1. Research Misconduct Overview
IU Office of Research Compliance

2. Contents of Presentation
Background/Federal Requirements
Institutional Responsibilities
What is Research Misconduct?
Policy Requirements
IU Policy and Procedure
Process
Research Integrity Office

3. Background: Lessons learned in 1970s &1980s
Historical Research Misconduct Incidents
1974: William Summerlin accused of fabricating data by using a marker to make black spots on white mice
1981: John Darsee, a postdoctoral fellow at Harvard, accused of fabricating data.
1982: William Broad and Nicholas Wade publish Betrayers of Truth, claiming that there is more misconduct in science than researchers want to admit.
: Luc Montagnier accused Robert Gallo misappropriating an HIV strain.
1987: NIMH panel concludes that Steven Breuning fabricated and falsified data in 24 papers.
1987: Martin Luther King accused of plagiarizing his Ph.D. dissertation.
: Imanishi-Kari accused of fabricating or falsifying data. The ensuing investigation leads to inquiries by M.I.T. and Tufts as well as the N.I.H. and a Congressional committee chaired by Rep. John Dingell. DHHS eventually exonerated Imanishi-Kari, who admitted only to poor record keeping.
No general rules governing academic conduct
Evidence hard to collect
Expertise needed to investigate
Varied standards for judging misconduct
Conflict of interest concerns
Complex and difficult task
Self-policing and self-regulation in science was not limited to scientists or university policy makers
Doubt on the efficacy of the peer review system
Nicholas H. Steneck,
“Research Universities and Scientific Misconduct: History, Policies, and the Future”
David Resnik, Research Ethics Timeline (1932-Present) Link:

4. US Response to Research Misconduct
Historical Research Misconduct Incidents continued
1989: Stanley Pons and Martin Fleischmann hold a press conference at the Univ. of Utah to announce that they have discovered a way to produce nuclear fusion at room temperatures. Dozens of labs fail to reproduce results. They are accused of fraud, sloppiness, and self-deception.
1994: Roger Poisson admits to fabricating and falsifying patient data in breast cancer clinical trials in order to qualify his patients to participate in research and have access to experimental treatments.
2002: Bell Labs determines Jan Hendrick Schon, a rising star working in condensed matter physics and nanotechnology who published dozens of articles in a short period in prestigious journals, had committed misconduct. 28 papers were withdrawn.
2002: Historian Stephen Ambrose is accused of plagiarism.
1987: Lancet retracts fraudulent paper by Andrew Wakefield that linked autism to measles vaccine.
1980’s: Define policies to respond to misconduct
1981, Congressional hearings, Fraud in Biomedical Research
1985, Second round of Congressional hearings
1986, First policies and definitions
US National Science Foundation
US Office of Research Integrity
1990s Promote training as a way to prevent misconduct
1990, Responsible Conduct of Research training requirement (NIH)
2000, Human Subjects Protections training requirement (NIH)
2009, Research Ethics/RCR training requirement (NSF)
Nicholas H. Steneck,
Creating a Climate
David Resnik, Research Ethics Timeline (1932-Present) Link:

5. Office of Research Integrity (ORI)
Federal Requirements & Institutional Policies
1985: NSF required universities to develop mechanism for dealing and reporting scientific misconduct
1989: PHS formed Office of Scientific Integrity and Office of Scientific Integrity Review to investigate scientific misconduct activities & Most of the major and about half of the middle range research universities reportedly had adopted scientific misconduct policies
ORI oversees Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.
Office of Research Integrity About ORI Link:
Research Integrity Office

6. What is Research Misconduct?
Fabrication: Making up data or results
Falsification: Manipulating materials, equipment or processes, or changing/omitting data or results such that the research is not accurately represented in the research record
Plagiarism: Appropriating another person’s ideas, processes, results , or words without giving appropriate credit.
Fabrication, Falsification, and/or Plagiarism when proposing, performing or reviewing research, or in reporting research results.
IU Policy and Procedures Link
Research Integrity Office

7. What is NOT Misconduct?
Research misconduct does not include: disputes regarding honest error or honest differences in interpretations or judgments of data, and is not intended to resolve bona fide scientific disagreement or debate.
Research misconduct is also not intended to include “authorship” disputes such as complaints about appropriate ranking of co-authors in publications, presentations, or other work, unless the dispute constitutes plagiarism (as defined above).
Research Integrity Office

8. Policy and Procedures on Research Misconduct at IU
Allegation: A written allegation of misconduct that triggers the procedures described by this
policy.
Inquiry: The process for information gathering and preliminary fact-finding to determine if a charge or apparent instance of Research Misconduct has substance & therefore warrants an Investigation.
Investigation: The process for the formal
examination and evaluation of all relevant
facts to determine whether Research
Misconduct occurred, and, if so, the
responsible person and the seriousness of
the misconduct.
Policy
Obligation to report research misconduct
Obligation to cooperate in the conduct of an Inquiry and/or Investigation
Ensures honesty and research integrity and responsible conduct of research
Procedure
Allegation→ Inquiry→ Investigation
IU Policy and Procedures Link:
Research Integrity Office

9. Policies and Procedures must also include:
Provisions for protections for the whistleblower
Confidentiality measures
Restoration of reputations
Research Integrity Office

10. Downstream effects Why do we care? What does it matter?
Validity of the science
Damaged reputations/careers
Collateral damage
Research Integrity Office

11. 2012 Federal Agency Research Misconduct Finding
Calleen S. Zach a former Research Assistant and Data Base Manager at Creighton University
Findings
falsified subject enrollment numbers in applications to NIH, a no-cost, one-year extension request, an application for additional funding, and falsified reports to the Creighton University IRB.
Sanctions (5 Years)
debarred from eligibility for any contracting or subcontracting with any agency of the US government and from eligibility for, or involvement in, nonprocurement programs of the US government. Prohibited from serving in any advisory capacity to the U.S. Public Health Service.
Office of Research Integrity Case Link:
Research Integrity Office

12. 2011 Federal Agency Research Misconduct Finding
Gerald Lushington, Ph.D., Director of the Molecular Graphics and Modeling Lab at Kansas University and Director of the KansasDeA Network of Biomedical Research Excellence
Findings
approved publication of three articles and one abstract he knew contained significant amounts of plagiarized text from other writers’ published papers.
Voluntary Settlement Agreement (2 year period)
any U.S. Public Health Service-supported research supervised, a plan for supervision of his PHS-related duties submitted to ORI, a summary report detailing how KU has ensured that Respondent's research and language in PHS grant applications and reports of PHS-supported research have been verified to be his own and accurately reported. An annual summary, provided by any institution employing him to provide assurance that PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent was involved, was based on actual experiments or was otherwise legitimately derived…
Office of Research Integrity Case Link:
Research Integrity Office

13. 2010 Federal Agency Research Misconduct Finding
Emily M. Horvath a former graduate student at IU
Findings
falsified original research data when entering values into computer programs for statistical analysis with the goal of reducing the magnitude of errors within groups, thereby gaining greater statistical power. Falsified figures in a NIH grant application, multiple publications, and in her Ph.D. thesis.
Voluntary Settlement Agreement (3 year period)
excluded from serving in any advisory capacity to the U.S. Public Health Service, cannot participate in any PHS-supported research until a supervisory plan is submitted to federal agency (ORI) and approved, and will write letters to journals editors of the published papers what she falsified/fabricated.
Office of Research Integrity Case Link:

14. How to Report Research Misconduct at IU
Contact Research Integrity Officer Shelley Bizila (317) Anonymous Hotline at IU ( )
IU Policy and Procedures Link:
Research Integrity Office