Research Misconduct

Overview

Clinical Research Compliance Office (CRCO)


Background: Lessons
learned in 1970s &1980s
• 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”
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.
1984-1993: 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.
1987-1996: 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.
David Resnik, Research Ethics Timeline (1932-Present) Link:
http://www.niehs.nih.gov/research/resources/bioethics/timeline/

Background: Lessons
learned in 1970s &1980s
1985 Health Research Extension Act
and subsequent legislation relating to
the National Science Foundation
required universities to
(1)develop mechanisms for dealing
with scientific misconduct and
(2)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”
Historical Research Misconduct Incidents
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.
1994-1995
The Ryan Commission, convened by the NIH,
holds meetings on scientific misconduct.
David Resnik, Research Ethics Timeline (1932-Present) Link:
http://www.niehs.nih.gov/research/resources/bioethics/timeline/
 What is Research Fabrication: Making up data or results
Misconduct ?
Falsification: Manipulating materials,
Fabrication, Falsification, equipment or processes, or
and/or Plagiarism when changing/omitting data or results such that
proposing, performing or the research is not accurately represented
reviewing research, or in in the research record
reporting research
results. Plagiarism: Appropriating another person’s
ideas, processes, results, or words without
giving appropriate credit.

IU Policy and Procedures Link: http://www.researchadmin.iu.edu/Policies/PoliciesProceduresOnResearchMisconduct.pdf

 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
 ORI’s Research Misconduct Responsibilities Include
Office of Research •Developing policies, procedures and
Integrity (ORI) regulations related to the detection,
investigation, and prevention
•Reviewing and monitoring investigations
ORI oversees Public Health conducted by applicant and awardee
Service (PHS) research institutions, intramural research programs,
integrity activities on behalf and the Office of Inspector General in the
of the Secretary of Health Department of HHS.
and Human Services with •Recommending findings and administrative
the exception of the actions to the Assistant Secretary for Health
regulatory research for decision, subject to appeal
integrity activities of the •Assisting the Office of the General Counsel
Food and Drug (OGC) to present cases before the HHS
Administration. Departmental Appeals Board; providing
technical assistance to institutions that
respond to allegations of research
misconduct.

Office of Research Integrity About ORI Link: http://www.researchadmin.iu.edu/Policies/PoliciesProceduresOnResearchMisconduct.pdf

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

Contact Research Integrity Officer Anonymous Hotline at IU

Shelley Bizila: (877) 526-6759
(317) 274-5524
sbizila@iu.edu Anonymous Web Alert link at IU
https://iu.alertline.com/gcs/welco
me

Office of Research Administration Research Integrity Link: http://researchadmin.iu.edu/cs-researchint.html

 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: http://ori.hhs.gov/content/case-summary-zach-calleen-s

 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: http://ori.hhs.gov/content/case-summary-lushington-gerald

 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: http://ori.hhs.gov/content/case-summary-horvath-emily-m

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