DA202

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COMP 323 Research Administration For Scientists
DA202 Research Ethics Wednesday, March 29,
2006
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(No Transcript)
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SCIENCE IS A COMMUNITY BASED ON TRUST
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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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Most Americans see a strong science as essential
to a successful future. Yet that generous social
support is based on the premise that science will
be done honestly and that mistakes will be
routinely identified and corrected.

• Bruce Alberts, President, National Academy
  of Sciences, 1989

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Scientific Fraud and Misconduct Frequency Over
the Past 10 Years
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Ethics

• A set of principles of right conduct
• The rules of standards governing the conduct of a
  person or the members of a profession

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ETHICS IN SCIENCE

• Faculty, students, and staff of the University
  should maintain their professional behavior and
  conduct research with the highest standards of
  integrity.

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

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DATA COLLECTION, MANAGEMENT AND RECORD KEEPING
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Accountability

• The laboratory notebook represents the final
  authority on data collection, manipulation, and
  presentation. It must contain
• All the information on an experiments design and
  execution
• The original data (preferably as the raw data
  output)
• Calculations and data reductions
• Conclusions and interpretations

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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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Case Study Data Fabrication

• A student believes that the work of a fellow
  student is forged. The data are too clean, the
  student isnt in the lab enough to support the
  amount of data, and sufficient reagents are not
  being consumed.

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Case Study Data Fabrication, cont.

• Is there enough evidence?
• How should the student proceed?

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Case StudyData Falsification- I

• A student prepares a scatter-graph that
  demonstrates a time-dependent effect.
  Unfortunately, several points do not closely
  follow the relationship.
• A peer suggests dropping the lowest points
  because the cells were obviously dead and the
  highest point because it is an obvious outlier.

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Case Study Data Falsification I, cont.

• How should the student go about determining
  which points to exclude?
• What other course(s) of action would you
  recommend to the student?

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Case StudyData Falsification II

• A student is using an autoanalyzer to test the
  effects of radioprotective agents on
  prostaglandin production. Only six of the ten
  assays demonstrate protection.
• Mentor suggests the lack of observed response
  was due to equipment failure.

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Case Study Data Falsification II, cont.

• Is the mentors assessment valid?
• How could the interpretation be tested?
• If the ambiguity persists, how should the student
  proceed?

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Case Study Plagiarism

• A student prepares a written qualifying
  examination paper which incorporates entire
  passages from other works (without attribution).
  When discovered, she is expelled from the
  graduate program.

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Case Study Plagiarism, cont.

• Was this an excusable offense?
• Was the punishment to severe?

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Research Misconduct

• Awardee institutions bear primary responsibility
  for prevention and detection of research
  misconduct and for the inquiry and investigation
  of alleged research misconduct.

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Authorship

• Authorship on a scientific paper should be
  limited to those individuals who have contributed
  directly to the design and execution of the
  experiments and who have participated in the
  preparation of the manuscript.

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Authorship

• A paper is being prepared concerning the
  metabolism of sulfites. Which of the following
  should be included as authors?
• Toxicologist who provided previously published
  information on animal models
• Wildlife specialist who provided information on
  breeding mice.
• Technician who helped develop assay and wrote the
  Methods section.
• Another scientist who helped design experiments
  and edited the final draft.

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Peer review is the process whereby other
scientists evaluate grant applicants for funding
or scientific papers for publications

• Fairness
• Confidentiality

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Case Study Peer Review

• An investigator (faculty member and biotech
  company official) serves on an NIH study section.
  He reviews a grant which contains information
  demonstrating that his current work (both
  academic and corporate) is headed down a blind
  alley.

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Case Study Peer Review, cont.

• How should the investigator proceed?
• What issues of confidentiality and conflict of
  interest are involved?
• How might this situation have been avoided?

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Case Study Data Ownership

• A graduate student has just defended his
  dissertation and is leaving for a post doctoral
  position.
• While packing up his office he is informed by his
  mentor that he may not remove the laboratory
  notebooks.

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Case Study Data Ownership, cont.

• Who do you think owns the research data?
• Should the student have been allowed to take the
  results of his labors?
• What if the student had been going to a
  competitors laboratory?

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Whistleblowers

• Institutions must
• Protect to the maximum extent possible the
  privacy of those who in good faith report
  apparent misconduct
• Undertake diligent efforts to protect the
  positions and reputations of those persons, who,
  in good faith make allegations

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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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Competing Interests (Conflicts?)

• Competing interests are unavoidable- it is how
  they are managed
• Conflicts of conscience
• Sometimes good, but not always
• Conflicts of commitment
• Assigned duties vs. free-lancing
• Conflicts of interest
• An expanding universe

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Conflicts of Interest

• Professional
• (reviewing friends/competitors grants and/or
  manuscripts)
• Financial
• (vested interest in experimental outcome)

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Conflicts of Interest

• Primary responsibilities and professional
  judgment (e.g., patients welfare, research
  validity)
• vs
• Secondary interests (e.g., financial gain)

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Conflicts of Interest

• The public (i.e., taxpayers) expect that
  University research is objective
• Protect research subjects and personnel
• Preserve public trust
• Promote scientific progress
• Bioethicists are concerned
• Financial gain may cloud scientific integrity
• Experiments may be pushed that might not be safe

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Conflicts of InterestPressures

• Desire for
• Faculty advancement
• Success in grant funding
• Acquisition of limited resources (space, staff
  support, tenure-track position)
• Prestigious national reputation
• Cure disease, alleviate pain and suffering

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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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Conflicts of Interest PHS and NSF Definition
Significant Financial Interest

• Anything of monetary value, including but not
  limited to, salary or other payments for
  services equity interests and intellectual
  property right
• gt 10,000 or gt 5 ownership interest for any one
  enterprise or equity

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Conflicts of InterestIndividual Conflict of
Interest

• Situations where financial considerations may
  compromise, or have the appearance of
  compromising, an employees professional judgment
  in designing, conducting, evaluating, or
  reporting research
• DISCLOSURE is key

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Conflicts of Interest Significant Financial
Interest

• University concerns regarding significant
  financial interests
• Are students adequately protected?
• Are publications resulting from research?
• Are inventions reported to University?
• Are laboratory personnel aware of PIs
  significant financial interest?
• If clinical research, are research participants
  made aware of PIs significant financial
  interest?

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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.