Presentation Title - Office of Research Compliance

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Research Misconduct
Overview
Clinical Research Compliance Office (CRCO)
Background: Lessons
learned in 1970s &1980s
Historical Research Misconduct Incidents
• 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
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.
Nicholas H. Steneck,
“Research Universities and Scientific Misconduct:
History, Policies, and the Future”
David Resnik, Research Ethics Timeline (1932-Present) Link:
http://www.niehs.nih.gov/research/resources/bioethics/timeline/
Historical Research Misconduct Incidents
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”
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
Misconduct ?
Fabrication, Falsification,
and/or Plagiarism when
proposing, performing or
reviewing research, or in
reporting research
results.
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.
IU Policy and Procedures Link: http://www.researchadmin.iu.edu/Policies/PoliciesProceduresOnResearchMisconduct.pdf
Principles of Research Integrity
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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
Office of Research
Integrity (ORI)
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.
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.
Office of Research Integrity About ORI Link: http://www.researchadmin.iu.edu/Policies/PoliciesProceduresOnResearchMisconduct.pdf
Policy and Procedures
on Research
Misconduct at IU
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
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.
IU Policy and Procedures Link: http://www.researchadmin.iu.edu/Policies/PoliciesProceduresOnResearchMisconduct.pdf
Roles within the Policy
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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
Shelley Bizila:
(317) 274-5524
[email protected]
Anonymous Hotline at IU
(877) 526-6759
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
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