Research Integrity

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Research Integrity

• Is it just following the regulations and avoiding
  misconduct?

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Research Misconduct
P.D. Magnus, Michael Kalichman, September 2002 Background There are some indications that research misconduct occurs only rarely. In 20 years, the federal government found an average of about 10 cases of research misconduct per year that is, about 1 case per year for every 10,000 researchers. However, there are many barriers to accurately quantifying the extent of research misconduct cases may go unreported and institutions may be biased against finding misconduct. The actual rate of research misconduct could be as low as 1 in 100,000 or as high as 1 in 100. (Steneck, 2000) In the past 20 years, numerous serious cases of alleged misconduct have been widely publicized. In many cases, the allegations were borne out by subsequent investigation. It is noteworthy that in these cases both whistleblowers and those accused of wrongdoing paid a price whether the allegations were ultimately sustained or not.
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What does this mean?

• "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.

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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 regulations
• 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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Principles

• The integrity of science depends on the integrity
  of research.Science is predicated on trust --
  without confidence in the integrity of their
  peers, scientists would be unable to trust one
  another's work. The demands of ethical and
  responsible conduct may not always seem
  expedient.
• The integrity of research depends in part on
  self-policing.Just as peer review operates to
  assure the legitimacy of published reports,
  self-policing operates to assure the legitimacy
  of research at a deeper level. This means that
  scientists should be familiar with definitions of
  research misconduct and procedures for dealing
  with it, regardless of whether they are actually
  party to allegations. Self-policing also demands
  that scientists attempt to communicate with one
  another to foster an environment in which
  responsible research is explicitly discussed and
  encouraged.

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Guidelines

• DocumentationA failure to keep good records can
  have serious consequences for the progress of a
  research project, but can be particularly
  devastating for someone involved in an allegation
  of misconduct.
• Rules and Procedures
• Although institutions receiving federal funds
  need to meet a common set of minimal
  requirements, individual institutions are granted
  substantial leeway in the rules and procedures
  for handling of allegations of misconduct.
• Institutional channels are preferable to public
  channels.

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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. Cindy Rankin
• Research Integrity Officer
• Biosciences West 274
• 621-3104
• crankin_at_email.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

• Office of Research Integrity http//ori.dhhs.gov/

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Examples

• Research Assistant Engaged in Scientific
  Misconduct (8/17/06)
• Former University of Maryland at Baltimore
  research assistant Sylvia Okoro was found by the
  Office of Research Integrity to have engaged in
  scientific misconduct by fabricating and
  falsifying patient data in research supported by
  the National Institute on Aging. Okoro
  "intentionally and knowingly" fabricated and
  falsified information on one patient data form,
  and on two other study subjects she failed to
  note that each patient had taken a fall as was
  documented in their medical charts. For a
  three-year period, which began July 17, 2006,
  Okoro is prohibited from serving in any advisory
  capacity to the Public Health Service (PHS) in
  addition, if any institution applies for PHS
  research support that includes Okoro's
  involvement, a plan to insure scientific
  integrity must be designed and submitted to ORI.
  Link
• http//ori.dhhs.gov/misconduct/cases/Okoro.shtml
  .

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Examples (continued)

• Former Vermont Professor Sentenced to Prison
  (6/29/06)
• Eric Poehlman, a former University of Vermont
  College of Medicine (UVM) professor, drew a
  one-year and one day prison term yesterday for
  fabricating data and making false statements
  related to his research studies. Poehlman will be
  the first researcher to serve prison time as a
  result of falsifying data in a grant application
  to the National Institutes of Health. In 2000, a
  research assistant began to question what
  appeared to be the addition of falsified data to
  the datasets Poehlman used. UVM launched an
  investigation after the research assistant filed
  a formal complaint. The university concluded that
  data had been falsified and turned the results
  over to the Office of Research Integrity and the
  Department of Justice. From approximately 1992 to
  2000, Poehlman was awarded NIH and Department of
  Agriculture grants worth 2.9 million those
  grant applications, the government found,
  included false and fabricated research. Link
  http//ori.dhhs.gov/.

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Examples (continued)

• ORI Finds Student Fabricated Data (12/21/06)
• Nicholas McMaster, an undergraduate biology
  student at the University of Chicago, was found
  to have engaged in research misconduct in
  connection with grants supported by the National
  Institute of Environmental Health Sciences and
  National Institute on Aging. McMaster was found
  to have fabricated data in research connected to
  the reproductive behavior of female rats.
  McMaster voluntarily agreed, for a period of
  three years beginning on Nov. 14, 2006, to
  exclude himself from serving in any advisory
  capacity to the Public Health Service, and he
  agreed to the requirement that any institution
  that submits an application for PHS support for a
  research project on which his participation is
  proposed or which uses him in any capacity on
  PHS-supported research, or that submits a report
  of PHS-funded research in which he is involved,
  must concurrently submit a plan for supervision
  of his duties to the funding agency for approval.
  Link
• www.ori.dhhs.gov/misconduct/cases/McMaster.shtml.