ADARUQ Conference

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ADARUQ Conference October 18, 2006
Timothy L. Quigg, Associate Chair of Computer
Science University of North Carolina at Chapel
Hill
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Overview of Current Research Administration
Issues in the United States
(Compared with Quebec!)
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Influences on Development of U.S.
Approach to Conducting and Managing
Research
Research System
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Outline

• Money
• Staffing (Central-Departmental)
• Compliance Unified Institutional Response
• Misconduct in Science
• Human Subject Testing
• Intellectual Property Management
• Technology Transfer
• Conflict of Interest (Individual-Institutional)

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Current State of Research Administration in the
United States
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• In the real world, Research Administrators
  strive to provide quality support to the research
  enterprise while following all of the applicable
  policies and rules. Its not always as easy as
  it sounds!

Department Chair
Purchasing Office
Sponsored Programs Office
Funding Agencies
Students
Deans Office
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Outline

• Money
• Staffing (Central-Departmental)

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History Projections of U.S. Research Funding

• Increase in National RD Funding
• Increase in Federal Health Funding
• RD at Colleges Increasing

Most of Increase is in Life Science
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Conclusions - National

• Funding increased significantly over last 50
  years
• Health funding increased
• NIH tripling
• Flattening in next 5 years

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Awards in Millions at UNC-CH
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Trends of Federally Sponsored Awards at UNC-CH
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Sponsored awards vs state appropriations at UNC-CH
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2006 Funding by School
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2006 Funding by Source
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Research Dollars vs Staffing at UNC-CH
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Conclusions UNC-Chapel Hill

• From zero to 600M in 45 years
• from federal sources decreasing
• Sponsored research exceeds state appropriations
• Staff size constant
• Need for new paradigms
• Central department cooperation
• Delegation of responsibility

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Outline

• Money
• Staffing (Central-Departmental)
• Compliance Unified Institutional Response
• Misconduct in Science
• Human Subject Testing
• Intellectual Property Management
• Technology Transfer
• Conflict of Interest (Individual-Institutional)

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The only ethical principle which has made
science possible is that the truth shall be told
all the time

• C.P.
  Snow The Search 1959
• Quoted in Honor in Science

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The right to search for truth implies also a
duty one must not conceal any part of what one
has recognized to be true.

- Albert Einstein
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Scientific Fraud and Misconduct Frequency Over
the Past 10 Years
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Institutional Compliance is

• A commitment to obey federal and state laws and
  sponsor policies, and follow internal policies
  and procedures
• An ongoing operational program to prevent,
  detect, and correct wrongdoing
• A system of internal control and procedures to
  evaluate operational practices, minimize legal
  and business risk and implement corrective action

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• Expectations of high standards of conduct in
  science
• Protection of human and animal research subjects
• Proper fiscal management of public funds
• Proper use and disposal of hazardous materials
• Adherence to scientific method to produce valid
  knowledge

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Federal Definition - Research Misconduct
Fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research or
in reporting research results. Research
misconduct does not include honest error or
differences of opinion.
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• Fabrication making up data or results and
  recording or reporting them
• Falsification 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
• Plagiarism the appropriation of another persons
  ideas, processes, results, or words without
  giving appropriate credit

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Whistleblowers

• A good faith allegation is made with the honest
  belief that research misconduct may have
  occurred. An allegation is not in good faith if
  it is made with reckless disregard for or willful
  ignorance of facts that would disprove the
  allegation

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Qui Tam provisions of the False Claims Act

• Allows private parties to sue entities and
  individuals that have submitted false claims to
  the federal government
• Can receive a portion of the settlement if the
  government receives a monetary agreement with the
  defendant

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Recent Settlements

• Revealed via Qui Tam (Whistleblower)
• University 1- 5.5 M (Feb, 2003)
• University 2 - 2.6 M (Feb, 2004)
• University 3- 3.4 M (Apr, 2005)
• University 4- 4.4 M (Jun, 2005)
• Revealed via voluntary disclosure
• University 5- 2.4 M (June 2004)
• All involved overstatement of effort on NIH grants

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Human Subject Testing Tuskegee Syphilis
Experiments
From 1932 to 1972, the US Public Health Service
conducted an experiment in Macon County, Alabama,
to determine the natural course of untreated
latent syphilis in black males. Treatment was
withheld even after the onset of penicillin
therapies became commonplace around 1940.
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Recent Cases

• Jesse Gelsinger Case (University of Pennsylvania,
  Institute for Gene Therapy) September 1999
• An 18 year old volunteer in a gene therapy
  clinical trial for Ornithine Transcarbamylase
  (OTC) Deficiency, died four days after being
  injected with corrective genetic material. It
  was determined that the death was
  research-related.
• The university held equity in the company
  developing the drug, and the lead doctor held
  one-third of its shares of stock

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Conflicts of Interest Its About Public Trust

• Is the situation likely to interfere or appear
  to interfere with the independent judgment one is
  supposed to show as a professional performing
  official duties?

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Conflicts of InterestFinancial Ties between
Researchersand Industry

• Grants and Contracts
• Consultants
• Advisory Boards
• Speakers Bureaus
• Patent/Royalty Arrangements
• Expensive Gifts/Trips
• Equity Interest

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Its About Public Trust
Conflict of Interest

• Longstanding interest in objectivity in research
  and financial conflict of interest.
• Key Question Is the situation likely to
  interfere or appear to interfere with the
  independent judgment one is supposed to show as a
  professional performing official duties?

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Conflict of Interest

• Institutional policy must ensure that
  investigators have provided all required
  financial disclosures at the time the proposal is
  submitted to NSF or NIH.

• It must also require that those financial
  disclosures are updated during the period of the
  award, either on an annual basis, or as new
  reportable significant financial interests are
  obtained.

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Technology Transfer Bayh-Dole Act

• Enacted December 1980 tech transfer born

• Encouraged universities and research institutions
  to collaborate with industry, to commercialize
  successes
• Institutions may elect to retain IP title
• Institutions must file patents if ownership is
  desired
• Government retains nonexclusive license plus
  march-in rights
• Preference provided to small businesses

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Research EthicsConclusions

• Science is a community of trust. When this trust
  is violated, it tends to be on the front page of
  the paper.
• You cannot teach ethics, but you can watch for it
• Conflicts of interest and commitment are natural.
  They cannot be eliminated, but they can (and
  should) be managed.