Research Misconduct

Ayodele S. Jegede, PhD, MHSc.

West African Bioethics Training Program
Outline

 Objective
 Learning outcome
 Research misconduct
 Authorship
 Case study
Objective

 To orientate participant to unethical practices in

publication of research findings
Learning outcomes

 Participant know the criteria for recognizing

research misconduct

 Participants able to determine the roles and

responsibilities of authors
Research Misconduct
 What is it?:
 Fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research
results.
 Fabrication: making up results and recording or reporting
them
 Falsification: manipulation of research materials,
equipment, or processes, or changing or omitting results
such that the research is not accurately represented in
the record.
 Plagiarism: the appropriation of another’s ideas,
processes, results, or words without giving proper credit.
 Department of Health and Human Services
How often does scientific
misconduct occur?
There seems to be no consensus on the answer,
although a range of estimates were presented
at a conference called last month by a key
federal watchdog agency to announce a $1
million grants program to investigate the
prevalence of fraud, data fabrication,
plagiarism, and other questionable practices in
science. The 8-year-old Office of Research
Integrity hopes to support studies gauging the
frequency of misconduct and assessing efforts
to raise ethical standards.
Science 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663
• Department of Health & Human Services received
267 reports of research misconduct (2004)
• 50% increase from 2003
• 35% of closed cases involve research misconduct
 What is it not:
 Honest error or differences of opinion
Criteria

 Represent a significant departure from

accepted practices
 Have been committed intentionally, or
knowingly, or recklessly; and
 Be proven by a preponderance of evidence

 What is NOT MISCONDUCT: honest, unintentional

error
Top ten “POOR” behaviors [1]

 1. Falsifying or ‘cooking’ research data

 2. Ignoring major aspects of human-subject
requirements
 3. Not properly disclosing involvement in firms whose
products are based on one‘s own research
 4. Relationships with students, research subjects or
clients that may be interpreted as questionable
 5. Using another’s ideas without obtaining permission
or giving due credit (plagiarism)
Top ten behaviors [2]

 6. Unauthorized use of confidential information in

connection with one’s own research
 7. Failing to present data that contradict one’s own
previous research ????
 8. Circumventing certain minor aspects of human-subject
requirements
 9. Overlooking others' use of flawed data or questionable
interpretation of data
 10. Changing the design, methodology or results of a
study in response to pressure from a funding source
(falsification)
Other Behaviours
 11. Publishing the same data or results in two or more
publications
 12. Inappropriately assigning authorship credit
 13. Withholding details of methodology or results in
papers or proposals
 14. Using inadequate or inappropriate research
designs
 15. Dropping observations or data points from
analyses based on a gut feeling that they were
inaccurate
 16. Inadequate record keeping related to research
projects
Why does misconduct happen?

 Publish or Perish Pressure

 Desire to “get ahead”
 Personal problems
 Character issues
 Cultural Differences
SCIENTIFIC MISCONDUCT:
Scandals Shake Chinese Science

 “Too many incentives have blurred the reasons

for doing science in some people's minds”
 Lu Yongxiang, president of the Chinese Academy of Sciences

 “Though it is difficult to ascertain the number of

misconduct cases, the negative impact of these
cases should not be underestimated”
 Ministry of Education spokesperson Wang Xuming
How is misconduct identified

 Suspected and reported by a colleague

 Failure to confirm research results

by own lab or others
Consequences (if misconduct is
substantiated)

 Withdrawal or correction of all pending and

published papers and abstracts affected by the
misconduct
 Removal from project, rank and salary
reduction, dismissal
 Restitution of funds to the granting agency
 Ineligibility to apply for grants for years
 End of research career!
Researcher Faces Prison for Fraud in NIH Grant
Applications and Papers
Science 25 March 2005: Vol. 307. no. 5717, p. 1851

A researcher formerly at the University of Vermont College of Medicine

has admitted in court documents to falsifying data in 15 federal grant
applications and numerous published articles.

Eric Poehlman, an expert on menopause, aging, and metabolism, faces

up to 5 years in jail and a $250,000 fine and has been barred for life
from receiving any U.S. research funding.

The number and scope of falsifications discovered, along with the

stature of the investigator, are quite remarkable. "This is probably one
of the biggest misconduct cases ever,"

Poehlman, 49, first came under suspicion in 2000 when Walter DeNino,
then a 24-year-old research assistant, found inconsistencies in
spreadsheets used in a longitudinal study on aging.

In an effort to portray worsening health in the subjects, DeNino tells

Science, "Dr. Poehlman would just switch the data points."
Who is investigated and who is held
accountable?

