Research Integrity

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Research Integrity

• Is it just adherence to the regulations?

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Academia

• "Scientists are not a special breed of human
  being," says Thomas Murray, president of the
  Hastings Center, a bioethics institute in
  Garrison, N.Y. "But they function in a special
  environment.... They are bright people working in
  a community where the best ideas rise to the top.
  If you're not in first place, you're no place. 1

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Examples

• In October, the Massachusetts Institute of
  Technology fired a young biologist and promising
  immunology researcher. MIT officials say Luk Van
  Parijs was dismissed after he admitted to school
  investigators that he fabricated and altered
  evidence in research papers to support grant
  applications. 1
• In March, a University of Vermont obesity
  scientist admitted faking data in order to
  buttress grant applications. (He netted 3
  million in government grants.) Under a deal with
  US prosecutors, Eric Poehlman agreed to plead
  guilty to criminal fraud and to retract or
  correct several research papers. 1

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Scientists Behaving Badly 2
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Federal Mandate

• 42 C.F.R. Part 50--Policies of General
  Applicability
• Subpart A--Responsibility of PHS Awardee and
  Applicant Institutions for Dealing With and
  Reporting Possible Misconduct in Science

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What does it Say?

• Institution must have misconduct policy if it
  accepts PHS funds
• Institutions policy must meet the minimum
  standard outlined in federal regs
• Institution must have a Research Integrity
  Officer who acts as the gatekeeper for this
  policy and serves as the interface with the
  federal govt for reporting purposes

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2.13 09 University Handbook for Appointed
Personnel

• Policy and Procedures for Investigations of
  Misconduct in Scholarly, Creative, and Research
  Activities
• http//www.vpr.arizona.edu/integrity/ResearchInteg
  rityPolicy-Final1.pdf
• Approved by Faculty Senate February 3, 2003 and
  Adopted by President Likins April 4, 2003

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Key Points in UA Misconduct Policy

• Applies to everyone - faculty, staff, students,
  fellows, visitors, guests, consultants,
  collaborators
• Applies to all scholarship, research and creative
  endeavors conducted at UA, funded or unfunded
  (not just PHS funded)

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Key Points in UA Misconduct Policy (continued)

• Misconduct is fabrication, falsification, or
  plagiarism in proposing, performing or reviewing
  research or creative endeavors, or in reporting
  research results or the results of creative
  endeavors. It does not include honest error or
  differences in interpretation or judgments in
  evaluating research methods or results or
  differences in opinion.

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Definitions

• Fabrication
• Making up data or results and recording or
  reporting them
• Falsification
• Manipulating research or scholarship materials,
  equipment, or processes, or changing or omitting
  data or results such that the scholarship or
  research is not accurately represented in the
  record
• Plagiarism
• The appropriation of another persons ideas,
  processes, results, or words without giving
  appropriate credit

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Fabrication

• creating records of interviews of subjects that
  were never performed
• making up progress notes for patient visits that
  never took place and inserting them into the
  medical record to support published and
  unpublished research reports and
• preparing records for calls and follow-up
  contacts to subjects who had already died.

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Falsification

• substituting one subject's record for that of
  another subject
• falsely reporting to a data coordinating center
  that certain clinical trial staff, who were
  certified to perform the procedures on the
  subjects, had done so, when they had not
• altering the dates and results from subjects'
  eligibility visits
• altering the dates on patient screening logs
  and/or submitting the same log with altered dates
  on multiple occasions

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Falsification (cont)

• failing to update the patients' status and
  representing data from prior contacts as being
  current
• altering the results of particular tests on blood
  samples to show that the test accurately
  predicted a disease or relapse
• backdating follow-up interviews to fit the time
  window determined by the study protocol and
• falsifying the times that blood samples were
  drawn from human subjects.

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Plagiarism

• The theft or misappropriation of intellectual
  property and the substantial unattributed textual
  copying of another's work. It does not include
  authorship or credit disputes.
• The theft or misappropriation of intellectual
  property includes the unauthorized use of ideas
  or unique methods obtained by a privileged
  communication, such as a grant or manuscript
  review.

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What Does Research Integrity Officer Do?

• Receives allegation(s)
• Conducts Pre-inquiry
• Notifies sponsors as appropriate
• Notifies respondent
• Notifies Chair of UCEC (faculty ethics panel) of
  need for Inquiry into allegation(s)
• Obtains and preserves evidence (paper,
  electronic, equipment etc.)

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What Does Research Integrity Officer Do? (cont)

• Receives report from Inquiry Panel
• Initiates ad hoc Investigative Committee if
  appropriate
• Receives transmits final investigation report
  to VPR Provost
• Notifies parties involved of outcome

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Research Integrity

• The UA promotes Responsible Conduct of Research
  by expecting all those involved in research to
  adhere to all university, state, federal, and
  other policies relating to the research or
  creative activity carried out under his/her
  direction.
• Sign up for the PRIE Newsletter by emailing
• Ruth Daniels at rhk_at_u.arizona.edu
• Visit the PRIE website to view past issues
• http//www.vpr.arizona.edu/integrity/index.html

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More thoughts.

• In the end, no system is infallible, ethicists
  note. "If you have someone determined to
  fabricate evidence, no screening system will
  catch that," says Alto Charo, a law professor at
  the University of Wisconsin who specializes in
  biomedical and research ethics. "You have to rely
  on the integrity of the individual."

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Responsible Conduct of Research

• Data sharing/ownership
• Mentor/trainee responsibilities
• Publication Practices Responsible Authorship
• Peer Review

• Collaborative Science
• Human Subjects
• Research Involving Animals
• Research Misconduct
• Conflict of Interest Commitment

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Where do I go for information/help?

• Dr. Tom Lindell
• Research Integrity Officer
• Life Sciences South 254
• 621-5125
• tlindell_at_u.arizona.edu

• Ruth Daniels
• Program Coordinator
• Program in Research Integrity Education
• 626-7643
• Research Compliance Office
• 1203 North Mountain
• rhk_at_email.arizona.edu

• Alice Langen
• Director, Research Compliance
• Associate Director, Program in Research Integrity
  Education
• Office of the VP for Research
• Administration Bldg 601
• 621-5196
• langena_at_email.arizona.edu

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References/Readings

• 1 Spotts, Peter N. (December 22, 2005) .
  Laboratory ethics What makes some scientists
  cheat?http//www.csmonitor.com/2005/1222/p02s01-s
  tss.htm
• (19 February 2006)
• 2 Martinson, Brian C., Anderson, Melissa S., de
  Vries, Raymond (9 June 2005). Scientists behaving
  badly.
• http//www.nature.com/nature/journal/v435/n7043/f
  ull/435737a.html
• access via http//www.ahsl.arizona.edu/journals/e
  jrnl_gateway.cfm?nameNatureID1567 (19 February
  2006)
• http//onlineethics.org/othersites.htmlscienglish