1. Research Misconduct Overview
Clinical Research Compliance Office (CRCO)

2. 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. Nobel Prize winner David Baltimore is one of the co-authors on the disputed paper.
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:

3. Background: Lessons learned in 1970s &1980s
Historical Research Misconduct Incidents
Background: Lessons learned in 1970s &1980s
1989: The PHS forms two agencies, the Office of Scientific Integrity and the Office of Scientific Integrity Review to investigate scientific misconduct and provide information and support for universities. It also amends its definition of misconduct. The two agencies are reorganized in 1992 as the Office of Research Integrity (ORI).
1989: The NIH requires that all graduate students on training grants receive education in responsible conduct of research.
1992:NAS publishes Responsible Science: Ensuring the Integrity of the Research Process. The book estimates the incidence of misconduct, discusses some of the causes of misconduct, proposes a definition of misconduct, and recommends some strategies for preventing misconduct.
The Ryan Commission, convened by the NIH, holds meetings on scientific misconduct.
1985 Health Research Extension Act and subsequent legislation relating to the National Science Foundation required universities to
develop mechanisms for dealing with scientific misconduct and
report activities relating to scientific misconduct to the federal government.
By March 1989 most of the major and about half of the middle range research universities reportedly had adopted scientific misconduct policies
Nicholas H. Steneck,
“Research Universities and Scientific Misconduct: History, Policies, and the Future”
David Resnik, Research Ethics Timeline (1932-Present) Link:

4. 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:

5. Principles of Research Integrity
Responsible conduct of research
Self-policing
Mechanisms for dealing with scientific misconduct
Policy and procedures
Monitoring research misconduct
Promotes intellectual honesty and trust of science
Ethical research
System of checks and balances
Protection of whistleblowers
Safe environment to explore science and inquiry

6. Office of Research Integrity (ORI)
ORI’s Research Misconduct Responsibilities Include
Developing policies, procedures and regulations related to the detection, investigation, and prevention
Reviewing and monitoring investigations conducted by applicant and awardee institutions, intramural research programs, and the Office of Inspector General in the Department of HHS.
Recommending findings and administrative actions to the Assistant Secretary for Health for decision, subject to appeal
Assisting the Office of the General Counsel (OGC) to present cases before the HHS Departmental Appeals Board; providing technical assistance to institutions that respond to allegations of research misconduct.
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:

7. 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:

8. Roles within the Policy
Complainant
Respondent
Research Integrity Officer (RIO)
Standing Committee on Research Integrity
Deciding Official (DO)
Inquiry Committee
Investigation Committee
University Counsel
Office of Research Integrity (ORI)
IU Policy and Procedures Link:

9. Allegation→ Inquiry→ Investigation
Procedures at IU
Allegation→ Inquiry→ Investigation
Allegation
Receive and review allegation
Informal meetings with involved parties
Collaborate with University Counsel, Standing Committee on Research Integrity
Collection of any information needed at this stage to determine a recommendation
Consult with Office of Research Integrity
Recommendation to the Deciding Official, Dr. José
Inquiry
Sequestration
Appointment of an Inquiry Committee
Notification of the Complainant(s), Respondent(s), and Dean
Meetings with the Inquiry Committee, RIO, and University Counsel
Interviews with the Complainant(s) and the Respondent(s)
Collection of information requested by the Inquiry Committee (e.g. Grants Office)
Inquiry Committee Report (allegation, process, findings, and recommendation)
Final Inquiry Record to Deciding Official, Dr. José
Deciding Official makes determination and any sanctions
Completed within 60 calendar days of initiation

10. Procedures at IU (Cont’d)
Allegation→ Inquiry→ Investigation
Investigation
Report and Collaborate with the ORI
Appointment of an Investigation Committee
Notification of the Complainant(s), Respondent(s)
Notification to external funding agencies
Notification to appropriate governmental offices
Commencement within 30 calendar days of determination
Investigation may be conducted through private interviews or at a hearing
All interviews or hearings are taped and transcribed and shared with each interviewee
Investigation Committee Report (allegation, process, findings, and recommendation)
Submitting report to Deciding Official, Dr. José
Deciding Official makes determination and any sanctions
Submitting report to ORI
Notifications to the involved parties
Investigation should be completed within120 days of initiation

11. How to Report Research Misconduct at IU
Contact Research Integrity Officer Shelley Bizila: (317)
Anonymous Hotline at IU
(877)
Anonymous Web Alert link at IU
Office of Research Administration Research Integrity Link:

12. 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:

13. 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:

14. 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:

15. Downstream Effects Validity of the science Damaged reputations/careers
Collateral damage