Prevention and Containing Misconduct in Research in the Age of

Big DataPresentation to:

5th World Congress on Good Medical ResearchOctober 19-25, 2015

By

Adil E. Shamoo, Ph.D., CIPUniversity of Maryland School of Medicine

108 N. Greene StreetBaltimore, MD 21201Tel# 410-706-3327Cell# 301-538-2599

E-mail: ashamoo@som.umaryland.edu05/03/23

Nobility Vs

PathologyCopyright, Shamoo Consulting 2005

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US Research enterprise

$450 Billion

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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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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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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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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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 imageso Excluding piece of datao Poor record keepingo Poor citationo Not giving credit to otherso Self-plagiarism

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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 BioresearchMonitoring 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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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 BioresearchMonitoring Office for Good Clinical Practicehttp://www.fda.gov/oc/gcp/slideshows/misconduct 2001/misconduct.ppt,Scientific Misconduct – The “F” Word – October 2001.

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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 +/-? hospitalizationsThe making of a scandal

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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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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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The Economist: In China: Widespread academic fraud may hamper drive for

innovation• Pervasive academic and scientific

misconduct• Falsification of credentials• PlagiarismOutcome:• 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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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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India: Plagiarism on the rise

(S. Neelakantan, www.globalpost.com)Anecdotal evidenceResignation 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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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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Meta analysis of 21 Surveys on Misconduct1.97 % 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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International Issues in Science Integrity

MisconductFalsificationFabricationPlagiarism Other misconducts

Collaboration challengesDiffering standards of conductDiffering regulationsDiffering Integrity oversight05/03/23 Adil E. Shamoo, Ph.D. 20

Big Data

• Healthcare data (Sharing?)• Genomic data• System biology• Research data– Biomedical research– Clinical trials

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Issues in Big Data Use

–Clinical trials•Informed consent•Privacy•IRBs

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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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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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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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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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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 - Present05/03/23

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The Procedures for data auditing will have to be non-obtrusive so that scientists can carry their work without fear of unnecessary interruptions

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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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….05/03/23

The END

Questions?05/03/23

Betrayers of the Truth(Broad and Wade, 1982, 1993)

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Fabrication

Fabrication is making up data or results and

recording or reporting them.

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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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Plagiarism

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

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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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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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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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Plagiarism in China In 1997, two cases of wholesale plagiarism NSFC investigated 542 allegations 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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