 Investigated
 All authors that are involved in the specific data in
question

 Held accountable
 Primary author
 Other authors whose results are found culpable
 The PI
Mentor Responsibilities

 Mentors have the responsibility to ensure that all

trainees (post-docs, grad students, undergrads) are
aware of the responsible conduct of research

 Define the Relationship

 Role of Trainee
 Publication/Authorship
 Serving as PI or Co-PI

 Obligation to report

 Good faith report

 Scientists behaving badly

“To protect the integrity of science, we must

look beyond falsification, fabrication and
plagiarism, to a wider range of questionable
research practices”
SCIENCE: Vol 435|9, p.737 June 2005 COMMENTARY
Responsible Research Conduct

• The Office of Research Integrity

(ORI) defines research integrity
as “adherence to rules,
regulations, guidelines, and
commonly accepted professional
codes or norms.”

• Research integrity is essential to

ensure the reliability of research
results and to preserve public
support for research.
PUBLICATION PRACTICES & AUTHORSHIP

 Publication of results fulfills our responsibility to

communicate research findings to the scientific
community.

 Publication of clinical studies also fulfills our

responsibility to have a scientific benefit in
return for putting human subjects at risk.
Why is publication so important for scientists?

Publications share findings that benefit society

and promote human health
Publications share findings that benefit society
and promote human health
Credit for a discovery belongs to the first to
publish
 Reputations and research funding are based on
the number and impact of publications
 Prestigious positions are gained through
reputation and publications
Other than presentations at scientific meetings,
publication in a scientific journal should
normally be the mechanism for the first public
disclosure of new findings.

Why?

[An exception may be appropriate when serious

public health or safety issues are involved.]
Authorship is:
the primary mechanism for determining the
allocation of credit for scientific advances and
thus the primary basis for assessing a
scientist's contributions to developing new
knowledge.

 As such, it potentially conveys great

benefit, as well as responsibility.
Authorship involves:

the listing of the names of participants in all

communications to scientific colleagues (oral or
written)

decisions about who will be the first author, the

senior author, and the corresponding author
Other ways of establishing credit
besides authorship ?

Acknowledgments - for individuals who have

provided encouragement and advice about the
study, editorial assistance, technical support, or
space, financial support, reagents, or
specimens.
The use of anyone else’s discoveries, words,
ideas, data, or analyses must be cited in a way
that others can find the reference and see the
contribution.
When should authorship issues be
discussed?

 before and during the course of a study.

 when material is to be presented in a public

forum or submitted (originally or in revision) for
publication.

 Each author should indicate willingness to

support the general conclusions of the study
before its presentation or submission.
Irresponsible Authorship

Honorary authorship
- an author who does not meet the criteria
Ghost authorship
- failure to include as an author someone who
made substantial contributions to the article
Refusal to accept responsibility for an article
despite ready acceptance of credit
Duplicate and redundant publications
Rennie et al, JAMA 280:222, 1998
Rennie et al’s Hypothesis

Research articles in large-circulation prestigious

medical journals would be more likely to have
honorary authors.
Review articles in smaller-circulation journals that
publish symposia proceedings would be more
likely to have ghost authors.

Rennie et al, JAMA 280:222, 1998

 Authorship Analysis
Research articles Reviews

Honorary 79 (16%) 61 (26%)

Ghost 65 (13%) 23 (10%)

The corresponding authors of 492 research articles

and 240 reviews in: Amer J Cardiology,
Amer J Medicine, Amer J ObGyn, Annals Internal
Medicine, JAMA, and NEJM were surveyed.

Rennie et al, JAMA 280:222, 1998

Annals of Internal Medicine Authorship Criteria

Authors should meet all of these criteria:

 Conceived and planned the work,

or interpreted the evidence it presents, or both

 Wrote the paper, or reviewed successive

versions and took part in the revision process

 Approved the final version

What is missing from this list?

Annals of Internal Medicine Authorship Criteria

The following, by themselves, are not criteria

for authorship:

o holding position of administrative leadership

o contributing patients or reagents

o collecting and assembling data

 Case Study
Dr. Colleen May is a participating neurologist in
a clinical trial to assess the efficacy and toxicity of
a new anticonvulsant medication.
For the duration of the 2-year study, each
neurologist is to meet with each of his/her patients
for an average of 30 minutes per month.
In Dr. May’s case, this amounts to an average of
20 hours per month.
During each visit, the physicians administer a
variety of specialized tests, requiring judgments
dependent on their experience and training in
neurology.
At the completion of the study,the results are to
be unblinded and analyzed by the project
leaders.
It is anticipated that at least two publications will
be prepared for the New England Journal of
Medicine.
Dr. May has just learned that she will be listed in
the Acknowledgements, but not as a coauthor of
the manuscript.
Dr. May argues that she has provided nearly
500 hours of her expert time, far more than
needed to complete a publishable study in her
experimental lab.

Does Dr. May have a case for authorship?

acknowledgement
 Dr. Thomas Inzana, Associate Vice President for Research
Programs, Office of the Vice President for Research
tinzana@vt.edu

 Guidelines for the Conduct of Research in the Intramural

Research Program at NIH
http://www.nih.gov/campus/irnews/guidelines.htm
$