Prevention and Containing Misconduct in Research in the Age of Big Data Presentation to MedicReS 5th World Congress on Good Medical Research October 19-25, 2015, New York by Adil E. Shamoo, PhD., CIP

1. Prevention and Containing Misconduct
in Research in the Age of Big Data
Presentation to:
5th
World Congress on Good Medical Research
October 19-25, 2015
By
Adil E. Shamoo, Ph.D., CIP
University of Maryland School of Medicine
108 N. Greene Street
Baltimore, MD 21201
Tel# 410-706-3327
Cell# 301-538-2599
E-mail: ashamoo@som.umaryland.edu
10/27/15

2. Nobility
Vs
Pathology
Copyright, Shamoo Consulting 2005

3. 10/27/15

4. US Research enterprise
$450 Billion

5. Betrayers of the Truth
(Broad and Wade, 1982, [1993])
Authors claimed:
•Galileo – made up the data of falling object
•Newton – forced fit data to theories—velocity of sound, procession of
equinoxes, and gravitational forces
•Dalton – cleaned up data on ratios of chemical reactions
•Mendel – manipulated heredity ratios
•Millikan – selective reporting?? (not true)
•Louis Pasteur – announced anthrax vaccine before he completed his
experiments
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6. Survey of US College Students
(2,100)
• 75 % admit to some cheating.
• 41 % have Plagiarized through
the Internet.
• The Center for Academic Integrity, 2002.
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7. Nationwide Survey of Doctoral Students in Norway
(BMC Med Ethics, 2013: 14:3,)
189 respondents from 262 (72.1%)
• 65% heard of researchers’ misconduct
• 11% experience pressure for order of authorship order
• 10% thinks using dry lab is OK
• 38% OK to change statistical method to find
significant results
• 13% Ok to selectively omit data to expedite publication
• 10% Acceptable to falsify or fabricate data to expedite
publication
• 79% Willing to report misconduct
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8. Misconduct Definition
“‘fabrication, falsification, or plagiarism [FFP], in
proposing, performing, or reviewing research,
or in reporting research results”……
Misconduct does not include honest errors or
disagreement about methods, interpretations
of data, or scientific issues”
(Office of Science and Technology Policy 2000)
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9. Misconduct in Research
(From: RCR 3rd
edition, 2015, p.38-39)
• Spectrum of behavior
• From: FFP to Questionable Research
Practices (QRP) such as:
o Enhancing digital images
o Excluding piece of data
o Poor record keeping
o Poor citation
o Not giving credit to others
o Self-plagiarism
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10. FDA Definition of Misconduct
• Research misconduct means falsification of data
in proposing, designing, performing, recording,
supervising or reviewing research, or in reporting
research results
• Falsification includes acts of omission and
commission
Source: Stan W. Woolen, Associate Director for Bioresearch
Monitoring Office for Good Clinical Practic
http://www.fda.gov/oc/gcp/slideshows/misconduct 2001/misconduct.ppt,
Scientific Misconduct – The “F” Word – October 2001.
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11. FDA and Research
Misconduct?
• Deliberate or repeated noncompliance with the
regulations can be considered misconduct, but is
secondary to falsification of data
• Research misconduct does not include honest
error or honest differences of opinion
Source: Stan W. Woolen, Associate Director for Bioresearch
Monitoring Office for Good Clinical Practice
http://www.fda.gov/oc/gcp/slideshows/misconduct 2001/misconduct.ppt,
Scientific Misconduct – The “F” Word – October 2001.
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12. Example of Potential Outcome of Misconduct
in Scientific Research
 In clinical trial (Phase III)
 1000 Subjects (Volunteers) as exp. Arm
 1000 subjects as Control arm.
 Adverse-events were not reported by:
 1 death, 2 hospitalizations
 Later Drug Used in 10 million people
 Adverse events would be
 10,000 +/- ? deaths,
 20,000 +/-? hospitalizations
The making of a scandal
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13. Scientific Misconduct Survey of Research
Coordinators
(Pryor, Habermann, and Broome, J. Med. Ethics, 2007, 33:365-369)
 Survey: 1645 of 5302 (31%) survey
 First Hand Knowledge: 18 %
 If CRC observe PI Misconduct:
10 % would not report
 37 % Confront the PI but not report
 27 % ask PI to report and then if not, they report
 26 % would report it to authorities
 Perceived Prevalence of Misconduct:
 Plagiarism 67 % Never
 Falsifying data 71 % Never
 Intentional protocol Violations 65 % Never
(Related to human subjects)
 Findings: Overall, the perceived misconduct was low??????
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14. Data of Misconduct in
other countries
In 2009, China Association for
Science and Technology (CAST)
reports from a survey of 30,000
Chinese researchers:
43.4 say plagiarism is not serious
misconduct.
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15. The Economist: In China: Widespread
academic fraud may hamper drive for
innovation
• Pervasive academic and scientific
misconduct
• Falsification of credentials
• Plagiarism
Outcome:
• Concerns for safety of Chinese products
• Difficulty in new recruitment of scientists
• Hampering innovations
(The Economist, July 22, 2010, p. 43., http://www.economist.com/node/16646212/print
accessed August 2, 2010)
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16. Plagiarism Allegations for Romanian
Minister (May 16, 2012) and Prime Minister (June 20, 2012)
• Ion Mang – Research Minister
• Prime Minister Victor Ponta –
Doctoral thesis
• Mang is a Computer scientist at the
University of Oradea in Romania.
• One paper is nearly identical copy
of a manuscript by Eli Biham.
• http://www.nature.com/news/plagiarism-charge-for-romanian-minister-1.10646
• http://www.nature.com/news/romanian-prime-minister-accused-of-plagiarism-1.10845
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17. India: Plagiarism on the
rise
(S. Neelakantan, www.globalpost.com)
Anecdotal evidence
Resignation of a leading science-policy
expert due to plagiarism.
7 out of 36 plagiarism and misconduct cases
investigated involved high-level academics.
Indian Institute found 80 cases of
plagiarism from their 2 year publications.
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18. Misconduct in UK (BMJ Survey)
• 2700 Researchers (31 % response rate)
• Submitted or reviewed to BMJ
• 13 % admitted knowledge of colleagues
“inappropriately adjusting, excluding,
altering, or fabricating data” for publication.
• 6 % aware of cases of misconduct not
investigated.
(Tavare, 2012, BMJ, 344:e377)
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19. Meta analysis of 21
Surveys on Misconduct
1.97 % of Scientists admitted to have fabricated,
falsified or modified data or results at least once.
33.7 % admitted other questionable practices.
14.2 % for falsification for other colleagues.
72 % of questionable practice for other
colleagues.
(Faneli, 2009, PLoS ONE, 4:e5738)
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20. International Issues in
Science Integrity
Misconduct
Falsification
Fabrication
Plagiarism
Other misconducts
Collaboration challenges
Differing standards of conduct
Differing regulations
Differing Integrity oversight
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21. Big Data
• Healthcare data (Sharing?)
• Genomic data
• System biology
• Research data
– Biomedical research
– Clinical trials
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22. Issues in Big Data Use
–Clinical trials
•Informed consent
•Privacy
•IRBs
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23. Factors leading to
misconduct in Science
• Bad apple vs. systemic
• Individual virtues vs. Institutional ethics
• Social control (Rewards and Sanctions)
(Emile Durkheim, Robert K. Merton, and Harriet Zuckermann)
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24. Factors contributing to
Misconduct in Science
• Reputation
• Fame (Nobel Prize Syndrome)
• Conflict of Interest (i.e. Financial)
• Promotion
• Pressure to produce
• Poor Training
• Complex research environment
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25. Current Methods To Prevent/Contain
Misconduct
(From: Shamoo, 2013, Accountability in Research:20:369-379, 2015)
1. Voluntary Compliance with Ethical
Norms.
2. Regulations and Standards.
3. Education and Training.
4. Whistleblowers.
5. Data Audit.
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26. Education and Training
• Formal training in RCR ineffective in reducing
unethical behavior(Anderson et. al., 2007). And it does not
improve skills in research ethics (Kalichman group, 1992,1996,
1998).
• Reviewing ORI Misconduct files found ¾ of mentors
did not review source data and 2/3 did not set
standards for their trainees (Wright et. Al., 2008).
• Only 8.2% of faculty/staff in 144 top NIH/NSF
funded research with human subjects receive
training in RCR (Resnik and Dinse, 2012)
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27. Data Audit
• Article in Nature on “Data Audit”
(Shamoo and Annau, 1987)
• Article in AAAS Observer “We Need
Data Audit” (Shamoo, 1988).
• Other Efforts 1987 - Present
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28. 10/27/15
The Procedures for data
auditing will have to be non-
obtrusive so that scientists
can carry their work without
fear of unnecessary
interruptions

