be higher
How do people respond to plagiarism?
Using computer programs, identify 212
pairs of similar articles
Survey to authors, journal editors of
these articles
Science 2009; 323; 1293.
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Individual response to misconduct
“There is no way under the stars we
could have picked that up ourselves.”
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Individual response to misconduct
“It is my understanding that copying
someone else’s description virtually
word-for-word is considered a
compliment to the person whose words
were copied.”
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Individual response to misconduct
“I have no idea why the pieces are
similar, except that I am sure I do not
have a good enough memory to have
allowed me to ‘copy’ his piece.”
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Responses to allegations
I didn’t know it was wrong Course precludes this defense
It’s just a personal vendetta
This is just creative science
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Institutional response to alleged misconduct
Inquiry Is a full investigation warranted?
Investigation Is there misconduct?
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Criticisms of institutional inquiry
Self-interest Can be unconscious
Underestimate problems
Assumption of trust
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Institutional responses to allegations of misconduct
Both whistleblower and accused have
rights No retaliation Written charges Accused may respond to charges Right to have lawyer Timely decision
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Consequences of research misconduct
Suspension of federal grant
Debarment from future grants
Institutional penalties Termination of employment
Civil and criminal liability
Questions about misconduct
Are you responsible for work of
colleagues in collaborative project? How much do you have to learn about their
specialty?
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Dilemmas for co-investigators
Value in multidisciplinary projects Encouraged by NIH Do not have expertise in other specialties
Accountable for misconduct of others Trust colleagues What review is reasonable to expect?
How to prevent misconduct
Close involvement during all phases of
research Look at primary data
• Challenges with direct computer entry of data
Data audits
Realistic expectations of progress and
productivity
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How to prevent misconduct
Know enough about other fields to ask
tough questions
Specify your exact role in project
Reconsider loose collaborations
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