29. Nature of Data Audit
• “The systematic process by which objective
evidence is obtained and evaluated as to
assertions about research data and their
value to determine the degree of
correspondence between those assertions
and established or predetermined criteria
which can then be communicated to
interested parties (Loeb and Shamoo, 1989, p. 28)
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30. Elements of Data Audit (Shamoo, ORI conference, Acc. In Res.,
2013)
• Systematic process
• Objective evidence
• Determine the degree of
correspondence
• Randomly selected sample from data or
from stratified data
• “For cause” audits if needed
And….
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31. The
END
Questions?
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32. Betrayers of the Truth
(Broad and Wade, 1982, 1993)
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33. Fabrication
Fabrication is making up data or results and
recording or reporting them.
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34. Falsification
Falsification is manipulating research
materials, equipment, or processes, or
changing or omitting data or results such that
the research is not accurately represented in
the research record.
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35. Plagiarism
Plagiarism is the appropriation of another
person’s ideas, processes, results, or words
without giving appropriate credit.
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36. South Korean human embryonic stem cell
fraud, 2005
• Woo Suk Hwang and 24 co-authors
(Hwang et al 2004 ( with U.S. Collaborator,
Schatten), 2005).
• Science Magazine
• 11 embryonic stem cell lines containing
nuclear DNA from somatic cells of
research subjects
• 2 employees oocytes.
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37. Misconduct in Germany
• German defense minister resigns in PhD
plagiarism March 1, 2011,
• German Education minister Annette
Schavan quits over 'plagiarism‘
Feb 9, 2013
• Both Stripped of their doctorate and their
jobs.
http://www.guardian.co.uk/world/2011/mar/01/german-defence-minister-resigns-plagiarism
http://www.bbc.co.uk/news/world-europe-21395102
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38. Misconduct in Other
Countries
• Reports of misconduct in:
Korea, China, Peru, Iran,
Bulgaria, Croatia, Russia.
• Middle East, Latin America,
India – not well defined.
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39. Plagiarism in China
 In 1997, two cases of wholesale plagiarism
 NSFC investigated 542allegations of misconduct and found:
40 %falsification
34%plagiarism
7%data fabrication or theft
19 %other misconducts
(Zeng and Resnik, 2010, Developing World Bioethics, 10:1471-8847 online)
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